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

5. 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

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 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

7. PTB Certification Body (CB)
Services offered
Organisation
Certification processes
Public available information
Harry Stolz
PTB Braunschweig, GERMANY
Certification Body
H. Stolz, PTB, July 2011

8. 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

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 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

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. Structure of PTB Certification BodyZS
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

12. 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

13. 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

14. PTB Certification Body (CB)
Services offered
Organisation
Certification processes
Public available information
Harry Stolz
PTB Braunschweig, GERMANY
Certification Body
H. Stolz, PTB, July 2011

15. 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

16. 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

17. PTB Certification Body (CB)
Services offered
Organisation
Certification processes
Public available information
Harry Stolz
PTB Braunschweig, GERMANY
Certification Body
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)
->
H. Stolz, PTB, July 2011