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 transcript:

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

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

Manuf. MTL Testing- Laboratory Evaluator(s) Certifier(s) H. Stolz, PTB, November 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 ?

H. Stolz, PTB, November 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

Evaluator(s) Certifier(s) H. Stolz, PTB, November 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

Evaluator(s) Certifier(s) H. Stolz, PTB, November 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

H. Stolz, PTB, November 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

H. Stolz, PTB, November 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

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