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PTB Certification Body (CB)
Services offered Organisation Certification processes Public available information Harry Stolz PTB Braunschweig, GERMANY Certification Body H. Stolz, PTB, July 2011
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PTB Certification Body (CB)
Services offered Organisation Certification processes Public available information Harry Stolz PTB Braunschweig, GERMANY Certification Body H. Stolz, PTB, July 2011
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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 H. Stolz, PTB, July 2011
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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 H. Stolz, PTB, July 2011
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Kinds of Reports Audit report Evaluation report Certificate
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 -> Measurement and inspection results 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
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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 Konformitätsaussage nach Richtlinie 94/9/EG Z1-08 IECEx Certificate of Conformity Z1-09 IECEx Quality Assesment Report Z1-10 IECEx Test Report Cover Sheet Z1-11 IECEx Conformity 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 Measuring instruments Total no. of certificates issued in 2009: ca. 2500 H. Stolz, PTB, July 2011
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PTB Certification Body (CB)
Services offered Organisation Certification processes Public available information Harry Stolz PTB Braunschweig, GERMANY Certification Body H. Stolz, PTB, July 2011
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Organisational Chart of PTB
Certification Body Notified Body No for 94/9/EC, 2009/23/EC, 2004/22/EC, 2006/42/EC H. Stolz, PTB, July 2011
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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) H. Stolz, PTB, July 2011
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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
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Structure of PTB Certification Body
ZS Advisory Board Explosion Protection Advisory Board Measuring Instruments Management of Certification Body Head of CB H. Stolz QM of CB H. Stolz Certification Council Head CB, QM CB, Sectors, Legal adv. accredited Sector 1 Explosion Protection and Shooting Devices Sector 2 Non automatic weighing instrum. and OIML-Certifications Sector 3 Measuring Instruments Directive Sector 4 Measuring instruments - Domestic and EEC-Type Approvals Dr. U. Johannsmeyer Dr. D. Ratschko Dr. H. Stolz Dr. C. Mengersen Certifiers Certifiers Certifiers Certifiers Evaluators Evaluators Evaluators Evaluators Auditors and experts Auditors and experts Self declaration + peer evaluation Technical PTB-Divisions 1…8 Laboratories acc. to ISO/IEC Responsible for Testing H. Stolz, PTB, July 2011
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Tasks Head of CB: Heads of Sectors: Certifiers: Evaluators:
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 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
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Formal Integration of CB in PTB Structure
Top management Strategy, Resources PTB Council for Metrological Services Head Prof. M. Peters (Vice President of PTB) Presidential Board of PTB PTB Council for Quality Management Head Dr. A. Odin (Senior Quality Manager of PTB) Operative level Department Q.3 Head Dr. P. Ulbig WG Q WG Q.32 WG Q.33 C. Mengersen H. Stolz B. Smandek Legal Certification Technology Metrology Body Transfer PTB-Divisions“ 1, 2, ….. 8, Q, Z Metrology Authority Notified Body Economy Support H. Stolz, PTB, July 2011
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PTB Certification Body (CB)
Services offered Organisation Certification processes Public available information Harry Stolz PTB Braunschweig, GERMANY Certification Body H. Stolz, PTB, July 2011
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Procedure of Type Examination according to 2004/22/EG Anh. B
Provision of information Application Order confirmation AGB of PTB Evaluation of technical documentation Evaluation of existing test reports Identification of tests still necessary Performance of remaining tests Test reports Review and final evaluation Evaluation report Certification decision Certificate Updating the certificates database Database MICert Evaluation of notifications on changes of the certified type Revision p.r.n. Prolongation (after 10 years) Certificate H. Stolz, PTB, July 2011
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Procedure of the QM-Approval according to 2004/22/EG Anh
Procedure of the QM-Approval according to 2004/22/EG Anh. D, D1, E, E1, H, H1 Provision of information Application Application form Order confirmation AGB + AZB of PTB Nomination of the audit team Stage 1 Audit Stage 2 Audit Audit report Evaluation of the quality system Evaluation report Decision about QM-Approval Certificate Updating the certificates database Database MICert Evaluation of notifications on changes of the quality system Revision p.r.n. Annual surveillance visits + spot check, where appropriate Audit report Reassessment (after 3 years) Certificate H. Stolz, PTB, July 2011
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PTB Certification Body (CB)
Services offered Organisation Certification processes Public available information Harry Stolz PTB Braunschweig, GERMANY Certification Body H. Stolz, PTB, July 2011
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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) -> H. Stolz, PTB, July 2011
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