Tariq khokhar kisr

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  • 1. Laboratory Accreditation & Training Dr. Tariq Mahmood Khokhar Section Head QA/QC & Trace Metals Analysis Section Central Analytical Laboratory Kuwait Institute for Scientific Research
  • 2. Contents
    • Introduction
    • Standard ISO/IEC 17025:2005
    • Overview
    • Requirements & Practical Aspects
    • Training
    • Planning & Implementation Steps
    • Accreditation Procedure
  • 3. Certification & Accreditation
    • Certification
      • Appropriate quality management system (e.g. ISO 9001)
      • Certification by a third party related to products , processes , systems or persons
    • Accreditation
      • Appropriate quality management system (e.g. ISO 9001)
      • Technical competence with valid results
      • Attestation by a third party, related to conformity assessment , conveying formal demonstration of its competence to carry out specific conformity assessment tasks.
  • 4. Accreditation Body
    • Usually there are national regulations for one or several accreditation bodies in each country
    • There is cooperation between accreditation bodies in international organizations
      • Europe: European Accreditation Cooperation (EA)
      • Worldwide: International Laboratory Accreditation Cooperation (ILAC)
  • 5. Why Accreditation?
    • Recognition of testing competence and reliability
    • International recognition for a laboratory for its competence and authenticity
    • Benchmark for performance
    • Marketing advantage
  • 6. ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    • Conformity assessment standard
    • Developed by ISO Committee CASCO and IEC
    • Revision: ISO/IEC 17025:1999
    • ISO/IEC Guide 25:1990
  • 7. ISO/IEC 17025:2005
    • Contents
    • 1. Scope
    • 2. Normative references
    • 3. Terms and definitions
    • 4. Management requirements
    • 5. Technical requirements
  • 8. 1. Scope
    • Specifies the general requirement for the competence of testing and calibrating laboratories.
    • Applicable to all organizations performing test and/or calibrations, including first-, second- and third-party laboratories.
    • Compliance with ISO 17025 also implies compliance with ISO 9001
    • (Management requirements – ISO 9001)
    • (Technical requirements – ISO/IEC Guide 1990)
    • 2. Normative references
      • As per ISO/IEC 17000 and VIM
    • 3 . Terms and definitions
      • As per ISO/IEC 17000 and VIM
  • 9. 4. Management requirements
    • 4.1 Organization
    • 4.2 Management system
    • 4.3 Document control
    • 4.4 Review of requests, tenders and contracts
    • 4.5 Subcontracting of tests and calibrations
    • 4.6 Purchasing services and supplies
    • 4.7 Service to the customer
    • 4.8 Complaints
    • 4.9 Control of nonconforming testing and/or calibration work
    • 4.10 Improvement
    • 4.11 Corrective action
    • 4.12 Preventive action
    • 4.13 Control of records
    • 4.14 Internal audits
    • 4.15 Management reviews
  • 10. 5. Technical requirements
    • 5.1 General
    • 5.2 Personnel
    • 5.3 Accommodation and environmental conditions
    • 5.4 Test and calibration methods and method validation
    • 5.5 Equipment
    • 5.6 Measurement traceability
    • 5.7 Sampling
    • 5.8 Handling of test and calibration items
    • 5.9 Assuring the quality of test and calibration results
    • 5.10 Reporting the results
  • 11. Organizatio n Organization & management structure Legal status & Lab. responsibility Awareness Confidentiality & proprietary rights Policies to avoid personnel involvement in disruptive activities Deputies of key Managerial personnel Impartiality & independence Specified Responsibilities & authorities Quality Manager Managerial & Technical Staff 4.1 Organization Organization Laboratory responsibility Legal status Confidentiality & proprietary rights Awareness Organization & management structure Internal communication Deputies Supervision Quality manager Impartiality/ independence
  • 12. 4.2 Management System
    • The laboratory shall establish, implement and maintain a “Management System” appropriate to the scope of its activities.
    • The management system’s policies , programs , procedures and instructions ; including a quality policy statement , shall
    • be defined in a “ Quality Manual ”. The overall objectives shall be established, and shall be reviewed during management review. The quality policy statement shall be issued by top management.
  • 13. 4.2 Management system Quality and Technical Records Quality Policy and Objectives Quality Manual Management System Policies and 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
  • 14. 4.2 Management System
    • The “Quality Manual” shall include or make reference to the supporting procedures including technical procedures.
    • The role and responsibilities of technical management and quality manager shell be defined in the “Quality Manual”.
    • In the “Quality Manual” it is described that how requirements pertaining to each clause and sub-clause of the standard are meet.
  • 15. 4.3 Document control Regulatory documents Procedural documents Contractual documents Technical documents External document control Change control Distribution control Obsolete document control Review & approval
  • 16. 4.4 Review of requests, tenders and contracts 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 P R O C E D U R E R E C O R D S End No
  • 17. 4.5 Subcontracting of test and calibration Register of subcontractors Client notification & approval Laboratory responsibility Competent subcontractor
  • 18. 4.6 Purchasing services and supplies Laboratory Receiving verification
    • Reagents
    • Consumables
    • Equipment
    • Services
    Supplier Review & approval Purchase order Selection and evaluation of suppliers
    • Type
    • Class
    • Grade
    • Specifications
    • Technical data
  • 19. 4.7 Services to the customer Laboratory C U S T O M E R R e q u i r e m e n t s Clarify requests Provide access C U S T O M E R S a t i s f a c t i o n Preparation, Analysis and calibration of items Surveys Review of results
  • 20. 4.8 Complaints Receipt of complaint Enter into complaint log Review of complaint Justified? P R O C E D U R E R E C O R D S Take immediate remedial measure Notify the customer Root cause analysis and corrective action Update the log & close out Yes No
  • 21. 4.9 Control of nonconforming testing and/or calibration work 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
  • 22. 4.10 Improvement OBJECTIVES define targets for improvement MONITORING & MEASUREMENT ANALYSIS OF DATA study the trends QUALITY REVIEWS review the achievement of objectives CORRECTIVE ACTION/ PREVENTIVE ACTION Revision
  • 23. 4.11/4.12 Corrective and Preventive Action Identify the problem Investigation the root causes Propose solutions Implement solution Evaluate the effectiveness of solution CORRECTIVE ACTION Action taken to eliminate the problems occurred to avoid their recurrence PREVENTIVE ACTION Action taken to eliminate the potential problems to avoid their occurrence
  • 24. 4.13 Control of records
      • audit reports
      • minutes of management reviews
      • supplier evaluation records
      • purchase records, etc.
      • test results
      • calibration result
      • original observations
      • derived data, etc.
    identification collection Indexing RECORD MANAGEMENT access filling storage maintenance disposal retention legibility security back-up
  • 25. 4.14 Internal audits P R O C E D U R E R E C O R D S Corrective Action And Follow-up Audit Execution Audit Planning Audit Reporting AUDIT CYCLE
  • 26. 4.15 Management review Management Review Meeting 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
  • 27. 5. Technical requirements
    • 5.1 General
    • 5.2 Personnel
    • 5.3 Accommodation and environmental conditions
    • 5.4 Test and calibration methods and method validation
    • 5.5 Equipment
    • 5.6 Measurement traceability
    • 5.7 Sampling
    • 5.8 Handling of test and calibration items
    • 5.9 Assuring the quality of test and calibration results
    • 5.10 Reporting the results
  • 28. 5.1 General
    • Factors effecting the correctness and reliability of test results and calibrations
    • Personnel
    • Accommodation and environmental conditions
    • Test and calibration methods and method validation
    • Equipment
    • Measurement and traceability
    • Sampling
    • Handling of test and calibration items
  • 29. 5.2 Personnel
    • Appropriate competence to perform specific tests and/or calibrations (defined recruitment policy)
    • Policy and procedures for education and training with defined goals
    • Competence and supervision of contact staff
    • Detailed job descriptions identifying responsibilities and authorities
    • Authorized personnel to perform specific tests and/or calibrations, and to issue test reports and/or calibration certificates.
  • 30. 5.3 Accommodation and environmental conditions
    • Adequate energy sources, lighting and environmental conditions which facilitate correctness of tests and/or calibrations
    • Control, monitor and record environmental conditions as per specific requirements
    • Effective separation from neighboring areas and prevention from cross contamination
    • Controlled access and use
    • Good housekeeping
  • 31. 5.4 Test and calibration methods and method validation
    • 5.4.1 General
      • Appropriate methods and procedures for all tests and/or calibrations
      • Written instructions and procedures for operations of equipments and preparation of items for testing and/or calibrations
    • 5.4.2 Selection of Methods
      • Meet needs of customers
      • Appropriate to perform required test and/or calibrations
      • Preferably published in international or national standards.
    • 5.4.3 Laboratory-developed methods
    • 5.4.4 Non-standard methods
  • 32. 5.4 Test and calibration methods and method validation (contd.)
    • 5.4.6 Estimation of uncertainty of measurement
    • Written, applied procedures and records to estimate uncertainty of measurement for all test and calibration types
    • 5.4.7 Control of data
    • Appropriate checks on calculations and data transfer
  • 33. 5.5 Equipment
      • Appropriate capability of equipment and its software, used for testing, calibration and sampling; to achieve the accuracy required
      • Procedures for operation, calibration, transport, storage and planned maintenance of measuring equipments and records
      • Operation of equipment by authorized personnel using up-to-date operational instructions
      • Identification/labeling of each item of equipment and its software and its record
      • Isolation and proper identification of defective equipment
  • 34. 5.6 Measurement traceability
      • The measurements and calibrations made should be traceable to the International System of Units (SI).
      • Reference materials should be traceable to SI units of measurement, or to certified reference materials.
      • If traceability of measurement to SI units is not possible and/or not relevant, calibration should have traceability to appropriate measuring standard.
  • 35. 5.7 Sampling
      • Sampling plan and procedures, in case the Laboratory carries out sampling of substances, materials or products for testing or calibration.
      • Available at the location where sampling is undertaken.
      • Sampling plan based on statistical methods.
      • Deviation (if any) should be recorded
  • 36. 5.8 Handling of test and calibration items
      • Procedures for the transportation, receipt, handling, protection, storage, retention and/or disposal of test and/or calibration items; including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer.
      • Identification system for proper identification of test and calibration items.
      • Checking at receipt of test and/or calibration item regarding any abnormality and record.
      • Procedures and appropriate facilities to avoid deterioration, loss or damage to the test or calibration items, during storage, handling and preparation.
  • 37. 5.9 Assuring the quality of test and calibration results
    • Established quality control procedures for monitoring
    • the validity of tests and calibrations performed.
    • Recording of data in way of trend indication.
    • Application of statistical techniques for data review.
    • Planned and reviewed monitoring which may include:
      • Regular use of certified reference materials and secondary reference materials.
      • Inter-laboratory comparisons and proficiency-testing
      • programs.
  • 38. 5.10 Reporting the results
    • Result of each test or calibration should be reported accurately, clearly, unambiguously and objectively, and in accordance with any specific instructions in the test or calibration method.
    • The results reported in a test report or a calibration certificate should include:
      • All information requested by the customer.
      • Information required for the interpretation of test or calibration results.
      • Information regarding the method used.
      • Opinion and interpretation should include its basis.
  • 39. Training
    • Familiarization and awareness training
    • Training for understanding of standard’s requirements
    • Training for preparation and implementation of required procedures
    • Training for internal auditors
    • Identifying training needs for continues improvement (e.g. on job trainings, special trainings etc) on regular basis and providing such trainings
  • 40. Planning and implementation steps
    • Commitment from the “Top Management”
    • Familiarization and awareness at all levels.
    • Establishment of “Quality Council” comprising of appropriate personnel, to plan, monitor and control the project.
    • Appoint “Quality Manager” for coordination and “Project team”, for document preparation and implementation.
    • Careful study of each clause of the standard and interpretation of its requirements.
    • Gap analysis (Standard’s requirements Vs current practices).
    • Preparation of the required policies, manuals, procedures and documents and implementation.
    • Formation of internal audit team and internal audit.
    • Identification and implementation of corrective and preventive actions.
    • Continues monitoring for effective implementation of the system and improvement.
    • Management review.
    • Application for accreditation.
  • 41. Accreditation Procedure
    • Selection and Application to the accreditation body.
    • Contract with the accreditation body.
    • Nomination and commissioning of assessors.
    • Technical audit of the documents.
    • On-site laboratory assessment.
    • If necessary proficiency testing.
    • Assessment report.
    • Inspection of the report in the committee.
    • Accreditation decision.
    • Publication.
  • 42. Thank You