ContractsContracts SubcontractingSubcontracting SuppliersSuppliers ComplaintsComplaints Corrective and preventive actions (CAPA)Corrective and preventive actions (CAPA) Internal auditsInternal audits Management reviewsManagement reviews

Management requirementsManagement requirements::

Review of request tenders and Review of request tenders and contracts -1 contracts -1 (ISO 17025: 2005, 4.4)(ISO 17025: 2005, 4.4)

Policy and procedures requiredPolicy and procedures required Differences between request and the Differences between request and the

contract shall be resolved before work contract shall be resolved before work startsstarts

Relevant discussions with a customer are Relevant discussions with a customer are registrated registrated

Review of request tenders and Review of request tenders and contracts - 2 contracts - 2 (ISO 17025: 2005, 4.4)(ISO 17025: 2005, 4.4)

Contract has to be acceptable for customer and Contract has to be acceptable for customer and laboratory laboratory

In contract procedure:In contract procedure:

Requirements including the method are Requirements including the method are adequately defined, documented and adequately defined, documented and understood understood

Capacity ad resources of laboratory are assuredCapacity ad resources of laboratory are assured How to act in case of deviations How to act in case of deviations

Review of request tenders and Review of request tenders and contracts - 3 contracts - 3 (ISO 17025:2005, 4.4)(ISO 17025:2005, 4.4)

A contract can be a written or oral A contract can be a written or oral agreementagreement

Review of compatibility by earlier work or Review of compatibility by earlier work or proven skills to performproven skills to perform

Subcontracting testsSubcontracting tests (ISO 17025; 2005, 4.5)(ISO 17025; 2005, 4.5)

Documented policy and procedure available Documented policy and procedure available including review of subcontractors (ISO 17025 including review of subcontractors (ISO 17025 accreditation preferred) accreditation preferred)

Contracts with subcontractors are documented Contracts with subcontractors are documented in a registerin a register

Laboratory is also responsible for subcontracted Laboratory is also responsible for subcontracted tests tests

Gain approval of customer for subcontractingGain approval of customer for subcontracting

Suppliers -1 Suppliers -1 (ISO 17025: 2005, 4.6)(ISO 17025: 2005, 4.6)

Policy and procedure for selection and use Policy and procedure for selection and use of supplies and servicesof supplies and services

Procedures for inspection, acceptance and Procedures for inspection, acceptance and storage of suppliesstorage of supplies

Suppliers -2 Suppliers -2 (ISO 17025: 2005, 4.6)(ISO 17025: 2005, 4.6)

Evaluation of suppliers critical for the quality Evaluation of suppliers critical for the quality of test resultsof test results

ServicesServices SubcontractingSubcontracting EquipmentEquipment Reference substancesReference substances ReagentsReagents Critical consumablesCritical consumables

Suppliers - 3 Suppliers - 3 (ISO 17025: 2005, 4.6)(ISO 17025: 2005, 4.6)

Criteria for evaluation of suppliersCriteria for evaluation of suppliers Documentation of evalutionDocumentation of evalution Preventive action in case of poor Preventive action in case of poor

performanceperformance

ComplaintsComplaints

The laboratory shall have a policy and procedure for the resolution of

complaints (ISO 17025:2005, 4.8)

Control of nonconforming testing Control of nonconforming testing work work (ISO 17025; 2005, 4.9)(ISO 17025; 2005, 4.9)

Policy and procedure required for Policy and procedure required for nonconforming work and registrationnonconforming work and registration

Evalution of the significance is made Evalution of the significance is made Correction is taken immediatelyCorrection is taken immediately When necessary customer is notified and When necessary customer is notified and

work recalledwork recalled Authorization of resumption of work is Authorization of resumption of work is

defineddefined

Corrective Actions -1Corrective Actions -1 (ISO 17025; 2005, 4.11)(ISO 17025; 2005, 4.11)

The laboratory shall establish a policy The laboratory shall establish a policy and procedure and shall designate and procedure and shall designate appropriate authorities for implementing appropriate authorities for implementing corrective action when nonconforming corrective action when nonconforming work or departures from the policies and work or departures from the policies and procedures in the quality system or procedures in the quality system or technical operations have been identified.technical operations have been identified.

Corrective actions -2Corrective actions -2

Analyse cause, select and implement Analyse cause, select and implement corrective actions (if necessary audit corrective actions (if necessary audit related activities)related activities)

Document changes resulting form Document changes resulting form corrective actionscorrective actions

Preventive actions Preventive actions (ISO 17025; 2005, 4.12)(ISO 17025; 2005, 4.12)

Needed improvements and potential Needed improvements and potential sources of nonconformities shall be sources of nonconformities shall be identifiedidentified

Pro-active process: elements can be risk Pro-active process: elements can be risk analysis, possibility for quality analysis, possibility for quality improvementimprovement

Internal audits -1 Internal audits -1 (ISO 17025: 2005, 4.12)(ISO 17025: 2005, 4.12)

Verify that laboratory operations continue Verify that laboratory operations continue to comply the requirements of the to comply the requirements of the management system and ISO 17025:2005management system and ISO 17025:2005

Internal audits - 2 Internal audits - 2 (ISO 17025: 2005, 4.12)(ISO 17025: 2005, 4.12)

All elements of the management system have to All elements of the management system have to be audited periodicallybe audited periodically

Audit programme made by Quality manager Audit programme made by Quality manager Carried out by trained and qualified independent Carried out by trained and qualified independent

personnel (if allowed by resources) personnel (if allowed by resources) If audit findings results in doubts about If audit findings results in doubts about

effectiveness of results/processes timely effectiveness of results/processes timely corrective actions are takencorrective actions are taken

Follow up audit activities shall verify undertaken Follow up audit activities shall verify undertaken actions actions

Audits in generalAudits in general

Horizontal audits 1 subject example Horizontal audits 1 subject example personnel and competencepersonnel and competence

Vertical audits following a process through Vertical audits following a process through an organizationan organization

Management reviews Management reviews (ISO 17025: 2005, 4.15)(ISO 17025: 2005, 4.15)

The laboratory’s executive The laboratory’s executive management shall management shall periodically conduct a periodically conduct a review of the laboratory's review of the laboratory's management systemmanagement system

PitfallsPitfalls

Managerial systemManagerial system

BureaucraticBureaucratic

Static systemStatic system

Not flexibleNot flexible

environment

law

permits

license

(local) government storage

acc

om

modati

o

n

personnel

management

Profi

ency

test

ing

Docu

ment

contro

l

samples registration

equipment

calib

ratio

n

validation

refe

rence

st

andard

sAnalyticalmethods

Building a Quality System

Final RemarkFinal Remark

Laboratory Accreditation Laboratory Accreditation is a tool to demonstrate is a tool to demonstrate the true underlying quality the true underlying quality of the analytical testing of the analytical testing programprogram

!!