Criteria and procedures for the approval of the quality ... the approval of the quality system of...

H. Stolz, PTB Germany, by 05/2013

PTB Procedure QM-Approval MID

Criteria and procedures for the approval of the quality system of measuring instruments manufacturers

according to 2004/22/EC

PTB Braunschweig/Germany Certification Body

Quality Management Review of Measuring Instrument Manufacturerswww.ptb.de/en/org/q/q3/q32


Structure

• Introduction

• Comparison ISO 9001-certification / QM-approval

• Procedure of the QM-approval

• FAQ – External production

• Structure of PTB Certification Body

• Contact/Links


Roll-out of new measuring instruments

Typical procedure at a manufacturer

Marketresearch

Concept, Customer requirement specifications

DevelopmentConstruction

Product requirement specifications,Design,Techn. Docu-mentation, Prototype

Production

Components,Final products,Final inspection

Manufacturing instructions, production facilities,Meas. and test equipment, Contracts with suppliers

Process planning

Specimens, Type tests,Design validation

DevelopmentVerification

Distribution,Start-up, service,maintenance

Purchase

Supplier


Legal inspections according to the old German verification law


Marketresearch




Production



Process planning



Purchase

Supplier

Type Approval Initial Verification


Possible Conformity assessment procedures (modules) according to directive 2004/22/EC (MID)

•MI-001, Water meters: B+D, B+F, H1

•MI-002, Gas meters and volume conversion devices B+D, B+F, H1

•MI-003, Active electrical energy meters B+D, B+F, H1

•MI-004, Heat meters B+D, B+F, H1

•MI-005, Measuring systems for the continous and dynamic measurement B+D, B+F, G, H1of quantities of liquids other than water

•MI-006, Automatic weighing instruments mechanical systems: B+D, B+E, B+F, D1, F1, G, H1electromechanical systems: B+D, B+E, B+F, G, H1 electronic systems or systems containing AWI: B+D, B+F, G, H1

•MI-007, Taximeters B+D, B+F, H1

•MI-008, Material measures I – Material measure of length B+D, D1, F1, G, H II – Capacity serving measures A1, B+D, B+E, D1, E1, F1, H

•MI-009, Dimensional measuring instruments mechanical or electromechanical: B+D, B+E, B+F, D1, E1, F1, G, H, H1electronic or with SW: B+D, B+F, G, H1

•MI-010, Exhaust gas analysers B+D, B+F, H1

An. A

Internal pro-duction control

An. F1

Product verifi-cationby N.B.

(if so, statistic. verific.)

An. C


An. D

Assess-ment + sur-veillance of QMS pro-duction by N.B.

An. E

Assess-ment and sur-veillance of QMS product by N.B.

An. F

Product verifi-cation by N.B.

(if so, statistic. verific.)

An. C1


+ product testing by N.B.

An. D1

Assess-ment and sur-veillance of QMS pro-duction by N.B.

An. E1

Assess-ment and sur-veillance of QMS product by N.B.

An. H1

Assess-ment and sur-veillance of full Quality Assu-rance

+

Design exami-nation by N.B.

An. G

Unit verifi-cationby N.B.

An. H

Assess-ment and sur-veillance of full Quality Assu-rance by N.B.

An. B

Type examination

by N.B. (Notified Body)

An. A1


+ product testing by N.B.

Technical documentation of the manufacturer

PTB-Offer:Modules B, D, D1, E, E1, H, H1


MID Conformity assessment proceduresModules B + F


Marketresearch




Production



Process planning



Purchase

Supplier

M13 xxxx

Declaration of conformity

Type examination

Modules B+F: Type Examination (B) and Product Verification (F)Applicable for small batch production of instruments MI-001 bis MI-007, MI-009, MI-010(corresponds to former type approval and initial verification)

Product Verification bynotified body

100 % or statisticalTEC

Attestation of conf.


Audit + surveillance

Modules B+D: Type examination (B) and approval of quality system for production (D) MI-001…MI-010

Applicable for large batch production with an existing ISO 9001-certificate

MID Conformity assessment proceduresModules B + D


Marketresearch




Production



Process planning



Purchase

Supplier

M13 xxxx


Type examination

TEC QAC


Module D1: Approval QMS Production (D1) – c.f D without B –

MID Conformity assessment proceduresModule D1

Applicable for „simple“batch production with an existing ISO 9001-certificateMI-006 (mech.), MI-008, MI-009 (mech., el.mech.)



Marketresearch




Production



Process planning



Purchase

Supplier

M13 xxxx



MID Conformity assessment proceduresModules B + E

Modules B+E: Type examination (B) and approval of quality system for final inspection (E)

Only applicable if final inspection covers all MID-relevant attributesMI-006 (mech., el.mech.), MI-008-II, MI-009 (mech., el.mech.)



Marketresearch




Production

Components,Final products,

Final inspection


Process planning



Purchase

Supplier

M13 xxxx


Type examination



MID Conformity assessment proceduresModule E1

Module E1: Approval of quality system for final inspection (E)- c.f. E without B -

Simple meas. instruments, if final inspection covers all MID-relevant attributesMI-008-II, MI-009 (mech., el.mech.)


Marketresearch




Production

Components,Final products,

Final inspection


Process planning



Purchase

Supplier

M13 xxxx



Global audit + surveillance

Module H1: Design examination and approval of quality system for development and production MI-001…MI-007, MI-009, MI-010

Applicable for manufacturers with own type test equipment and ISO 9001-certificate

MID Conformity assessment proceduresModule H1


Marketresearch




Production



Process planning

Specimens,

Type tests,Design validation


Purchase

Supplier

M13 xxxx


Design examinationQACDEC


Difference between modules F and D

• In the case of module F the notified body performs product tests to ensure conformity to type and conformity to MID. The notified body issues a attestation of conformity of each product or each lot of instruments to the manufacturer puts his number on the instrument.

• In the case of module D the manufacturer performs the product tests and other quality measures to ensure conformity to type and conformity to MID. The notified body assesses and evaluates the final inspection and the additional quality measures of the manufacturer. The notified body issues a certificate of the approval of the quality system to the manufacturer. The manufacturer puts the number of the notified body on the instruments.


Difference between D and D1

• Module D: The notified bodies audits and surveils, whether the quality managements system of the manufacturer secures, that instruments meet the stipulations stated in the type examination certificate and in the technical documentation and the other requirements of the MID.

• Module D1: Within the audit the notified bodies evaluates the technical documentation of the manufacturer and surveils, whether the quality managements system of the manufacturer secures, that instruments meet the stipulations stated in the technical documentation and the other requirements of the MID.


Difference between B+D and H1

• Module D bases on the specifications given in the type-examination certificates (module B), which must not be issued until the instruments have successfully passed the type examination tests.The audit done by the notified body largely covers production and final testing.

• Module H1: The intrinsic type examination is performed by the manufacturer himself (product tests by the notified body are possible within the surveillance audits).Within the design examination the notified body evaluates the technical documentation and the result of the design validation of the manufacturer.The audit done by the notified body also covers development.


ComparisonISO 9001-Certificate / QM-Approval

ISO 9001-Certification

Compliance with customer requirementsDecrease of failure costsContinuous improvement

Get customer confidence

All processes and products of an organisation

Application / audit / evaluation / decision / surveillance

3 years

Annual surveillance visits

Purpose of QM-Systems

Purpose of certificates

Scope of certificate

Typical procedure

Validity period

Surveillance period

QM-Approval

Securing of the compliance of measuring instruments with legal requirements

Authorisation of conformity declaration

Measures of quality assurance forcertain product categories(includes if necessary further organisations – i.E. subcontractors)

Application / audit / evaluation / decision / surveillance

3 years

Annual surveillance visits + unexpected visits


Effect of an existing ISO 9001-Certificate for Quality System Approval

• An ISO 9001-Certificate does not replace the approval audit by the notified body

• ISO 9001-Certification is not a requirement for the approval of the quality system, but helpful (lower costs, audit of notified body is restricted to the „technical delta“)

• Some notified bodies offer ISO 9001-Certification in addition to the approval of the quality system (not PTB)

Useful WELMEC-Guide for Measuring Instrument Manufacturers:WELMEC Guide 8.6 „Measuring Instruments Directive 2004/22/EC

Presumption of Conformity of the Quality System of Manufacturers with Module D or H 1 when EN ISO 9001:2000 is applied“http://www.welmec.org/publications/8-6.asp


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

Audit report


Application documents which have to be submitted

• Filled and signed application form + list of preliminary questions

• Acceptation of the General Terms and Conditions of Certification of the PTB

• Copies of existing QM-Certificates(e.g. ISO 9001 certificates, accreditation certificates)

• List of the measuring instrument types which are designated for the Conformity Declaration with regard to the quality system approval applied(with number of design examination certificates / type examination certificates if existing)

• Copies of type-examination-certificates (for modules D, E, unless not issued by PTB)

• Technical documentation of the measuring instruments (for modules D1, E1, H, H1)

• Quality plans for several measuring instrument types, (i.e. short description of the key elements of production to make sure that the requirements of the MID will be met, e.g. quality system approval of suppliers, 100% final inspection including calibration, justification and sealing or placing into operation on site by own service technicians)

• Quality Management Manual of the company

• List of all documents subordinated to the QMM and relevant to the quality system approval

All documents have to be submitted in German or English !!!

Further documents will be requested by the audit teamduring the approval procedure


Certificate content

• Certificate No.• Manufacturer• Validity of certificate• Scope:

• Site(s)• Measuring instrument category

Statements:- The Notified Body keeps a list of measuring instrument types covered by this certificate- By means of this certificate, the Physikalisch-Technische Bundesanstalt (PTB) certifies that the Quality

Management System ensures - within the scope specified in this certificate - compliance of the produced measuring instruments with the requirements of the Directive.

- The company is entitled to provide the metrology marking for the measuring instruments produced within the scope of this approved quality management system with the PTB identification number 0102.

- The assessment is based on an evaluation of the submitted documents and on an audit on site. The quality management system is subject to permanent surveillance according to Annex D, No. 4, of the Directive.


Model certificate


Model type list


Audit-team for quality system assessment

Audit-team has to provide as follows:• Well-founded knowledge on legal metrology

• Knowledge in quality management (auditor training)

• Expertise in corresponding measuring instruments category

Typical audit team:

Lead Auditor + ExpertBoth registered in the list of auditors of the certification body of PTB

The certification body of PTB is equipped with competent auditors and experts from the German verification authorities, from the technical PTB divisions and from other notified bodies.


Estimated charges(non-binding experience values)

Effort depends on• Scope of the measuring instruments category• Complexity of development-/ manufacturing process• Number of locations and potential contractual partners to be taking into

account • Potential additional labour (i.e. translations, additional audits)

Typical effort for the initial approval(Module D, 1 instrument category, 1 location, German language, ISO 9001-Certificate present)

• Stage 1 Audit:Lead Auditor: ½-1 day on location + travel time, ½ day pre-/post processing

• Stage 2 Audit:Lead Auditor: 1-2 days on location + travel time, 1-2 days pre-/post processing1 Expert: 1-2 days on location + travel time, 1-2 days pre-/post processing

• Certification Body: 1 day

Computation of fees according to effort and the work performed• Basis: Regulations Governing the Charges for Services Supplied by PTB• ca. 1.000 € /day /person plus travel expenses


Changes on an approved QM-System

Examples for notifiable Changes:• Relocation or extension of sites• Change of a subcontractor for metrological relevant components• Change of testing methods in final inspection of the production• Basic changes in production process• Lapse of ISO 9001-Certification• Add new measuring instrument types on the scope of quality

system approval

-> notification to audit team or certification body

-> review by the notified body

-> potential changes of QM-Approval


FAQ – External production

Definition of manufacturer according to MID article 2:(d) ‘manufacturer’ means a natural or legal person responsible for the conformity of the measuring instrument with this Directive with a view to either placing it on the market under his own name and/or putting it into use for his own purposes;

-> It is not required that the “manufacturer” is the producer of the instruments

-> The manufacturer may use external suppliers that produce the instruments or essential parts of them

-> Such a manufacturer may get a module D QS approval, if his quality system (and the audit by the notified body) is (on a contractual basis) is extended to the supplier.


FAQ – External production

Example: Modul D approval in the case of external production of instruments

Producer

Manufacturer

Notified Bodyfor module D

Produces instruments according to type examination certificate, and delivers them tothe manufacturer

Places instruments produced by his supplier tothe market under his own name. Issues EC conformity declaration

Assesses manufacturer and producer.May take into account existing audit reports ofthe producer.

contract

contract


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. StolzQM of CB

H. StolzCertification Council

Head 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 BoardMeasuring Instruments

Advisory BoardExplosion Protection

Auditors andExperts

Dr. D. Ratschko

Certifiers

Evaluators

Dr. H. Stolz

Certifiers

Evaluators

Auditors andExperts

B. Wegner

Certifiers

Evaluators

ZS


Contact technical experts (MID)EG Type Examination Certificates acc. to MID Annex B and EG Design Examination Certificates acc. to MID Annex H1:MID-Annex PTB-Dept. Contact Person/Certifier

MI-001 1.5 Dr. Rinker [email protected]

MI-002 1.4 Dr. Kramer [email protected]

MI-003 2.3 Dr. Kahmann [email protected]

MI-004 7.6 Dr. Rose [email protected]

MI-005 1.5 Dr. Rinker [email protected]

MI-006 1.1 Dr. Mack [email protected]

MI-007 1.3 Dr. Jäger [email protected]

MI-008 5.4 I. Lohse [email protected]

MI-009 5.4 I. Lohse [email protected]

MI-010 3.2 Dr. Böse [email protected]

QM-Approval acc. to MID Annexes D, D1, E, E1, H and H1:all Q.3 M. Urner [email protected]

Dr. Stolz [email protected]


Contact

General questions on legal metrology in Germany:PTB Working Group Legal Metrology (Q.31)Dr. Mäuselein [email protected]

General questions on conformity assessment services of PTB:Head of Certification Body (Q.32)Dr. Stolz [email protected]

Links

Further Information

PTB Certification Body:http://www.ptb.de/cms/en/dienstleistungen/zs.html

New approach of EU: http://ec.europa.eu/enterprise/policies/single-market-goods/regulatory-policies-common-rules-for-products/new-legislative-framework/

Notified Bodies (NANDO-Database):http://ec.europa.eu/enterprise/newapproach/nando/

EU-Webpage Measuring Instruments: http://ec.europa.eu/enterprise/sectors/legal-metrology-and-prepack/measuring-instruments/index_en.htm

WELMEC: http://www.welmec.org

MID Certificates: http://www.welmec.org/welmec/mid-certificates.html

Questions? Remarks?

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