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ISO/IEC 17025


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ISO/IEC 17025

  2. 2.  ISO/IEC 17025 is the international standard used by laboratories in developing their quality, administrative and technical systems that govern their operations.
  3. 3.  The two main clauses are: o Clause No. 4.0 Management Requirements o Clause No. 5.0 Technical Requirements
  4. 4. Legally Identifiable Meet the needs of Client, ISO/IEC- 17025, regulatory authorities Scope • permanent facilities/mobile facility • Sites away from permanent facility/temporary facility Defined Authority / Responsibility • Part of large organization • Key personnel :- potential conflict of interest • Nominated managers for Quality and Technical Function • Nominated deputies Cont’d
  5. 5.  Free from commercial , financial pressure.  Clients confidential information, proprietary rights.  Competence, Impartiality, judgment and Integrity  Organization chart indicating relationship between Quality Manager, Technical operations and support services  Inter-personnel relationship
  6. 6.  Quality system documentation shall be communicated to, understood by , available to, and implemented by the appropriate personnel.
  7. 7. “a document stating the quality policy and describing the quality system of an organization” ISO 10013
  8. 8. Quality Manual Standard Operation Procedures Test method manual Forms & datasheets Raw Data
  9. 9. - It is to ensure that each person working in laboratory has with him/her, the current version of document, to perform his/her work.
  10. 10.  Review and approval of documents  Master List of procedure • availability • Review, revision & amendment • Externally-generated Documents • removal of obsolete documents • identification of obsolete documents retained for other reasons Cont’d
  11. 11.  Identification of Document • Title • date of issue • revision status • page numbering to signify end of document • authority for issue
  12. 12. The laboratory must have a format procedure for the planned and systematic evaluation of its capability to undertake each new request to provide a testing or measuring service. The procedure will also apply to undertaking or accepting a significant increase in the volume of testing work currently performed.
  13. 13.  Approval from client, preferably in writing, when the lab intends to subcontract.  Ensure and demonstrate subcontractors competence and compliance with 17025.  Laboratory maintains responsibility.  Maintain a register of all subcontracting work.
  14. 14.  Procedures for selection and purchasing of service and supplies that affect the quality of tests  Procedures for handling consumable materials  Purchasing document contains description  Inspected or otherwise verified as complying  Record of evaluation of suppliers of critical service
  15. 15.  Clients allowed to clarify requirements and monitor performance of laboratory.  Laboratory to ensure confidentiality to other clients.
  16. 16.  Policy and procedure for resolution of complaints  Records of complaints, including all investigations and corrective actions
  17. 17.  Policy and procedures for nonconformance in testing. Procedure shall include: • responsibilities and authorities are defined • evaluation of significance • remedial actions • recall of nonconforming work released to clients • responsibility for resumption of work
  18. 18.  Corrective actions focuses on fixing problems that already exist.  Corrective action must be implemented when departures from acceptable practices are identified.  Cause analysis - root cause.  Eliminate the problem, prevent recurrence. Cont’d
  19. 19. Problem Identified Records & Document Updated Corrective Action Affective? Likely Cause Identified Corrective Action Identified Corrective Action Taken No Yes Corrective Action Loop
  20. 20.  Identify potential sources for nonconformance, technical or relating to quality system.  Procedures • initiation of action , implementation • controls to ensure effectiveness
  21. 21.  Procedure for identification, collection, indexing, access, storage, maintenance, disposal of quality and technical records.  Records legible, readily retrievable, stored in a suitable environment.  Secure and in confidence.  Protection and backup of computer records.
  22. 22.  Predetermined schedule.  Comply with requirements of Quality System and ISO/IEC 17025.  All elements of Quality System.  Trained and qualified personnel, independence & Conflict of Interest.  Records maintained of audits findings and corrective actions.
  23. 23.  Management with executive responsibility.  Predetermined schedule.  Suitability and effectiveness.  Changes for improvements.  Record the findings and also corrective actions.  Quality manager is responsible to prepare the agenda.  Quality manager is responsible for action taking as decided by Management Review.
  24. 24. Technical Requirements Clause No. 5.0
  25. 25.  Number required for workload  Qualifications and experience  Responsibilities and authorities  Job descriptions  Performance criteria and performance appraisal  Training needs identification  Training records  Continuing education
  26. 26.  Approved signatory status is granted to those staff members of a laboratory who are sufficiently qualified and experienced and who have been assessed by AB to be fully competent in technical and quality management aspects of the laboratory.
  27. 27. Technical Competence including:  Relevant qualifications and/or experience.  Close involvement in the day-to-day operations.  Familiarity with test procedures including scientific basis and technical limitations.  Ability to make critical evaluation of test results.  Knowledge of Quality Management system.  Knowledge of and commitment to AB and their criteria and ISO/IEC 17025.  Sufficient time in the laboratory to become fully familiar with the operating systems of the laboratory.
  28. 28. A laboratory is any place, in a building or in the field where measurements, tests, calibrations are carried out. ISO/IEC 17025 “The laboratory facilities for testing and/or calibration shall be such as to facilitate correct performance of tests and/or calibrations. The laboratory shall ensure that the environment does not invalidate the results or adversely affect the required quality of any measurement.
  29. 29. The environment is the set of conditions that may influence the test and/or measurement results. Considerations : • Temperature and humidity • Dust, biological sterility,chemical cleanliness • Ventilation and fume extraction • Noise levels and acoustics and ergonomics • Vibration and radiation • Cross contamination prevention • Power Supply and electromagnetic compatibility • Lighting • People access and security issues
  30. 30. ISO/IEC 17025 :1999 - the laboratory shall have instructions on the use of equipment, on the handling, and preparation of items and for test and calibration procedures and the calculation of uncertainty of measurement.  Meets Clients requirements  Test methods from standard writing institution  Laboratory developed test methods  Non standard test methods
  31. 31. Consider:  Client’s wants and needs  Regulatory or standard requirements  Industry acceptance  Sampling and sample preparation  Environmental and accommodation requirements  Staff capability requirements  Repeatability, reproducibility and uncertainty  Recovery or matrix effects  Safety  Cost and time
  32. 32.  Selectivity & specificity  Range  Linearity  Limit of detection  Limit of repeatability  Reproducibility  Ruggedness  Bias  Precision
  33. 33. ISO/IEC 17025 (5.4.6) Calibration laboratory or testing laboratory doing calibrations must formally estimate uncertainty for all calibrations. Testing laboratories must estimate uncertainty but may be with less rigor:- …..They must make a “reasonable estimation” and “attempt to identify all components”.
  34. 34.  Sufficient and appropriate for workload  Fit for purpose  Instillation, Environment  Commissioning and Verification  In-use status to prevent other staff interfering  Maintenance schedules  Operational status - damaged?  Control and repair procedures  Calibrations and schedules  Records of all above items.
  35. 35. Property of the result of a measurement or the value of a standard whereby it can be related to stated references, usually , national or international standards , through an unbroken chain of comparisons all having stated uncertainties NOTES 1. The concept is often expressed by the adjective Traceable 2. The unbroken chain of comparisons is called a Traceability chain.
  37. 37. Reference Material accompanied by, a certificate, one or more of whose property value are certified by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed and for which each certified value is accompanied by an uncertainty at a stated level of confidence. ISO Guide 39 : 1992
  38. 38. Reference materials must be:  Characterized (certified value)  Homogeneous  Stable  Certified, traceable reference materials purchased from reputable sources.  Certified traceable calibration standards traceable to national or international measures.  Reference materials and items used for no other purpose than calibration.  Check intermediate materials and items regularly against reference standards.  Store reference items and materials carefully.
  39. 39.  The sampling process may be one of the most critical aspects of the entire testing procedure, and may be a major contributor to the overall uncertainty of measurement.  The laboratory must assure that the samples for testing have been taken by a skilled person following approved sampling procedures.  When laboratory is not directly responsible for sampling or has no assurance that samples truly representative of the bulk of product to be assessed, the laboratory must protect itself thus: Each test report shall carry a statement such as: “Results relate only to the sample as received”
  40. 40. ISO/IEC 17025:1999 “the laboratory shall have procedure to protect the integrity of test/calibration items ”  Identify test/calibration items & sub- samples throughout.  Record abnormalities of items & consult client for advice.  Prevent deterioration during storage & handing – monitor and record conditions.  Security during storage.  In non-destructive testing, prevent damage/injury to samples/people.  Sampling plan & handling procedures available to sampling staff.
  41. 41.  Quality Control – Operational activities aimed at monitoring the quality of testing throughout the process and at identifying unsatisfactory results. Checking calculations and data transcriptions Blanks, standards, reference items, retest of retained items Replicate testing and statistical calculations (confidence limits) Trends analysis and trend charts The laboratory Comparison Programmes ( Proficiency testing) QUALITY CONTROL INCLUDES PROFICIENCY TESTING
  42. 42.  ILAC Guidance to Clause 5.10 (G.5.10.1) G.5.10.1 laboratories that are accredited by an accreditation body which is a signatory of the ILAC or regional multilateral agreement in the field of testing or calibration, may state on certificates and reports, in the appropriate language: xxxxx (full name or acronym of accreditation body) is one of the signatories to the yyyyy (full name or acronym of the regional or international organization) multilateral agreement / arrangement for the mutual recognition of test reports and/or calibration certificates (whichever is relevant). Cont’d.
  43. 43.  ILAC Guidance to Clause (G. G. accreditation bodies should provide rules for the way in which measurement uncertainty has to be taken into account when statements of compliance are made. Such rules should follow ILAC G8 or EA5/01.  Clause 5.10.6 testing and calibration results obtained from subcontractors.  ILAC Guidance to Clause 5.10.6. (G. G. accreditation bodies should ensure that when the laboratory does not take responsibility for the subcontracted work, as provided for in ISO/IEC 17025 clause 4.5.3 this fact is clearly stated in the report.
  44. 44.  Laboratory clients want the solution to their problem, not a list of numbers  Opinions and interpretations include  Opinions on conformity of samples/items with requirements  Fulfillment of contractual requirements  Recommendation on how to use test results  Guidance on improvements  Special staff will be granted signatory approval for opinions and interpretations.  They may have special technical qualifications.  Knowledge and experience assessed by the technical assessor. Example: Medical Pathologists verses Technologists