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PTB Principles for the Use of External Certificates for Type Evaluation of Measuring Instruments

PTB Principles for the Use of External Certificates for Type Evaluation of Measuring Instruments Harry Stolz PTB Braunschweig, GERMANY Certification Body www.ptb.de/en/org/zs. Type Examination (PTB). Manufacturer. Notified Body (PTB). Test-/ Inspection Reports.

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PTB Principles for the Use of External Certificates for Type Evaluation of Measuring Instruments

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  1. PTB Principles for theUse of External Certificatesfor Type Evaluation of Measuring Instruments • Harry Stolz • PTB Braunschweig, GERMANY • Certification Bodywww.ptb.de/en/org/zs H. Stolz, PTB, November 2010

  2. Type Examination (PTB) Manufacturer Notified Body (PTB) Test-/ Inspection Reports Testing- TL1Laboratory Testing- TL2Laboratory Techn. Docu. Testing- TL3Laboratory Evaluation Report Evaluator(s) Speciments TEC Certifier(s) H. Stolz, PTB, November 2010

  3. Subcontracting (PTB) Manufacturer Notified Body (PTB) Testing- TL1Laboratory Testing- TL2Laboratory Testing- TL3Laboratory  ? Subcontract forbidden Evaluation Report Evaluator(s) Order Manuf. MTLTesting- Laboratory TEC Certifier(s) Contract Contract Contract External Testing Lab. orInspection Body National Metrology Institute AnotherNotifiedBody Test-/ Inspection Report Test-/ Inspection Report(s) (Partial)Evaluation Report H. Stolz, PTB, November 2010

  4. Subcontracting • PTB criteriafor subcontracting of test and examinations • within conformity assessment services • as notified body 0102: • PTB subcontractors shall fulfill the same criteria as a notified body (competence and impartiality, see MID article 12) • no subcontracting of evaluation activities (at the moment) H. Stolz, PTB, November 2010

  5. Test Results submitted by the manufacturer Manufacturer Notified Body (PTB) Spotchecks Testing- TL1Laboratory Testing- TL2Laboratory Techn. Docu. Testing- TL3Laboratory Evaluation Report Evaluator(s) Speciments Manuf. MTLTesting- Laboratory TEC Certifier(s) Test-/ Inspection Report H. Stolz, PTB, November 2010

  6. Test Results submitted by the manufacturer Manufacturer Notified Body (PTB) Spotchecks Testing- TL1Laboratory Order Testing- TL2Laboratory Testing- TL3Laboratory Evaluation Report Evaluator(s) Manuf. MTLTesting- Laboratory TEC Certifier(s) Contract Contract Contract ExternalTesting Lab. orInspection Body OIMLIssuing Authority AnotherNotifiedBody OIML TestReport(s) OIMLEvaluation Report Test-/ Inspection Report(s) (Partial)Evaluation Report Test-/ Inspection Report OIML Certificate Parts- or Evaluation Certificate acc. WELMEC Gd. 8.8 H. Stolz, PTB, November 2010

  7. Test Results submitted by the manufacturer • PTB criteriafor acceptance of test results submitted by the manufacturer within conformity assessment services as notified body 0102: • identical test objects • comparable test procedures • proof of competence of testing laboratory(ISO/IEC 17025) • proof of reliability and integrity of testing laboratory by long term experience, spot checks or witnessing H. Stolz, PTB, November 2010

  8. Conclusion • A notified body may take into account external test results or partial evaluations under clear defined conditions, which secure that the notified body remains responsible for its certificates: • Subcontracting -> only to bodies which fulfill MID article 12 • Acceptance of test results submitted by the manufacturer -> only if the notified body proofs competence and integrity and has the ability to perform spot checks or witnessing • Recommendation to WELMEC WG 7: • Consider possibilities and necessary conditions for a modular testing and/or evaluation of the software (or IT-aspects ?) of measuring instruments by specialized external laboratories. H. Stolz, PTB, November 2010

  9. PTB Principles for theUse of External Certicicatesfor Type Evaluation of Measuring Instruments • Thank you for your attention !! H. Stolz, PTB, November 2010

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