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H. Stolz, PTB, July 20111 PTB Certification Body (CB) Services offered Organisation Certification processes Public available information Harry Stolz PTB.

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Presentation on theme: "H. Stolz, PTB, July 20111 PTB Certification Body (CB) Services offered Organisation Certification processes Public available information Harry Stolz PTB."— Presentation transcript:

1 H. Stolz, PTB, July PTB Certification Body (CB) Services offered Organisation Certification processes Public available information Harry Stolz PTB Braunschweig, GERMANY Certification Body

2 H. Stolz, PTB, July PTB Certification Body (CB) Services offered Organisation Certification processes Public available information Harry Stolz PTB Braunschweig, GERMANY Certification Body

3 H. Stolz, PTB, July Service Offer of PTB Certification Body Competent and independent (3rd Party) Product Conformity Assessment Services TE(Type Examinations) CTT (Conformity To Type) assessements for Manufacturers of legally controlled instruments or equipment as a basis for the access to the German, European or International Market Measuring Instruments Explosion Protection Shooting Devices

4 H. Stolz, PTB, July 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 Proof Testing Act ­ ­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

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

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

7 H. Stolz, PTB, July PTB Certification Body (CB) Services offered Organisation Certification processes Public available information Harry Stolz PTB Braunschweig, GERMANY Certification Body

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

9 H. Stolz, PTB, July 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 and ISO/IEC 17021, integral part in quality management system of PTB Technical PTB divisions serve as corresponding “testing laboratories” according to ISO/IEC (Technical PTB divisions are part of the “Notified Body” PTB, but not part of the certification body)

10 H. Stolz, PTB, July 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

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

12 H. Stolz, PTB, July 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 Certifiers: Order reception Supervision of orders Certification decision Signing and Issuing of Certificates Evaluators: Order processing Evaluation report Preparation of Certificates Laboratory personell: Performing Tests Test report Auditors and experts: Performing audits Audit report The Certifier must not be Evaluator, Auditor or expert for the same order

13 H. Stolz, PTB, July Formal Integration of CB in PTB Structure 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 Presidential Board of PTB PTB Council for Metrological Services Head Prof. M. Peters (Vice President of PTB) PTB Council for Quality Management Head Dr. A. Odin (Senior Quality Manager of PTB) Top management Strategy, Resources Operative level PTB-Divisions“ 1, 2, ….. 8, Q, Z Metrology Authority Notified Body Economy Support

14 H. Stolz, PTB, July PTB Certification Body (CB) Services offered Organisation Certification processes Public available information Harry Stolz PTB Braunschweig, GERMANY Certification Body

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

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

17 H. Stolz, PTB, July PTB Certification Body (CB) Services offered Organisation Certification processes Public available information Harry Stolz PTB Braunschweig, GERMANY Certification Body

18 H. Stolz, PTB, July 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) ->


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