1、ISO Guide 25, ISO 17025 and Optical Metrology: An Assessors Perspective,Gene A. ZerlautSC-International Inc.,CORM 2000Rochester, NYMay 19, 2000,ISO/IEC 17025 - General Requirements for the Competence of Testing and Calibration Laboratories,Approved by ISO & IEC Member Nations in 1999First edition pu
2、blished on December 15, 1999Laboratories will be permitted by A2LA to be accredited to both 17025 and Guide 25 in the second half of 2000Mandatory accreditation to ISO/IEC 17025 will be phased in by A2LA over the next two years,Broad Comparison of Guide 25 and 17025,ScopeNormative ReferencesTerms an
3、d definitionsManagement requirementsFourteen criteria elementsTechnical requirementsNine criteria elementsAnnexes (informative)Bibliography,ScopeReferencesDefinitionsRequirementsThirteen criteria elements,ISO/IEC 17025,ISO/IEC Guide 25,ISO-IEC 17025 Management Requirements,Organization and managemen
4、tQuality systemDocument controlReview of . . . ContractsSub-contracting tests/calPurchasing services & suppliesService to the client,ComplaintsControl of nonconform-ing testing or calibrationCorrective actionPreventive actionControl of recordsInternal auditsManagement reviews,ISO/IEC 17025 Sections
5、With Essen-tially No Differences from Guide 25,Management requirements4.5 Sub-contracting4.8 Complaints4.13 Internal auditsTechnical requirements No new ideas, but more detail Details covered in subsequent overheads,ISO/IEC 17025Differences: 4.1 Organization,4.1.1 - Laboratory shall be an entity tha
6、t 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 recognition4.1.4 - Potential conflicts of interest must be identified,ISO/IEC 17025Differences: 4.2 Qualit
7、y System,Detailed requirements for quality policy statementLess prescriptive of what must be in Quality Manual, except thatQuality Policy StatementStructure of all documentation used in quality systemRoles 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 uncertaintyA2LA Requirements per ANSI/ASQC M1-1987Assure accuracy by use of TUR 4:1 by co
9、ntrolling equipment, procedures, and calibration intervals, orUse 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,ISO/IEC 17025Differences: 4.3 Document Control,Incorporates ISO 9001
10、clause 4.5 requirementsContains specific requirements for control, review and approval, issue and amendment of documents,17025 also includes Guide 25s clause 5.2.(d) relating to procedures for control and maintenance of documentation,ISO/IEC 17025 Differences: 4.4 Requests, Tenders, Contracts,NEWIde
11、ntification of customer needsEnsure capability to meet needsHandle changes and deviationsIncorporates ISO 9001 requirementsFrom Guide 25, clause 5.2(i)Arrangements for reviewing new work,ISO/IEC 17025 Differences: 4.6 Purchasing,New Requirements (taken from ISO 9001)Inspection/verification to ensure
12、 purchased items meet specificationsRequires records of such inspections/verificationsReview of purchasing documents prior to releaseEvaluation of suppliers of consumables, supplies and services (including outside calibration services)Also combines some Guide 25 requirements from clause 10.8 and sec
13、tion 15.0,ISO/IEC 17025 Differences: 4.7 Service to Clients,Cooperation with clientsNotes cover various aspects of laboratory-client relationshipsEquivalent to ISO 9001 clause 4.19 on Servicing,Major new requirement:,ISO/IEC 17025 Differences: 4.9 Non-conforming Work,More prescriptive procedures for
14、 dealing with non-conformities in testing, results, reportingRequires formal corrective action procedures under most circumstancesA2LA Calibration Program requirements additionally mandate that calibration reports contain a statement of any corrective actions bearing on the calibrations,ISO/IEC 1702
15、5 Differences: 4.10 Corrective Action,Now prescriptive, and requires:Root cause analysisSelection and implementation of corrective actionsMonitoring of corrective actionsFollow-up partial auditsEssentially expands the brief mentions of corrective action in Guide 25,ISO/IEC 17025 Differences: 4.11 Pr
16、eventive Action,Wholly new requirement mandates:Identification of opportunities for improvement and potential sources of non-conformitiesAction plans Preventive action (PA) procedures shall include initiation of PA and application of controls to ensure effectivenessNo equivalent in Guide 25,ISO/IEC
17、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 recordsOther requirements consistent with Guide 25A2LAs Calibration P
18、rogram also requires:Retention for not less than 5 yearsInclusion of “as found” results,ISO/IEC 17025 Differences: 4.14 Management Reviews,Now more prescriptive; reviews must include:suitability of policies annual reviews are suggested,ISO/IEC 17025 Technical Requirements,GeneralPersonnelAccommodati
19、on & Envi-ronmental ConditionsTest/Calibration methods and method validationEquipment,Measurement traceabilitySamplingHandling of test and calibration itemsAssuring quality of test and calibration resultsReporting the results,ISO/IEC 17025 Differences in Technical Requirements,More prescriptive than
20、 Guide 25, but nonew ideas.The most significant details are described in the following slidesThe following slides also delineate A2LA & NVLAP Calibration Program requirements,ISO/IEC 17025 Differences: 5.2 Personnel,Much more prescriptive than Guide 25supervision of traineesappropriate education, tr
21、aining & experience for specific testspolicy and procedures for trainingsuggests minimum content of job descriptions ANSI/NCSL Z540-1 requires that the training of test personnel be maintained up-to-dateA2LA requires individual approval of staff performing calibrations in the field,ISO/IEC 17025 Dif
22、ferences: 5.3 Accommodation & Environment,Little change from Guide 25A2LAs Calibration Program requirements include additional details, several of which are:maintain records of continuous temperature affect on uncertainties must be demonstratedother factors such as air cleanliness, vibration, electr
23、ical power and EMI may require control,ISO/IEC 17025 Differences: 5.4 Test & Calibration Methods,Significantly more detailed than Guide 25Laboratory-developed and non-standard methods must be validatedFormat of such in-house methods is suggestedValidation requirements are given, and validation techn
24、iques suggestedDetermination of uncertainty of measurement now required of both testing and calibration laboratories,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, 1
25、993NIST TN 1297, Guidelines for Evaluating and Expressing Uncertainty of NIST Measurement Results, Barry N. Taylor and Chris E. Kuyatt, 1993NAMAS M 3003 “The Expression of Uncertainty and Confidence in Measurement,” December 1997SINGLAS TECHNICAL GUIDE 1 “Guidelines on the evaluation and expression
26、of the measurement uncertainty,” July 1995,* Selected by the author,ISO/IEC 17025 Differences: 5.5 Equipment,More definitive than Guide 25 in some areas: up-to-date instructions on use and maintenancecouples software control to equipment issuescouples between-calibration checks with equipment issues
27、A2LA Calibration Program requires unique identification of measuring instruments for tracking calibration and maintenance (e.g., asset numbers, or equivalent identifications),ISO/IEC 17025 Differences: 5.6 Measurement Traceability,More definition in following areas:Wherever possible, traceability to
28、 SI units of measurementSuggests traceability through calibration lab-oratories accredited to 17025Both A2LA & NVLAP require traceability through accredited calibration laboratoriesA2LA Calibration Program requires formal establishment of calibration intervals*,*this requirement presented earlier,IS
29、O/IEC 17025 Differences: 5.7 Sampling,Requires sampling plan when samplingNot really germane to calibration laboratories,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 inspe
30、ctionA2LA Calibration Program requires two distinct work areas for:Receiving and cleaning, andCalibration where measurement standards are maintained,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 ce
31、rtified and/or secondary reference materialsparticipation in interlaboratory comparison or proficiency testing programsreplicate testing/calibrationsre-calibration or re-testing of retained itemsANSI/NCSL Z540-1 & Guide 25 requires same*, but also suggests use of statistical techniques,*Note A2LA Ca
32、libration Programrequirement,Calibration Laboratories:Proficiency Testing,Both A2LA & NVLAP require that calibration laboratories participate in initial and annual calibration of artifactsNVLAP normally requires three artifacts per optical radiation field Typically, A2LA requires two to three measur
33、ement audits per yearBoth evaluate a calibration laboratorys proficiency test results based on a formula that indicates the labs deviation from the associated reference measurement results and the associated measurement uncertainty,Calibration Laboratories:Typical Artifacts In Proficiency Testing,Ph
34、otometrySpectrophotometryPyrheliometry and PyranometryUV RadiometrySpectral IrradianceSpectral Responsivity,Standard Lamps (NIST)SRMs or MAPs* (NIST)Pyrheliometers & pyranometers (WRR)Reference Radiometers (NIST)Regulated Lamps (NIST)Reference Detectors (NIST),Optical Field,Artifact/Reference Device
35、,*MAP = Measurement Assurance ProgramWRR = World Radiometric Reference,ISO/IEC 17025 Differences: 5.10 Reporting Results,Simplifies Guide 25 reporting requirements for internal calibrationsEvidence of traceability on calibration certifi-cates, e.g., logo of accrediting bodyCertificates must not cont
36、ain recommendations of calibration interval except when agreed upon with clientPermits inclusion in reports and certificates of interpretations of results,ANSI/NCSL Z540-1-1994, Calibration Laboratories and Measuring and Test Equipment - General RequirementsISO 10012-1 (1993) Quality assurance requi
37、rements 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. 1993Peter J. Unger, ISO/IEC 17025 Differences with Guide 25,Other Resource Documents,
