1. ISO Guide 25, ISO 17025 and Optical Metrology: An Assessor’s Perspective Gene A. Zerlaut SC-International Inc. CORM 2000 Rochester, NY May 19, 2000

2. ISO/IEC 17025 - General Requirements for the Competence of Testing and Calibration Laboratories Approved by ISO & IEC Member Nations in 1999 First edition published on December 15, 1999 Laboratories will be permitted by A2LA to be accredited to both 17025 and Guide 25 in the second half of 2000 Mandatory accreditation to ISO/IEC 17025 will be phased in by A2LA over the next two years

3. Broad Comparison of Guide 25 and 17025 Scope Normative References Terms and definitions Management requirements –Fourteen criteria elements Technical requirements –Nine criteria elements Annexes (informative) Bibliography Scope References Definitions Requirements –Thirteen criteria elements ISO/IEC 17025ISO/IEC Guide 25

4. ISO-IEC 17025 Management Requirements Organization and management Quality system Document control Review of... Contracts Sub-contracting tests/cal Purchasing services & supplies Service to the client Complaints Control of nonconform- ing testing or calibration Corrective action Preventive action Control of records Internal audits Management reviews

5. ISO/IEC 17025 Sections With Essen- tially No Differences from Guide 25 Management requirements –4.5 Sub-contracting –4.8 Complaints –4.13 Internal audits Technical requirements – No new ideas, but more detail – Details covered in subsequent overheads

6. ISO/IEC 17025 Differences: 4.1 Organization 4.1.1 - Laboratory shall be an entity that can be held legally responsible - versus legally identifiable (a subtle difference) 4.1.2 - Laboratory responsible for satisfying the client, regulatory authorities and organizations providing recognition 4.1.4 - Potential conflicts of interest must be identified

7. ISO/IEC 17025 Differences: 4.2 Quality System Detailed requirements for quality policy statement Less prescriptive of what must be in Quality Manual, except that –Quality Policy Statement –Structure of all documentation used in quality system –Roles and responsibilities of technical management and quality manager must be in the Quality Manual

8. Additional Calibration Program Requirements for 4.2 Quality System Z540-1/A2LA Requirements (Quality Manual) –Policy establishing/changing calibration intervals* –Policy on techniques used to determine measurement uncertainty A2LA Requirements per ANSI/ASQC M1-1987 –Assure accuracy by use of TUR  4:1 by controlling equipment, procedures, and calibration intervals, or –Use of statistical control to obtain measurement assurance using check standards, control charts, round robins and measurement audits. *e.g., per Annex A of ISO 10012-1

9. ISO/IEC 17025 Differences: 4.3 Document Control Incorporates ISO 9001 clause 4.5 requirements Contains specific requirements for control, review and approval, issue and amendment of documents 17025 also includes Guide 25’s clause 5.2.(d) relating to procedures for control and maintenance of documentation

10. ISO/IEC 17025 Differences: 4.4 Requests, Tenders, Contracts NEW –Identification of customer needs –Ensure capability to meet needs –Handle changes and deviations –Incorporates ISO 9001 requirements From Guide 25, clause 5.2(i) –Arrangements for reviewing new work

11. ISO/IEC 17025 Differences: 4.6 Purchasing New Requirements (taken from ISO 9001) –Inspection/verification to ensure purchased items meet specifications –Requires records of such inspections/verifications –Review of purchasing documents prior to release –Evaluation of suppliers of consumables, supplies and services (including outside calibration services) Also combines some Guide 25 requirements from clause 10.8 and section 15.0

12. ISO/IEC 17025 Differences: 4.7 Service to Clients Cooperation with clients Notes cover various aspects of laboratory-client relationships Equivalent to ISO 9001 clause 4.19 on Servicing Major new requirement :

13. ISO/IEC 17025 Differences: 4.9 Non-conforming Work More prescriptive procedures for dealing with non-conformities in testing, results, reporting Requires formal corrective action procedures under most circumstances A2LA Calibration Program requirements additionally mandate that calibration reports contain a statement of any corrective actions bearing on the calibrations

14. ISO/IEC 17025 Differences: 4.10 Corrective Action Now prescriptive, and requires: –Root cause analysis –Selection and implementation of corrective actions –Monitoring of corrective actions –Follow-up partial audits Essentially expands the brief mentions of corrective action in Guide 25

15. ISO/IEC 17025 Differences: 4.11 Preventive Action Wholly new requirement mandates: –Identification of opportunities for improvement and potential sources of non-conformities –Action plans –Preventive action (PA) procedures shall include initiation of PA and application of controls to ensure effectiveness No equivalent in Guide 25

16. ISO/IEC 17025 Differences: 4.12 Records New Aspects: –Requires prescriptive procedures for identification, collection, indexing, access, filing, storage, maintenance and disposal, regardless of media form. –Covers quality system and technical records Other requirements consistent with Guide 25 A2LA’s Calibration Program also requires: –Retention for not less than 5 years –Inclusion of “as found” results

17. ISO/IEC 17025 Differences: 4.14 Management Reviews Now more prescriptive; reviews must include: –suitability of policies & procedures –reports from managerial and supervisory personnel –results of both internal and external audits –corrective and preventive actions –results of interlaboratory and/or proficiency tests –client feedback and complaints No longer need be annual, but must be periodic; annual reviews are suggested

18. ISO/IEC 17025 Technical Requirements General Personnel Accommodation & Envi- ronmental Conditions Test/Calibration methods and method validation Equipment Measurement traceability Sampling Handling of test and calibration items Assuring quality of test and calibration results Reporting the results

19. ISO/IEC 17025 Differences in Technical Requirements More prescriptive than Guide 25, but no new ideas. The most significant details are described in the following slides The following slides also delineate A2LA & NVLAP Calibration Program requirements

20. ISO/IEC 17025 Differences: 5.2 Personnel Much more prescriptive than Guide 25 –supervision of trainees –appropriate education, training & experience for specific tests –policy and procedures for training –suggests minimum content of job descriptions ANSI/NCSL Z540-1 requires that the training of test personnel be maintained up-to-date A2LA requires individual approval of staff performing calibrations in the field

21. ISO/IEC 17025 Differences: 5.3 Accommodation & Environment Little change from Guide 25 A2LA’s Calibration Program requirements include additional details, several of which are: –maintain records of continuous temperature & relative humidity for five years, or more –control must be exercised commensurate with the uncertainties claimed; affect on uncertainties must be demonstrated –other factors such as air cleanliness, vibration, electrical power and EMI may require control

22. ISO/IEC 17025 Differences: 5.4 Test & Calibration Methods Significantly more detailed than Guide 25 Laboratory-developed and non-standard methods must be validated Format of such in-house methods is suggested Validation requirements are given, and validation techniques suggested Determination of uncertainty of measurement now required of both testing and calibration laboratories

23. ISO/IEC 17025 Differences: Resources for Determining Uncertainties References to the measurement of uncertainty* –ISO/TAG 4/WG3 “Guide to the Expression of Uncertainty in Measurement, 1993 –NIST TN 1297, Guidelines for Evaluating and Expressing Uncertainty of NIST Measurement Results, Barry N. Taylor and Chris E. Kuyatt, 1993 –NAMAS M 3003 “The Expression of Uncertainty and Confidence in Measurement,” December 1997 –SINGLAS TECHNICAL GUIDE 1 “Guidelines on the evaluation and expression of the measurement uncertainty,” July 1995 * Selected by the author

24. ISO/IEC 17025 Differences: 5.5 Equipment More definitive than Guide 25 in some areas: –up-to-date instructions on use and maintenance –couples software control to equipment issues –couples between-calibration checks with equipment issues A2LA Calibration Program requires unique identification of measuring instruments for tracking calibration and maintenance (e.g., asset numbers, or equivalent identifications)

25. ISO/IEC 17025 Differences: 5.6 Measurement Traceability More definition in following areas: –Wherever possible, traceability to SI units of measurement –Suggests traceability through calibration lab- oratories accredited to 17025 Both A2LA & NVLAP require traceability through accredited calibration laboratories A2LA Calibration Program requires formal establishment of calibration intervals* *this requirement presented earlier

26. ISO/IEC 17025 Differences: 5.7 Sampling Requires sampling plan when sampling Not really germane to calibration laboratories

27. ISO/IEC 17025 Differences: 5.8 Handling Test & Calibration Items Less stringent with respect to recording condition of test item when abnormalities are not found on incoming inspection A2LA Calibration Program requires two distinct work areas for: –Receiving and cleaning, and –Calibration where measurement standards are maintained

28. ISO/IEC 17025 Differences: 5.9 Quality Assurance/Control Incorporates Guide 25 clause 5.6 and requires monitoring of results by the following: –use of certified and/or secondary reference materials –participation in interlaboratory comparison or proficiency testing programs –replicate testing/calibrations –re-calibration or re-testing of retained items ANSI/NCSL Z540-1 & Guide 25 requires same*, but also suggests use of statistical techniques *Note A2LA Calibration Program requirement

29. Calibration Laboratories: Proficiency Testing Both A2LA & NVLAP require that calibration laboratories participate in initial and annual calibration of artifacts NVLAP normally requires three artifacts per optical radiation field Typically, A2LA requires two to three measurement audits per year Both evaluate a calibration laboratory’s proficiency test results based on a formula that indicates the lab’s deviation from the associated reference measurement results and the associated measurement uncertainty

30. Calibration Laboratories: Typical Artifacts In Proficiency Testing Photometry Spectrophotometry Pyrheliometry and Pyranometry UV Radiometry Spectral Irradiance Spectral Responsivity Standard Lamps (NIST) SRMs or MAPs* (NIST) Pyrheliometers & pyranometers (WRR^) Reference Radiometers (NIST) Regulated Lamps (NIST) Reference Detectors (NIST) Optical FieldArtifact/Reference Device *MAP = Measurement Assurance Program ^WRR = World Radiometric Reference

31. ISO/IEC 17025 Differences: 5.10 Reporting Results Simplifies Guide 25 reporting requirements for internal calibrations Evidence of traceability on calibration certifi- cates, e.g., logo of accrediting body Certificates must not contain recommendations of calibration interval except when agreed upon with client Permits inclusion in reports and certificates of interpretations of results

32. ANSI/NCSL Z540-1-1994, Calibration Laboratories and Measuring and Test Equipment - General Requirements ISO 10012-1 (1993) Quality assurance requirements for measuring equipment - Part 1: Metrological confirmation.. A2LA Calibration Program Requirements (April 1995) A2LA Proficiency Testing Requirements for Accredited Testing and Calibration Laboratories (1999) NVLAP Technical Guide for Optical Radiation Calibrations, James L. Cigler et al, Nov. 1993 Peter J. Unger, ISO/IEC 17025 Differences with Guide 25 Other Resource Documents