H. Stolz, PTB, July 2011 1

PTB Certification Body (CB)

•Services offered •Organisation

•Certification processes•Public available information

Harry Stolz

PTB Braunschweig, GERMANY

Certification Body

www.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 Body

www.ptb.de/en/org/zs

H. Stolz, PTB, July 2011 3

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 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 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

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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

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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. VIIZ1-04 Konformitätsbescheinigung über die Prüfung der Produkte nach Richtlinie 94/9/EG, Anhang VZ1-05 Mitteilung über die Konformität mit der Bauart nach Richtlinie 94/9/EG, Anhang VIZ1-06 Schreiben über die Aufbewahrung von Referenzunterlagen von HerstellernZ1-07 Konformitätsaussage nach Richtlinie 94/9/EGZ1-08 IECEx Certificate of ConformityZ1-09 IECEx Quality Assesment ReportZ1-10 IECEx Test Report Cover SheetZ1-11 IECEx Conformity Mark LicenseZ1-12 Zertifikat – FlammpunktbestimmungZ1-13 EG-Baumusterprüfbescheinigung nach Richtlinie 2006/42/EGZ1-14 Bauartzulassung nach §§ 7, 8 und 9 BeschGZ1-15 Anzeigen nach § 9 Abs.2 BeschGZ1-16 Bauartzulassung nach § 20 WaffGZ1-17 Markenanzeige nach § 24 Abs. 5 WaffGZ2-01 EG-Bauartzulassung nach Richtlinie 2009/23/EGZ2-02 Prüfschein einer benannten Stelle für NAWI-Komponenten gemäß QM-VA-21Z2-03 OIML-Zertifikat nach dem OIML Basis-Zertifizierungssystem gemäß OIML B3Z2-04 OIML-Zertifikat nach dem OIML MAA gemäß OIML B10Z3-01 EG-Baumusterprüfbescheinigung nach Richtlinie 2004/22/EG Anh. B Z3-02 EG-Entwurfsprüfbescheinigung nach Richtlinie 2004/22/EG Anh. H1Z3-03 QM-Anerkennung nach Richtlinie 2004/22/EG Anh. D, D1, E, E1, H bzw. H1Z3-04 Bewertungs-Zertifikat nach WELMEC Leitfaden 8.8Z3-05 Baueinheiten-Zertifikat nach WELMEC Leitfaden 8.8Z4-01 Innerstaatliche Bauartzulassung nach § 16 Abs. 1 bis 3 EOZ4-02 EWG-Bauartzulassung nach § 16 Abs. 4 EO

Measuring instruments

Explosions-Protection

Shooting Devices

Total no. of certificates issued in 2009: ca. 2500

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PTB Certification Body (CB)

•Services offered •Organisation

•Certification processes•Public available information

Harry Stolz

PTB Braunschweig, GERMANY

Certification Body

www.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)

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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

Structure of PTB Certification Body

Technical PTB-Divisions 1…8 Laboratories acc. to ISO/IEC 17025

Responsible for Testing

Management of Certification Body

Head of CB H. Stolz

QM of CB H. Stolz

Certification CouncilHead CB, QM CB, Sectors, Legal adv.

Sector 1Explosion Protection and Shooting Devices

Dr. U. Johannsmeyer

Certifiers

Evaluators

Sector 2Non automatic weighing instrum. and

OIML-Certifications

Sector 3Measuring Instruments Directive

Sector 4Measuring instruments -

Domestic andEEC-Type Approvals

Advisory Board Measuring Instruments

Advisory BoardExplosion Protection

Auditors andexperts

Dr. D. Ratschko

Certifiers

Evaluators

Dr. H. Stolz

Certifiers

Evaluators

Auditors andexperts

Dr. C. Mengersen

Certifiers

Evaluators

ZS

Self declaration + peer evaluation

accredited

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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

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Formal Integration of CB in PTB Structure

Department Q.3Head Dr. P. Ulbig

WG Q.31 WG Q.32 WG Q.33C. Mengersen H. Stolz B. SmandekLegal Certification TechnologyMetrology Body Transfer

Presidential Board of PTB

PTB Council for Metrological ServicesHead Prof. M. Peters (Vice President of PTB)

PTB Council for Quality Management Head Dr. A. Odin (Senior Quality Manager of PTB)

Top managementStrategy, Resources

Operative level

PTB-Divisions“1, 2, ….. 8, Q, Z

Metrology Authority

Notified Body

EconomySupport

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PTB Certification Body (CB)

•Services offered •Organisation

•Certification processes•Public available information

Harry Stolz

PTB Braunschweig, GERMANY

Certification Body

www.ptb.de/en/org/zs

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

www.zs.ptb.de

Test reports

Evaluation report

Certificate

Database MICert

CertificateProlongation (after 10 years)

Identification of tests still necessary

AGB of PTB

Revision p.r.n.

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H. Stolz, PTB, July 2011

Procedure of the QM-Approvalaccording 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

www.zs.ptb.de

Application form

Audit report

Evaluation report

Certificate

Database MICert

CertificateReassessment (after 3 years)

Stage 2 Audit

AGB + AZB of PTB

Revision p.r.n.

Audit report

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PTB Certification Body (CB)

•Services offered •Organisation

•Certification processes•Public available information

Harry Stolz

PTB Braunschweig, GERMANY

Certification Body

www.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