Tariq khokhar kisr

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Laboratory Accreditation Laboratory Accreditation & Training& Training

Dr. Tariq Mahmood KhokharDr. Tariq Mahmood Khokhar

Section HeadSection Head

QA/QC & Trace Metals Analysis SectionQA/QC & Trace Metals Analysis Section

Central Analytical LaboratoryCentral Analytical LaboratoryKuwait Institute for Scientific ResearchKuwait Institute for Scientific Research

ContentsContentsIntroductionIntroductionStandard ISO/IEC 17025:2005Standard ISO/IEC 17025:2005

OverviewOverview

Requirements & Practical AspectsRequirements & Practical AspectsTrainingTrainingPlanning & Implementation StepsPlanning & Implementation StepsAccreditation ProcedureAccreditation Procedure

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Certification & AccreditationCertification & Accreditation CertificationCertification

• Appropriate quality management system (e.g. ISO Appropriate quality management system (e.g. ISO 9001)9001)

• Certification by a third party related to Certification by a third party related to productsproducts, , processesprocesses, , systemssystems or or personspersons

AccreditationAccreditation• Appropriate quality management system (e.g. ISO Appropriate quality management system (e.g. ISO

9001)9001)• Technical competence with valid resultsTechnical competence with valid results• Attestation by a third party, related to Attestation by a third party, related to conformity conformity

assessmentassessment, conveying formal demonstration of its , conveying formal demonstration of its competence to carry out specific conformity competence to carry out specific conformity assessment tasks.assessment tasks.

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Accreditation BodyAccreditation Body

Usually there are national regulations Usually there are national regulations for one or several accreditation bodies for one or several accreditation bodies in each countryin each country

There is cooperation between There is cooperation between accreditation bodies in international accreditation bodies in international organizationsorganizations• Europe: European Accreditation Europe: European Accreditation

Cooperation (EA)Cooperation (EA)• Worldwide: International Laboratory Worldwide: International Laboratory

Accreditation Cooperation (ILAC)Accreditation Cooperation (ILAC)

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Why Accreditation?Why Accreditation?

Recognition of testing competence Recognition of testing competence and reliability and reliability

International recognition for a International recognition for a laboratory for its competence and laboratory for its competence and authenticityauthenticity

Benchmark for performanceBenchmark for performance Marketing advantageMarketing advantage

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ISO/IEC 17025:2005 ISO/IEC 17025:2005 General requirements for the competence of General requirements for the competence of

testing and calibration laboratoriestesting and calibration laboratories

Conformity assessment standardConformity assessment standard Developed by ISO Committee Developed by ISO Committee

CASCO and IECCASCO and IEC Revision: ISO/IEC 17025:1999Revision: ISO/IEC 17025:1999

ISO/IEC Guide 25:1990ISO/IEC Guide 25:1990

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ISO/IEC 17025:2005ISO/IEC 17025:2005

ContentsContents

1. Scope1. Scope

2. Normative references2. Normative references

3. Terms and definitions3. Terms and definitions

4. Management requirements4. Management requirements

5. Technical requirements5. Technical requirements

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1. Scope1. Scope Specifies the general requirement for the Specifies the general requirement for the

competence of testing and calibrating laboratories.competence of testing and calibrating laboratories. Applicable to all organizations performing test Applicable to all organizations performing test

and/or calibrations, including first-, second- and and/or calibrations, including first-, second- and third-party laboratories.third-party laboratories.

Compliance with ISO 17025 also implies compliance Compliance with ISO 17025 also implies compliance with ISO 9001 with ISO 9001

(Management requirements – ISO 9001)(Management requirements – ISO 9001) (Technical requirements – ISO/IEC Guide 1990)(Technical requirements – ISO/IEC Guide 1990)2. Normative references2. Normative references

• As per ISO/IEC 17000 and VIMAs per ISO/IEC 17000 and VIM33. Terms and definitions. Terms and definitions

• As per ISO/IEC 17000 and VIMAs per ISO/IEC 17000 and VIM

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4. Management requirements4. Management requirements 4.1 Organization 4.1 Organization 4.2 Management 4.2 Management

systemsystem 4.3 Document control4.3 Document control 4.4 Review of 4.4 Review of

requests, tenders and requests, tenders and contractscontracts

4.5 Subcontracting of 4.5 Subcontracting of tests and calibrationstests and calibrations

4.6 Purchasing 4.6 Purchasing services and suppliesservices and supplies

4.7 Service to the 4.7 Service to the customercustomer

4.8 Complaints4.8 Complaints 4.9 Control of 4.9 Control of

nonconforming testing nonconforming testing and/or calibration and/or calibration workwork

4.10 Improvement4.10 Improvement 4.11 Corrective action4.11 Corrective action 4.12 Preventive action4.12 Preventive action 4.13 Control of 4.13 Control of

recordsrecords 4.14 Internal audits4.14 Internal audits 4.15 Management 4.15 Management

reviewsreviews

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5.1 General5.1 General 5.2 Personnel5.2 Personnel 5.3 Accommodation 5.3 Accommodation

and environmental and environmental conditionsconditions

5.4 Test and 5.4 Test and calibration methods calibration methods and method and method validationvalidation

5.5 Equipment5.5 Equipment

5.6 Measurement 5.6 Measurement traceabilitytraceability

5.7 Sampling5.7 Sampling 5.8 Handling of test 5.8 Handling of test

and calibration and calibration items items

5.9 Assuring the 5.9 Assuring the quality of test and quality of test and calibration results calibration results

5.10 Reporting the 5.10 Reporting the results results

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Organization

Laboratory responsibility

Legal statusConfidentiality& proprietary

rights

AwarenessOrganization

& management structure

Internal communication

Deputies

SupervisionQuality

manager

Impartiality/ independence

Organization

Organization & management

structure

Legal status & Lab.

responsibility

Awareness

Confidentiality & proprietary

rights

Policies toavoid personnel involvement in

disruptive activities

Deputies of key

Managerial personnel

Impartiality &

independence SpecifiedResponsibilities

& authorities

QualityManager

Managerial &Technical

Staff

4.1 Organization

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4.2 Management System4.2 Management System The laboratory shall establish, implement The laboratory shall establish, implement

and maintain a “Management System” and maintain a “Management System” appropriate to the scope of its activities.appropriate to the scope of its activities.

The management system’s The management system’s policiespolicies, , programsprograms, , proceduresprocedures and and instructionsinstructions; ; including a including a quality policy statementquality policy statement, shall , shall

be defined in a “be defined in a “Quality ManualQuality Manual”. The overall ”. The overall objectives shall be established, and shall be objectives shall be established, and shall be reviewed during management review. The reviewed during management review. The quality policy statement shall be issued by quality policy statement shall be issued by top management.top management.

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Quality and Technical RecordsQuality and Technical Records

QualityPolicy andObjectives

Quality Manual

Management System Policiesand Procedures

Technical Procedures, Programs, Instructions,Test Methods, Specifications

Evidences

Technical

documentation

System Level

procedures

Overall summary and structure of quality system

Commitments to quality

Level V

Level IV

Level III

Level II

Level I

4.2 Management system4.2 Management system

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4.2 Management System4.2 Management System

The “Quality Manual” shall include or make The “Quality Manual” shall include or make reference to the supporting procedures reference to the supporting procedures including technical procedures.including technical procedures.

The role and responsibilities of technical The role and responsibilities of technical management and quality manager shell be management and quality manager shell be defined in the “Quality Manual”.defined in the “Quality Manual”.

In the “Quality Manual” it is described that In the “Quality Manual” it is described that how requirements pertaining to each clause how requirements pertaining to each clause and sub-clause of the standard are meet.and sub-clause of the standard are meet.

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Regulatorydocuments

Proceduraldocuments

Contractualdocuments

Technicaldocuments

External

document

controlChange control

Distribution control

Obsolete document

control

Review & approval

4.3 Document control4.3 Document control

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Receipt of request or tender document

Preparation of quotation/proposal/contract

Review of request•Requirements•Capability and recourses•Test of calibration method

Ok?

Yes

Review of contract•difference with request•Terms and conditions•Any subcontracted work

Signing of contract

Ok?

Yes

PROCEDURE

RECORDS

4.4 4.4 Review Review

of of requests, requests, tenders tenders

and and contractscontracts

End

No

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Register of subcontractors

Client notification& approval

Laboratory responsibility

Competent subcontractor

4.5 Subcontracting of test and 4.5 Subcontracting of test and calibrationcalibration

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Laboratory

Receivingverification

•Reagents•Consumables•Equipment•Services

Supplier

Review & approval

Purchaseorder

Selection and evaluation of

suppliers

•Type•Class•Grade•Specifications•Technical data

4.6 Purchasing services and 4.6 Purchasing services and suppliessupplies

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LaboratoryLaboratory

CUSTOMER

CUSTOMER

Requirements

Requirements

Clarify requests

Provide access

CUSTOMER

CUSTOMER

Satisfaction

Satisfaction

Preparation, Analysis and calibration of

items

Surveys

Review of results

4.7 Services to the customer4.7 Services to the customer

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Receipt of complaint

Enter into complaint log

Review of complaint

Justified?

PROCEDURE

RECORDS

Take immediate remedialmeasure

Notify the customer

Root cause analysis and corrective action

Update the log & close out

Yes

No

4.8 4.8 ComplaintsComplaints

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Control of non-

conformity

Notifying the customer and recalling the

work

Correction of nonconformity

Evaluation of significance

Identification of nonconforming

work

Records

Policy and Procedure

4.9 Control of nonconforming 4.9 Control of nonconforming testing and/or calibration worktesting and/or calibration work

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OBJECTIVESdefine targets for improvement

OBJECTIVESdefine targets for improvement

MONITORING & MEASUREMENTMONITORING & MEASUREMENT

ANALYSIS OF DATAstudy the trends

ANALYSIS OF DATAstudy the trends

QUALITY REVIEWSreview the achievement of objectives

QUALITY REVIEWSreview the achievement of objectives

CORRECTIVE ACTION/PREVENTIVE ACTIONCORRECTIVE ACTION/PREVENTIVE ACTION

Revision

4.10 Improvement4.10 Improvement

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Identify the problemIdentify the problem

Investigation the root causesInvestigation the root causes

Propose solutionsPropose solutions

Implement solutionImplement solution

Evaluate the effectiveness of solutionEvaluate the effectiveness of solution

CORRECTIVEACTION

Action taken toeliminate the

problems occurredto avoid theirrecurrence

CORRECTIVEACTION


problems occurredto avoid theirrecurrence

PREVENTIVEACTION


potential problemsto avoid theiroccurrence

PREVENTIVEACTION


potential problemsto avoid theiroccurrence

4.11/4.12 Corrective and 4.11/4.12 Corrective and Preventive ActionPreventive Action

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• QUALITY RECORDS

• audit reports• minutes of management reviews• supplier evaluation records• purchase records, etc.

• QUALITY RECORDS

• audit reports• minutes of management reviews• supplier evaluation records• purchase records, etc.

• TECHNICAL RECORDS

• test results• calibration result• original observations• derived data, etc.

• TECHNICAL RECORDS

• test results• calibration result• original observations• derived data, etc.

identification collection Indexing

RECORD MANAGEMENT

access filling storage

maintenance disposal retention

legibility security back-up

4.13 Control of 4.13 Control of recordsrecords

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PROCEDURE

RECORDS

Corrective ActionAnd Follow-up

Audit Execution

Audit Planning

Audit Reporting

AUDITCYCLE

4.14 Internal 4.14 Internal auditsaudits

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ManagementReviewMeeting

ManagementReviewMeeting

Suitability of policies/procedure

Results of Internal audits

Corrective/preventive actions

Assessment by external bodies

Results of proficiency tests

Changes in volume & type of work

Customer feedback/complaints

Improvement suggestions

Resources needs

Revision of policy

Revision of objectives

Corrective/Preventive Action

Improvement Actions

INPUTS OUTPUTS

4.15 Management 4.15 Management reviewreview

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5.1 General5.1 General 5.2 Personnel5.2 Personnel 5.3 Accommodation 5.3 Accommodation

and environmental and environmental conditionsconditions

5.4 Test and 5.4 Test and calibration methods calibration methods and method and method validationvalidation

5.5 Equipment5.5 Equipment

5.6 Measurement 5.6 Measurement traceabilitytraceability

5.7 Sampling5.7 Sampling 5.8 Handling of test 5.8 Handling of test

and calibration and calibration items items

5.9 Assuring the 5.9 Assuring the quality of test and quality of test and calibration results calibration results

5.10 Reporting the 5.10 Reporting the results results

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5.1 General5.1 General Factors effecting the correctness and Factors effecting the correctness and

reliability of test results and reliability of test results and calibrationscalibrations

PersonnelPersonnel Accommodation and environmental conditionsAccommodation and environmental conditions Test and calibration methods and method Test and calibration methods and method

validationvalidation EquipmentEquipment Measurement and traceabilityMeasurement and traceability SamplingSampling Handling of test and calibration itemsHandling of test and calibration items

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5.2 Personnel5.2 Personnel Appropriate competence to perform specific Appropriate competence to perform specific

tests and/or calibrations (defined recruitment tests and/or calibrations (defined recruitment policy)policy)

Policy and procedures for education and Policy and procedures for education and training with defined goalstraining with defined goals

Competence and supervision of contact staffCompetence and supervision of contact staff Detailed job descriptions identifying Detailed job descriptions identifying

responsibilities and authoritiesresponsibilities and authorities Authorized personnel to perform specific Authorized personnel to perform specific

tests and/or calibrations, and to issue test tests and/or calibrations, and to issue test reports and/or calibration certificates.reports and/or calibration certificates.

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5.3 Accommodation and 5.3 Accommodation and environmental conditionsenvironmental conditions

Adequate energy sources, lighting and Adequate energy sources, lighting and environmental conditions which facilitate environmental conditions which facilitate correctness of tests and/or calibrationscorrectness of tests and/or calibrations

Control, monitor and record environmental Control, monitor and record environmental conditions as per specific requirementsconditions as per specific requirements

Effective separation from neighboring Effective separation from neighboring areas and prevention from cross areas and prevention from cross contaminationcontamination

Controlled access and useControlled access and use Good housekeepingGood housekeeping

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5.4 Test and calibration methods and 5.4 Test and calibration methods and method validationmethod validation

5.4.1 General5.4.1 General• Appropriate methods and procedures for all tests and/or Appropriate methods and procedures for all tests and/or

calibrations calibrations • Written instructions and procedures for operations of Written instructions and procedures for operations of

equipments and preparation of items for testing and/or equipments and preparation of items for testing and/or calibrationscalibrations

5.4.2 Selection of Methods5.4.2 Selection of Methods• Meet needs of customersMeet needs of customers• Appropriate to perform required test and/or calibrationsAppropriate to perform required test and/or calibrations• Preferably published in international or national Preferably published in international or national

standards.standards.

5.4.3 Laboratory-developed methods5.4.3 Laboratory-developed methods5.4.4 Non-standard methods5.4.4 Non-standard methods

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5.4 Test and calibration methods and 5.4 Test and calibration methods and method validation (contd.)method validation (contd.)

5.4.6 Estimation of uncertainty of 5.4.6 Estimation of uncertainty of measurementmeasurement

Written, applied procedures and Written, applied procedures and records to estimate uncertainty of records to estimate uncertainty of measurement for all test and calibration measurement for all test and calibration typestypes

5.4.7 Control of data5.4.7 Control of data

Appropriate checks on calculations and Appropriate checks on calculations and data transferdata transfer

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5.5 Equipment5.5 Equipment• Appropriate capability of equipment and its Appropriate capability of equipment and its

software, used for testing, calibration and software, used for testing, calibration and sampling; to achieve the accuracy required sampling; to achieve the accuracy required

• Procedures for operation, calibration, Procedures for operation, calibration, transport, storage and planned maintenance transport, storage and planned maintenance of measuring equipments and recordsof measuring equipments and records

• Operation of equipment by authorized Operation of equipment by authorized personnel using up-to-date operational personnel using up-to-date operational instructionsinstructions

• Identification/labeling of each item of Identification/labeling of each item of equipment and its software and its recordequipment and its software and its record

• Isolation and proper identification of Isolation and proper identification of defective equipmentdefective equipment

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5.6 Measurement traceability The measurements and calibrations made should The measurements and calibrations made should

be traceable to the International System of Units be traceable to the International System of Units (SI).(SI).

Reference materialsReference materials should be traceable to SI should be traceable to SI units of measurement, or to certified reference units of measurement, or to certified reference materials.materials.

If traceability of measurement to SI units is not If traceability of measurement to SI units is not possible and/or not relevant, calibration should possible and/or not relevant, calibration should have traceability to appropriate measuring have traceability to appropriate measuring standard.standard.

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5.7 Sampling

Sampling plan and procedures, in case the Sampling plan and procedures, in case the Laboratory carries out sampling of Laboratory carries out sampling of substances, materials or products for testing substances, materials or products for testing or calibration.or calibration.

Available at the location where sampling is Available at the location where sampling is undertaken.undertaken.

Sampling plan based on statistical methods.Sampling plan based on statistical methods. Deviation (if any) should be recordedDeviation (if any) should be recorded

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5.8 Handling of test and calibration items Procedures for the transportation, receipt, handling, Procedures for the transportation, receipt, handling,

protection, storage, retention and/or disposal of test protection, storage, retention and/or disposal of test and/or calibration items; including all provisions and/or calibration items; including all provisions necessary to protect the integrity of the test or necessary to protect the integrity of the test or calibration item, and to protect the interests of the calibration item, and to protect the interests of the laboratory and the customer. laboratory and the customer.

Identification system for proper identification of test Identification system for proper identification of test and calibration items.and calibration items.

Checking at receipt of test and/or calibration item Checking at receipt of test and/or calibration item regarding any abnormality and record.regarding any abnormality and record.

Procedures and appropriate facilities to avoid Procedures and appropriate facilities to avoid deterioration, loss or damage to the test or calibration deterioration, loss or damage to the test or calibration items, during storage, handling and preparation.items, during storage, handling and preparation.

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5.9 Assuring the quality of test and calibration results

Established quality control procedures for monitoringEstablished quality control procedures for monitoringthe validity of tests and calibrations performed.the validity of tests and calibrations performed.

Recording of data in way of trend indication.Recording of data in way of trend indication. Application of statistical techniques for data review. Application of statistical techniques for data review. Planned and reviewed monitoring which may include:Planned and reviewed monitoring which may include:

Regular use of certified reference materials and Regular use of certified reference materials and secondary reference materials.secondary reference materials.

Inter-laboratory comparisons and proficiency-testingInter-laboratory comparisons and proficiency-testingprograms.programs.

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5.10 Reporting the results

Result of each test or calibration should be reported Result of each test or calibration should be reported accurately, clearly, unambiguously and objectively, accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the and in accordance with any specific instructions in the test or calibration method.test or calibration method.

The results reported in a test report or a calibration The results reported in a test report or a calibration certificate should include:certificate should include: All information requested by the customer.All information requested by the customer. Information required for the interpretation of test Information required for the interpretation of test

or calibration results.or calibration results. Information regarding the method used.Information regarding the method used. Opinion and interpretation should include its basis.Opinion and interpretation should include its basis.

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Training Familiarization and awareness trainingFamiliarization and awareness training Training for understanding of standard’s Training for understanding of standard’s

requirements requirements Training for preparation and implementation of Training for preparation and implementation of

required proceduresrequired procedures Training for internal auditorsTraining for internal auditors Identifying training needs for continues Identifying training needs for continues

improvement (e.g. on job trainings, special trainings improvement (e.g. on job trainings, special trainings etc) on regular basis and providing such trainingsetc) on regular basis and providing such trainings

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Planning and implementation steps Commitment from the “Top Management”Commitment from the “Top Management”

Familiarization and awareness at all levels.Familiarization and awareness at all levels. Establishment of “Quality Council” comprising of appropriate Establishment of “Quality Council” comprising of appropriate

personnel, to plan, monitor and control the project.personnel, to plan, monitor and control the project. Appoint “Quality Manager” for coordination and “Project team”, Appoint “Quality Manager” for coordination and “Project team”,

for document preparation and implementation.for document preparation and implementation. Careful study of each clause of the standard and interpretation of Careful study of each clause of the standard and interpretation of

its requirements.its requirements. Gap analysis (Standard’s requirements Vs current practices).Gap analysis (Standard’s requirements Vs current practices). Preparation of the required policies, manuals, procedures and Preparation of the required policies, manuals, procedures and

documents and implementation.documents and implementation. Formation of internal audit team and internal audit.Formation of internal audit team and internal audit. Identification and implementation of corrective and preventive Identification and implementation of corrective and preventive

actions.actions. Continues monitoring for effective implementation of the system Continues monitoring for effective implementation of the system

and improvement.and improvement. Management review.Management review. Application for accreditation.Application for accreditation.

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Accreditation ProcedureAccreditation Procedure Selection and Application to the accreditation Selection and Application to the accreditation

body.body. Contract with the accreditation body.Contract with the accreditation body. Nomination and commissioning of assessors.Nomination and commissioning of assessors. Technical audit of the documents.Technical audit of the documents. On-site laboratory assessment.On-site laboratory assessment. If necessary proficiency testing.If necessary proficiency testing. Assessment report.Assessment report. Inspection of the report in the committee.Inspection of the report in the committee. Accreditation decision.Accreditation decision. Publication.Publication.

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Technology

Tariq khokhar kisr