QMS for Laboratories Testing and Calibration ISO 17025

8/20/2019 QMS for Laboratories Testing and Calibration ISO 17025

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Prepared by the

(ISO/IEC 17025)

Caribbean Laboratory Accreditation Services (CLAS)

An European Union Funded Project

TESTING AND CALIBRATION

FOR LABORATORIES

GUIDANCE ON

QUALITY MANAGEMENT

November 2010 Edition 1

“Obstacles are what you see when you take your eyes off the goal”

SYSTEMS



Q UAL IT Y MANAGEMENT SYST EM GUIDANCE

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PREAMBLE

This document is a consolidation of information and resources on the process of Developing aQuality Management System for Testing Laboratories. Many resources were consulted in preparation of the guide, and therefore contributed to its completion. Laboratories shouldunderstand that there are many ways of accomplishing the goal of Accreditation and producing areliable output and therefore do not restrict themselves or their staff only to what pertains herein.

The development of this manual on “Quality Management systems for Laboratories” was supportedby the European Union through the 9th EDF Funded Caribbean Laboratory Accreditation ServicesProject implemented by the CARICOM Regional Organisation for Standards and Quality (CROSQ).

This guidance manual is not used for commercial purposes.

For further information, please contact :

CARICOM Regional Organisation for Standards and Quality (CROSQ)

2 nd Floor Nicholas House

29-30 Broad Street

Bridgetown

Barbados, W.I.www.crosq.org

[email protected]

Authors

Giselle Guevara, BSc., MPhil, MBAProject Coordinator 9th EDF Funded Caribbean Laboratory Accreditation Services Project (CLAS)CROSQBridgetownBarbados

Ing. Manfred Kindler Accreditation Expert and ConsultantKindler International DivisionBerlin, [email protected]




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This Manual is dedicated to my colleague and dear friendBertha Munguia

Acknowledgements

The Authors are most grateful to the several persons who provided support, very useful input, feedback andgave generously of their time in the development and production of this document. We especially wish tothank those colleagues who reviewed the Manual and paused in their busy schedule to provide incisivecomments, helpful tips and stimulating input. Thank you for everyone who provided examples and ideas forthe content of this manual, sometimes without even knowing you were helping.

We are truly thankful and wish to recognise the contributions of Valerie Wilson and Wendy Kitson-Piggott asTechnical Editors, Michael Seepersaud, CROSQ-IDB Project Manager for assisting with the manualpublication. Thanks to Manfred Kindler who provided useful technical information, invaluable feedback andassistance, in the preparation and compilation of this material.

We wish to thank CROSQ, the CARICOM Secretariat and the European Union funded CISP Project for theircontribution to the production of this guide. Preparation and Editing of this manual was a long and precisetask and we therefore wish to extend our special gratitude to all who assisted and facilitated the process.

Produced and Printed with support from the European Union under the 9 th EDF Fund




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Table of Contents

FOREWORD.......... .................... .................... ................... .................... .................... ................... .... 6

CHAPTER 1 LABORATORY QUALITY FUNDAMENTALS .................................................. 7

1.1

INTRODUCTION..................................................................................................... 7

1.2

QUALITY TERMS AND DEFINITIONS ..................................................................... 8

1.3

ACCREDITATION vs. CERTIFICATION ................................................................. 11

1.4 QUALITY MANAGEMENT SYSTEM ...................................................................... 13

1.5

DOCUMENT HIERARCHY .................................................................................... 14

1.6 A STEPWISE APPROACH TO DEVELOPING A QMS ............................................ 17

1.7

ACTION PLANNING USING THE MILESTONES .................................................... 20

1.8 CONTINUOUS QUALITY IMPROVEMENT ............................................................. 22

1.9

DOCUMENTATION PLAN..................................................................................... 29

CHAPTER 2 ELEMENTS OF THE QUALITY MANAGEMENT SYSTEM.............................. 35

2.1

THE QUALITY PLAN ............................................................................................ 35

2.2

STRUCTURING YOUR QUALITY MANAGEMENT SYSTEM ................................... 37

2.3

THE QUALITY POLICY STATEMENT .................................................................... 38

2.4

THE QUALITY MANUAL ....................................................................................... 39

2.5

DOCUMENT CONTROL ........................................................................................ 42

2.6

RECORDS ........................................................................................................... 46

CHAPTER 3 PROCEDURES ............................................................................................ 47

3.1

PROCEDURE MANUAL ........................................................................................ 47

3.2

OVERVIEW OF PROCEDURE WRITING ................................................................ 47

3.3

ADVICE FOR WRITING PROCEDURES ................................................................ 48

3.4 ADMINISTRATIVE PROCEDURE OUTLINE ........................................................... 49

3.5 OVERVIEW OF TECHNICAL PROCEDURES (SOPs) ............................................. 53

3.6 DOCUMENTATION CHECKLIST ........................................................................... 57

3.7 USE OF FLOW DIAGRAMS .................................................................................. 58

CHAPTER 4 FAQs in LABORATORY QUALITY ............................................................... 61

CHAPTER 5 APPENDICES.............................................................................................. 67

REFERENCE DOCUMENTS ............................................................................................ 85




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List of Figures

Figure 1 Summary of the Applic ation Process towards Accreditati on ....................................12

Figure 2 Process Approach to Laborato ry Quality Management..............................................13Figure 3 Document Hierarchy ......................................................................................................15

Figure 4 Implement ing a Quali ty Management System .............................................................16

Figure 5 The Twenty Milestones summarised ............................................................................18

Figure 6 Milestone 1: Quality Pol icies ........................................................................................20

Figure 7 Milestone 2: Managemen t.............................................................................................21

Figure 8 Example of Responsib ili ty Matrix for train ing .............................................................21

Figure 9 House of Acc redit ation ..................................................................................................17

Figure 10 The PDCA Model fo r QMS Impr ovement ....................................................................24

Figure 11 Example of a Quali ty Plan ...........................................................................................25

Figure 12 Diagram of QMS Process Ac tiv ities............................................................................28

Figure 13 Documentation plan .....................................................................................................29

Figure 14 Quality Plan Outl ine .....................................................................................................36

Figure 15 Doc umentat ion Status .................................................................................................38

Figure 16 Example of Table of Contents for Manual .................................................................41

Figure 17 Example of Quality Manual Amendment table...........................................................42

Figure 18 Example of Master list (Document cont rol log) .........................................................43

Figure 19 Example of Header/Footer combination.....................................................................44

Figure 20 Example of a Header ....................................................................................................44

Figure 21 Example of a Footer .....................................................................................................44

Figure 22 Examp le of Document c ont rol notes ..........................................................................45

Figure 23 Example Header/Footer with Document cont rol note ...............................................45Figure 24 Example of Record Managem ent Database ...............................................................46

Figure 25. The P’s of Procedure wr iti ng ......................................................................................48

Figure 26. Documentation Checkli st for the QMS Program ......................................................57

Figure 27 Flowchart ing Log ic ......................................................................................................59

Figure 28 Flowchart sym bols .......................................................................................................60

List of Appendices

Appendix 1 Summary of Clauses in ISO/IEC 17025 ............................................................. 67

Appendix 2 L ist o f Policies in ISO/IEC 17025

...................................................................... 70

Appendix 3 L ist o f Procedures in ISO/IEC 17025 ................................................................ 71

Appendix 4 L ist o f “ SHALLs” in ISO/IEC 17025

.................................................................. 73 Appendix 5 Document Control Check lis t ............................................................................ 78

Appendix 6 Examp le of a Flowchart

................................................................................... 79

Appendix 7 Check list fo r reviewing Qual ity Management System Implementation

............. 80




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FOREWORD

aboratory accreditation is a formal process that recognizes the technical competence of a laboratory toperform specific tests or calibrations. Accreditation requires laboratories to maintain a documentedquality management system (QMS) and personnel who are qualified and authorized to perform tasks

related to the scope of accreditation. The added value of accreditation far outweighs the necessaryinvestment in human resources, finances and time, since it is an independent method of monitoringlaboratory competence and performance, and assures the validity of results disseminated to users.

One very critical benefit of laboratory accreditation is that it provides assurance to trading partners that anexporting country is competent to test or inspect to the trading partners’ requirements, while at the sametime addressing and assuring compliance with the World Trade Organisation’s (WTO) Technical Barriers toTrade (TBT) Agreement.

The CLAS PROJECT (2008-2010) has sought to develop a framework that would facilitate co-ordination ofregional laboratory accreditation in a manner that would leverage regional capacity and harmonize

accreditation processes and procedures used across the Caribbean region while also addressing the needfor regional accreditation services to be cost-effective and internationally accepted. It was envisioned thatCLAS would create a platform for:

• Strengthening regional communication through providing a mechanism for negotiation and

consensus building

• Building the relevant human resource capacity

• Forging strong linkages and relationships among regional stakeholders

• Enabling the smaller countries of the region to participate in and more easily access expertise and

services to support their accreditation efforts.

Overall it strengthened and improved regional capacity for the continued functioning of the Laboratory

Accreditation infrastructure. More specifically, CLAS provided:

• Assistance and support for the coordination of activities of the national accreditation bodies in the

region, aimed at avoiding duplication and promoting transfer of knowledge; and ensuring an

internationally recognized accreditation infrastructure in the Caribbean;

• Interaction among the National Accreditation Focal points (NAFPs) for multiplication of benefits;

• Access to international expertise by the NAFPs;

• Access to proficiency testing programs by the NAFPs;

• Access to training programs for Labs and Assessors;

•A structure to uphold the principles of Cross frontier Accreditation (ILAC G21) and ensure that

confidence in the Caribbean Accreditation infrastructure is not eroded by extra-regional

Accreditation Bodies.

This manual has been developed to support the development of laboratory quality management systems inregional laboratories and to build regional capacity to meet accreditation requirements.

L




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CHAPTER 1 LABORATORY QUALITY FUNDAMENTALS

1.1 INTRODUCTION

The International Standards ‘ISO/IEC 17025 - General Requirements for the Competence ofTesting and Calibration Laboratories’ and ‘ISO 15189 – Medical Laboratories – ParticularRequirements for Quality and Competence’ both respectively state that a laboratory shall establish,implement and maintain a quality system appropriate to the scope of its activities including thetype, range and volume of testing and/or calibration activities it undertakes

Laboratory Accreditation is the formal recognition of a laboratory’s technical competency toperform specific tests, types of tests or calibrations. ISO/IEC 17025 and ISO 151891 requirementsare recognised internationally as defining and incorporating essential elements of a quality

management system for laboratories (ref: Appendix 1). The requirements for each stage of thequality improvement process are described in the various clauses of the ISO/IEC 17025 and ISO151892. Achieving compliance with the ISO/IEC 17025 and/or ISO 15189 Standard can beachieved in a stepwise manner that ensures efficient use of resources.

Essential components of these standards include the following:

• A laboratory that operates within a Quality Management System (QMS) will have asingle QUALITY MANUAL (ref: Section 2.4) hereafter referred to as ‘the Manual’, thatcontains the documented policies for the laboratory and either includes or refers to theprocesses, procedures and forms used by laboratory staff to implement the QMSthroughout all the disciplines in the laboratory.

• A laboratory shall periodically and in accordance with a predetermined schedule andprocedure, conduct internal audits of its activities to verify that its operations continueto comply with the requirements of the quality system and the Standard (ISO17025/15189 clause 4.14).

Some laboratories have significant gaps in the required QMS documentation and as suchimplementation of the QMS can at first appear to be a daunting task. However, if everyone in thelaboratory can be motivated and involved the task usually becomes easier. The Manual not onlyserves as a guide for laboratory quality improvement but can also serve as a training manual fornew and existing staff because it outlines all the processes and procedures that must be executedin the laboratory. Additionally, by describing all of the laboratory’s processes and procedures, theManual allows laboratory staff to accurately identify the resources required for the laboratory’s

operations.

1 This document references the ISO/IEC 17025:2005 –General Requirements for the competence of Testingand Calibration Laboratories2 Please note that wherever “Clause” is mentioned in this document, it refers to a Clause of the ISO/IEC17025 Standard




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In designing a quality plan (Figures 11 & 14), the laboratory establishes clear quality objectives thatensure compliance with requirements of relevant regulatory authorities, clients and/or accreditation

bodies. The quality plan is intended to ensure that implementation of the QMS is efficient and cost-effective.

The guidelines given in this publication are of a general nature. The complexity of a QMS dependson the size, scope and organizational structure of the laboratory and many of the processes andprocedures described in this publication can be implemented in a simplified manner.

In order to master the process of Quality Management System implementation you must firstunderstand some related key concepts and definitions. These are described in the followingsection.

Note

Essential areas of focus in your QMS include: org anisation, personnel, equipment, purchasing and inventory,

process control, documents and records, information management, occurrence management, internal andexternal assessment, process improvement, facilities and safety, customer service

1.2 QUALITY TERMS AND DEFINITIONS

a. Quality Management System A program developed to support efficient and effective, high quality and appropriatelaboratory services (e.g. accurate and precise results, appropriate test selection, timelyreporting, and correct interpretation of results, clinical usefulness, and recommendations forfurther tests).

Comprehensive and coordinated efforts (policies, processes and procedures) designed tomeet quality objectives, to direct and control an organization with regard to quality. Thesystem is comprised of the Quality Manual (Quality Policy, General policies, OrganisationalChart, etc), Administrative Procedures, Technical Procedures and Technical and QualityRecords.

b. PolicyStatement describing what is done and why.

c. ProcessSeries of inter-related steps involved in an activity or examination that uses resources and is

managed to transform inputs into outputs. Processes may often be linked since the outputof one process is often the input to the next. Rarely is there a process that is not linked tosome other.




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d . ProcedureWritten work instructions that specify the way to carry out a step in the process, an activity or

examination. Procedures describe in detail exactly how one individual should perform anactivity.

e. Record Any information that produces evidence (e.g. requisitions, examination results and reports,instrument printouts, laboratory workbooks and worksheets, accession records, calibrationrecords, quality control records, records of audits, complaints and action taken, externalquality assessment records, instrument maintenance records, incident/accident reports, stafftraining and competency records, personnel records).

f.Document Any information that provides information (e.g. instructions including policy statements,textbooks, reference intervals and their origins, procedures, specifications, calibration tables,charts, posters, notices, memoranda, plans, software, drawings, regulations and standards).

g. Document ControlIs a system to regulate the handling and management (including archiving, storing anddestruction) of documents containing information that communicates policies, processes,procedures as well as records. Usually pertains to documents that are part of the qualitymanagement system

h. AuditSystematic and independent examination to determine whether quality activities and relatedresults comply with planned arrangements and whether these arrangements areimplemented effectively and are suitable to achieve the objectives.

Note: In this document the term “Internal Audit” is used to emphasize that the audit is doneby the organization itself

i. Audit scopeThe extent and boundaries of an audit. Usually established before the audit process begins

j. Audi t p lanDescription of the activities and arrangements for an audit

k. Management review A formal evaluation by top management of the status and adequacy of the quality system in

relation to quality policy and objectives

l. Quality managementThat aspect of the overall management function that determines and implements the qualitypolicy




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m. Quality manager

The staff member (by whatever title) who has responsibility for the laboratory’s qualitysystem, its development, maintenance and ensuing implementation and who, in thiscapacity, reports directly to top management.

n. Qual ity audi tor Person qualified to perform quality audits

o. Observat ion A statement of fact made during an audit and substantiated by objective evidence.

p. Objective evidenceQualitative or quantitative information, records or statements of fact pertaining to the qualityof an item or service or to the existence and implementation of a quality system element,which is based on observation, measurement or test and which can be verified.

q. Audit f indingsResults of the evaluation of the collected audit evidence against specified audit criteria.

r.NonconformityThe non fulfillment of specified requirements.

s. Corrective Action An action taken to eliminate the causes of an existing nonconformity, defect or otherundesirable situation, to prevent recurrence

t.Preventive Action An action taken to eliminate the cause of a potentially undesirable result

u. Continuous Quality ImprovementThe use of incremental and breakthrough quality management techniques to constantlyimprove processes, products, or services provided to internal and external customers andthus achieve higher levels of customer satisfaction

v. Quality Improvement Plan A written description of the organization’s quality improvement program that has beenapproved by the management and is then periodically reviewed and updated, as necessary.




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1.3 ACCREDITATION vs. CERTIFICATION

Laboratory accreditation requires the use of criteria specifically developed to determine technicalcompetence. These criteria are based on the international standards ISO/IEC 17025 and ISO15189, for Testing/Calibration and Medical Laboratories respectively. Accreditation bodies,through specialist technical assessors, use these standards to conduct a thorough evaluation of allfactors relevant to the laboratory’s competence and aim to ensure the laboratory’s test data areaccurate and reliable.

The ISO 9001 standard is widely used in manufacturing and service organizations to evaluate theirsystem for managing the quality of their product or service. The ISO 9001, however, does NOTassess the technical competence of the organisation’s operations. This standard is thus used forcertification and cannot be used for accreditation of laboratories.

Note

While laboratories may be certified to ISO 9001, such certification does not make any statement about thetechnical competence of a laboratory as this standard does not contain technical requirements for laboratorypersonnel and operations 3

Why Is a Laboratory’s Technical Competence Critical?

Because it is important for laboratories to:

Minimise RiskIn the world today, customers seek reassurance that the products, materials or services theyproduce or purchase meet their expectations or conform to specific requirements. This often

means the product is sent to a laboratory to determine its characteristics against a standard or aspecification. For the manufacturer or supplier, choosing a competent laboratory minimizes therisk of producing or supplying a faulty product.

Avoid Expensive Retest ingTesting of products and materials can be expensive and time consuming, even when they are donecorrectly the first time. If not done correctly, then the cost and time involved can be even higher ifthe product has failed to meet specifications or expectations and re-testing is required. This cannegatively impact the reputation of a supplier or manufacturer. Additionally, the supplier can alsobe held liable for any failure of the product, particularly if it involves public safety or financial loss toa client. Choosing a competent laboratory thus minimises the chance of retesting being required,increase in operational costs and/or exposure to legal action.

3 See ISO CASCO Communiqué on Accreditation vs. Certification and ILAC Publication on LaboratoryAccreditation or ISO 9001 Certification (www.ilac.org.tt)




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How does a Laboratory Apply for Accreditation?

Figure 1 summarises the steps in the accreditation process from the pre-audit visit to the finalaward of the accreditation certificate.

Figure 1 Summary of the Application Process towards Accreditation

Accreditation Body Pre-AuditExternal Audit by pre-Assessment Visit with Experts from

Accreditation BodyCorrective actions completed

Accreditation Body Document Review – On-siteVisit

Review of Documents forwarded by laboratory previouslyOn site Assessment by Assessor team

Laboratory Corrective Actions

Cause Analysis – identify the source of Non conformancesand Confirm Corrective Actions

Application to Accreditation BodyComplete Application process for Accreditation to ISO/IEC

17025

Accreditation

Accreditation Body -Vote on Accreditation DecisionLab - Receipt of Accreditation Certificate




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1.4 QUALITY MANAGEMENT SYSTEM

Laboratory management, tasked with the responsibility for developing the QMS, must define thepolicies under which the laboratory will operate. These policies are operationalised by defining theprocesses and procedures (specific actions) that describe what must be done to implement thepolicies (Appendix 2). Many laboratories may already be adhering to the best technical andmanagement practices and may only need to now document these practices. Some laboratoriesmay already have all or most of the documentation they need and all that is required is collation,rationalization, and organization of the existing documentation with possibly some additionaldocumentation of the general administrative procedures (e.g. document control, purchasing ofsupplies, retention of records, etc).

What is a Quality Management System (QMS)?

The procedures (activities, mechanisms, actions) that a laboratory uses to achieve and

demonstrate control over its system constitute the Quality Management System (QMS). EveryQMS is driven by an overarching quality policy (philosophy) from which a series of connectedprocesses and procedures are derived. These define the resources needed to provide the desiredlaboratory outputs. The QMS outlines the inputs needed to produce the desired laboratory outputsas well as the processes and procedures that transform these inputs into outputs. The laboratory’sinput-output relationships are thus connected through the laboratory’s processes and proceduresand collectively shape the laboratory’s quality system (Figure 2).

The decision to implement a QMS has to be made by top management since management’scommitment is essential for the implementation and successful maintenance of the system. Thedesign and implementation of a QMS will vary depending on the type, size and output of thelaboratory with each one having its own objective. The QMS is often designed to align with the

requirements of an international standard. For laboratories, the standard commonly used is eitherthe ISO 17025 or ISO 15189.

Figure 2 Process Approach to Laboratory Quality Management

Personnel

Environment

Methods

Equipment

Materials

Criticalprocess

necessary toprovidereliableoutput

Product orService

Satisfied orDissatisfied

INPUT

Measures of performance (Time, quantity,

quality)

OUTPUTInternal or

External

Customer

PROCESS




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What are Quality Objectives?

In order for a QMS to be effective, its quality objectives must be clearly defined and must reflect thelaboratory’s overall service objectives. Objectives must also be practical, able to be regularlyreviewed and measured for effectiveness. All laboratory staff must be familiarized with thesequality objectives. Ongoing adjustments must be made to reflect major changes to the laboratoryand its practices.

What are Quality Documents?

A QMS consists of documented policies, processes and procedures for establishment and effectiveimplementation of the system, as well as records to provide evidence that the system is incompliance. Key documents include the Quality Manual (which includes the quality policy orphilosophy of the laboratory and general policies); administrative and technical procedures(specific work instructions), Test Methods (SOP’s), and technical and quality records (proof).

1.5 DOCUMENT HIERARCHY

Figure 3 illustrates a typical document hierarchy. It shows that the laboratory must first establishthe Quality Policy (philosophy) for the organization, followed by the development of the moregeneral policies that reflect the overarching goals for every area of the laboratory’s operations (alist of policies from ISO/IEC 17025 are referenced at Appendix 2). Although very important, thesepolicies can be stated in a relatively simple way.

Administrative or operational processes and procedures that your organization performs to achievethe goals or objectives expressed in the quality policies are then developed in addition to thedocumentation of technical procedures that describe the specific analytical work performed in your

laboratory. These documents outline “how” you do things in your laboratory.

Finally the document hierarchy includes all the forms and records that are used to document theresults and activities of day-to-day operations. Records can be classified as either Quality orTechnical records, and as such the retention times and instructions for archiving both categoriesshould be documented. It is these records that are used as documented evidence of the work andrepresent the proof of compliance with the standard’s requirements. All of these documentscollectively comprise the laboratory’s QMS documentation.

The laboratory’s safety management system, which will include policies, procedures and records,can also be integrated into the Quality Management system.




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Figure 3 Document Hierarchy

What are the Benefits of a QMS?

• Increases operational efficiency and productivity

• Provides a system to enable control of all processes

• Reduces costs and risks/errors

• Provides ability to identify improvement opportunities

• Provides employee participation and motivation of human resources

• Increases customer satisfaction

• Allows effective and efficient use of resources

•

Provides flexibility and ability to respond to market opportunities• Increases competitiveness and industry reputation

Implementing a Quality Management System –who does what?

Successfully implementing a laboratory QMS needs careful planning, detailed identification of tasksand clear guidance on the roles and responsibilities of the key stakeholders. Figure 4 details thecritical roles and responsibilities of management, the quality manager and the quality team.




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Figure 4 Implementing a Quality Management System

Responsibility Tasks

Management

• Set objectives and goals of the QMS

• Appoint a Qual it y Manager (QM) or Quali ty Team (QT)

• Set tim elines and project scope

to develop and maintainthe QMS

• All ocate resourc es requi red fo r t he development, i mpl ementatio n and on-go ingmanagement of the system

• Inform all staff and seek participation from all l evels

Management/QM/QT

• Decide if a consultant is required for the project

• Prepare a project plan an allocate resources

• Develop a budget based on equipment, tr aining, time and personnel required

• Seek approval from management to procure required resources and executetraining

QM/QT

• Assess metho d fo r do cumenting t he QMS

•

Design templates and documentation• Set tim elines for the various tasks

• Schedule individual departments and positions for development of policies andprocedures

QM/QT/Management

• Develop QMS policies to reflect laboratory objectives

• Start to develop procedures and work instructions (SOPs) with eachdepartment

• Report to management any risks and improvement opportunities that havebeen found

• Document any Quality Corrective Action Requests that might be identified(identified risk areas that r equire management attention and impro vements)

Management • App rov e and issue the QMS

• Operate the QMS for a minimum period of 3 months

QM/QT

• Carry out initial audits to ensure documentation matches processes

•

Ensure that “you do what you say you do”. If any deficiencies are foundchange processes or QMS to r eflect what is actually done

• Assess t he eff ecti veness of the QMS and implement any changes that m igh t berequired.

Management

• Undertake management review of the QMS

• Adj ust resource requ irements

• Decide if accreditation assessment is required

• Set accreditation assessment timelines

• Appoint Accredi tati on Body

QM/QT/Management

• Continue to audit, review and assess the QMS at the agreed time intervals

• Continue to assess risk areas and identify improvement opportunit ies

• Continue to review policies and p rocedures and make amendments as required

• Continue to measure effectiveness of QMS to the overall laboratoryperformance

The ISO standards mention “shall” where it requires the laboratory to perform an activity withoutquestion (i.e. all requirements that begin with shall are mandatory). Additionally, it mentionsPolicy and Procedure wherever one of these documents is required. Where it does not require adocumented procedure, the standard may ask that the laboratory implement an activity.




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Naturally, if an activity is performed, records of its performance will be produced in a number ofdifferent ways. Probably you will find that the most difficult task in implementing your QMS is

ensuring that all these activities are documented in one form or another and the records can beretrieved when necessary.

Note

As stated in the standard, the establ ishment and effect ive implementat ion of the QMS Proceduresrequires them to be documented. Quality Management System documents may be kept in variousforms, such as written on paper, in electronic format, photographic, or in any other media

1.6 A STEPWISE APPROACH TO DEVELOPING A QMS

HOUSE OF ACCREDITATION

(Model developed by Manfred Kindler, Berlin, Germany)

The following diagram illustrates how the 20 milestones can be put together in a systematicpathway to achieve the desired endpoint, i.e. Accreditation for your laboratory. Let us picture ahouse in which the policies are the foundation of the house, and the walls are comprised of thedocuments and activities which make up the Management and Technical requirements of thestandard. The roof is the final pinnacle in the effort towards the achievement of accreditation. Thehouse is complete only after each brick has been laid.

Figure 5 House of Accreditation




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THE 20 MILESTONES FOR TESTING LABORATORIES

(Model developed by Manfred Kindler, Berlin, Germany 4

Successful implementation of a QMS requires a structured and strategic approach. One suchapproach entitled ‘The Twenty Milestones to Accreditation” is outlined in Figure 6. Thesemilestones present a stepwise approach that can be used to develop and implement a QualityManagement System and represent the actions you would undertake prior to applying for Accreditation. The achievement of each milestone should signal the development and completionof that particular aspect of the QMS. A

)

timeline chart can be drawn using the milestones againstthe estimated time allocated to conducting the activities. As each is completed it can be ticked off(see example below).

Figure 6 The Twenty Milestones summarized

1. Policies

•

Legal status established• Quality policy developed and documented

• Quality goals agreed and documented

• Quality Indicators determined and documented

• General Policies developed and documented

• Quality Plan developed and documented

2. Managemen t

• Conflict of Interest Analysis conducted

• Commitments fr om Top Management

• Technical (testing s taff) responsibiliti es developed and documented

• Technical and Quality Responsibilities/Job Descriptions developed and doc umented

3. Scope• Descriptio n of Scope of tests for Accreditation

• Procedures/Equipment/Personnel identifi ed for test scope

• Inventory of all Requirements for testing do cumented

4. Qual i ty System

• Quality Manual Structure developed

• Continuous Quality Improvement plan developed

5. Pr ocedu res

• Admin ist rati ve Work Procedures developed and d ocumented

• Process for Control of Documents developed

• Records identif ied and filed

6. Tes t Methods

• Instructions f or Equipment operation documented

• Examinations documented

4 Kindler International Division – [email protected]




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7. Sampl ing

• Instructions for Pre-Analysis pr ocesses and procedures documented

• Sampling procedures developed, and Sampling pl an and processes documented

8. Review Requests, Tenders and Contracts

• Review Quality Manual

• Review Requests and Contracts

• Identify Process and procedures for Advisors

• Evaluation of Subcontracting laboratories

9. Qual it y Cont ro l

• Reference Methods developed and documented

• Internal and External Quality Control pro cesses established

10. Validation

• Verification Procedures developed and documented

• Validation o f new or modified Test Procedures documented

11. Work Conditions

• Accomm odat ion con dit ion s doc umented and mo nit ored

• Faciliti es evaluated for suitabilit y

• Work Environment monitored

12. Literature

• Review of current Standards

• Research current Scientific Literature

13. Traceability

• Check of Test Equipment

• Calibration of Equipment• Reference Materials purchased and used

14. Uncertainty

• Training in Estimation of Measurement Uncertainty

• Calculation of Uncertainties

15. Training

• Job Descriptions documented

• Plan and Implement Staff conti nuing education

16. Monitoring

• Monitoring System developed

• Internal Audit plan and Schedule developed

17. Internal Audit

• Training of Auditors

• Internal Audit conducted

• Aud it Report p repared and evaluated




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18. Complaints

• Complaint Management syst em implemented

• Root Cause Analysis procedure impl emented

•

Corrective Action pro cedure implemented• Preventive Acti on pro cedure implemented

19. Review Documents

• Internal Review of Quality Documentation (Final review)

• Review Manual, Procedures, Forms, Lists, Technical and Quality Records

20. Management Review

• Management Review conducted,

• Corrective Action pl an implemented

• Implementation and Control of Plan for Effectiveness

END OF THE SYSTEMS DEVELOPMENT PROCESS

1.7 ACTION PLANNING USING THE MILESTONES

Each of the twenty milestones can be broken down into the steps of an action plan, where eachaction must end in a tangible result. In Figures 7 and 8 that follow, Milestone 1 and 2, for example,are broken down into a series of 10 achievable steps with related laboratory and management staffresponsibilities. Each step yields a distinct result and responsibilities for achieving the result ateach step can be assigned to different persons. The responsibility matrix (Figure 9) can be used todetermine what each person’s role is at each step.

Figure 7 Milestone 1: Quality Policies

Step Action HL QM TM EP SEC Results1 Legal Status E P P P P (Company) Registration

2 Decide about Policy E P P P P Quality Policy

3 Define Objectives D E P P P List of Objectives

4 Determine Indicators D E P P P List of Indictors

5 Create monitoring lists D P E P P Monitoring Procedure

6 General managementPolicies

D E P P P Management policies

7 General Technical Policies E C D P P Technical Policies

8 Design Quality Plan E C P P P Quality Plan

9 Issue Quality Records C E P P P Quality Records

10 Quality Report C E P P I Report




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Figure 8 Milestone 2: Management

Step Action HL QM TM EP SEC Results1 Introduction Workshop D E P P P Agenda and Minutes

2 Conflict Analysis D E P P P Structure, Process,Outcome Analysis, RiskMatrix

3 Organisational Structure D E P P P Organisation Chart

4 Management Commitment D E P P P Commitments in writing

5 Clinical interpretationResponsibility

D P E P P List of Responsibilities

6 Technical Responsibility D P E P P List of Responsibilities

7 Quality Responsibility D E P P P List of Responsibilities

8 Job Descriptions D E P P P CVs, Job Descriptions

9 Final Check C E P P P Checklist10 Final Report C E P P I Milestones Report

Responsibili ty MatrixThe following matrix is very useful for highlighting the responsible persons and the necessaryactivities which must be performed in the normal conduct of daily operations for the laboratory.The matrix can be used on its own or integrated into a procedure to illustrate the responsibilitiesneeded for effective implementation

Figure 9 Example of Responsibility Matrix for training

Activi ty HL QM TM EP Secr Assessment of train ing needs D P E C

Creation of a training plan D E I P C

Interview of employees about training P P E C

Approv ing the t raining plan D/E I C I

Orientation o f new s taff D E P P I

Technical training and exchange of experiences (seminar,staff experiences)

D P E P P

Control of training activities D/E P C C

HL – Head of Lab E - ExecuteKey

QM – Quality Manager P - Perform/Develop activitiesTM – Technical Manager C – Cooperate/AssistEP – Employee D - DecideSec – Secretary I - Informed




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Staff competency is key to the quality of laboratory operations and thus the laboratory must alsoensure that the personnel they employ are:

• Trained

• Experienced and

• Evaluated (to competently perform the tests which the laboratory offers.)

To ensure that well-trained and competent personnel are recruited the laboratory must developprocedures which aim to:

• Establish criteria for recruitment of staff

• Develop appropriate job descriptions

• Ensure that relevant qualifications are included in job descriptions

• Develop orientation and continuing education programmes

Additionally, new and re-assigned staff must be properly supervised and trained before they areallowed to perform tests on client samples. Competency evaluations should be performed anddocumented. These records now serve as proof of the laboratory’s confidence in the staff’s abilityto perform testing independently. The laboratory can use several different techniques for evaluatingcompetence. These can include but are not limited to:

• Testing of unknown samples

• Testing using reference materials, and

• Testing of replicate samples

Up to date training records must also be kept to prove that ALL staff have undergone initialorientation, competency evaluation and participate regularly in continuing education. This caneasily be kept in a separate training file developed for each staff member (ISO/IEC 17025 Clause5.2 Personnel).

Repeat the action plan format for each of the milestones (Figure 6 The Twenty Milestones ) aboveand share it with staff. This can comprise the majority of the Lab’s quality plan, clearly outliningwhat is to be done and by whom.

1.8 CONTINUOUS QUALITY IMPROVEMENT

QUALITY SYSTEMS PLANNING

The ‘Continuous Quality Improvement’ process uses established incremental quality managementtechniques to constantly improve processes, products and/or services provided to internal and

external customers towards achieving higher levels of customer satisfaction.

Continual improvement of the laboratory, its staff, and facilities and of course the QMS is vital tothe success of a laboratory’s accreditation effort. A strong Quality Plan facilitates effectivecommunication with the parent organization, laboratory staff and clients about the laboratory’s




Page 23 of 85

quality goals and operations. The purpose statement may be generated by using goals orobjectives previously defined by the parent organization and/or the laboratory, for example, in

Strategic planning. This will give guidance to decision making as the Plan is developed andimplemented.

What is a Quality Improvement Plan?

A written description of the organization’s quality improvement program that has been approved bythe management and is then periodically reviewed and updated, as necessary.

What is a Purpose Statement?

A purpose statement will give guidance to the development and implementation of a quality plan.Quality principles previously defined by the parent organization and/or the laboratory in, forexample, a strategic plan, can provide a foundation for the formulation of a purpose statement.

How will a Quality Plan Benefit the Laboratory?

• It provides documentation of your commitment to quality improvement

• It enables your laboratory to more efficiently use the resources available

• It assists the staff and management to meet the requirements of accreditation bodies

How is a Quality Plan Developed?

There are several approaches to the development of quality plans, as there are for thedevelopment of business plans. Figure 10 below illustrates how the Plan-Do-Check-Act (PDCA)

quality improvement model is applicable to the laboratory’s quality planning and improvementprocess and Figure 11 goes even further to outline an example of a quality plan drawn up by alaboratory that is seeking to achieve accreditation.




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Figure 10 The PDCA Model fo r QMS Improvement

PLAN

Act ions Staffresponsible

Means ofVerification

Actions in Define Procedures

Theory Plan/Determine what will be done

How frequent?

Who is accountable?

DO

Actions in Initiate Activities in plan

Practice Perform processes

Gather data on performance

Execute training or improvement programsCHECK

Review Monitoring and evaluation of trends

and Who is responsible for summarizing, reviewingand reporting

Evaluation Report results to the Quality Committee

How will this activity be considered for thepurposes of detecting patterns of problems and

opportunities for improvement, undertakingquality interventions and corrective actions

ACT

Sustainable Identification of indicators

Actions The plan is modified as necessary

The process is implemented

A quality plan should clearly identify the laboratory’s overall quality goals and the purpose of thequality improvement effort. The plan should also detail the desired outcomes of the laboratory’squality initiative and the activities that must be undertaken if these outcomes are to be realized.Figure 11 outlines some of the outcomes and activities that a laboratory preparing for accreditationmay want to include in their quality plan.




Page 25 of 85

Figure 11 Example of a Quality Project Plan

Objectives Success Measures Verification Assumptions

Goal

Customers haveincreased confidenceand are satisfied withreliable services

Less Customercomplaints

Evaluation Record of customercomplaints

Customers are willing to continueworking with the organization

More requests forservices/products

Client request data Services offered meet thecustomers’ needs

Purpose

Laboratory achievesaccreditation

On site visitconducted by Accreditation

Assessors

Assessor report Lab pays Accreditation fees

Non conformancereport prepared withfindings of root cause

analysis

Non conformance report andsupporting records

Root cause analysis finds andeliminates non conformances

Outcomes

1)Accreditation action

plan prepared and

responsibilities

identified

Staff trained in QMS,20 Milestones, writing

documents

Quality system group trained andstaff sensitized

Action plan prepared andapproved

2) Quality Manual

written and approved

Quality Manual writtenaccording to ISO

Standard requirements

Approved and Issued QualityManual

Quality Manager appointed

3) SOPs wri tten and

implemented

Administrative and

Technical proceduremanuals prepared and

implemented

Approved and Issued Procedure

manuals

Consultant provides complete

documentation service

4) Internal Audits

performed

Audit program,schedule and reports

prepared annually

Internal Audit plan approved Internal Auditors trained

Inputs

Act iv it ies

Outcome 1: Accreditation Acti on plan prepared

How Who When Assumptions

Determine status of

QMS

Do lab self Assessment

QualityManager

First QMS actionplan prepared

Laboratory can getManagement commitment to

processArrange training of

staff

Do training needs

Assessment

Executive

Management

While preparing

action planAcquire standard and

determine scope

Purchase standard andreview testing scope

Management While preparingaction plan




Page 26 of 85

Outcome 2: Quality Manual written and approved


Perform a GAP

analysis

What do youhave?

Quality Manager First month of actionplan

Laboratory can getManagement commitment to

processPrepare report based

on findings

What do youneed?

Quality Manager Within two weeks ofGAP Analysis

Prepare RIPOF

Analysis for Quality

team

What ismissing?

Quality Manager Within two weeks ofGAP Analysis report

Outcome 3: SOPs writ ten and imp lemented


Fill in the GAPS

discovered in the

Gap analysis

Develop policies,

processes andprocedures

Quality working

group

At working group

sessions

Quality Manager has

sufficient knowledge to guideteam

Improve existingpolicies,

processes andprocedures

Quality systemsreview group

At QMS reviewmeetings

Write Quality Manual Prepare/obtaintemplate for

Quality Manual

Quality Manager After GAP Analysis

Develop policiesrequired by

standard andOrganization

Quality Manager At QMS Documentwriting meetings

List of policies prepared andavailable for use

Write Quality

Manual

Quality Manager At Document writing

meeting

Write QMS

Administrative

Procedures

Prepare templatefor SOPs

Quality Manager After GAP Analysis List of Procedures preparedand available for use

Distribute SOPTemplate

Quality Manager At QMS Documentwriting meetings

Write Administrativeprocedures as

needed

Personsresponsible for

executingprocedure

One procedure perweek at Document

writing meeting

Write QMS Test

Procedures

Prepare templatefor Test methods

Quality Manager After GAP Analysis Reference documentsavailable

Distribute

Template

Quality Manager At QMS Document

writing meetings

Write TestMethods as

needed

Personsresponsible for

procedure

One procedure perweek at Document

writing meeting

Develop record

Management system

Prepare masterlist of documents

Quality Manager Updated asprocedures are




Page 27 of 85

written

Outcome 4: Internal Audits performed


Review system for

compliance

Perform internalaudit

Trainer/QualityManager

After GAP Analysis Internal Audit team trained andexperienced

Evaluate system

routinely

Identifyopportunities for

continuousquality

improvement

Managementreview team

After internal Audit, After Management

review

Management team participatein meeting

Correct non

conformances

PrepareCorrectiveaction plan

Auditee andQuality Manager

After the Internal audit Non conformances are easy tosolve

A flowchart of the QMS implementation process helps to simplify and clarify the laboratory’splanning and quality improvement process. In Figure 12 below, key activities, functions, duties andresponsibilities critical to the QMS planning and implementation process are detailed.




Page 28 of 85

Figure 12 Diagram of QMS Process Activiti es

Clerical/AdministrativeFunctions

Staff functions/Responsibilities/DutiesClerical/administrative functionsTechnical functions, Management functionsQualit Mana er functions

Prepare lists ofReference laboratoriesQuality Control materialsSuppliers, Equipment

Staff Tests offered

Arrange filing forPackage insertsReagent certificatesReports

Other records

Activities:Purchase the standard (ISO 17025)Prepare staff orientation program, Assign computer accessPrepare a Safety plan (to include evacuation plan, fire andbiological hazards)Prepare an accident report formSet up housekeeping schedule and write procedures

Technical Functions:Compile list of tests done, Collect and compile technical proceduresReview technical procedures to ensure that they are appropriate and complete

Prepare equipment records using equipment list, maintenance plans

Managerial Functions:Review report format for conformance to standardPrepare waste disposal plans, Arrange laboratory securityDecide on the Quality Policy

Appoint a Laboratory Director; Appoint a Quality Manager (however named),Set Management review dates

Quality Manager Functions:Prepare audit plan, and audit report forms, train internal auditorsSet quality indicators e.g. turnaround timesReview technical procedures to ensure they are appropriate and completeDocument any missing (outstanding) proceduresSet Retention time for - Records, Sample storage




Page 29 of 85

1.9DOCUMENTATION PLAN

As described above, the ISO/IEC 17025 Standard require that the laboratory develop acomprehensive Quality Management System that controls the daily operations of the laboratorysupported by a considerable amount of documentation. Every clause in these standards hasspecific requirements in terms of the policies, procedures and records required to prove tomanagement, staff and clients that activities have been executed as needed. There are severalapproaches or tools used to facilitate a laboratory’s development of the QMS in preparation foraccreditation. One such tool is entitled ‘The Twenty Milestones to Accreditation”. This can be usedto define and track the documentation required for compliance with relevant standards. Figure 13summarizes the documents needed to meet the requirements of the ISO/IEC 17025 standard usingthe 20 Milestones tracking framework.

Figure 13 Documentation planPurpose: To facilitate the development of the Quality Management System by the Laboratory in preparationfor Accreditation

Milestone Clause # Docs required Action (Output)required

Records produced Status

1. Quality Policy 4.1, 4.2 Policies andprocedures 4.1.5c,

4.1.5d, 4.2.3

Write policies, prepareprocedures

Policy andProcedures

Legal Entity with Quality policy,Quality Goals and Quality

Indicators, General Policies

Companyregistration,

Quality Policystatement and Goals

(SMART),

Quality indicators

Register company,

Develop Quality Policystatement and QualityManual

Develop Quality Team,

Host team meeting andincorporate writing group

Registrationcertificate,

Quality Policystatement,

Indicator Monitoringtools

List of teammembers andmeeting minutes

2. Management 4.2, 5.1 4.2.5 (Program),5.1.1 Policy

Write policy andprocedure

Policy and procedure

Conflict of Interest Analysis andCommitments from Top

Management, Medical, Technicaland Quality Responsibilities/Job

Descriptions

Job DescriptionsQM & Deputies

Confidentialitystatements,

Application forRegistration

Organization Chart

Develop JobDescriptions, AppointQuality Manager,

Meeting with Ministry,

Develop or review OrgChart

Job Descriptions,

Signed Contracts,

Signed

ConfidentialityStatements

Meeting Minutes

Organization Chart




Page 30 of 85

3. Scope 5.2.10, 5.3.11,5.3.12, 5.3.13

Prepare procedures Procedures

Description of Scope(Procedures/Equipment/Personnel

and Analysis of all specificRequirements)

5.3, 5.4, 5.5,5.7

TechnicalProcedures, List ofEquipment, List of

authorizedpersonnel,

QC Requirements,

CompetencyEvaluation Forms

Revise procedures,decide on scope(selection of tests),Check Equipment andMaintenance records, Authorize personnel andperform competencyevaluation

Updated TechnicalProcedures

Validation records

Training andCompetency records

Equipment andMaintenance records

4. Quality System 4.2, 4.3,4.12

4.3, Policy andprocedures

Prepare policies andprocedures

Policies andProcedures

Quality Manual Structure,Continuous Quality Improvement

Quality Manual

CQI Plan

SOP for SOPs

Develop Quality Manual

Develop CQI Plan

Prepare safety program,waste disposal plan

Develop technicalrequirements

Quality Manual,

Plan forImprovements,

SOP,

Safety Manual

Disposal plan

5. Procedures 4.3.1, 4.3.2, 4.13.1,4.3.13

Prepare policy andprocedure

Policy andprocedures

Work Procedures /Control ofDocuments and Records

4.3, 4.13,5.5

Retention policy

Document controlprocedure

Document masterLog

Develop DocumentMaster log,

Develop retention policy,

Prepare Archive system,

Prepare Backup systemfor data, Develop recordmanagement system

Updated MasterDocument log,

Record managementprocedure, Retentionpolicy,

Data Backup

medium (CDs, etc),

6. Test Instructions 5.4, 5.4. Prepare policy andProcedures


Instructions for Equipment andProcedures

5.5 Equipment Records

TechnicalProcedures

Validation procedure

Develop log ofEquipment,

Document or referenceapplicable test methods,Prepare Maintenancelogs,

Perform methodvalidation,

Analyze QC data and

trends,Prepare reagent lists,

Execute training of staff

Equipment Records,

Technical Proceduremanual,

Maintenance andcalibration logs,

Validation procedure,

Validation records,

QC Data records,

Reagent lists,

Training records




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7. Sampling 5.4, 5.7, 5.8 5.4. 5.7, 5.8, 5.8, 5.8(Policies)

5.4, 5.8, 5.8, 5.8.(Procedures)

Prepare Policies andProcedures

Policies andProcedures

Instructions for collecting samplesand related

Primary samplecollection,

Sample collectionprocedure,

Result reports,

Prepare samplecollection instructions,

Prepare samplecollection procedure,

Perform Workflowanalysis,

sample collectioninstructions,

Sample collectionprocedure,

Result reports,

Corrective actionreports

8. Review Contracts 4.4, 4.5, 4.7 4.4.1, 4.5.1 Policyand Procedure

Prepare Policy andProcedure


Review Quality Manual, Requests,

Advisories, Contracts,Subcontracting labs

Contract review

procedureRequisition forms

Register ofSubcontracting labs

Perform contract review,

Evaluate referral labs,

Conduct meetings of labadvisors

Contract review

procedure,Contract reviewrecords,

Client contracts(requisitions)

Register ofSubcontracting labs,

Meeting Minutes

9. Quality Control 5.6

Reference Methods/Internal andExternal Quality Control

List of Referencematerials

QC Data,

PT reportsCorrective action

forms

Perform inventory ofreference materials,

Perform QC according

to requirements of testprocedures,

Monitor QC data,

Participate in PT,

Investigate bad PTresults, determine rootcause,

Do corrective actions

List of Referencematerials,

MSDS Sheets,

QC Data,PT Reports,

Root causeinvestigation,

Corrective Actionreports

10. Validation 5.5 5.5.1, 5.5.2 Prepare policy andprocedure


Verification and Validation of TestProcedures

Validationprocedures

Perform validationanalysis

Verify calibratedequipment

Validation procedure

Validation records(X, SD, CV, TE, etc)




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11. Work Conditions 5.2 5.2.4, 5.2.10 Prepare policy andprocedure


Accommodation, Facilities andWork Environment

Environmental logs,

Housekeepingprocedures,

Preventivemaintenanceprocedures,

Disaster mitigationprocedure

Perform environmentalmonitoring,

Perform preventivemaintenance,

Safety audit,

Facility improvementplan,

Ensure properarrangements forpossible disasters

Environmental logs,

Housekeepingprocedures,

Preventivemaintenanceprocedures,

Preventivemaintenancerecords,

Plan for facilityimprovement,

Disaster mitigationprocedure

12. Literature 4.3, 5.4, 5.5,5.8

4.3.1, 5.4.1,5.5.1,5.5.2

Check of current Standards and upto date Scientific Literature

Reference books(e.g. Journals, kitsinserts, instruction

manuals)

Ensure current andeffective examinationprocedures are in use,

Verify suitability ofreporting format,

Ensure proper documentcontrol,

Search scientificliterature on internet andlibrary,

Research innovations intechnology

Examinationprocedures,

Reporting format

13. Traceability (Calibration) 5.6, 5.5 5.6,3, 5.5.1 Prepare policy andprocedure


Check of Test Equipment(Calibration, Reference Materials)

Calibrationprocedures

Calibrationcertificates

List of Equipment

List of Referencematerials andstandards

Reference material

procedure

Prepare Calibration logs

Verifycalibration/referencematerials

Calibrate measuringdevices (test specific)

Produce secondaryreference materials,Prepare calibration

curves

Calibration logs

CalibrationCertificates

Certificate of Analysis, MSDS

Calibration curves

Secondary referencematerials procedure




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14. Measurement Uncertainty 5.4 5.4.6

Training in Estimation ofMeasurement Uncertainty Procedure forMeasurementuncertainty

Facilitate measurementuncertainty trainingcourses,

Calculate Measurementuncertainty, whereapplicable

Monitor QC data andanalyze,

Perform statistical Analysis on data

Procedure forMeasurementuncertainty,

Measurementuncertainty budget,

Statistical results andcalculations

15. Training 5.1 5.1.1, 5.1.8(Policies)

Prepare policies Policies

Job Descriptions, plan and

Implementation of Trainingprogramme for the Lab Staff

Job descriptions

Training planContinuingEducation plan

Competencyevaluation forms

Prepare Job

Descriptions,Determine criteria forselecting staff

Perform competencyevaluations

Job descriptions

Training planContinuingEducation plan

ContinuingEducation materials

16. Monitoring 4.14, 5.6,4.9, 4.12,

4.6

4.9.1, 4.9.2, 4.9.3,4.6.1 Policy and

Procedures

Prepare Policy andProcedures


Monitoring System and Internal Audit plan and Schedule

Procedure foridentifying nonconformities

Procedure forevaluating suppliers

Procedure forpurchase andverification ofsupplies andservices

Evaluate proceduresand testing process,

Appoint responsibleperson for dealing withnon conformities in

testing,

Design or obtaineffective InformationManagement system(e.g. LIS)

Evaluate all suppliers

Appoint person to verifypurchased items

Procedure foridentifying nonconformities,

Record of nonconformities,

Supplier evaluationProcedure,

Supplier evaluationregister,

Procedure forpurchase andverification ofsupplies andservices




Page 34 of 85

17. Internal Audit 4.14, 4.10,4.11

4.14.2, 4.10.1,4.11.2 Procedures

Prepare procedures Procedures

Training of Auditors and Internal Audit, Audit Report

Internal Auditprocedure

Corrective actionprocedure

Preventive actionprocedure

Select and Train internalauditors,

Prepare criteria for Auditors

Prepare internal Auditschedule

Conduct internal audits

Address all nonconformances, anddetermine root cause

Investigate opportunitiesfor Preventive action

Internal Auditprocedure, Internal Auditor criteria,

Training certificate,

Internal Auditschedule,

Internal Audit report,

Corrective actionprocedure,

Corrective actionreport,

Preventive actionprocedure and plan

18. Complaints 4.8 4.8 Policy andProcedure

Prepare policy andprocedure


Complaint Management, Cause Analysis, Corrective and

Preventive Actions

Resolution ofcomplaintsprocedure

Review complaints,

Investigate root cause,

Perform correctiveactions

Develop preventiveaction report

Feedback forms,Complaints forms,

Corrective actionreports,

Preventive actionreport

19. Review Documents 4.3, 4.13

Internal Review of Quality

Documentation (Manual,Procedures, Forms, Lists,

Technical and Quality Records)

Document control

procedure,Document Masterlog

Record retentionpolicy

Perform scheduled

reviews ofdocumentation asrequired,

Ensure obsoletedocuments are removedfrom general use andarchived

Updated procedures,

Updated documentmaster log

Record retentionpolicy,

List of obsoletedocuments

20. Management Review 4.15 Prepare procedure Procedure

Management Review, Corrective Action plan, Implementation and

Control of Effectiveness

Management reviewprocedure

Meeting documents(e.g. Agenda,reports, etc)

Determine date for MRand invite attendees,

Prepare reports forManagement review,

Execute MR,

Prepare Action plancoming out ofdiscussions

Management reviewprocedure

Meeting documents(e.g. Agenda,reports, etc)

Management reviewSchedule

Meeting minutes and Action plan




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CHAPTER 2ELEMENTSOF THE QUALITY MANAGEMENT SYSTEM

2.1 THE QUALITY PLAN

Developing a quality plan is comparable to developing a business plan. This plan will serve as thelaboratory’s blueprint for its quality management program and should outline the process anddetails used to meet your objectives. It constitutes a concrete statement of purpose whichfacilitates communication among the laboratory’s management, staff and clients and will giveguidance to effective decision making.

Requirements for effective quality program functioning:

• There is a written description of the quality program.

• The program is reviewed annually and modified as appropriate.

• A designated senior staff member is responsible for the quality program implementation.• Top management has substantial involvement and participates in quality improvement

activities.

• There is an active quality systems committee with a defined role, structure and function.

• The scope of the quality improvement program is comprehensive.

• The quality assessment process and improvement are systematic.

These requirements dictate that the following elements should be addressed in your quality

plan:

• The Quality Program’s purpose, scope, goals and objectives

• Completion of the quality management system’s structure including a description of rolesfor each staff member and function

• Description of the process to be used for gathering feedback and conducting satisfactionsurveys

• Description of the methods to be used for identifying non conformities, finding the rootcauses and performing corrective and preventive actions

• Development of a listing of the staff employed, tests performed and equipment used

• Creation of records for each instrument and a description of how the laboratory willreasonably ensure that its professionals are qualified to provide testing services tocustomers

• Identification of a mechanism to ensure that the Quality Systems Committee’s functioningis conducted in a manner that protects the confidentiality and impartiality of the laboratory’sclients

• Development of a process to be used by the Quality Systems Committee to present,

recommend and seek approval from management.• Development of a process to be used by the Quality Committee to report to the top

management and staff

Figure 14 provides a more detailed breakdown of the components to be considered in the processof developing and implementing your quality plan and program.




Page 36 of 85

A critical initial step is the formation of a laboratory team that involves staff and management in thequality improvement effort. Quantifying resources and devising strategies for mobilizing what’s

needed is also critical to the laboratory’s ultimate success. Identifying clear goals and objectives,conducting periodic audits and continually taking corrective action is fundamental to success.

Figure 14 Quality Plan Outline

WHAT ISThe POLICY The PLAN The PROGRAM

Document expressingmanagement’s commitment toQuality in the laboratory

The strategy for developingyour laboratory QualityManagement plan andprogram

The details and content ofyour Quality Managementsystem

A. Develop the Plan

1. Form a team (workers and management)2. Analyze firm’s compliance with the standard3. Review laboratory scope4. Develop Quality objectives goals5. Obtain senior management commitment6. Develop a budget7. Obtain necessary resources8. Develop rules, practices & procedures9. Get a professional review & evaluation10.Quality System Committee11. Decide on Responsibilities12. Set timelines for the various tasks

B. Develop the Program

1. Quality Policy Statement2. Develop Training, Orientation & Communication3. Assess method for documenting the QMS4. Design templates and documentation5. Develop QMS policies to reflect lab objectives6. Schedule individual departments and positionsfor development of policies and procedures7. Start to develop procedures (SOPs) with eachdepartment8. Report to management any risks andimprovement opportunities9. Document any Quality Corrective Action Requeststhat might be identified (identified risk areas thatrequire management attention and improvements)

C. Implement t he Program1. Decide if a consultant is required for the project2. Prepare a project plan an allocate resources3. Assess an appropriate budget based onequipment, training, time and personnel required4. Seek approval from management to procure

required resources and attend any training5. Instruct employees in their responsibilities6. Provide guidance and follow-up

D. Evaluate the Program1. Continue to audit, review and assess the QMS atthe agreed time intervals2. Continue to assess risk areas and identifyimprovement opportunities3. Continue to review policies and procedures and

make amendments as required4. Continue to measure effectiveness of QMS tolaboratory performance, review key elementsfrequently5. Identify weakness in the program6. Ensure deficiencies corrected promptly




Page 37 of 85

2.2 STRUCTURING YOUR QUALITY MANAGEMENT SYSTEM

The first step in the structuring of your quality management system is achieving consensus amongkey laboratory stakeholders - management & staff - on what processes and procedures are neededto support the policies required by the standard (Appendix 2). Responsibilities for the developmentof these documents should then be assigned. As each of these clauses is addressed, you shouldassess the extent of your laboratory’s compliance with the standard and seek the resourcesneeded to address the gaps and to fully comply. A periodic audit of progress towards the goal ofcompliance is helpful to ensure that resources continue to be focused on the most important gaps.

Note

There are clauses of the standard not requiring a writ ten policy or pr ocedure, but these must be fully compliedwith to ensure the efficiency and effectiveness of your syst em.

What should you include in documentation?

Efficient and effective documentation comprise the foundation of your QMS. The QMS itself mustinclude within its control all of the activities of the laboratory that influence or have the potentialto influence the validity of the test results or the satisfaction of clients. Hence some questions thatyou may ask are:

● If the activity were to be conducted incorrectly or inadequately would it impact theresult?

● Can this problem occur under reasonably foreseeable circumstances if it were notcontrolled within the QMS?

If the answer to any of the above questions is yes, the activity needs to be controlled within theQMS. Al l activities within the QMS need to be documented to ensure effective control over theactivity concerned. Staff must be familiar with documentation and all documents must be availablewhen needed, must be complete, effective, easy to use, and consistently used whenever required.

Note

The name of the organization should at least appear on the first page of all documents developed by thelaboratory.

The laboratory’s QMS documentation may include both internally and externally generateddocuments. For most laboratories, the QMS will include both documentation generated in thelaboratory (for example the quality manual, administrative procedures, quality plans, technicalprocedures, calibration procedures, reports, certificates), documentation used within the laboratory

but generated outside (for example contracts, requests, standards, specifications, clientcorrespondence), and records (for example worksheets, log books, environmental control records,training records, test reports). The status of a laboratory document at any point in time must berecorded and easily accessed. Figure 15 below illustrates the possible status of a document withinthe laboratory’s QMS.




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Figure 15 Documentation Status

2.3 THE QUALITY POLICY STATEMENT

The Quality Policy statement defines the laboratory’s overall philosophy with respect to quality andthe aim or expected outcomes from the Quality Management System (Clause 4.2.2 of the ISO17025). The Quality Policy statement is documented in the quality manual. This statement is usedto establish and reinforce the Management’s commitment to the quality effort. Quality must enjoy

the same high priority as the laboratory’s or parent organization's other major goals.

The policy should be Issued under the authority of the Laboratory Director Present in the quality manual Clearly stated in terms that are easily understood Posted in a conspicuous place and distributed and explained to all employees Followed by every employee, including senior management, in all work activities

Reviewed annually to keep it up-to-date and in tune with current activities of thelaboratory and with the latest legislation.




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2.4 THE QUALITY MANUAL

AN OVERVIEW The Quality Manual contains the laboratory’s quality policy and objectives. The Quality Manual alsoincludes policies (Appendix 2) and general information about the laboratory including the testingservices, lists of major equipment, an illustration of the organisational structure, outline ofresponsibilities and authority. Additionally, it should include how the elements of the QMS arecontrolled. (All clauses are not mandated by a policy).

The quality manual should be used to inform staff members about the policies, and clients aboutthe laboratory’s operation and structure. Confidential information need not be included. No formatis mandatory.

QUALITY MANUAL BASICS

The following should be considered when creating your quality manual:• It is the primary or foundation document of a quality management system and must

provide a thorough description of the quality management system and its policies

• The size usually ranges from 20-50 pages although this may vary depending on the sizeand scope of the laboratory and the amount of information included

The policy statement should be readily available to appropriate personnel shall be

concise and shall include the following:

1. the scope of service the laboratory intends to provide;2. the laboratory management’s statement of the laboratory’s standard of

service;3. the laboratory management's commitment to good professional practice and

to the quality of its testing and calibration in servicing its customers;4. the objectives and purpose of the quality management system related to

quality5. a requirement that all personnel concerned with testing and calibration

activities familiarize themselves with the quality documentation and implementthe policies and procedures at all times in their work;

6. the laboratory’s commitment to good professional practice, the quality of itsexaminations, and compliance with the quality management system;

7. the laboratory management’s commitment to compliance with thisInternational Standard and to continually improve the effectiveness of themanagement system.




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• It may include processes, but does not usually

• It will reference your laboratory’s supporting documentation: administrative and technicalprocedures, records, forms, charts, etc. Some of the supporting documentation could beincluded within the manual or as appendices

include any administrative and technicalprocedures. Procedures are referred to in the Quality Manual where appropriate (ref:

Chapter 2 Section 2.5 - Document control requirements)

• The Quality Manual should indicate where all documents are located (eg. ProcedureManual)

• It can be kept in either electronic or paper format

• It must be easy for authorized personnel to update and easy for staff to access.

• It is typically maintained and reviewed by a Quality Manager (however named)

STRUCTURE AND CONTENT OF THE QUALITY MANUAL

The exact format, structure and contents of the quality manual are at the discretion of eachlaboratory. You have the freedom to design your manual in keeping with your laboratory’s size andcomplexity. The manual must, however, address every clause contained in the standard ISO17025 or ISO 15189 unless the clause is not relevant to your laboratory (this is rarely the case). Ifyour manual format does not follow the layout/design of the standard then you should provide amatrix that cross references the standard’s clauses to the manual’s layout to facilitate ease of QMSimplementation and audits. In developing your quality manual content, remember that your qualitymanagement system must encompass all management activities, technical activities andprocesses relating to quality assurance. Organize the manual as you wish and at minimum includethe following:

Proper identification (title of document, organization name, page numbers)

A brief introduction (overview of the manual)

A description of the organization (name, address, brief history) A quality policy statement (Clause 4.2.2 ISO 17025)

General Policies (as required by ISO/IEC 17025)

Policies of the Parent Organisation (e.g. policy on cell phone use)

Figure 16 below illustrates the typical contents page of a Quality Manual.




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Figure 16 Example of Table of Contents for Manual

SectionNumber

Section Title ISO StandardCrossReference

Pagenumber

Introduction

Organisational Chart

Definitions/glossary of terms

Cross Reference table

Quality Policy Statement, Mission, Vision

General Organisational Policies

Personnel

Equipment

Purchasing and inventory

Process control, validation of processes,

Internal quality control and Proficiency testingDocuments and records

Information management

Investigation of non-conformities

Evaluation (includes the use of quality indicators andinternal audits)

Continual (process) improvement

Service and satisfaction

Facilities and safety

Note

Everyone in the laboratory must prov ide input into t he development of the Quality Manual, and it is essentialthat the entire staff is familiar with, and understands the contents of the Quality manual and its relateddocumentation

MAINTAINING THE QUALITY MANUAL

a. The quality manual shall be maintained current under the authority of an individual giventhis responsibility by laboratory management, this could be the quality manager(however named) (ISO/IEC 17025, clause 4.1.5)

b. All laboratory personnel shall be instructed on the use and application of the qualitymanual.

c. The quality manual should be reviewed, approved and updated regularly, at a minimumannually by the individual given this responsibility by top management.

d. All amendments to the manual must be authorised by agreed personnel. Figure 17 thatfollows outlines an example of a documented amendment table




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Figure 17 Example of Quality Manual Amendment table

REVISION NO. DATE OF CHANGE AUTHORISED BY PAGE AND TEXT AFFECTED

0 4/10/09 Quality Manager Initial Release

1 25/11/09 Quality Manager List of Tests amended Page 4

2

3

Note

This type of table reminds personnel to ensure that they are using the most up-to-date version of anydocument and can be placed at the front of the binder.

2.5 DOCUMENT CONTROL

OVERVIEW

Your quality manual and ALL documen ts

1. Laboratory management shall define, document and maintain procedures tocontrol documents and records. Documents and records may be maintained andstored on any appropriate medium that maintains its integrity (Paper or electronic).

in your QMS will be considered controlled documents(ref: Appendix 10–document control checklist). Changes to documents must be controlled toprevent irrelevant and unauthorised changes being introduced. The standard requires thatdocuments shall be reviewed and approved by the original reviewer(s) or by other authorized staffthoroughly conversant with the background information on which the original documents werebased. In order to ensure that documents can be issued and withdrawn efficiently and accurately, acontrol mechanism - such as a MASTER LIST - should be developed to record and identifydocuments, their revision status and the document location. Requirements for document controlare as follows (ref: ISO 17025 Clause 4.3):

2. Authorized documents shall be available at all locations where operationsessential to the effective functioning of the laboratory are performed (e.g. withineasy reach of the work areas in the laboratory).

3. All documents issued to laboratory personnel as part of the quality managementsystem shall be reviewed and approved for use by authorized personnel prior touse.

4. A MASTER LIST, also referred to as a DOCUMENT CONTROL LOG, thatidentifies the current valid revisions and their distribution, must be maintained. An

example of a master list is provided in Figure 18 below.




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Figure 18 Example of Master list (Document control log )

Documentnumber

Documentname

IssueDate

Editionno .

Preparedby

Approvedby

Revisionstatus

Revisiondate

Retentiontime

Issued to

ACME –P001

Documentcontrolprocedure

1/4/09 31/3/10 John Smith,SeniorTechnologist

5. Invalid or obsolete documents shall be promptly removed from all points of use, orotherwise assured against inadvertent use.

6. A retention period for out of date documents shall be identified (this is defined by the

country’s regulations or laboratory policy)7. Retained or archived out of date documents shall be appropriately identified to preventtheir inadvertent use (for example by labelling as obsolete)

8. Only currently authorized versions of appropriate documents must be available for activeuse at relevant locations.

ELECTRONIC DOCUMENTS

Electronic files comprise Quality System documents, data from tests, staff records, inventory filesand client information among others. These must be protected from unauthorised changes anddeletions. Password protection, administrator privileges and limited access to confidentialinformation are techniques that can be employed to ensure the protection of important electronicfiles.

DOCUMENT IDENTIFICATION

Unique identification numbers on documents should be easy to use, with a simple format followedthroughout the QMS and communicated to everyone involved in their use. An example of anumbering system follows:

All documents relevant to the quality management system shall have a unique identification,including:

a. Title (simple and relevant to the procedure)b. Edition and/or current revision date or revision number (e.g. Edn 1 Revision 2)c. Number of pages (e.g. Page 1 of 6)d. Authority for issue (not necessarily a signature, e.g. Authorised by…)

e. Location of documents (including electronic documents)

EXAMPLE OF A DOCUMENT IDENTIFICATION SYSTEM

The following is an example of a numbering system used by the GGMLab:GGMLAB–X-000P - Standard Operating Procedures (GGMLAB-P-001 series)R – Records (GGMLAB-R-001 series)




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T – Test method Documents (GGMLAB-T-001 series)E – Equipment instructions (E-001 series)

L – Lists (L-001 series)F – Forms (F-001 series)

EXAMPLES OF HEADERS AND FOOTERS

Figures 19-23 that follow present a variety of document identification examples including examplesof headers and footers that meet the standard’s requirements for document identification. Any ofthese can be adapted for your quality manual and related documentation in your QualityManagement System. Note that pagination can either be continuous or sectioned. Additionally,you should include a revision history for each individual policy and/or procedure as part of astandard header or footer. The revision history indicates the date when the document was lastreviewed and what the current version is. This ensures that all persons have the same version andobsolete versions of documents are not used in the laboratory.

Figure 19 Example of Header/Footer comb ination

Figure 20 Example of a Header

Section 1.0 Quality Manual Date Issued: 21/01/09 Page 1 of 1

Table of Contents Authorized by: Lab Manager

Revision 2 Approved by: Quality Manager

Figure 21 Example of a Footer

Prep Date: 05/11/10, Revision Date: 09/01/21 Quality manual Pg 1 of 42

Authority for Issue: Quality Manager

Header :Good Test Laboratories

QualityManual

Section 0.0TABLE OF CONTENTS

Page 1 of 1Revision date: Jan 31 2009

Footer :Prepared by

Approved bySenior TechnicianLab Manager

Issue Number Issue Date

2Jan 31, 2005




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CONTROLLED AND UNCONTROLLED DOCUMENTS

All documents in the QMS should have some label or mark indicating whether they are controlledunder the Document control system. Figures 22 and 23 below provide examples of acceptablecontrol labelling. If the document is no longer under the control of the person responsible forQuality or the document has left the supervision of that person it is considered to be uncontrolled.For example, a document sent to a person outside of the lab for review, for information, as aresource document, etc. This is applicable whether the QMS documents are in electronic or paperformat. If your quality manual and procedures are primarily electronic documents whereuncontrolled printed paper copies may exist, you can consider adding footers either electronicallyor you may use a coloured rubber stamp on the bottom of the printed pages to identify thesedocuments

Figure 22 Example of Document control notes

Figure 23 Example Header/Footer with Document control note

Header :

Good TestLaboratory

Quality Manual Section 5.1 Page 1 of 2

Status: Approved Title: Document and Record Management Policy Version 2.0Rev. Date: 2006/08/26

Footer:

Prepared by: Senior Technician Approved by: Lab Manager Effective Date: 2005/08/26

NOTE: This is a CONTROLLED document for internal use only. Any documents appearing in paper form are not controlled and should be checkedagainst the document (titled as above) on the file server prior to use.

Notice: The hard copy of this Document may be used for reference purposes only.

The on-line copy must be considered the current document

NOTE: This is a CONTROLLED Document, as are all management system files onthis server. Any documents appearing in paper form are not controlled and should bechecked against the server file version prior to use.




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2.6 RECORDS

The Standard requires that the Laboratory keep detailed records of all the activities it performs asproof that the activity has been completed, the data is correct or corrective actions have beenperformed to improve the process. Examples of laboratory records required by the QMS are datasheets, purchasing documents, training records, raw data from testing, sampling records andequipment maintenance records.

All records must be kept in a safe location that allows them to remain legible and easily accessibleand able to be disposed of in a manner that maintains confidentiality. A reasonable retention time,taking into account lab operations and storage options, should be established for each record. Anexample of an appropriate record management database is illustrated in Figure 24 below

Figure 24 Example of Record Management Database

Record Management Database

Name ofRecord

Type ofRecord

Datecreated

Retentiontime

Datedeleted

Back up Createdby

Enteredby

StorageLocation

Referenceno

Comments




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CHAPTER 3PROCEDURES

3.1 PROCEDURE MANUAL

It is suggested that the quality system procedures be compiled into a manual to instruct thoseinvolved in managing the process of transforming laboratory policies into laboratory outcomes i.e.who, what, when, where, why and how the policies and objectives expressed in the quality manualare to be addressed and achieved.

Your procedure manual outlines one or more procedures arising from the relevant policies laid outin the quality manual. These define how individuals or groups of people in the same or differentdepartments will work to meet management’s stated objectives for quality. The quality systemprocedures must address each requirement of the relevant clause of the standard andcollectively they will define the organisation’s administrative operation, from receiving an enquiry to

delivering a completed product or service.

Note

It should be noted that the procedures do not have to be assembled into a manual, but it is qui te likely that onemaster set will be in th e form of a manual, to facilitate control.

3.2 OVERVIEW OF PROCEDURE WRITING

Several procedures may be required in the conduct of any of the processes conducted in the labthat arise from the laboratory’s stated policies. If you do not have a written procedure, you maystart by simply writing down how you actually carry out the activity and then verify it works as you

have described. This outline may be prepared as a flow chart. Flow charting is a powerfultechnique for generating a description of processes and is usually a good way to start (ref: Section3.8). In documenting your administrative and technical procedures you may use the followingsteps:

Step 1 Produce an outline of the procedure which should simply list:I. What is done?II. When it is done?III. Who does it?IV. How is it done?

All other parts of the procedure can be included at a later time. This outline may be prepared as aflow chart.

Step 2 When the procedure outline has been prepared it must be reviewed by several personswho have to use it. The reviewers must check to make sure that the outline adequately describeswhat is being done.




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Step 3 Once the details of the procedure are listed, then the document should be reviewedfollowing the questioning technique to evaluate the efficiency of the procedure outlined in Figure 25

below.

Figure 25 The P’s of Procedure writing

Purpose Place Progression Person Process/Method

What is done?

What shoul d bedone?

Where is it done?

Where should it bedone?

When is it done?

When should it bedone?

Who does it?

Who should do it?

How is it done?

How should it bedone?

Why is it done? Why is it done there? Why is it done then? Why does thatperson do it?

Why is it done thatway?

What else might be

done?

Where else might it

be done?

When might it be

done?

Who else might do

it?

How else might it be

done?

Step 4 When the procedure has been reviewed and is found to be adequate, the team shouldproduce a draft procedure that is circulated for comment and, as well, should set and enforce adeadline for responses.

Step 5 Comments are reviewed, suggested changes made and the procedure can then be issuedfor use.

3.3 ADVICE FOR WRITING PROCEDURES

• Procedures are short documents and should not exceed three pages if possible. If theprocedure is too long it should be split into two separate procedures

• In each stage of a procedure each action should have a person responsible, e.g. Clerkcompletes

• Procedures should be written with

the request form

an eye to auditing

• Procedures should be written in simple direct language, long sentences or unfamiliarwords cause misunderstandings and misinterpretations

. At every point the question shouldbe asked. How do you prove this has been done?

• The language used should be precise, there is no room for interpretation of the meaning ofa word in a procedure

• Use verbs (active words) in the procedure description




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3.4 ADMINISTRATIVE PROCEDURE OUTLINE

For Administ rat ive Qual ity System Procedures, the following headings are applicable.3.4.1 Title

All procedures should have a title that clearly states the intent of the document. The title should beconcise and descriptive. E.g. “Procedure for Purchasing Supplies and Services.” Because aprocedure describes how to do something, the title should use direct language to declare what isbeing done to what. A procedure titled "Laboratory Equipment" is not descriptive of theprocedure's content; a more appropriate title would be, "Procedure for Purchasing of LaboratoryEquipment."

3.4.2 Purpose

This section would outline the intention of the document. If a procedure were being written forprocedure writing the section would read as follows:The purpose of this procedure is to define the steps to be taken in writing a procedure, to ensurethat all procedures written have been adequately reviewed and are consistent.

3.4.3 Scope

This section would outline the limits of applicability of the procedure. This section would indicatethe function, department or group to which the procedure is applicable.This procedure is applicable to all staff of the stores department and is to be applied to all newequipment delivered to the laboratory.

3.4.4 References

This section would list all the other documents referred to in the procedure or which have a bearingon the activity. These could be legislation, standards or associated procedures.

3.4.5 Definitions

This section would list definitions of all acronyms, initials and abbreviations. It would also listdefinitions of all words which have specific meaning in the context of the document.

3.4.6 Responsibil ity

This section would list persons with specific responsibilities under the procedure, Example:“The superintendent is responsible for reviewing all test data before incorporation into the testreport.”

3.4.7 Process/Methods (Actions)

This section would describe the details of the activity as laid out during the review steps above

(Section 3.2 Procedure Writing).

3.4.8 Documents Generated (Records)

This section would list the documents generated by the procedure.

End of Outline




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Example of an Adminis trative Procedure

Prepared By: Laboratory Technician Date: 2009.05.01

Reviewed By: Senior Laboratory Technician Date: 2009.05.30

Approved By: Quality Manager Date 2009.06.01

Title: Procedure for controlling Documents

Purpose

• To control all quality system documents (internally generated and from external sources).

• To identify changes made to documents including amendments by hand and electronically.

• To control documents maintained in computerized systems.

• To dispose of documents which are obsolete or irrelevant

Scope

This procedure applies to the Quality Manual, all Test Methods, Forms, Standards, Specifications,Work Instructions, Registers and Standard Operating Procedures (SOP’s).

The procedure ensures that: authorized editions of appropriate documents are available at all locations where

operations essential to the effective functioning of the laboratory are performed documents are periodically reviewed and where necessary revised to ensure continuing

suitability and compliance with applicable requirements invalid or obsolete documents are promptly removed from all points of issue or use to

assure against unintended use obsolete documents retained for either legal or knowledge preservation purposes are

suitably marked documents are uniquely identified

documents are approved and issued by authorized laboratory personnel

Definitions and Acronyms

Quality manual – a document stating the quality policy, quality system, and quality practices of anorganization

Standard operating procedure (SOP) – a document that specifies or describes how an activity isto be performed. It may include methods to be used and sequence of operations.

Test Methods – a document that specifies activities performed in the determination of analyze(s)in a specific test sample (s)

Responsibilities

Laboratory management ensures that this document control procedure is established, implementedand maintained. The Quality Manager/Laboratory supervisor/Senior Laboratory technicianoversees the day-to-day operations of document control. Laboratory technical personnel areresponsible for following this procedure in its entirety.




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Laboratory technical personnel include Quality Manager, Technical Manager, Laboratory ManagerLaboratory Supervisor, Senior Laboratory technician and Laboratory technician.

ProcedureNote – Documents in the QMS may consist of signs, flowcharts, pictures, drawings, sketches,forms, and numbered lists. Regardless of the format, all quality system documents must becontrolled through this procedureThe Quality Manager develops and reviews a master list of all controlled documents (LAB-P001)and circulates for comments to all staff.

Quality Manual:1. The Quality Manual is approved by the ACME Lab Director, who signs the master copy.2. Controlled hard copies are indicated by the “Controlled Copy” Number on the Title page of the

Manual.

Operating Procedures:1. Test methods and standard operating procedures are controlled documents with limited

distribution, and working copies are kept in three-ring binders. The Table of Contents includesall current procedures assigned to a given work area and the following information: the code and title of each procedure the revision number of each procedure the effective date of each procedure the issue date of each procedure review date – the date each procedure was last reviewed total number of pages

2. Unique codes are assigned for each procedure.3. Test methods are written with the following headings (as applicable): Scope Description of Test Items, Sample Identification, Holding Times Quantities to be Tested Materials and Equipment Required Physical Environmental Conditions Required Procedure Safety Measures Method for Data Analysis and Presentation Sensitivity, Quality Control Plan Reference Procedures Documents Generated Revision History

Appendix

4. SOPs are written with the following headings (as applicable): Purpose Scope Definitions and Acronyms




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Responsibility Materials Required

Procedure References Documents Generated Revision History Appendix

5. Procedures and Test Methods are prepared, reviewed by Laboratory technical staff authorizedby Quality Manager; copies are uniquely identified, and distributed to users, with a “ControlledCopy” Number on the title page.

Note – the issue date is the date the document was issued to the user for review. The effectivedate is the date the document is effectively in place and followed.

6. Obsolete master copies are archived for at least five (5) years. All other draft copies andobsolete versions are kept in LAB-OBS-07–Obsolete Document Folder.

7. The Quality Manager maintains the master copies of the current procedures.8. The master list of procedures includes:

Code, copy number title revision number review date status (current, obsolete)

Document Review:1. Quality manual is reviewed on an annual basis by the Quality Manager/Technical Manager.

Records are kept of this review and any changes made.2. Written Administrative procedures and Test Methods are reviewed on a biennial basis. The

reviewer makes a record of this review, any required changes, and forwards to the QualityManager.

Document Changes:If any changes are required for any Controlled Documents these are documented on the ChangeRequest Form outlining the description of the change and forwarded to the Quality Manager. Thisform is held as a record.

1. Changes to the Quality Manual, Test Method or a procedure require the same review andapproval by technical laboratory personnel who performed the original review and approval.

2. Changes are indicated by typewritten bold italic font to the revised area. The master list is

updated to reflect the changes in revision status and revision release date.3. Personnel affected by the issue of a revised procedure are informed in writing. Holders of

obsolete copies return them to the Quality Manager who ensures the updated version is placedin the manual. A list of obsolete quality manual sections and procedures is maintained.




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Amendments by Hand :

1. Where permitted, hand written amendments in ink are clearly marked, initialed, approvedby Laboratory Supervisor/Senior Laboratory technician and dated on all copies. Therelevant changes are made at the next revision of the document.

Computerized Documents:1. Electronic copies of documents are maintained under the authority of the Quality Manager.2. Access to electronic copies is password protected and changes are made and controlled by

Laboratory manager/Quality Manager/Laboratory Supervisor.3. Documents that are revised are maintained in a folder identified as current; the obsolete

version is moved to a folder identified as obsolete.4. Relevant personnel are informed of any amendment(s)

Documents Generated

Document Change request FormDocument Master List Approved master copies of Quality Manual and procedures

END OF EXAMPLE PROCEDURE

3.5 OVERVIEW OF TECHNICAL PROCEDURES (SOPs)

Technical procedures or Standard Operating Procedures (SOPs) describe or reference all activitiesnecessary to conducting tests and describe in detail how specific tests or calibrations areconducted. While it is not necessary to transcribe the contents of a kit insert or manufacturer’sprocedure manual once the documented format is appropriate, however, these documents mustform part of the controlled documentation of the laboratory and be numbered appropriately. SOPscould be presented as drawings, pictures, kit inserts, analytical methods and models. They mayoriginate within the organization, be provided by the customer or from international scientificreferences.

TECHNICAL PROCEDURE/SOP OUTLINE

A technical procedure must normally be supplemented by additional information. It can be written

in a very condensed form with considerable cross-referencing. For Technical Procedures, thefollowing headings may be applicable:




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3.5.1 Title

All Test Methods should have a title that clearly states the intent of the document. The title should

be concise and descriptive. E.g. “Determination of Calcium in drinking water”Because a procedure describes how to do something, the title should use direct language todeclare what is being done to what. A procedure titled "Maintenance Chemical Analyser" is notdescriptive of the procedure's content; a more appropriate title would be, "Preventive MaintenanceProcedure for the Photometer."

3.5.2 Principle of test

The scientific basis behind the reactions which occur in the test

3.5.3 Responsibil ity

Who is responsible for performing the work described? Who is responsible for reporting the work? Are there special training or certification requirements? i.e., who will be qualified to perform thework described?

3.5.4 Reagents and Media

The Method should include a list of the reagents or media used, which should include: List of required reagents and/or media, Reagent name or chemical formula Special safety requirements Step-by-step instructions for reagent or media preparation Degree of accuracy and any special handling instructions for measuring device QC of reagents or media (e.g., pH testing or visual assessment) Labelling requirements, including expiration, Storage requirements, including containers and

stability

Note

Only provide instructions for preparing reagents when the reagents are to be prepared each time theprocedure is performed

3.5.5 Equipment

Only include a list of equipment. Instructions for calibrations and maintenance are written asseparate procedures. They are only included in the technical procedure where they are performedeach time the procedure is done.

3.5.5.1 Procedures for equipment calibration should include the following: Schedule for performing the calibration – daily, weekly, monthly, semi-annually Schedule for performing calibration verifications (Assaying of calibration materials in the same

manner as patient samples to confirm that the calibration of the instrument, kit or test system

has remained stable throughout the laboratory’s reportable range for patient test results) Calibration material specifications, preparation and storage Source of the calibration material Step-by-step instructions for performing the calibration, including expected readings Troubleshooting guidelines Documentation methods and storage requirements for calibration data




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3.5.5.2 Procedures for equipment maintenance should i nclude the following:

Schedule for performing preventative maintenance – daily, weekly, monthly, semi-annually Step-by-step instructions for performing preventative maintenance or references to equipment

manuals containing instructions Troubleshooting guidelines Records for documenting results of maintenance

3.5.6 Supplies

The method should include a list of the supplies (consumables) used in performing the procedure.E.g., disposable pipettes, pipette tips

3.5.7 Sample Information

The analytic procedure should include the following information regarding the sample required: Sample type and source

Amount of sample required, including minimum requirements Acceptable collection containers Sample stability and storage requirements, Preservative/Additive Criteria for acceptable samples and follow-up action

3.5.8 Special Safety Precautions

This is included when ADDITIONAL safety requirements - beyond the basic handling of hazardousmaterials are necessary. They should include the following: Engineering controls (E.g., Use of Fume hood) Personal protective equipment (E.g., Respirators, gloves, face shields) Work practice controls (E.g., Beginning a step only after certain conditions have been met or

precautions have been taken)

3.5.9 Quality Control

Instructions for QC are usually written as separate procedures. They are only included in thetechnical procedure where they are performed eachQC procedures should include the following information:

time the procedure is done.

Type of QC material to be used Instructions for preparation and handling of control materials Frequency with which controls must be run, number of controls to use QC expected values and/or ranges Explanation of control criteria (E.g., Accept or reject runs or batch criteria) Corrective action, to be taken if controls do not meet the expected criteria Instructions for documentation of QC data Alternate QC measures (E.g. correlation)

3.5.10 Process/Method

Write in a step-wise fashion rather than lengthy paragraphs. Provide a COMPLETE listing of thesteps required to accomplish the analysis.




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3.5.11 Interpretation of Results

This section should include:

Comparison of the results to the expected values or to determine if the result is normal,abnormal, or indeterminate. Follow-up for indeterminate results Recognition of results that fall outside the reportable range, and reference back to the Method

Limitations section of the original procedure Recognition and follow-up of results that exceed critical limits

3.5.12 Calculations (Quantitative procedures )Quantitative analytic procedures should include the equations for calculations when they areapplicable to the test. Include: The full equation Step-by-step instructions to solve the equation, An example of how to solve the equationNormal Values (Where applicable)

Include a range of expected values for the test result, where necessary or applicable.Method Limitations

The limitations may be due to the method itself or interfering substances. Include the following: Analytic sensitivity and specificity Reportable range Appropriate dilutions or reporting measures if the reporting range is exceeded Interfering substances such as chemicals (E.g., Preservatives).Procedure Notes (Hints, special precautions, comments)

Insert appropriate comments which could include special hazards in performing the test. If specialreporting of results is required it should be noted in this section.

3.5.13 References

Procedures should include the references that were used as the source of the information, whenapplicable. References may originate from any of the following: Manufacturer’s product literature Text books Published standards and guidelines Laboratory policy manuals Applicable regulations

3.5.14 Related Documents

Reference (List) other related procedures, e.g. Procedure for cleaning glasswareRecords such as Forms used or data sheets produced

END OF PROCEDURE OUTLINE




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3.6 DOCUMENTATION CHECKLIST

The following checklist may be used to determine if you have developed the documents required for themost crucial portions of the QMS. At minimum these documents will assist your system implementation andensure effective operation of the laboratory on a daily basis.

Figure 26 Documentation Checklist for the QMS Program

Do you have documentation to prove that these things have been done?1. Policy Statement 8. Quality Control

The written policy statement has been: Yes No Yes No

Distributed to all employees Procedures have been established andimplemented for Quality control

Properly explained to all employees Trends are monitored and discordantresults are acted on

2. Responsibilities 9. TrainingQuality System responsibilities have beencommunicated to:

Yes No Training records are kept for: Yes No

Managers Professional training

Supervisors New worker orientation

Workers Continuing education

Subcontractors First Aid training

New managers have received a health andsafety orientation

All training sessions

3. Document control 10. Reporting & Investigating Accidents

Document control procedures are beingfollowed

Yes No Reports are kept for: Yes No

Critical injuries

Lost-time injuries

4. Purchasing o f Supplies Medical aid injuries

Yes No Property damageItems are inspected before use Accident investigat ions

Supplier Evaluations are performed Are Standard forms used

5. Non conformit ies 11. Internal Audits

Yes No Yes No

There are written procedures foridentifying and controlling NCs

Standard checklists are used

There are written procedures forperforming corrective actions

Planned audits are done as scheduled

Audit reports are kept

6. Examination/Test Procedures Deficiencies are corrected

Yes No

Examination/Test procedures have beenproperly documented

12. Management Review

Are available for use by relevantemployees

Management Reviews are done Yes No

The recommendations are answered and anaction plan effected




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7. Accommodation and Environmental condit ions

Yes No 13. Personnel

Environment suitable for testing Yes No

Proper housekeeping is performed Worker training records are kept

There are staff files/ records

3.7 USE OF FLOW DIAGRAMS

Flow charts are used to simplify a process by representing it in a diagrammatic fashion. They helpto clarify what outcomes are expected, and what should be done to provide better customer focusand satisfaction. This is accomplished with an illustration of the sequence of steps that areperformed to produce an output. The output can be a product, service, information or acombination of all three.

Many complex processes or procedures can best be illustrated by the use of flow diagrams.Wherever possible, diagrams can form part of documented procedures and be used to simplifycomplex text. It provides a simple mechanism for greater understanding of a process and betteridentification of areas of variability, redundancy and potential waste and is an essential aid todeveloping effective procedures.

You can prepare flowcharts for all processes and they can be used to identify the sequence ofactivities involved in a process and to identify where documented procedures are needed todescribe a given task. The following is a listing of common flow chart symbols:




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Figure 27 Flowcharting Logic

To construct aprocess flow chart L is t the s teps Sequencethe steps Drawappropriatesymbols

Sy stem Mo del Ch ec k fo rCompleteness

Determine theboundaries

Use a verb tostart the taskdescription

Use post-itnotes soyou canmove tasks

Start with thebasic symbols

Draw charts usingsystem (input–process-output)approach

Ensure documentcontrol is Included andcomplete, using title anddate for easy reference

Where does aprocess begin?

The flowchartcan either beless detailedwhen providingthe informationto understandthe general

process flow orbe very specificand detail everyfinite action anddecision

Do not drawarrows untillater

Input – useinformation basedupon people,machines,material, methodand environment

Where does aprocess end?

Process – useseries ofprocesses in stepsor parallel

Output – useoutcomes ordesired results

Finalise the

flowchart

Ask if this

process is beingrun the way itshould be

Are people

followingthe processas charted?

Do we have a

consensus?

Remove what is

redundant, addwhat is missing

Key to symbols:

• Ovals show input to start the process or output at the end of the process

• Boxes or rectangles show task or activity performed in the process

• Diamonds show points in the process, where yes/no questions are asked or a decision isrequired

• Arrows show process direction flow, usually there is only one arrow out of an activity box.If there is more than one arrow, a decision diamond is needed

• If there are feedback arrows, make sure the feedback loop is closed, i.e. it should take you

back to an input box.• Small circles are connectors from one page to another

• Flags contain a brief description of records generated while performing an action

Below are examples of the Flow chart symbols used in Quality Management. (See Appendix for example ofa flow chart)




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Figure 28 Flowchart symbols

task or activity performed in theprocess

Arrows show direction or the flowof the process

An oval is used to showthe input to start theprocess or the output atthe end of the process

A diamond showsthose points in theprocess where ayes/no question isasked or a decisionis required

YES

NO

There is usually only one arrowout of an activity. If there is morethan one arrow, you may need adecision diamond

An oval is used to showthe input to start theprocess or the output atthe end of the process

Make sure every feedbackloop is closed i.e. every pathtakes you back or ahead toanother activity




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CHAPTER 4 FAQs in LABORATORY QUALITY

What is Calibration?Calibration is the process of comparing a measuring instrument against a measurement standardto establish the relationship between the values indicated by the instrument and those of thestandard (standard in measurement is considered to be the reference base). The purpose ofcalibration is to eliminate or reduce bias in your measurement system relative to the referencebase. The calibration procedure compares an "unknown" or test item(s) or instrument withreference standards according to a specific algorithm.

Do all measuring instruments need to be calibrated? All measuring devices usually need to be calibrated - whether they are simple devices or state-of-the art systems - because certain characteristics change with time. There are situations where aninstrument need not be calibrated, for example where its readings are ‘for information only’ and

their accuracy has little or no impact on the test, product or service being provided.

How often should an instrument be calibrated?Calibration frequency can be established using manufacturer’s recommendations. In some cases,commercial calibration laboratories can suggest intervals for particular instruments. There are twomain considerations when determining the calibration frequency. Firstly, the instrument’sreproducibility should be taken into account - new devices should be calibrated frequently in orderto establish their reproducibility. Secondly, the required uncertainty of measurement should beassessed. If the instrument’s reproducibility is shown, by successive calibrations, to besubstantially better than the uncertainty required then the interval between calibrations can beextended. At the other extreme, where the instrument’s reproducibility approaches the uncertaintyneeded, the calibration intervals should be much shorter.

To provide confidence in the accuracy of calibration results, the measurement must showtraceability. This means that all results associated with a calibration – including those relating tothe calibration of the measurement standard used - must be traceable back to standards held at anational measurement institute, through an unbroken chain of comparisons and where each linkhas stated measurement uncertainties. In addition, it is important that appropriate equipment andprocedures are used in the calibration process, in that they are used by trained and authorizedpersonnel operating in an experimental environment.

Why perform calibrations?• To improve the measurement accuracy and reliability of the instrument• To reduce the number of end-products rejected because they are outside acceptable

tolerances• To provide products with reduced and more competitive tolerances, better reliability, and

access to quality-conscious markets• To minimize unnecessary rework and delays, resulting in customer dissatisfaction• To eliminate health and safety, legal and regulatory issues

§




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What is Traceability?Traceability is the property of the result of a measurement whereby it can be related to appropriate

measurement standards, generally international or national standards, through an unbroken chainof comparisons (traceability chain) in which all uncertainties are indicated. It should be noted thatthe instrument itself is not traceable, but the result produced by the instrument is! Traceabilityapplies to both physical and chemical measurements. The standard referred to is a materialmeasure, measuring instrument, reference material or measuring system that define, realize,conserve or reproduce a unit, or one or more values of a quantity to serve as a reference.

What is Traceability to in ternational standards?Representatives of seventeen nations signed the Metre Convention treaty which provided thefoundation for the establishment of the International System (SI) Units. Since then, nationalstandards laboratories have cooperated in the development of measurement standards that aretraceable to the SI.

The units of measurement with the highest accuracy are realized by international measurementstandards. The value of the international standard is usually determined by comparison of nationalstandards of the highest quality, or in the case of the kilogram by the mass of the InternationalPrototype. National measurement standards, maintained in a National Metrology Institute (NMI) arecompared with these international standards before they are used as a reference for calibration ofstandards of lower precision. Therefore it is possible to demonstrate an unbroken chain ofcomparisons that ends at a national standards body.

What is the tr aceability chain?It is a series of comparisons between the device under test to a reference. The final comparison inthe chain is made using the International System (SI) units as a reference. Each comparison is alink in the chain and the uncertainty of each comparison (link) must be known and documented.

NMIs provide the ultimate measurement references for their country. The intent of all NMIs is torealize the SI units as closely as possible so that traceability to the SI can be established bycomparing to an NMI that in turn compares its references to the SI.

SI UNITS

Primary National Standard

NMI

Secondary Standards

NMI

Working Standards NMI or other

Calibration of instrument




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What are the benefits of Traceability?

• Allows you to be competitive and operate in the global environment thus reducing technicalbarriers to trade

• It provides another way of guaranteeing a measurement’s accuracy.• It is an essential element of quality control systems

• It links people, organizations, documents, techniques and measurements within a large anddiverse measurement community

§

What is Measurement Uncertainty?Test or calibration measurements are subjected to imperfections in each step of the process – fromsampling to final measurement. Measurement uncertainty (also referred to as “uncertainty of ameasurement”) is the term used to describe this imperfection, and is defined as the parameter

associated with the result of a measurement, that defines the range of the values that couldreasonably be attributed to the measured quantity. This indicates the interval within which the truevalue of the quantity being measured is expected to lie with a stated level of confidence.

How is measurement uncertainty evaluated?Measurement uncertainty is evaluated by quantifying and combining a number of uncertaintycomponents, which can be:

• Random Effects – e.g., fluctuations in temperature, humidity, air-pressure, variability inperformance of the measurement, sampling.

• Systemic Effects – e.g., offset of measuring instruments, drift in its characteristics betweencalibrations, personal bias in reading an analogue scale or uncertainty of the value of areference standard.

The components are quantified either by evaluation of the results of several repeatedmeasurements, or by estimation based on data from records, previous measurements, knowledgeof the equipment and experience of the measurement. The evaluation from repeatedmeasurements is done by applying a mathematical formula derived from statistical theory. Theparameter determined is the standard uncertainty expressed as a standard deviation.Measurement uncertainty is usually written as an expanded uncertainty and provides an intervalwithin which the value of the measurand is believed to lie with a higher level of confidence. It isobtained by multiplying the combined standard uncertainty by a coverage factor (k); where k isbased on the level of confidence desired. For a level of confidence of 95%, k is 2.

Why is measurement uncertainty i mportant?• It provides laboratories and customers with valuable information about the accuracy and reliability

of test or calibration data.• It tells how well the results represent the value of the quantity being measured.• It gives confidence in comparability of results (which help to reduce barriers to trade).• It shows whether the result is within the acceptable limits or outside of it.• It is a requirement of ISO 17025:2005 (5.4.6).

§




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What is quality control (QC)?Quality control (QC) is an integral part of a laboratory’s operation. It is defined as the observation

techniques and activities used to fulfill requirements for quality. The control can be a substance,sample or procedure intended to verify performance characteristics of a system. QC should not beconfused with quality assurance (QA), which encompasses everything a laboratory does to assurehigh quality services to its customers.

Why establish a QC program?Your QC program should be a monitoring system that provides immediate information about theacceptability of results, as well as a method for evaluating data over time. Most control material isaccompanied by stated target values for the mean and standard deviations (S.D.). These statedvalues may be used if they correspond to the methodology and instrumentation employed by thelaboratory. If they are not provided, then calculate the parameters after a statistically significantnumber of control determinations have been completed (repetitions of 20 or more). Develop controlcharts using the mean and S.D. to record the results of the control. Establish criteria foracceptability, e.g. by applying Westgard rules to analyze the data. Also, develop policies andprocedures for remedial action for QC failures and apply them as needed to maintain accurate andreliable test results.

What to look for on QC charts?1. Excessive scatter – points are widely scattered above and below the mean. It shows poor

reproducibility of results. Common cause is operator variability in pipetting or inattention tocritical steps in the procedure.

2. Bias – majority of points fall either above or below the mean. The two most commoncauses are an error in calibration or an error in reconstituting a control material.

3. Drift or trend – QC results move away from the mean in a particular direction over anextended period of time. Causes are outdated reagents, deterioration in reagents or

instrument is losing its calibration.4. Shift – controls suddenly change from moving above and below the mean to a line that is

either always above the mean or always below the mean. Common causes are:recalibration was just performed; change in reagent lot; sudden deterioration of reagent(possibly not refrigerated overnight); new analyst; major change instrument performance.

What are the benefits of QC?• Demonstrates analytical capability of laboratory personnel.• Monitors the stability of test methods or systems.• Assesses the accuracy and precision of test results and test methods.• Alerts the analyst if there is a problem with the reagent, test method, or instrument.• Allows the laboratory to track the overall performance of a test procedure over time.

• Detects random and systemic errors.

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What is Method Validation?Method validation is defined as the confirmation, through the provision of objective evidence, that

the requirements for a specific intended use or application have been fulfilled. The aim is toestablish the operational limits and performance characteristics of a new, modified or otherwiseinadequately characterised test method.

When is Method Validation done?Test methods should be validated when:

• a new test method is being developed

• an established test method is modified

• QC indicates that an established method is changing with time

• demonstrating the equivalence between two methods, e.g. a new method and a standardmethod.

How is Method Validation done?The experiments used to determine method performance characteristics should be conducted withequipment that is within specification, working correctly and adequately calibrated. The analystcarrying out the experiments must be competent in the field of study and capable of makingappropriate decisions from the data produced during the study.

The following are common characteristics tested during method validation studies:

• Specificity/selectivity

•

– ability to accurately measure the analyte in the presence ofinterferences.

Linearity

•

- ability of an analytical method to produce test results which are proportional tothe concentration of analyte in samples within a given concentration range.

Accuracy

•

– closeness of the measured value to the true value for the sample.

Range

•

– the concentration interval over which acceptable accuracy, linearity and precisionare obtained.

Precision (Repeatability & Reproducibility)

•

– the amount of scatter in the results obtainedfrom multiple analyses of a homogeneous sample.

Detection Limit

•

– lowest concentration of the analyte that can be confidently detected bythe method.

Quantization Limit

•

– strictly the lowest concentration that can be determined with anacceptable level of repeatability, precision and trueness.

Robustness

•

– ability of the test method to remain unaffected by small but deliberatechanges, e.g. temperature.

Recovery – assesses the efficiency of the method in detecting all of the analyte present.

Why is Method Validation necessary?• To provide objective evidence that the results are accurate and reliable

• To demonstrate that a test method is “fit for purpose”

• Validation data can be used to design QC programs

§




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What is Verification?Test method verification is a simplified validation process employed to check or verify a test

method’s performance characteristics. It typically includes a subset of the parameters evaluatedwhen a complete validation is performed, and asks the question “Does this new test method perform to its specification in my laboratory?”

When is Verification done?It should be done before a new externally validated test method is employed by the laboratory toreport results.

How is Verification done?The laboratory should:

• Develop a clear, detailed verification procedure that defines the parameters to beevaluated.

•

Define and approve the acceptance criteria (e.g., manufacturer’s package insert) to beused in analyzing the results.

• Compare experimental results to the previously established performance characteristics.

• Based on the results, accept or reject the test method.

• Summarize the data collected from the verification study in a final report.

The following is the most common subset of characteristics used in verification studies:

Characteristics Analyzed Types of Experiments Performed

• Accuracy

•Precision

•Reportable range of test results for the

test method•Manufacturer’s reference intervals

(medical laboratories)

• Comparison of methods to estimate inaccuracy orbias

• Replication experiment to estimate imprecision

• Linearity type experiment to estimate imprecisionand to determine reportable range

• Collecting reference values to verify the establishedreference range

Why is Verification necessary?

• To provide objective evidence that your laboratory has the ability to achieve acceptableresults for a given test method.

• To prove that an externally validated test method is acceptable for its intended use.




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CHAPTER 5 APPENDICES

Appendix 1 Summary of Clauses in ISO/IEC 17025

General Requirements for Quality and Competence in Testing and Calibration Laboratories.

Following is a summary of its requirements:

MANAGEMENT REQUIREMENTS4.1 Organi zation

Laboratory management shall have responsibility for the design, implementation, maintenance andimprovement of the quality management system.

4.2 Management system (QMS)The QMS shall have all its procedures documented. It shall include internal quality control andparticipation in interlaboratory comparisons. A quality policy statement and a documented quality

manual are needed.

4.3 Document controlDefine, document and maintain procedures to control all documents and information. Define retentionperiods and archive documents for later reference.

4.4 Review of Request, tenders and contractsEnsure that all parties understand and abide by the provisions made in contracts. Keep records of allreviews, including significant changes and maintain these records.

4.5 Subcontracting of tests and calibrationsHave procedures for evaluation and selection of subcontracted laboratories and consultants. Maintaina register of all subcontractors used.

4.6 Purchasing External services and suppliesEnsure external services, equipment and consumable supplies consistently meet the laboratory’sstandards. Have an inventory control system and quality records of external commodities purchased.

4.7 Service to the cl ientClients shall be afforded consideration to verify their samples are appropriately handled and analyzed.Confidentiality shall be maintained.

4.8 Complaint sKeep records of any complaints or feedback and of investigations or corrective action taken by thelaboratory.

4.9 Identif ication and control of non-conformit ies

When a non-conformity is detected: a) Personnel must be designated for problem resolution; b)Corrective action must be defined and taken immediately; c) The deviation must be documented, andreviewed by staff.

4.10 ImprovementReview all procedures at regular intervals to identify any potential source of non-conformance. Actionplans must be developed, documented and implemented as appropriate.




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4.11 Corrective ActionCarry out investigations to determine the root causes of problems. Document and implement anychanges made to procedure. Review all procedures regularly and take action to improve the system.

4.12 Preventive ActionIdentify any necessary improvements and areas of non-conformities, either technical or concerningthe management system. Develop action plans and procedures to reduce the likelihood of potentialnon-conformities.

4.13 Control of recordsEstablish procedures for

• Identification

• Collecting, Indexing, Access

• Maintenance

• Safe disposal of quality and technical records

4.14 Internal AuditsFormally and periodically carry out internal audits to ensure that the QMS is maintained.

4.15Management reviewLaboratory management must periodically review the QMS to maintain and improve the system.Findings must be recorded and any corrective action needed must be taken immediately.

TECHNICAL REQUIREMENTS5.1 Gen eral5.2 Pers on nel

Define qualifications and duties for all personnel. Implement the Quality Management System (QMS)and procedures.

5.3 Accommodation and environmental condit ionsEnsure the facilities for examination allow for correct performance of tests and reliability of results.

5.4 Test and Calibration Methods and Method validationUse only relevant, validated, documented procedures which meet the needs of the users of thelaboratory’s services. Record any deviations or changes in procedure.

5.5 EquipmentProvide the laboratory with relevant, functioning and calibrated equipment. Ensure authorizedpersonnel operate equipment in a safe working environment.

5.6 Measurement TraceabilityThe laboratory must have documented evidence that measurements made by the laboratory can betraced to the International System of Units (SI). Calibration certificates issued by or to laboratoriesshall contain the measurement results, including the measurement uncertainty or a statement ofcompliance with an identified metrological specification.

5.7 Sam pl ingSampling plans should be based on sound statistical sampling techniques. The laboratory must besure that there is a good understanding and agreement between the customer and the laboratory as




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to how the sampling process is to be carried out. It must be properly documented and carried outaccording to an authorized sampling plan and its associated procedures.

5.8 Handling of Test and Calibration items Authorized personnel must review results and determine reliabili ty before releasing results. Disposalof samples must be in accordance with local standards.

5.9 Assuring the Quality of test and calibration resultsEstablish quality control methods to verify attainment of quality results. Document, record and retainrecords of results. Take action if results are suspected to be incorrect.

5.10 Reporting resultsResults must be reported legibly, unambiguously and in an identifiable manner. Use an audit log if thepresent reporting system cannot capture changes or alterations




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Appendix 2 List of Pol ic ies in ISO/IEC 17025

Policy Name (Description) ISO 17025Clause Number

Section in QualityManual

Done NotDone

For ensuring the protection of confidential information 4.1.5c

For avoiding involvement in activities that woulddiminish c onfidence in its competence, impartiality, jud gmen t or o perat ion al in tegr ity

4.1.5 d

Quality Policy Statement 4.2.2

For conducting r eview of requests, tenders andcontracts

4.4.1

For the selection and purchasing external services andsupplies, equipment and consumable supplies that

affect the quality of Tests and Calibrations

4.6.1

For the resolution of comp laints 4.8

To identify and control nonconfor mities when theyoccur

4.9.1

To designate appropriate authorities for implementingcorrective actions

4.11.1

For identifying training needs and providi ng personneltraining

5.2.2




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Appendix 3 List of Procedures in ISO/IEC 17025

Procedure Name (Description) ISO17025ClauseNumber

Section inQuality/Procedure

Manual

Done NotDone

For ensuring protection of confidential information 4.1.5c

For avoiding involvement in any activities which would dimini shconfidence in its competence, impartiality, judgment, oroperational integrity

4.1.5d

To control all documents 4.3.1

Approval and issue of docu ments 4.3.2.2

For hand amendments of documents pending re-issue (if

allowed)

4.3.3.3

To describe changes in documents maintained in thecomputerized systems are made and control led

4.3.3.4

For review of requests, tenders and contracts 4.4.1

For the selection and purchasing external services and suppli esthat affect the quality of t ests and calibrations

4.6.1

For the resolution of complaints 4.8

To identify and control nonconfor mities when they arise 4.9.1

To designate appropriate authorities fo r impl ementing correctiveactions

4.11.1

To identify, document and eliminate the root cause(s) ofnonconformities

4.11.2

For initiating and monitoring preventive actions 4.12.2

For identification, col lection, indexing, access, storage,maintenance and safe disposal of records

4.13.1.1

To protect and back up records stored electronically 4.13.1.4

For internal audits which i nclude the types of audit, frequencies,methodologies and required documentation

4.14.1

For conduct ing Management reviews 4.15.1

For checking that t he environment does not adversely affect theperformance of specimen collection and equipment

5.2.2

To ensure good housekeeping 5.3.5

Test and Calibrations methods 5.4.1

Procedure for validating test methods 5.4.5.2

For estimating uncertainty of measurement for calibration labs 5.4.6.1

For estimating uncertainty of measurement for testing Labsperforming calibrations

5.4.6.2

For protecting th e integrity of (electronic/computer) data at all 5.4.7.2b




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times

Up to date instructions on the use and maintenance of equipment 5.5.3

For safe handling, transport, storage and use of equipment 5.5.6

For performing int ermediate checks to maintain confid ence in thecalibration status of equipment

5.5.10

For ensuring correction factors are correctly updated 5.5.11

For calibration of equipment 5.6.1

For calibration of reference standards 5.6.3.1

For intermediate checks to maintain confidence in the calibrationstatus of reference, primary, transfer or working standards andreference materials

5.6.3.3

For safe handling, transport , storage and use of referencestandards

5.6.3.4

For sampling performed by the lab 5.7.1

For recording relevant data and operations relating to sampling 5.7.3

For transportation, receipt, handling, prot ection, storage,retention and/or disposal of test/calibration it ems

5.8.1

For avoiding deterioration, loss or damage to the test orcalibration item duri ng storage, handling and preparation.

5.8.4

Quality control procedures for monitori ng the validity of testsand calibrations undertaken

5.9.1




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Appendix 4 List of “ SHALLs” in ISO/IEC 17025

MetRequirement Not Met N/A Clause

The laboratory shall b e an entity that can be held legallyresponsible.

4.1.1

The laboratory management system shall co ver all work carriedout in p ermanent and mobile facilities

4.1.3

If personnel do perform other activities th an testing, e.g.consulting, the organization shall be defined in order to identifyconflicts of i nterest

4.1.4

The laboratory shall have personnel and resources needed tocarry out its duties according to its scope of accreditation

4.1.5.a

The laboratory shall have arrangements to avoid that theirpersonnel are not i nfluenced of in ternal / external pressure thatcould in fluence the quality of their work, e.g. paid by the numbertests performed

4.1.5.b

The laboratory shall h ave policy and procedures to avoidinvolvement in anything that could diminish its confidence

4.1.5.d

The laboratory shall define its organization and managementstructure and the relationships in the in the organization, e.g. byusing an organization chart.

4.1.5.e

The laboratory shall s pecify the responsibility, authority andinterrelations of personnel that could influence the test results.

4.1.5.f

The laboratory shall provide supervision of testing staff, includingtrainees, by competent personnel.

4.1.5.g

The laboratory shall have technical management with thecompetence and resources needed with the overall responsibilityfor the quality.

4.1.5.h

The laboratory shall appoint a Quality Manager. 4.1.5.i

The laboratory shall appoint deputies for key personnel. 4.1.5.j

The laboratory shall establish, implement and maintain anappropriate quality system for its activities.

4.2.1

The laboratory’s quality system and policies sh all be defined in a

named Quality Manual.

4.2.2

The quality policy statement shall be signed by the management. 4.2.2.a-e

The Quality Manual shall make references to supporting documentsystems and outline the s tructure of the sys tem.

4.2.3




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The roles of responsib ilities of the Technical Management andQuality Manager shall be defined.

4.2.4

The laboratory shall include / make references to external and

internal documents in the quality system.

4.3.1

Al l documents issued as part o f th e quali ty s ys tem shal l bereviewed and approved. A master list (or equivalent) shall outlinethe documented quality system and be used to control thedocuments.

4.3.2.1

The procedures adopted shall ensure that: 4.3.2.2

- Authorized documents are available where needed

- Documents are periodically reviewed and if necessary

Replaced

- Invalid/obsolete documents are removed and marked as such

Quality system documents generated by the lab shall have id,page numbering, and information if they are valid and beauthorized.

4.3.2.3

Changes to documents shall be reviewed and approved by thesame function that made the original.

4.3.3.1

Al tered text in documents shall if poss ible be ident if ied in therevised docu ment.

4.3.3.2

If the laboratory allows that changes are made by hand indocuments, that procedure must be documented.

4.3.3.3

If changes to “ electronic documents” are allowed, that proceduremust be documented.

4.3.3.4

The laboratory shall have procedures for the review of requests,tenders and co ntracts.

4.4

Records of reviews (including subcontractors) shall bemaintained.

4.4.2 / 4.4.3

When the laboratory is goi ng to use a subcon tractor, it shall use acompetent one.

4.5.1

The laboratory shall inform the cli ent if the laboratory usessubcontractors

4.5.2

The laboratory shall maintain a register with its approvedsubcontractors and their competence.

4.5.4

The laboratory shall h ave a policy and pro cedure for the selectionof purchasing of services and supplies and a procedure for theapproval of bought goods.

4.6.1 / 4.6.2

The laboratory shall offer its clients service. 4.7




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The laboratory shall h ave a policy and procedure for complaintsand a list o f received complaints.

4.8

The laboratory shall have a policy and procedure to control nonconforming work.

4.9.1

The laboratory shall m onitor the effect of any corrective action. 4.10.4

When there is a doubt that the laboratory does not follow its ownprocedures, the laboratory shall p erform an internal audit:

4.10.5

If there is the need / opportunity to perform a preventive action thelaboratory shall do that.

4.11

The laboratory shall have a system for archiving of its documents. 4.12

Each observation etc. shall be documented in such a way makingit possibl e to identify the responsible person, and if of importance,the time.

4.12.2.1

Mistakes shall not b e “ tippexed” or erased, the wrong note shallbe over-lined, dated and signed together with th e correct result.

4.12.2.3

The laboratory shall have a procedure and a predeterminedschedule for internal audits covering the whole quality system.

4.13

The management shall periodically, according to a schedule,perform management reviews.

4.14

The laboratory shall ensure the competence of i ts personnel. Thatcompetence shall be documented.

5.2.1

The laboratory shall have a policy about training/competence anda procedure to detect the need of training.

5.2.2

The laboratory shall have up-dated doc umented job d escriptions. 5.2.4

The laboratory shall have documented authorizations forpersonnel to perform specific tasks, e.g. signing of test reports.

5.2.5

The laboratory must have facilities and environment that does notaffect the test result.

5.3.1

The laboratory shall, if n ecessary monitor, control and recordenvironmental conditions.

5.3.2

The laboratory shall use appropriate test methods and laboratoryspecifi c SOPs where needed.

5.4.1

The laboratory shall i nform the cli ent of the appropriate method tomeet the clients’ needs; the lab shall choose international,regional or national methods or methods p ublished in reputableorganizations / technical journals or methods proposed by themanufacturer of the equipment used.

5.4.2

Non standard methods sh all be validated before use. 5.4.4 / 5.4.5.2




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When calibrating, the uncertainty shall be estimated. 5.4.6.1

Testing laboratories shall have procedures to estimate itsuncertainty.

5.4.6.2

Calculations and data transfers shall be checked periodically. 5.4.7.1

The laboratory shall validate own developed software and haveprocedures to protect data stored electronically, e.g. log i n / username and backups.

5.4.7.2

The laboratory shall have the equipment needed to perform thetests.

5.5.1

Used equipment shall have the quality needed and shall beappropriate calibrated.

5.5.2

The equipment shall be operated by c ompetent persons;instructions shall be available where needed.

5.5.3

Each item of equipment shall be identified and properlydocumented. 5.5.4 / 5.5.5

Equipment suspected to function in correct shall be prevented forunintended use.

5.5.7

When intermediate checks (verifications) are needed to guaranteethe function of a piece of equipment those checks shall beperformed according to a defined plan and procedure.

5.5.10

The laboratory shall have a program for calibration of itsequipment.

5.6.1

When necessary the testing laboratory shall have traceability to SIunits for the physical factors in qu estion.

5.6.2.2

The laboratory shall have a program and procedures for thecalibration of its reference standards.

5.6.3.1

Reference material shall be traceable to SI units or to certifiedreference material if possible.

5.6.3.2

The laboratory shall have procedures to ensure the calibrationstatus of its standards and reference material.

5.6.3.3

The laboratory shall have procedures for the handling of i tsstandards and reference materials.

5.6.3.4

If the laboratory carries out sampling, it sh all have a plan andprocedure for that.

5.7

The laboratory shall have procedures for receipt, transport, pre-treatment labeling / identification etc. of test items.

5.8.1 / 5.8.2

If any abnormal is detected upon receipt of a test item that shallbe recorded and noted in the test report.

5.8.3 /5.10.3.1.a /5.10.3.2.e




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The laboratory shall h ave plans and procedures for monitori ng thevalidity of its results. Systems shall be used in o rder to detecttrends, e.g. the use of statistical evaluations.

5.9

The result shall be presented in a calibration certificate or testreport fulfilling the requirements in ISO 17025.

5.10

If opinions and interpretations are includ ed in the report, the basisof that must be explained and clearly separated from the result.

5.10.5

If subcontractors have been used that must be c lear from thereport.

5.10.6

In the case of electronic transmission o f results that must beagreed (in writin g) with the client and the requirements in ISO17025 mus t be met.

5.10.7

Addi tions or cor rec tions to a tes t report can only be made by anew document with an explanation.

5.10.9






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Appendix 6 Example of a Flowchart

START

Schedule and organize training

Develop training materials

Identify facilitator and establish

Identify persons to train as auditors

Conductinvestigation

& document

findings

Conduct training

Update training records

END

Is thetraining

effective?

Documents

Generated

List of Trainee

Internal Auditors

Training Proposal

Training Manual

Training Schedule

Attendance

Register Evaluation Forms

CompetencyEvaluation

Investigation

Report

Personnel Records

Audit plan and

schedule

Responsibilities

Quality

Manager

Quality

Manager

Trainer

HumanResources

Trainer

QualityManager

Quality

Manager

Quality

Manager

No

Plan and execute Audits

YES




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Appendix 7 Checkl ist fo r reviewing Qual it y Management System Implementation

This checklist will be used to review the Quality Management Implementation process being conducted bythe Lab against ISO/IEC 17025. Items from this checklist are discussed in detail in the standards. If the

item is present simply tick the checkbox, otherwise leave it blank if element is not available.

Note that all items below must be included in a QMS. If an item is not relevant, an explanation must beprovided. Also note that the process may either be described or referenced in the Quality Manual; however,all references should be readily accessible within the organization and provided to the Staff.

Lab Name:

Lab Address:

Country :Tel: Fax: Email:

Quality Manager:

Yes Comments/Page(s)

ORGANIZATION

1. Is Legal status of Laboratory identified and available (e.g. Companyregistration certificate, etc)?

2. Are arrangements for confidentiality and impartiality outlined?

3. Is there a description of the process for resolving disputes?

4. Is there a statement of the organization's Quality policy?

4a. Q policy statement includes general objectives/goals?

4b. Q policy statement includes requirements from standard?

5. Is organizational chart available?

5a. Organizational chart identifies all important Managerial/Technicalpositions of the organization?

5b. Organizational Chart identifies position of QA manager and lines ofreporting?

6. Does it include authorities and independence of the QA manager andstaff?

7. Describes procedures to ensure QA staff has access to appropriate levelsof management?




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8. Discusses how management assures understanding and implementation inall programs?

9. Identifies how internal coordination of QA and QC activities is performed?

QUALITY SYSTEM COMPONENTS

11. Describes principal quality system components (e.g., quality manual,administrative procedures, test procedures, records managementsystem, annual reviews and planning, project-specific qualitydocumentation? (Please identify the components in Comments section.)

12. Description of components includes how they are implemented andresponsibilities of management and staff??

13. Lists responsibilities for implementing each component (e.g., QualitySystems Audits, Training Plans, Management review?

14. Identifies review and approval procedures?

QUALIFICATIONS AND TRAINING

15. Is there a policy regarding Quality training for management and staff?

16. Does it describe the process for identifying, maintaining, ensuring, anddocumenting that personnel have necessary quality-relatedqualifications?

16a Have records of competency analysis been prepared?

17. Is there a process for identifying the need for quality-related retrainingbased on changing requirements and the roles, responsibilities, and

authorities for these processes?PROCUREMENT OF ITEMS AND SERVICES

18. Is there a process for reviewing and approving all purchase agreements?

18a. The process ensures documents are complete and accurate andagreement clearly describes the item or service needed?

18b. The process ensures agreement describes the associated technicaland quality requirements?

18c. The process ensures agreement describes the quality systemelements for which the supplier is responsible?

18d. The process ensures that the supplier’s conformance to the

customer’s requirements will be verified?19. Describes process for reviewing and approving applicable requisitions to

ensure that they satisfy all technical and quality requirements?

19a. Review process ensures the review of evidence of the supplier’scapability to satisfy quality requirements?




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19b.Review process ensures procured items and services areacceptable?

20. Describes process for review and approval of suppliers’ quality-relateddocumentation (e.g., QA Project Plans and QMPs)?

21. Describes roles, responsibilities, and authorities for the above processesprocess to ensure policies are satisfied?

DOCUMENTS AND RECORDS

24. Describes process for identifying quality-related documents and records(including electronic) requiring control?

25. Describes procedure for preparing, reviewing, approving, issuing, usingand revising documents and records?

26. Describes process for maintaining documents and records includingconfidentiality, transmittal, distribution, retention, access, preservation,traceability, retrieval, removal of obsolete documentation, and disposal?

26a. Have all test methods been documented?

27. Does it describe the roles, responsibilities, and authorities for the aboveprocesses?

COMPUTER HARDWARE AND SOFTWARE

28. Describes process for developing, installing, testing, using, maintaining,controlling, and documenting computer hardware and software?

29. Describes process for assessing and documenting the impact of changesto user requirements and/or the hardware and software on performance?

30. Describes process for evaluating purchased hardware and software?

31. Describes process for ensuring that data and information produced from orcollected by computers is backed up and secured?

32. Describes the roles, responsibilities, and authorities for the aboveprocesses?

PLANNING

33. Includes a description of the systematic planning process for operationsand identification and involvement of all customers and suppliers?

34. Does process include specification of needed QA and QC activities toassess the quality performance criteria?

35. Does process include specification of performance criteria for measuringquality (e.g. Control chart)?





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IMPLEMENTATION OF WORK PROCESSES

37. Describes process for ensuring that work is performed according toplanning and technical documents?

38. Describes the roles, responsibilities and authorities for the above process?

AUDIT

39. Describes the process for assessing the adequacy of the quality system atleast annually?

40. Describes the process for planning, implementing and documenting auditsand reporting results to management?

40a. Process includes selecting an audit tool, the expected frequency,and the roles and responsibilities of assessors?

40b.Process includes determining the level of competence, experience

and training needed for audit personnel?

40c. Process includes ensuring that personnel have no real or perceivedconflict of interest, and have no direct involvement orresponsibility for the work being assessed?

40d.Process includes ensuring that personnel conducting audits havesufficient authority, access to programs and managers, access todocuments and records?

41. Describes process for management’s review of, and response to findings?

42. Describes process for identifying how and when corrective actions are tobe taken in response to the findings of the audit?

42a. Process includes ensuring corrective actions are made promptlyand actions documented?

42b.Process includes confirming the implementation and effectiveness ofany corrective action?

43. Are past QS management audit findings resolved? (Put date of Final Reportin Column 3.)


QUALITY IMPROVEMENT

44. Describes process for ensuring that conditions adverse to quality areprevented, identified promptly, corrected promptly and that actions aretaken toward prevention, documented and actions tracked to closure?

45. Describes process for encouraging staff to establish communicationsbetween customers and suppliers, identify process improvementopportunities, and identify and propose solutions for problems?

46. Describes the roles, responsibilities and authorities for the aboveprocesses?




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OTHER REVIEW CRITERIA47. Have all administrative procedures as required by standard been

documented and implemented?

48. Has scope of testing been defined and documented?

49. Have staff been trained in use of the QMS documentation?

50. Has a Quality team been designated?




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REFERENCEDOCUMENTS

Preparing For Accreditation: Guidance on Implementation of Quality Management Systems (QMS) for MedicalLaboratories. A QMS “How To” Guide. Edition 1 December 2006 Strengthening Of Medical Laboratory Services In TheCaribbean. A CARIFORUM Project Funded by the European Union (CAREC EU Project)

Estimation of uncertainty of measurement in Medical Laboratories, 12 th September 2006. European DiagnosticManufacturers Association Position paper. www.edma-ivd.be

M3003 The Expression of Uncertainty and Confidence in Measurement, Edition 2 August 2006 United Kingdom Accreditation Service www.ukas.com

Uncertainty of Measurement in Clinical Microbiology. Fuentes-Arderiu X, eJIFCC vol 13 no. 4.www.ifcc.org/ejifcc/vol13no4/130401006

International Laboratory Accreditation Cooperation (ILAC) Documents www.ilac.orgILAC G2 Traceability of Measurement

ILAC G9 Guidelines for the Selection and Use of Certified Reference Materials

ILAC G13 Guidelines for the requirements for the Competence of Providers of Proficiency Testing Schemes

ISO 15189:2003 Medical laboratories – Particular requirements for quality and competenceClinical laboratory testing and in vitro diagnostic test systems

ISO 15190:2003 Medical laboratories –Requirements for safetyISO/TR 22869:2005 Medical laboratories – Guidance on laboratory implementation of ISO 15189:2003

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories

Quality Management Standards

ISO/IEC 17043 Conformity Assessment – General Requirements for Proficiency testing

ISO/IEC Guide 2:2004 Standardisation and related activities – General Vocabulary

ISO/IEC 17000 Conformity Assessment - General Vocabulary

ISO 19011:2002 Guidelines for quality and/or environmental management system auditing

ISO/TR 10013:2001 Guidelines for Quality Management System documentation

ISO 10002: 2004 Quality Management – Customer Satisfaction – Guidelines for complaints handling inorganisations

ISO 10002: 2004 Quality Management – Customer Satisfaction – Guidelines for complaints handling inorganizations

ISO 9000 Quality Management Systems – Fundamentals and vocabulary

ISO 9001 Quality Management Systems – Requirements



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