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H. Stolz, PTB, November 20101 PTB Principles for the Use of External Certificates for Type Evaluation of Measuring Instruments Harry Stolz PTB Braunschweig,

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Presentation on theme: "H. Stolz, PTB, November 20101 PTB Principles for the Use of External Certificates for Type Evaluation of Measuring Instruments Harry Stolz PTB Braunschweig,"— Presentation transcript:

1 H. Stolz, PTB, November 20101 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

2 Evaluator(s) Certifier(s) H. Stolz, PTB, November 20102 Type Examination (PTB) ManufacturerNotified Body (PTB) Speciments Techn. Docu. Testing- TL3 Laboratory Testing- TL2 Laboratory Testing- TL1 Laboratory Test-/ Inspection Reports Evaluation Report TEC

3 Manuf. MTL Testing- Laboratory Evaluator(s) Certifier(s) H. Stolz, PTB, November 20103 Subcontracting (PTB) ManufacturerNotified Body (PTB) Testing- TL3 Laboratory Testing- TL1 Laboratory External Testing Lab. or Inspection Body National Metrology Institute Another Notified Body Contract Subcontract forbidden Order Test-/ Inspection Report Test-/ Inspection Report(s) (Partial) Evaluation Report TEC Testing- TL2 Laboratory Evaluation Report ?

4 H. Stolz, PTB, November 20104 PTB criteria for 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) Subcontracting

5 Evaluator(s) Certifier(s) H. Stolz, PTB, November 20105 Test Results submitted by the manufacturer ManufacturerNotified Body (PTB) Testing- TL3 Laboratory Testing- TL1 Laboratory Manuf. MTL Testing- Laboratory Test-/ Inspection Report Speciments Techn. Docu. Testing- TL2 Laboratory Spot checks TEC Evaluation Report

6 Evaluator(s) Certifier(s) H. Stolz, PTB, November 20106 Test Results submitted by the manufacturer ManufacturerNotified Body (PTB) Testing- TL3 Laboratory Testing- TL1 Laboratory External Testing Lab. or Inspection Body OIML Issuing Authority Another Notified Body Manuf. MTL Testing- Laboratory Contract Order Test-/ Inspection Report Contract Testing- TL2 Laboratory TEC Evaluation Report OIML Test Report(s) OIML Evaluation Report OIML Certificate Test-/ Inspection Report(s) (Partial) Evaluation Report Parts- or Evaluation Certificate acc. WELMEC Gd. 8.8 Spot checks

7 H. Stolz, PTB, November 20107 PTB criteria for 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 Test Results submitted by the manufacturer

8 H. Stolz, PTB, November 20108 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. Conclusion

9 H. Stolz, PTB, November 20109 PTB Principles for the Use of External Certicicates for Type Evaluation of Measuring Instruments Thank you for your attention !!


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