Guide25 vs ISO/IEC17025


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  • community members who go through the auditing process–which can be anxiety inducing–but you make a great point about how strong systems and dedication to continuous improvement are what management systems are all about. Thanks for sharing.
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  • My presentation is based on the assumption that many of you are at least somewhat familiar with the requirements of ISO/IEC Guide 25. Therefore, I will neither dwell in detail on Guide 25 criteria elements, nor on the details of ISO 17025. Time simply doesn’t permit examination of either document in detail. Also, let me note that for the sake of brevity, I may often refer to these two standards as ISO documents rather than ISO/IEC 17025, or ISO/IEC Guide 25
  • Rather, I will attempt to define the differences between the two standards. First, we should note that 17025 has the same title as Guide 25. Like Guide 25, 17025 applies to both testing and calibration laboratories. The last slide of the pre-printed handout (#32) is a listing of the resource documents used for my presentation. All new applicants whose applications are received after January 1, 2001 will be assessed to 17025. Renewal labs will have the option of compliance with 17025. If they choose Guide 25, they will be required to undergo surveillance for compliance to 17025 in Y2002
  • The 13 requirements of Guide 25 have been split between Management and Technical Requirements sections in 17025. ISO 17025 is aligned much more closely with ISO 9001 than is Guide 25. In fact, Annex 1 is a cross reference between 17025 and 6001 Annex 2 is a set of informative (that is, non-normative) guidelines for establishing interpretations for specific testing fields . . . such as, for example, the calibration field.
  • Of these 14 criteria elements, the requirements for contract review, service to the client, and preventive actions are entirely new. A number of Guide 25 requirements have been split into two or more requirements in 17025 . . accounting for the larger number of requirements. I will discuss them in greater detail later in this presentation.
  • It should be noted that, like Guide 25, the sub-contracting of calibrations to outside services is covered in the criteria element dealing with purchased services and supplies (4.6). The details associated with the section of ISO 17025 that covers technical requirements will be discussed in subsequent slides.
  • The most significant of these differences is the requirement that the laboratory must identify potential conflicts of interest. This new requirement is in addition to the Guide 25-type language requiring that the laboratory have arrangements to ensure that its personnel are free from external pressures that may affect the quality of their work.
  • The requirement that all documentation used in the quality system must be identified in the Quality Manual effectively means that the Quality Manual should address all twenty-three (23) criteria elements of ISO/IEC 17025. This does not mean that all quality procedures and documents need to be contained in the Manual. Rather, the Quality Manual should present all quality policies, and at the same time must identify all daughter documentation. . . .whether located in separate procedures manuals or whether maintained as stand-alone documents. The Quality Manual needs to be a road map to the quality system and its documentation.
  • 17025 is more prescriptive than Guide 25.
  • The new requirements correspond to 10.8 of Guide 25 covering procedures for purchase, receiving and storage of consumable materials, which applies most cogently to chemistry laboratories. 17025 element 4.6 also corresponds to element 15 of Guide 25, which applies to purchased services
  • One approach to meeting this requirement is to have a policy in place that addresses the informative notes to 4.7 (for example, to operate a formal client feed-back program using questionnaires after the work has been completed). With respect to specific calibration program requirements, it is certainly conceivable that either A2LA or NVLAP could recommend, or even require, that calibration laboratories accredited to ISO 17025 offer a calibration- recall service to their clients.
  • The new corrective action requirements are presented in the next slide
  • It should be noted that the bottom line requires that the reason, or reasons, for the non-conformity be determined, that a corrective action be selected and implemented and that it sticks!
  • In addressing this issue, the laboratory must remember that preventive actions are required for quality system elements such as procedural failures (e.g., document control), as well as for its technical activities (such as equipment, calibration, tests and reports).
  • The essential aspect of records retention is the need to preserve sufficient information such that [1] the test can be re-run in all details (test operator, test method, test conditions, etc.), and [2] both raw and analyzed data are retained in all the detail that is necessary for critical technical examination at any time during the entire period of retention.
  • In other words, management review is defined in terms of the scope of the review process, the documentation requirements and the response to any corrective actions that are identified. The assessor must judge the appropriateness of the frequency with which the laboratory performs its management reviews. The frequency must be evaluated against the findings of non-conformities during an audit to 17025.
  • There is more detail in these ISO/IEC 17025 requirements, but no radically new ideas.
  • Unlike Guide 25, 17025 does not directly address the need for maintaining the training of test personnel up-to-date.
  • “ Validation is the confirmation by examination and the provision of objective evidenced that the particular requirements for a specific intended use are fulfilled.” Validation may be done by one or more of the following methods, among others: - calibration using reference standard or materials - comparison of results achieved with other methods - inter-laboratory comparisons - systematic assessment of the factors influencing the result
  • I will not dwell on this slide since I furnished it for information purposes.
  • As both an assessor and quality consultant, I have found that one of the poorest levels of documentation observed in many test laboratories is that of maintenance and preventive maintenance procedures. Too often they are nothing more than aged, dog-eared and faded maintenance suggestions taken from their OEM’s operating instructions and manuals.
  • Although there is no absolute requirement for recording the fact of inspection of incoming samples prior to testing or calibration, it is a very good practice to do so. You, as the operator of either a testing or calibration laboratory, must decide how relevant this idea is for your operation. Lack of a notation that the sample was inspected prior to testing or calibration, regardless of whether a discrepancy was noted, can come back to haunt the laboratory in third party actions.
  • In point of fact, re-testing of retained samples, and re-testing of laboratory-developed secondary reference materials, samples or devices, can permit the generation of statistical quality control charts that provide a great deal of information. SQC charts that show trending, sliding averages, and frequent data outside the established control limits, can signal out-of-control conditions in advance of obtaining defective data. Contra-wise, charts that show a stable mean measurement result with random data about the mean provides a good measure of the accuracy of the measurement.
  • The last item may not apply to calibration laboratories.
  • Guide25 vs ISO/IEC17025

    1. 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. 2. ISO/IEC 17025 - General Requirements for the Competence of Testing and Calibration Laboratories <ul><li>Approved by ISO & IEC Member Nations in 1999 </li></ul><ul><li>First edition published on December 15, 1999 </li></ul><ul><li>Laboratories will be permitted by A2LA to be accredited to both 17025 and Guide 25 in the second half of 2000 </li></ul><ul><li>Mandatory accreditation to ISO/IEC 17025 will be phased in by A2LA over the next two years </li></ul>
    3. 3. Broad Comparison of Guide 25 and 17025 <ul><li>Scope </li></ul><ul><li>Normative References </li></ul><ul><li>Terms and definitions </li></ul><ul><li>Management requirements </li></ul><ul><ul><li>Fourteen criteria elements </li></ul></ul><ul><li>Technical requirements </li></ul><ul><ul><li>Nine criteria elements </li></ul></ul><ul><li>Annexes (informative) </li></ul><ul><li>Bibliography </li></ul><ul><li>Scope </li></ul><ul><li>References </li></ul><ul><li>Definitions </li></ul><ul><li>Requirements </li></ul><ul><ul><li>Thirteen criteria elements </li></ul></ul>ISO/IEC 17025 ISO/IEC Guide 25
    4. 4. ISO-IEC 17025 Management Requirements <ul><li>Organization and management </li></ul><ul><li>Quality system </li></ul><ul><li>Document control </li></ul><ul><li>Review of . . . Contracts </li></ul><ul><li>Sub-contracting tests/cal </li></ul><ul><li>Purchasing services & supplies </li></ul><ul><li>Service to the client </li></ul><ul><li>Complaints </li></ul><ul><li>Control of nonconform-ing testing or calibration </li></ul><ul><li>Corrective action </li></ul><ul><li>Preventive action </li></ul><ul><li>Control of records </li></ul><ul><li>Internal audits </li></ul><ul><li>Management reviews </li></ul>
    5. 5. ISO/IEC 17025 Sections With Essen-tially No Differences from Guide 25 <ul><li>Management requirements </li></ul><ul><ul><li>4.5 Sub-contracting </li></ul></ul><ul><ul><li>4.8 Complaints </li></ul></ul><ul><ul><li>4.13 Internal audits </li></ul></ul><ul><li>Technical requirements </li></ul><ul><ul><li>No new ideas, but more detail </li></ul></ul><ul><ul><li>Details covered in subsequent overheads </li></ul></ul>
    6. 6. ISO/IEC 17025 Differences: 4.1 Organization <ul><li>4.1.1 - Laboratory shall be an entity that can be held legally responsible - versus legally identifiable (a subtle difference) </li></ul><ul><li>4.1.2 - Laboratory responsible for satisfying the client, regulatory authorities and organizations providing recognition </li></ul><ul><li>4.1.4 - Potential conflicts of interest must be identified </li></ul>
    7. 7. ISO/IEC 17025 Differences: 4.2 Quality System <ul><li>Detailed requirements for quality policy statement </li></ul><ul><li>Less prescriptive of what must be in Quality Manual, except that </li></ul><ul><ul><li>Quality Policy Statement </li></ul></ul><ul><ul><li>Structure of all documentation used in quality system </li></ul></ul><ul><ul><li>Roles and responsibilities of technical management and quality manager </li></ul></ul>must be in the Quality Manual
    8. 8. Additional Calibration Program Requirements for 4.2 Quality System <ul><li>Z540-1/A2LA Requirements (Quality Manual) </li></ul><ul><ul><li>Policy establishing/changing calibration intervals* </li></ul></ul><ul><ul><li>Policy on techniques used to determine measurement uncertainty </li></ul></ul><ul><li>A2LA Requirements per ANSI/ASQC M1-1987 </li></ul><ul><ul><li>Assure accuracy by use of TUR  4:1 by controlling equipment, procedures, and calibration intervals, or </li></ul></ul><ul><ul><li>Use of statistical control to obtain measurement assurance using check standards, control charts, round robins and measurement audits. </li></ul></ul>*e.g., per Annex A of ISO 10012-1
    9. 9. ISO/IEC 17025 Differences: 4.3 Document Control <ul><li>Incorporates ISO 9001 clause 4.5 requirements </li></ul><ul><li>Contains specific requirements for control, review and approval, issue and amendment of documents </li></ul>17025 also includes Guide 25’s clause 5.2.(d) relating to procedures for control and maintenance of documentation
    10. 10. ISO/IEC 17025 Differences: 4.4 Requests, Tenders, Contracts <ul><li>NEW </li></ul><ul><ul><li>Identification of customer needs </li></ul></ul><ul><ul><li>Ensure capability to meet needs </li></ul></ul><ul><ul><li>Handle changes and deviations </li></ul></ul><ul><ul><li>Incorporates ISO 9001 requirements </li></ul></ul><ul><li>From Guide 25, clause 5.2(i) </li></ul><ul><ul><li>Arrangements for reviewing new work </li></ul></ul>
    11. 11. ISO/IEC 17025 Differences: 4.6 Purchasing <ul><li>New Requirements (taken from ISO 9001) </li></ul><ul><ul><li>Inspection/verification to ensure purchased items meet specifications </li></ul></ul><ul><ul><li>Requires records of such inspections/verifications </li></ul></ul><ul><ul><li>Review of purchasing documents prior to release </li></ul></ul><ul><ul><li>Evaluation of suppliers of consumables, supplies and services ( including outside calibration services ) </li></ul></ul><ul><li>Also combines some Guide 25 requirements from clause 10.8 and section 15.0 </li></ul>
    12. 12. ISO/IEC 17025 Differences: 4.7 Service to Clients <ul><li>Cooperation with clients </li></ul><ul><li>Notes cover various aspects of laboratory-client relationships </li></ul><ul><li>Equivalent to ISO 9001 clause 4.19 on Servicing </li></ul>Major new requirement :
    13. 13. ISO/IEC 17025 Differences: 4.9 Non-conforming Work <ul><li>More prescriptive procedures for dealing with non-conformities in testing, results, reporting </li></ul><ul><li>Requires formal corrective action procedures under most circumstances </li></ul><ul><li>A2LA Calibration Program requirements additionally mandate that calibration reports contain a statement of any corrective actions bearing on the calibrations </li></ul>
    14. 14. ISO/IEC 17025 Differences: 4.10 Corrective Action <ul><li>Now prescriptive, and requires: </li></ul><ul><ul><li>Root cause analysis </li></ul></ul><ul><ul><li>Selection and implementation of corrective actions </li></ul></ul><ul><ul><li>Monitoring of corrective actions </li></ul></ul><ul><ul><li>Follow-up partial audits </li></ul></ul><ul><li>Essentially expands the brief mentions of corrective action in Guide 25 </li></ul>
    15. 15. ISO/IEC 17025 Differences: 4.11 Preventive Action <ul><li>Wholly new requirement mandates: </li></ul><ul><ul><li>Identification of opportunities for improvement and potential sources of non-conformities </li></ul></ul><ul><ul><li>Action plans </li></ul></ul><ul><ul><li>Preventive action (PA) procedures shall include initiation of PA and application of controls to ensure effectiveness </li></ul></ul><ul><li>No equivalent in Guide 25 </li></ul>
    16. 16. ISO/IEC 17025 Differences: 4.12 Records <ul><li>New Aspects: </li></ul><ul><ul><li>Requires prescriptive procedures for identification, collection, indexing, access, filing, storage, maintenance and disposal, regardless of media form. </li></ul></ul><ul><ul><li>Covers quality system and technical records </li></ul></ul><ul><li>Other requirements consistent with Guide 25 </li></ul><ul><li>A2LA’s Calibration Program also requires: </li></ul><ul><ul><li>Retention for not less than 5 years </li></ul></ul><ul><ul><li>Inclusion of “as found” results </li></ul></ul>
    17. 17. ISO/IEC 17025 Differences: 4.14 Management Reviews <ul><li>Now more prescriptive; reviews must include: </li></ul><ul><ul><li>suitability of policies & procedures </li></ul></ul><ul><ul><li>reports from managerial and supervisory personnel </li></ul></ul><ul><ul><li>results of both internal and external audits </li></ul></ul><ul><ul><li>corrective and preventive actions </li></ul></ul><ul><ul><li>results of interlaboratory and/or proficiency tests </li></ul></ul><ul><ul><li>client feedback and complaints </li></ul></ul><ul><li>No longer need be annual, but must be periodic; annual reviews are suggested </li></ul>
    18. 18. ISO/IEC 17025 Technical Requirements <ul><li>General </li></ul><ul><li>Personnel </li></ul><ul><li>Accommodation & Envi-ronmental Conditions </li></ul><ul><li>Test/Calibration methods and method validation </li></ul><ul><li>Equipment </li></ul><ul><li>Measurement traceability </li></ul><ul><li>Sampling </li></ul><ul><li>Handling of test and calibration items </li></ul><ul><li>Assuring quality of test and calibration results </li></ul><ul><li>Reporting the results </li></ul>
    19. 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. 20. ISO/IEC 17025 Differences: 5.2 Personnel <ul><li>Much more prescriptive than Guide 25 </li></ul><ul><ul><li>supervision of trainees </li></ul></ul><ul><ul><li>appropriate education, training & experience for specific tests </li></ul></ul><ul><ul><li>policy and procedures for training </li></ul></ul><ul><ul><li>suggests minimum content of job descriptions </li></ul></ul><ul><li>ANSI/NCSL Z540-1 requires that the training of test personnel be maintained up-to-date </li></ul><ul><li>A2LA requires individual approval of staff performing calibrations in the field </li></ul>
    21. 21. ISO/IEC 17025 Differences: 5.3 Accommodation & Environment <ul><li>Little change from Guide 25 </li></ul><ul><li>A2LA’s Calibration Program requirements include additional details, several of which are: </li></ul><ul><ul><li>maintain records of continuous temperature & relative humidity for five years, or more </li></ul></ul><ul><ul><li>control must be exercised commensurate with the uncertainties claimed; affect on uncertainties must be demonstrated </li></ul></ul><ul><ul><li>other factors such as air cleanliness, vibration, electrical power and EMI may require control </li></ul></ul>
    22. 22. ISO/IEC 17025 Differences: 5.4 Test & Calibration Methods <ul><li>Significantly more detailed than Guide 25 </li></ul><ul><li>Laboratory-developed and non-standard methods must be validated </li></ul><ul><li>Format of such in-house methods is suggested </li></ul><ul><li>Validation requirements are given, and validation techniques suggested </li></ul><ul><li>Determination of uncertainty of measurement now required of both testing and calibration laboratories </li></ul>
    23. 23. ISO/IEC 17025 Differences: Resources for Determining Uncertainties <ul><li>References to the measurement of uncertainty* </li></ul><ul><ul><li>ISO/TAG 4/WG3 “Guide to the Expression of Uncertainty in Measurement, 1993 </li></ul></ul><ul><ul><li>NIST TN 1297, Guidelines for Evaluating and Expressing Uncertainty of NIST Measurement Results, Barry N. Taylor and Chris E. Kuyatt, 1993 </li></ul></ul><ul><ul><li>NAMAS M 3003 “The Expression of Uncertainty and Confidence in Measurement,” December 1997 </li></ul></ul><ul><ul><li>SINGLAS TECHNICAL GUIDE 1 “Guidelines on the evaluation and expression of the measurement uncertainty,” July 1995 </li></ul></ul>* Selected by the author
    24. 24. ISO/IEC 17025 Differences: 5.5 Equipment <ul><li>More definitive than Guide 25 in some areas: </li></ul><ul><ul><li>up-to-date instructions on use and maintenance </li></ul></ul><ul><ul><li>couples software control to equipment issues </li></ul></ul><ul><ul><li>couples between-calibration checks with equipment issues </li></ul></ul><ul><li>A2LA Calibration Program requires unique identification of measuring instruments for tracking calibration and maintenance (e.g., asset numbers, or equivalent identifications) </li></ul>
    25. 25. ISO/IEC 17025 Differences: 5.6 Measurement Traceability <ul><li>More definition in following areas: </li></ul><ul><ul><li>Wherever possible, traceability to SI units of measurement </li></ul></ul><ul><ul><li>Suggests traceability through calibration lab-oratories accredited to 17025 </li></ul></ul><ul><li>Both A2LA & NVLAP require traceability through accredited calibration laboratories </li></ul><ul><li>A2LA Calibration Program requires formal establishment of calibration intervals* </li></ul>*this requirement presented earlier
    26. 26. ISO/IEC 17025 Differences: 5.7 Sampling <ul><li>Requires sampling plan when sampling </li></ul><ul><li>Not really germane to calibration laboratories </li></ul>
    27. 27. ISO/IEC 17025 Differences: 5.8 Handling Test & Calibration Items <ul><li>Less stringent with respect to recording condition of test item when abnormalities are not found on incoming inspection </li></ul><ul><li>A2LA Calibration Program requires two distinct work areas for: </li></ul><ul><ul><li>Receiving and cleaning, and </li></ul></ul><ul><ul><li>Calibration where measurement standards are maintained </li></ul></ul>
    28. 28. ISO/IEC 17025 Differences: 5.9 Quality Assurance/Control <ul><li>Incorporates Guide 25 clause 5.6 and requires monitoring of results by the following: </li></ul><ul><ul><li>use of certified and/or secondary reference materials </li></ul></ul><ul><ul><li>participation in interlaboratory comparison or proficiency testing programs </li></ul></ul><ul><ul><li>replicate testing/calibrations </li></ul></ul><ul><ul><li>re-calibration or re-testing of retained items </li></ul></ul><ul><li>ANSI/NCSL Z540-1 & Guide 25 requires same*, but also suggests use of statistical techniques </li></ul>*Note A2LA Calibration Program requirement
    29. 29. Calibration Laboratories: Proficiency Testing <ul><li>Both A2LA & NVLAP require that calibration laboratories participate in initial and annual calibration of artifacts </li></ul><ul><li>NVLAP normally requires three artifacts per optical radiation field </li></ul><ul><li>Typically, A2LA requires two to three measurement audits per year </li></ul><ul><li>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 </li></ul>
    30. 30. Calibration Laboratories: Typical Artifacts In Proficiency Testing <ul><li>Photometry </li></ul><ul><li>Spectrophotometry </li></ul><ul><li>Pyrheliometry and Pyranometry </li></ul><ul><li>UV Radiometry </li></ul><ul><li>Spectral Irradiance </li></ul><ul><li>Spectral Responsivity </li></ul><ul><li>Standard Lamps (NIST) </li></ul><ul><li>SRMs or MAPs* (NIST) </li></ul><ul><li>Pyrheliometers & pyranometers (WRR^) </li></ul><ul><li>Reference Radiometers (NIST) </li></ul><ul><li>Regulated Lamps (NIST) </li></ul><ul><li>Reference Detectors (NIST) </li></ul>Optical Field Artifact/Reference Device *MAP = Measurement Assurance Program ^WRR = World Radiometric Reference
    31. 31. ISO/IEC 17025 Differences: 5.10 Reporting Results <ul><li>Simplifies Guide 25 reporting requirements for internal calibrations </li></ul><ul><li>Evidence of traceability on calibration certifi-cates, e.g., logo of accrediting body </li></ul><ul><li>Certificates must not contain recommendations of calibration interval except when agreed upon with client </li></ul><ul><li>Permits inclusion in reports and certificates of interpretations of results </li></ul>
    32. 32. <ul><li>ANSI/NCSL Z540-1-1994, Calibration Laboratories and Measuring and Test Equipment - General Requirements </li></ul><ul><li>ISO 10012-1 (1993) Quality assurance requirements for measuring equipment - Part 1: Metrological confirmation . . </li></ul><ul><li>A2LA Calibration Program Requirements (April 1995) </li></ul><ul><li>A2LA Proficiency Testing Requirements for Accredited Testing and Calibration Laboratories (1999) </li></ul><ul><li>NVLAP Technical Guide for Optical Radiation Calibrations, James L. Cigler et al, Nov. 1993 </li></ul><ul><li>Peter J. Unger, ISO/IEC 17025 Differences with Guide 25 </li></ul>Other Resource Documents