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PTB Certification Body (CB) Services offered Organisation Certification processes

PTB Certification Body (CB) Services offered Organisation Certification processes Public available information Harry Stolz PTB Braunschweig , GERMANY Certification Body www.zs.ptb.de. PTB Certification Body (CB) Services offered Organisation Certification processes

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PTB Certification Body (CB) Services offered Organisation Certification processes

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  1. PTB Certification Body (CB) • Services offered • Organisation • Certification processes • Public available information • Harry Stolz • PTB Braunschweig, GERMANY • Certification Bodywww.zs.ptb.de H. Stolz, PTB, July 2011

  2. PTB Certification Body (CB) • Services offered • Organisation • Certification processes • Public available information • Harry Stolz • PTB Braunschweig, GERMANY • Certification Bodywww.ptb.de/en/org/zs H. Stolz, PTB, July 2011

  3. Service Offer of PTB Certification Body • Competentandindependent (3rd Party) • ProductConformityAssessment Services • TE (Type Examinations) • CTT (ConformityTo Type) assessements • forManufacturersoflegallycontrolledinstrumentsorequipment • as a basisfortheaccesstotheGerman, European or International Market Measuring Instruments Explosion Protection Shooting Devices H. Stolz, PTB, July 2011

  4. Service Offer of PTB Certification Body • Conformity assessments in the legally controlled area: • EC- und EFTA: • Conformity assessments (in the first instance type examinations and quality management approvals) according to European directives of the New Approach(Notified Body No. 0102) 94/9/EC, 2009/23EC, 2004/22/EC, 2006/42/EC • EEC-type approvals of measuring instruments on the basis of the outline directive 2009/34/EC and the instrument specific directives 71/347/EEC, 76/765/EEC, 76/766/EEC, 86/217/EEC • Germany: • Nation type approvals in accordance with the German Verification Act • Nation type approvals in accordance with the German ProofTestingAct • Nation type approvals in accordance with the German Weapon Act • Conformity assessments in the voluntary area: • International: • OIML-Certifiations within the scope of the OIML certification system (acc. OIML B 3 + B 10) • IECEx-Certifiations within the scope of the IECEx System (acc. IECEx Rules) • Germany, EC, EFTA : • Voluntary type tests of measuring instruments and components of measuring instruments in accordance with accepted rules of technology H. Stolz, PTB, July 2011

  5. Kinds of Reports -> Measurement and inspection results • Test report / Inspection report • result report of testing laboratory / technical PTB division • Internal record, customer (if requested) • recipient: evaluator, market surveillance (if requested), customer (if requested) • signature by testing laboratory / technical PTB division • Audit report • Report of audit team • recipient: certifier, customer, market surveillance (if requested) -> Audit findings and corrective actions • Evaluation report • internal record • recipient: certifier, market surveillance (if requested) • signature by evaluator -> Statement of compliance with certification criteria • Certificate • result report of CB • responsible signature by authorized certifier • partly additional signature by evaluator -> Certification Scope: Description of certified products or systems H. Stolz, PTB, July 2011

  6. Kinds of Certificates issued by PTB CB • Z1-01 EG-Baumusterprüfbescheinigung nach Richtlinie 94/9/EG, einschließlich Ergänzung und Datenblatt • Z1-02 Konformitätsbescheinigung über die Einzelprüfung nach Richtlinie 94/9/EG, Anhang IX • Z1-03 Mitteilung über die Anerkennung der Qualitätssicherung Produktion nach Richtlinie 94/9/EG, Anhang IV bzw. VII • Z1-04 Konformitätsbescheinigung über die Prüfung der Produkte nach Richtlinie 94/9/EG, Anhang V • Z1-05 Mitteilung über die Konformität mit der Bauart nach Richtlinie 94/9/EG, Anhang VI • Z1-06 Schreiben über die Aufbewahrung von Referenzunterlagen von Herstellern • Z1-07 KonformitätsaussagenachRichtlinie 94/9/EG • Z1-08 IECEx Certificate of Conformity • Z1-09 IECEx Quality Assesment Report • Z1-10 IECEx Test Report Cover Sheet • Z1-11 IECExConformity Mark License • Z1-12 Zertifikat – Flammpunktbestimmung • Z1-13 EG-Baumusterprüfbescheinigung nach Richtlinie 2006/42/EG • Z1-14 Bauartzulassung nach §§ 7, 8 und 9 BeschG • Z1-15 Anzeigen nach § 9 Abs.2 BeschG • Z1-16 Bauartzulassung nach § 20 WaffG • Z1-17 Markenanzeige nach § 24 Abs. 5 WaffG • Z2-01 EG-Bauartzulassung nach Richtlinie 2009/23/EG • Z2-02 Prüfschein einer benannten Stelle für NAWI-Komponenten gemäß QM-VA-21 • Z2-03 OIML-Zertifikat nach dem OIML Basis-Zertifizierungssystem gemäß OIML B3 • Z2-04 OIML-Zertifikat nach dem OIML MAA gemäß OIML B10 • Z3-01 EG-Baumusterprüfbescheinigung nach Richtlinie 2004/22/EG Anh. B • Z3-02 EG-Entwurfsprüfbescheinigung nach Richtlinie 2004/22/EG Anh. H1 • Z3-03 QM-Anerkennung nach Richtlinie 2004/22/EG Anh. D, D1, E, E1, H bzw. H1 • Z3-04 Bewertungs-Zertifikat nach WELMEC Leitfaden 8.8 • Z3-05 Baueinheiten-Zertifikat nach WELMEC Leitfaden 8.8 • Z4-01 Innerstaatliche Bauartzulassung nach § 16 Abs. 1 bis 3 EO • Z4-02 EWG-Bauartzulassung nach § 16 Abs. 4 EO Explosions-Protection Shooting Devices Measuringinstruments Total no. of certificates issued in 2009: ca. 2500 H. Stolz, PTB, July 2011

  7. PTB Certification Body (CB) • Services offered • Organisation • Certification processes • Public available information • Harry Stolz • PTB Braunschweig, GERMANY • Certification Bodywww.ptb.de/en/org/zs H. Stolz, PTB, July 2011

  8. Organisational Chart of PTB Certification Body Notified Body No. 0102 for 94/9/EC, 2009/23/EC, 2004/22/EC, 2006/42/EC H. Stolz, PTB, July 2011

  9. PTB Certification Body • Founded October 2008 • Horizontal organisation unit • Certifiers and Evaluators are functional supervised by the certification body, but remain staff members of the technical PTB divisions • Overall responsibility for most conformity assessment activities of PTB (in general type examinations and quality management system approvals) • Operates quality management system according to EN 45011 and ISO/IEC 17021, integral part in quality management system of PTB • Technical PTB divisions serve as corresponding “testing laboratories” according to ISO/IEC 17025 (Technical PTB divisions are part of the “Notified Body” PTB, but not part of the certification body) H. Stolz, PTB, July 2011

  10. Certification Policies • Competence • Impartiality and Independency • The PTB CB acts only as third party(the personnel involved in the certification process shall not be directly involved in the design, manufacture, marketing, installation, use or maintenance of the instruments) • With regard to ist certification activities CB personnel (particular CB management and certifiers) is free form instructions of its diciplinarians • Four-eye principle (Personal separation of evaluation and certification decision) • Remuneration of CB personnel is not affected by certification results • Neutrality • Non discrimination of customers • Confidentiality H. Stolz, PTB, July 2011

  11. Management of Certification Body Head of CB H. Stolz QM of CB H. Stolz Certification CouncilHead CB, QM CB, Sectors, Legal adv. Structure of PTB Certification Body ZS Advisory BoardExplosion Protection Advisory Board Measuring Instruments accredited Sector 1Explosion Protection and Shooting Devices Sector 2Non automatic weighing instrum. and OIML-Certifications Sector 3Measuring Instruments Directive Sector 4Measuring instruments - Domestic andEEC-Type Approvals Dr. U. Johannsmeyer Dr. H. Stolz Dr. C. Mengersen Dr. D. Ratschko Certifiers Certifiers Certifiers Certifiers Evaluators Evaluators Evaluators Evaluators Auditors andexperts Auditors andexperts Self declaration + peer evaluation Technical PTB-Divisions 1…8 Laboratories acc. to ISO/IEC 17025Responsible for Testing H. Stolz, PTB, July 2011

  12. Tasks • Head of CB: • Overall responsibility of CB, particularly • Conformity assessment activities within CB scope • Central Contact • Operation of QM-System (integrated in QMS PTB) • Report to Presidential Board of PTB • Heads of Sectors: • Appointment, coordination and supervision of Certifiers and evaluators • Sector specific decisions • Evaluators: • Order processing • Evaluation report • Preparation of Certificates • Certifiers: • Order reception • Supervision of orders • Certification decision • Signing and Issuing of Certificates The Certifier must not be Evaluator, Auditor or expert for the same order • Laboratory personell: • Performing Tests • Test report • Auditors and experts: • Performing audits • Audit report H. Stolz, PTB, July 2011

  13. PTB-Divisions“ 1, 2, ….. 8, Q, Z Formal Integration of CB in PTB Structure Top managementStrategy, Resources PTB Council for Metrological ServicesHead Prof. M. Peters (Vice President of PTB) Presidential Board of PTB PTB Council for Quality ManagementHead Dr. A. Odin (Senior Quality Manager of PTB) Operative level Department Q.3 Head Dr. P. Ulbig WG Q.31 WG Q.32 WG Q.33 C. Mengersen H. Stolz B. Smandek Legal Certification Technology Metrology Body Transfer EconomySupport Metrology Authority Notified Body H. Stolz, PTB, July 2011

  14. PTB Certification Body (CB) • Services offered • Organisation • Certification processes • Public available information • Harry Stolz • PTB Braunschweig, GERMANY • Certification Bodywww.ptb.de/en/org/zs H. Stolz, PTB, July 2011

  15. Procedure of Type Examinationaccordingto 2004/22/EG Anh. B Provision of information www.zs.ptb.de Application AGB ofPTB Order confirmation Evaluation oftechnicaldocumentation Evaluation of existing test reports Identification of tests still necessary Performance of remaining tests Test reports Evaluation report Review and final evaluation Certificate Certification decision Updating the certificates database Database MICert Revision p.r.n. Evaluation ofnotifications on changes of the certified type Certificate Prolongation (after 10 years) H. Stolz, PTB, July 2011

  16. Procedure of the QM-Approvalaccordingto 2004/22/EG Anh. D, D1, E, E1, H, H1 Provision of information www.zs.ptb.de Application Application form Order confirmation AGB + AZB ofPTB Nomination of the audit team Stage 1 Audit Audit report Stage 2 Audit Evaluation of the quality system Evaluation report Decision about QM-Approval Certificate Updating the certificates database Database MICert Evaluation ofnotifications on changes of the quality system Revision p.r.n. Annual surveillancevisits + spot check, where appropriate Audit report Certificate Reassessment (after 3 years) H. Stolz, PTB, July 2011

  17. PTB Certification Body (CB) • Services offered • Organisation • Certification processes • Public available information • Harry Stolz • PTB Braunschweig, GERMANY • Certification Bodywww.ptb.de/en/org/zs H. Stolz, PTB, July 2011

  18. Public available Information of CB • Service offer • Contact persons • Quality Manual of PTB CB (incl. statement of independence, impartiality, liability and confidentiality) • Information about fees • General Terms and Conditions of Business of PTB • General Terms and Conditions of Certification of PTB • Databases of Certificates issued by PTB CB • Specific information about Certification Schemes(e.g. Certification Criteria, Procedures, Application forms) • -> www.zs.ptb.de H. Stolz, PTB, July 2011

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