Présentation charki-sharebiotech

Management Quality Systems

in Life Sciences (ISO/IEC 17025, ISO 15189, etc.)

A. Charki

University of [email protected]

6th December 2011 / Nantes - France International Days for Biotech Quality Management 1

Pyramid of

Conformity Assessment

6th December 2011 / Nantes - France International Days for Biotech Quality Management [email protected]

Industries

Certification

Bodies

Accreditation

Bodies

Consumers

ILAC

EA

www.ilac.org

ILAC - International Laboratory

Accreditation Cooperation

www.european-accreditation.org

EA - European cooperation

for Accreditation

Products, Services, Processus

Certification

« Label rouge », NF, Food

Products, Protected Designation

of Origin (PDO), Organic farming,

International Food Standard (IFS),

etc.

Personal Certification

Diagnosis, auditors of quality

systems management, etc.

Quality systems Certification

ISO 9001, ISO 14001,

ISO 22000, etc.

ISO/IEC 65

NF EN 45011

ISO/IEC 17021

ISO/IEC 17024


Context ?

3

Inspection Bodies

Food, Health, environment, etc.

Laboratories

Food, Health, environment,

Testing, calibration, etc.

LAB BPE REF 02*

Directive 91/414/CEE,

Directive 2004/10/CE

ISO/IEC 17020 ISO/IEC 17025

ISO 15189 (BML)GPE / GPL« Good Practice of Expérimentation (1)»/

« Good Practice of Laboratory(2) »

* Direction Générale de

l’Alimentation / Sous

Direction de la Qualité et de la

Protection des Végétaux

http://www.cofrac.fr

( 1)(2) Regulation of chemical

industry,

(2) Pharmaceutical, comestic

and veterinary products


Context ?

4

Focus on

accreditation according to

ISO/IEC 17025

and ISO 15189


Suitable Management Systems for Life Sciences

Case of Laboratories

ISO/IEC 17025 and ISO 15189


“A medical laboratory's fulfilment of

the requirements of ISO 15189 : 2007

means the laboratory meets both the

technical competence requirements

and the management system

requirements that are necessary for it

to consistently deliver technically valid

test results. The management system

requirements in ISO 15189 (Section 4)

are written in a language relevant to a

medical laboratories operations and

meet the principles of ISO 9001:2008

Quality management systems -

Requirements and are aligned with it

pertinent requirements.”

CASCO Communiqué

http://www.iso.org


September 2009

7

“A laboratory's fulfilment of the

requirements of ISO/IEC 17025:2005

means the laboratory meets both the

technical competence requirements

and management system requirements

that are necessary for it to consistently

deliver technically valid test results and

calibrations. The management system

requirements in ISO/IEC 17025:2005

(Section 4) are written in language

relevant to laboratory operations and

meet the principles of ISO 9001:2008

Quality Management Systems —

Requirements and are aligned with its

pertinent requirements.”

January 2009


CASCO Communiqué

http://www.iso.org

8

What is « accreditation »?

Important steps in preparing for the accreditationprocess :• quality management requirements• and technical requirements

An overview during the full assessment (ISO 15189 as example) of Managment Quality System


Accreditation of a laboratory :

A good challenge!

Accreditation?

Accreditation is not certification and inspection !

Accreditation means that evaluators i.e. testing and calibration

laboratories, certification and inspection bodies have been

assessed against internationally recognized standards to

demonstrate their competence, impartiality and performance

capability.

Certification and inspection bodies cannot use the ISO/IEC 17025

ISO 15189, ISO 45011 , ISO/IEC 17020, ISO/IEC 17021 and ISO/IEC

17024 standards


Medical A laboratory of many integrated procedures intended for diagnosis, confirmation, documentation of human health information

CommunityHospitalPublic Health

Testing A laboratory of limited stand-alone procedures intended to confirm conformity of a product to its expected target or goal

ManufacturingElectricalWaterFoodPublic Health

Calibration A laboratory of a very limited range of procedures intended to ensure traceability of equipment or material to highest level possible.

All industries, testingand other laboratories (Reference)

Accreditation?Not all laboratories are the same


How do accreditation bodies evaluate the competence of

accredited laboratories?

On-site evaluation to the requirements of ISO/IEC 17025 and ISO 15189

Only accreditation bodies can use the ISO/IEC

17025 and ISO 15189 standards

12

Accreditation?


www.ilac.org

ILAC - International Laboratory Accreditation Cooperation

www.european-accreditation.org

EA - European cooperation for Accreditation

As an organization which is mandated by

public authorities,

COFRAC = Comité français d’accréditation

(the French accreditation committee)

is officially recognized as national accreditation

body.

[email protected] December 2011 / Nantes - France International Days for Biotech Quality Management

COFRAC ?

13

Cofrac has been designated as the sole national accreditation body

by the Decree of 19 December 2008,

thus recognizing accreditation as a public authority activity.

Cofrac’s mission is to prove the skills and perfect

organization of conformity assessment bodies: laboratories,

certification bodies and inspection bodies.

Cofrac, a non-profit association under the law of July 1901, was

created in 1994. All interested parties are represented within

its governing bodies (Board of Administrators and Section’s

committees): accredited bodies, professional groupings and

companies, major associations of purchasers and consumers

and public authorities.


COFRAC ?

14

Accreditation goes further than ISO 9001 certification by

providing more than just recognition that a quality system

complies with a reference guide or standard. It provides

recognition the reliability of their results and of the skills,

especially the technical skills, of the personnel

organization concerned by using quality assessors,

assessors and technical experts.


COFRAC ?

15

[email protected] December 2011 / Nantes - France International Days for Biotech Quality Management 16

COFRAC ?


COFRAC ?

Certified Quality System

Accredited Quality and

Technical System

Accredited Quality System

17

Case 1 Case 2 Case 3

Case 4 Case 4

Laboratory types concerned ?

Main Laboratory: A laboratory (organization) that maintains a single location only

Permanent Laboratory: A laboratory erected on a fixed location. This is the

laboratory location (address) denoted on the scope of accreditation

Branch Laboratory [multi-location system]: A laboratory system that consists of

two or more laboratories owned and operated by the same organization, utilizing

the same management system

Mobile Laboratory: Fully equipped, self-contained, transportable testing or

calibration laboratory capable of performing tests or calibrations under

controlled environmental conditions. Mobile laboratories are subject to the same

terms of accreditation as a field laboratory

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Accreditation?


What do you essentially need for accreditation?

• Scope of accreditation : proposed scope of testing or calibration in terms of field(s) of testing or cali bration, testing or calibration technologies, methods and relevant s tandards, and measurement uncertainty budgets if applicable ( always required for calibration);

• Organization structure ;

• Technical competence of the personnal of laboratory ;

• Reliability of measurement (equipments, methods and laboratory environment checked, validated, adapted to the activities,…) ;

• Proficiency testing results .

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Accreditation?


Accreditation?Scope of accreditation?


Scope of accreditation?

For tests, the scope of accreditation is normally identified in terms

of standard test methods prepared by national, international, and

professional standards writing bodies.

21

Accreditation?


If a laboratory wishes accreditation for the use of its own

methods (good for research), then it must provide the

following information to the assessor(s) before assessment:

- Origin of method;

- Comparison with the standard methods they replace

including any departures from the standard (if applicable);

- Reasons for and effects;

- Validation data (per Section 5.4.5 of ISO/IEC 17025).

Important steps in preparing

for the accreditation : Quality

Management Part• Ensure the competence of persons of the laboratory (training, capability,

experiments, ...)

•Create and implement a Quality Manual and Management System policies and

procedures that meets ISO/IEC 17025:2005 or ISO 15189 requirements and

accreditation body requirements as well .

•Perform a self-assessment (internal audit) to verify compliance with all

requirements, standards and the laboratory’s own management system and

applicable test or calibration methods and document the results.

It is important to seek feedback from all the applicable individuals to get the most

comprehensive evaluation of the organization.

•Perform a management review in accordance with section 4.2.2 and 4.15 of ISO/IEC

17025 and document the results.


• Identify an individual to assume responsibility of upholding the accreditation requirements and make available the relevant resources.

• Identify the person in charge of the management sys tem (e.g., the Quality Manager).

An effective management system functions as such wi th the support and commitment from the top management (as required in ISO/IEC 17025). In a large organization, the coordination o f these activities may be too large a task for the top manager and it is i mperative that the individual(s) decide how to handle this important s ubsidiary function. Top management may need assistance from an individu al(s) who would be responsible for the development and maintenance of the documented quality system.

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Management Part


The laboratory should ensure that there are records demonstrating compliance with all of the Quality Management System (QMS).The QMS includes:� Organization and Management,� Document Control.� Contracting,� Services and Supplies,� Customer Feedback,� Nonconformance,� Corrective and Preventive actions,� Continuous Improvement,� Quality and technical records,� Internal Audits,� Management Reviews,� Personnel Qualifications, Responsibilities, trainin g and competency,� Accommodations and Environment,� Laboratory Equipment System, Measurement Traceability� Methods validation� Pre-examination, examination and post-examination pro cedures (ISO 15189)� Result reporting

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Management Part


All calibrations and verifications of measuring and test equipment and

reference standards, be conducted by:

- a calibration laboratory accredited to ISO/IEC 17025 by a mutually

recognized Accreditation Body;

- or a recognized National Metrology Institute (NMI) including designated

institutes.

Recognition of the NMI is based on the Institute or designated institute being

a signatory to the CIPM (Comité International des Poids et Mesures) MRA

(Mutual Recognition Arrangement) and supporting the measurement

comparison activities of the CIPM.

A listing of these recognized Institutes can be found at

http://www.bipm.org/en/cipm-mra/participation/signatories.html

25


for the accreditation : Technical Part



The in-house laboratory must have and apply

procedures for evaluating measurement uncertainty.

27




An in-house calibration system ensures that all

measuring and test equipment used in a company is

calibrated regularly against its own reference

standards. The in-house calibration system shall ensure

traceability of measurement by having its reference

standards calibrated at an accredited calibration

laboratory or a national metrology institute.

Proficiency testing is a process for checking actual

laboratory testing performance, usually by means of

interlaboratory test data comparisons.

For many tests and calibrations, results from

proficiency testing are very good indicators of

competence. Proficiency testing programs may take

many forms and standards for satisfactory

performance can vary depending on the field.

28




29


for the accreditation : Technical PartDEFINITIONS (refer ISO/IEC Guide 43-1)(laboratory) proficiency testing: -

“determination of laboratory testing performance by means of interlaboratory comparisons”

� The aim is to test the laboratory’s ability to cali brate equipment within its claimed accuracy

� Secondary aims:

- interpret documentary standards

- calculating results and uncertainties

- reporting the results

TEST ITEM Reference value assigned by the coordinating laboratory

LAB 1 LAB 2 LAB 3

1

2

3

N

ValueRef

= Uncertainty Range

LAB N


The laboratory must also be able to explain when proficiency testing is

not possible for certain testing and this explanation must be included in

the plan.

When inter-laboratory comparisons (ILCs) are not available or relevant

to the scope of accreditation, internal performance-based data in

accordance with clause 5.9 of ISO/IEC 17025 are acceptable.

Internal performance-based checks (or data or evaluations) include (but

are not limited to) the following types of activities: regular use of

certified reference materials and/or internal quality control using

secondary reference materials; replicate tests or calibrations using the

same or different methods; retesting or re-calibration of retained items;

and correlation of results for different characteristics of an item.

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During the full assessment

The full assessment generally involves:

- An entry briefing with laboratory management;

- Interviews with also technical staff;

- Demonstration of selected tests or calibrations including, as applicable,

tests or calibrations at representative field locations;

- Examination of equipment and calibration records;

- Audit of the management system to verify that it is fully operational and

that it conforms to all sections of ISO/IEC 17025 or ISO 15189, including

documentation;

- Evaluation of your laboratory’s compliance with the accreditation body

requirements documents (Policy on Estimating Measurement Uncertainty

for Testing Laboratories, on Proficiency Testing for ISO/IEC 17025

Laboratories, etc.);

- A written report of assessor findings;

- An exit briefing including the specific written identification of any

deficiencies.31



During the assessment, assessors may observe deficiencies. A

deficiency is any nonconformity to accreditation requirements

including:

- a laboratory’s inability to perform a test, type of test, or

calibration for which it seeks accreditation;

- a laboratory’s management system does not conform to a clause

or section of ISO/IEC 17025 or ISO 15189, is not adequately

documented, or is not completely implemented in accordance

with that documentation;

- a laboratory does not conform to any additional requirements of

the accreditation body or specific fields of testing or programs

necessary to meet particular needs.


33

ISO 15189:2007Medical Laboratories – particular requirements for

quality and competence.


ISO 15189 as example


34

Management Requirements1. Organization

2. Quality Management System

3. Document Control

4. Review of Contracts

5. Referral Laboratories

6. External Services and Supplies

7. Identification and control of non-conformities

8. Corrective Actions

9. Preventive Actions

10. Continual Improvement

11. Quality and Technical Records

12. Internal Audits

13. Management Review

Technical Requirements1. Personnel

2. Accommodation / environment

3. Laboratory Equipment

4. Pre-examination procedures

5. Examination procedures

6. Assuring quality of examinations

7. Post-examination procedures

8. Reporting Results




35

• Organization– A medical laboratory shall be a legal entity.

– Medical laboratories shall be designed to meet patient needs.

– Laboratory personnel responsibilities shall be defined.

– Laboratory management shall provide personnel with the resources and authority to perform their duties.

– Laboratory policies and procedures shall protect confidential information.

– The laboratory shall appoint a quality manager.

– The laboratory shall have technical management for overall responsibility of technical operations and the provision of resources needed to ensure the required quality of laboratory procedures.


ISO 15189 as exampleLet’s see some requirements


36

• The laboratory shall be directed by a person or persons having executive

responsibility and the competence to assume responsibility for the

services provided. (note: competence is the product of basic, academic,

postgraduate, continuing education, and training and experience of several years

in a medical laboratory).

• The laboratory director shall be responsible for professional, scientific,

consultative or advisory organization, administrative and educational

matters.

• The laboratory director need not perform all responsibilities personally.

However it is the laboratory director who remains responsible for the

overall operation and administration of the laboratory, for ensuring quality

services provided for patients.




37

• Laboratory management shall review the laboratory’s quality management system and all of its medical services, including examination and advisory activities to ensure their continuing suitability and effectiveness in support of patient care and to introduce any necessary changes or improvements.

• The results of the review shall be incorporated into a plan that includes goals, objectives and action plans.

• The typical period for conducting a management review is once every twelve months.

• Management review shall take into account, follow-up of previous review, status of corrective actions, reports from managers and supervisors, internal audits, assessments of external bodies, quality indicators, feedback (complaints), non-conformities, continual improvement processes, evaluation of suppliers.




38

• Laboratory management shall have an organization plan, personnel policies and job descriptions that define qualifications and duties for all personnel.

• Laboratory management shall authorize personnel to perform particular tasks.

• Personnel shall have training specific to quality assurance and quality management for services offered.

• There shall be a continuing education program available to staff at all levels.

• Employees shall be trained to prevent or contain the effects of adverse incidents.

• The competency of each person to perform assigned tasks shall be assessed following training and periodically thereafter. Retraining and reassessment shall occur when necessary.




39

• The laboratory shall appoint a quality manager with delegated

responsibility and authority to oversee compliance with the

requirements of the quality management system.

• The quality manager shall report directly to the level of

laboratory management at which decisions are made on

laboratory policy and resources.

• The quality manager shall plan, organize and conduct internal

audits.



Let’s see some requirements


40

• The laboratory shall design internal quality control.

• It is important that the control system provide staff with clear and easily understood information.

• The laboratory shall determine the uncertainty of results where relevant and possible.

• A programme for calibration of measuring systems and verification of trueness shall be designed and performed so as to ensure that results are traceable to SI units

• The laboratory shall participate in a suitable inter-laboratory comparison.

• The laboratory shall use suitable reference materials, certified to indicate the characterization of the material.

• For those examinations performed using different procedures or equipment at different sites, there shall be a defined mechanism for verifying the comparability of results throughout the clinically appropriate intervals.




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• Internal audits shall address all elements of the system, both management and technical, and emphasize areas critically important to patient care.

• Audits shall be planned, organized and carried out by the quality manager

• Procedures of the audits shall be documented and carried out within an agreed upon time.

• The main elements of the quality system should be subject to internal audit once every 12 months.

• The results of internal audits shall be submitted to laboratory management for review.




Continuous Improvement

• Laboratory management shall have a policy and procedure to be implemented when it detects that any aspect of its examinations does not conform with its own procedures or the agreed upon requirements of the quality management system, or the requesting physician.

• Procedures for corrective action shall include an investigative process to determine the underlying cause or causes of the problem.

• Corrective action shall be appropriate to the magnitude of the problem and commensurate with the risk.

• These shall lead, where appropriate to preventive actions.

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Let’s see some requirements


• All operational procedures shall be systematically reviewed by laboratory management at regular intervals in order to identify potential sources of non-conformance.

• Action plans for improvement shall be developed, documented and implemented.

• After the action has been implemented, management shall evaluate the effectiveness of the action.

• Management shall implement quality indicators for systematically monitoring and evaluating the laboratory’s contribution to patient care.

• When opportunities for improvement are detected, management shall address them regardless of where they occur.

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ISO 15189 as exampleLet’s see some requirements ….


Establish

Mechanisms of Detection

Investigate for:

Impact – Underlying Cause - Risk

REMEDIALCORRECTIVE

PREVENTIVE

EVALUATE

EFFECTIVENESS

MANAGEMENT

REVIEW

44


ISO 15189 as exampleDon’t forget !


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