criteria and procedures for the approval of the quality ... · roll-out of new measuring...

Criteria and procedures for the approval of the quality systems

of measuring instruments manufacturers

according to

• the German Measures and Verification Ordinance (MessEV), Annex 4, module D or D1

• the European Measuring Instruments Directive (2014/32/EU, MID), module D, D1, H1

• the European Directive on nonautomatic Weighing Instruments (2014/31/EU, NAWID), module D or D1

by 02/2020

Conformity Assessment Body

Structure

• Introduction

• Comparison ISO 9001-certification / QS-approval

• Procedure QS-approval

• Contact

New German Measuring and Verification Law (since 2015)

Former German EichG (until 2014) New German MessEG (since 2015)

Bri

ngi

ng

to t

he

mar

ket

Use

PTBType approval

Verification authorityInitial verification

Manufacturer + CABConformity assessment

Manufacturer Conformity declaration

Verification authoritySubsequent verification

Verification authorityVerificationUser surveillance

Verification authorityMarket surveillance

Roll-out of new measuring instruments

Market research

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

Development Verification

Distribution,Start-up, service, maintenance

Purchase

SupplierTypical procedure at a manufacturer

Former legal inspections

Market research




Production



Process planning




Purchase

Supplier

Old German verification law (before 2015)

Type approval Initial verification

Conformity assessment procedures (modules) according to the German MessEV annex 4 (since 2015)

Mod. A Internal pro-duction control

Mod. F Product verifi-cation by CAB

(if so, statistic. verific.)

Mod. C Internal prod. control

Mod. D Assess-ment + sur-veillance of QS pro-duction by CAB

Mod. E Assess-ment + sur-veillance of QS product by CAB

Mod. F Product verifi-cation by CAB

(if so, statistic. verific.)

Mod. C1Internal prod. control + prod. testing (100%) by CAB or accred. internal body

Mod. D 1Assess-ment + sur-veillance of QS pro-duction by CAB

Mod. E 1Assess-ment + sur-veillance of QS product by CAB

Mod. H1 Assess-ment and sur-veillance of full Quality Assu-rance + Design exami-nation by CAB

Mod. GUnit-verifi-cation by CAB

Mod. H Assess-ment and sur-veillance of full Quality Assu-ranceby CAB

Mod. B Type examination by N.B. (Notified Body)

Mod. A1Internal prod. control + Product testing (100%)

by CABor accred. internal body

Technical documentation of the manufacturer

Mod. A2Internal prod. control + spot checks

by CAB or accred. internal body

Mod. A2Internal prod. control + spot checks by CAB or accred. internal body

PTB-Offer:Modules B, D, D1, G

possible:For all kinds of instruments: B+D, B+FFurther modules for specific kinds of instrumentsSee: www.rea.ptb.de

http://www.rea.ptb.de/

Mod. A Internal pro-duction control

Mod. F1 Product verifi-cation (if so, statistic. verific.)

Mod. C Internal pro-duction control

Mod. D Assess-ment + sur-veillance of QS pro-duction

Mod. E Assess-ment and sur-veillance of QS product

Mod. F Product verifi-cation (if so, statistic. verific.)

Mod. C1 Internal pro-duction control + product testing

Mod. D1 Assess-ment + sur-veillance of QS pro-duction.

Mod. E1 Assess-ment and sur-veillance of QS product

Mod. H1 Assess-ment and sur-veillance of full Quality Assu-rance + Design exami-nation

Mod. G Unit verifi-cation

Mod. H Assess-ment and sur-veillance of full Quality Assu-rance

Mod. B Type examination

Mod. A2 Internal pro-duction control + product testing


PTB-Offer:Modules B, D, D1, G, H1** H1 only for

Mi-001 and MI-004

•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, H1

of quantities of liquids other than water•MI-006, Automatic weighing instruments mechanical systems: B+D, B+E, B+F, D1, F1, G, H1

electromechanical 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 A2, 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, H1

electronic or with SW: B+D, B+F, G, H1•MI-010, Exhaust gas analysers B+D, B+F, H1

Conformity assessment procedures (modules) according to directive 2014/32/EU (MID)since 2006

Mod. F1 Product verifi-cation (if so, statistic. verific.)

Mod. D Assess-ment + sur-veillance of QS pro-duction

Mod. F Product verifi-cation (if so, statistic. verific.)

Mod. D1 Assess-ment + sur-veillance of QS pro-duction.

Mod. G Unit verifi-cation

Mod. B Type examination


PTB-Offer:Modules B, D, D1, G

Conformity assessment procedures (modules) according to directive 2014/31/EU (NAWID)

possible:• Nonautomatic weighing instruments: B+D, B+F, G• Nonautomatic weighing instruments, which do not use electronic devices and the

load-measuring device of which does not use a spring to balance the load: B+D, B+F, D1, F1, G

• If the instrument’s performance is sensitive to gravity variations , the conformity assessment according to module D, D1, F, F1 or G may be carried out in two stages, with the second stage carried out at the place of use of the instrument.

Detailed description of the modules

German Measures and Verification Ordinance (MessEV):https://www.gesetze-im-internet.de/messev/MessEV.pdf

See annex 4: - Part 1 „General provisions“- Part 2 „Details of conformity assessment procedures“

European Measuring Instruments Directive 2014/32/EU (MID): http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0032

See annex II

European Directive on Nonautomatic Weighing Instruments 2014/31/EU (NAWID): http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031

See annex II

https://www.gesetze-im-internet.de/messev/MessEV.pdf

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0032

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32014L0031

Module combination B+F

Market research




Production



Process planning




Purchase

Supplier

Modules B+F: Type examination (B) + Product verification (F)

Type examination

Product verification100% oder statistical

Conformity declaration

DE-M 20 XXXX

M20 XXXX

Applicable for small batch production(Comparable to former type approval and verification)

Audit + surveillance

Module combination B+D

Market research




Production



Process planning




Purchase

Supplier

Type examination


DE-M 20 XXXX

M20 XXXX

Modules B+D: Type examination (B) + QS-approval (D)

Applicable for large batch production with an existing ISO 9001 certificate

Requirements to the quality system

3.2. The quality assurance system must be structured in the way that the compliance of the measuring instrument with the type described in the type examination certificate and the relevant requirements of the Weights and Measures Act and this Regulation is ensured.

3.3. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written principles, procedures and instructions. This quality system documentation must be designed in such a manner as to ensure consistent interpretation of the quality programmes, plans, manuals and records. It must contain in particular an adequate description of the following :

3.3.1. The quality objectives and organisational structure, responsibilities and powers of the management with regard to product quality,

3.3.2. the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be implemented,

3.3.3. the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

3.3.4. quality records such as inspection reports, test data, calibration data and qualification reports on the personnel involved and other reports required to assess the quality assurance system and

3.3.5. the means of monitoring the achievement of the required product quality and the effective operation of the quality assurance system.

Extract from German MessEV Annex 4, Part 2, Module D:

Obligations of the manufacturer (acc. to. module D)

2. Manufacturing The manufacturer shall operate an approved quality system for production, final product inspection and testing of the measuring instruments concerned as specified in point 3.

…3.1 The manufacturer shall lodge an application for assessment of his quality system with a conformity

assessment body according to § 13 or § 14 of the Mess- und Eichgesetzes of his choice, for the measuring instruments concerned.The application shall include: 3.1.1 the name and address of the manufacturer and, if the application is lodged by the authorised

representative, his name and address as well,3.1.2 a written declaration that the same application has not been lodged with any other conformity

assessment body ,3.1.3 all relevant information for the instrument category envisaged, 3.1.4 the documentation concerning the quality system, 3.1.5 the technical documentation of the approved type and a copy of the type examination certificate.

….. (continuation next page)


Tasks of the manufacturer (acc. to module D)

Kriterien und Verfahren zur Anerkennung von QS-Systemen von Messgeräteherstellern

3.7 The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved by the conformity assessment body and to maintain it so that it remains adequate and efficient.

3.8 The manufacturer shall keep the conformity assessment body that has approved the quality system informed of any intended change of the quality system. The conformity assessment body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in points 3.2 and 3.3 or whether a re-assessment is necessary. The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

…5. Conformity marking and EU declaration of conformity5.1 The manufacturer shall affix the metrology marking set out in § 14 of this ordinance, and, under the

responsibility of the conformity assessment body referred to in point 3.1, the latter’s identification number to each individual measuring instrument that is in conformity with the type described in the type examination certificate and satisfies the applicable requirements of the Mess- und Eichgesetz and this ordinance.

5.2 The manufacturer shall draw up declaration of conformity according to § 11 for each instrument model.

6. Storage of documentsThe manufacturer shall keep the following documents for a period of at least 10 years after the instrument has been placed on the market:

6.1 the documents refered in 3.1, 6.2 the change refered in 3.8 as approved by the conformity assessment body, 6.3 decisions and reports of the conformity assessment body according to 3.8, 4.3 and 4.4.


Tasks of the conformity assessment body

3.4. The conformity assessment body shall assess the quality system to determine whether it satisfies the requirements referred to in points 3.2 and 3.3. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard, normative document or rule determined by the committee referred in § 46 of the Mess-und Eichgesetz.

3.5. In addition to experience in quality management systems, the auditing team performing an audit in terms of point 4.3 shall have at least one member with experience of evaluation in the relevant instrument field and instrument technology concerned, and knowledge of the applicable requirements of the Mess- und Eichgesetz this ordinance. The audit shall include an assessment visit to the manufacturer’s premises. The auditing team shall review the technical documentation referred to in point 3.1.5, to verify the manufacturer’s ability to identify the relevant requirements of the Mess- und Eichgesetz this ordinance and to carry out the necessary examinations with a view to ensuring compliance of the instrument with those requirements .

3.6. The result of the evaluation shall be notified to the manufacturer in written or electronically. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

….3.8. The manufacturer shall keep the conformity assessment body that has approved the quality system informed

of any intended change of the quality system. The conformity assessment body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in points 3.2 and 3.3 or whether a re-assessment is necessary.


Surveillance under the responsibility of the conformity assessment body

4. Surveillance under the responsibility of the conformity assessment body4.1 The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out

of the approved quality system.4.2 The manufacturer shall, for assessment purposes, allow the conformity assessment body access to the

manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

4.2.1 the quality system documentation, 4.2.2 the quality records, such as inspection reports and test data, calibration data, qualification reports on the

personnel concerned. 4.3 The conformity assessment body shall carry out periodic audits to make sure that the manufacturer

maintains and applies the quality system and shall provide the manufacturer with an audit report. 4.4 In addition, the conformity assessment body may pay unexpected visits to the manufacturer. During

such visits the conformity assessment body may, if necessary, carry out instrument tests, or have them carried out, in order to verify that the quality system is functioning correctly. The conformity assessment body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.



Module D1

Market research




Production



Process planning




Purchase

Supplier


DE-M 20 XXXX

M20 XXXX

Modules D1: QS-approval production (D1) - c.f. D without B


Module H1

Market research




Production



Process planning




Purchase

Supplier

Design examination


DE-M 20 XXXX

M20 XXXX

Modules B+D: Full Quality Assurance + Design ExaminationApplicable for manufacturers with type examination facilities and existing ISO 9001 certificate

Extend of the audit program• Module D:

The audit program covers all sites, where quality assurance measures occur, which are necessary to ensure the conformity of the measuring instruments with the approved type, the technical documentation, and the other requirements of MessEG, NAWID or MID. This may include suppliers or service partners of the manufacturer.Exisiting QS approvals will be taken into consideration.

• Module D1:In addition to conformity of the type the audit program covers an evaluation of the technical documents of the measuring instruments.The CAB keeps copies of technical documents.

• Module H1: In addition to conformity of the type the audit program covers the development of the measuring instruments.

Structure

• Introduction



• Contact

✓

Comparison ISO 9001-Certificate / QM-Approval

ISO 9001-CertificationCompliance 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 Quality-System

Purpose of certificate

Scope of certificate

Typical procedure

Validity period

Surveillance period

QS-ApprovalSecuring of the compliance of measuring instruments with legal requirements

Authorisation of conformity declaration

Measures of quality assurance for certain 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 QS Approval

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

• 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 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• Non- Automatic Weighing Instruments Directive 2014/31/EU - Presumption of Conformity of the Quality System of

Manufacturers with Module D when EN ISO 9001:2015 is applied• Measuring Instruments Directive 2014/32/EU - Presumption of Conformity of the Quality System of Manufacturers with

Module D or H1 when EN ISO 9001:2015 is applied

https://www.welmec.org/documents/guides/86/

https://www.welmec.org/documents/guides/86/

Structure

• Introduction



• Contact

✓

✓

Procedure of the QS-Approval

Provision of information

Application

Order confirmation

Nomination of the audit team

Stage 1 Audit

Evaluation of the quality system

Review of the report and certification decision

Updating the certificates database

Evaluation of notifications on changes of the quality system

Annual surveillance visits + spot check, where appropriate

www.kbs.ptb.de

Application form

Audit report(s)

Certificate

Database MICert

Certificate RevisionRe-approval (after 3 years)

Stage 2 Audit

AGB + AZB of PTB

Certificate Revision

Audit report

Action plan

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, audit-reports etc. relevant to the QS-approval(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

• Module D: Copies of type-examination-certificates (unless not issued by PTB)Module D1: Technical documents of the measuring instrument types (-> audit team)

• 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)

• List of all QS-documents relevant to the quality system approval (-> audit team)

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

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

QS-Approval CertificateP.1 P.2

QS-Approval CertificateP.4P.3

Sites listed in the QS approval certificate

Sites documented in the certificate:

• Site where the manufacturer operates the management system in which hosts the quality system is incorporated („headquarter”, “central office“),

• Sites which are responsible for the final inspection of the measuring instruments („final inspection sites“)

Sites to be audited:

• All sites where quality assurance measures are implemented, which are necessary to ensure conformity of the measuring instruments with corresponding requirements.

• That may include suppliers or service partners.

List of measuring instrument types

Acceptable certificates for the certified type

The following type examination certificates are acceptable for QS-approvals according to module D if their

validity has not expired:

for EU regulated measuring instruments according to MID or NAWID:

• EU type examination certificates according to the EU directives 2014/31/EU, 2014/32/EU, 2009/23/EC, 2004/22/EC,

issued to the (future) holder of the module D certificate

• EU type-examination certificates according to the EU directives 2014/31/EU, 2014/32/EU, 2009/23/EC, 2004/22/EC,

issued to other legal entities, provided the manufacturer meets the conditions listed in Blue Guide 2016, Section

5.1.5.

for national regulated measuring instruments according to MessEV:

• type examination certificates according to MessEV module B, issued to the (future) holder of the module D

certificate

• type examination certificates according to MessEV module B, issued to other legal entities, provided the

manufacturer meets the conditions listed in Blue Guide 2016, Section 5.1.5.

• type approvals issued before December 31, 2014 according to the old German verification law §13, which are either

issued to the holder of the QS certificate or in which the holder of the QS certificate is listed as a co-distributor

• type approvals issued before December 31, 2014 according to the old German verification law §13, issued to other

legal entities, provided the manufacturer meets the conditions listed in Blue Guide 2016, Section 5.1.5.

This also applies if the name of the manufacturer has been changed in the meantime, but the manufacturer can prove that

it is the same legal person.

The possibility of using type approvals issued before December 31, 2014 according to the old German verification law §13

ends with the expiry of the transitional regulation according to MessEG § 62 (2) on December 31, 2024.

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:

Both are registered in the list of auditors of PTB

The conformity assessment body of PTB is equipped with competent auditors and experts from the German verification authorities, from the technical PTB divisions and from other CABs.

Lead-Auditor Technical Expert

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 taken 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 processing1 Expert: 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. 1.200 € /day /person plus travel expenses

Changes on an approved QS-System to be notified

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

• Fundamental organizational chances (e.g. chance of the company’s ownership or legal status, start of insolvency proceedings

-> notification to audit team

-> review by the audit team

-> potential changes of QS-Approval certificate or its annex

Structure

• Introduction



• Contact

✓

✓

✓

Structure of PTB Conformity Assessment Body

Sector 1Explosion Protection and Shooting Devices

Dr. F. Lienesch

Sector 2Non automatic weighing instruments and OIML-Certifications

Sector 3Measuring Instruments Directive

Sector 4National regulated measuring instruments

Advisory Board

Dr. D Knopf Dr. H. Stolz Dr. F. Renner

Certifiers

Evaluators

PTB-CAB

Checkers

Inspectors

Certifiers

Evaluators

Auditors andExperts

Checkers

Inspectors

Certifiers

Evaluators

Checkers

Inspectors

Certifiers

Evaluators

Auditors andExperts

Checkers

Inspectors

Sector 5Radiation Protection

Dr. A. Roettger

Certifiers

Evaluators

Checkers

Inspectors

Management of PTB Conformity Assessment Body

Head CABR. Schwartz (PTB VP)

Office CABH. Stolz

CAB Management Committee Certification Councilon demand

Contact experts (modules B or G)

Technical questions concerning modules B or G:Length and area measuring instruments Ingo Lohse PTB Working Group 5.45Measuring instruments for liquids Michael Rinker PTB Working Group 1.51Measuring instruments for gas Rainer Kramer PTB Working Group 1.42Measuring instruments for thermal energy Jürgen Rose PTB Working Group 7.51Measuring instruments for electrical energy Christoph Leicht PTB Working Group 2.43Weighing Instruments Oliver Mack PTB Working Group 1.12Measuring instruments of the grading of cereals and oilseeds Regina Klüß PTB Working Group 3.41Densimeters Jürgen Rauch PTB Working Group 3.32Measuring instruments for temperature Steffen Rudtsch PTB Working Group 7.42Pressure gauges Wladimir Sabuga PTB Working Group 3.33Measuring Instruments for traffic control Frank Märtens PTB Working Group 1.31Exhaust gas analysers Sonja Pratzler PTB Working Group 3.44Measuring devices for diary examinations Regina Klüß PTB Working Group 3.41Taximeters Helga Grohne PTB Working Group 1.31Sound level meters Ingolf Bork PTB Working Group 1.63Measuring Instruments for Radiation Protection Oliver Hupe PTB Working Group 6.31Software in Measuring Instruments Marko Esche PTB Working Group 8.51

General questions concerning modules B or G :Non Automatic Weighing Instruments Dorothea Knopf CAB Sector 2OIML-Certifications Dorothea Knopf CAB Sector 2Measuring Instruments Directive Harry Stolz CAB Sector 3Domestic regulated Measuring Instruments Franziska Renner CAB Sector 4

Contact experts (modules D, D1, H1)

PTB working group 9.22:

Markus Urner, Coordinator QS-approval measuring instrument manufacturers Tel. +49 531/592-8321, E-Mail: [email protected]

Anna Pfaff, Coordinator QS-approval weighing instrument manufacturersTel. +49 531/592-8322, E-Mail: [email protected]

-> https://www.ptb.de/cms/ptb/fachabteilungen/abt9/fb-92/ag-922.html

https://www.ptb.de/cms/ptb/fachabteilungen/abt9/fb-92/ag-922.html

General questions

General questions on legal metrology in Germany:PTB Working Group Legal Metrology (9.21)

Dr. Mäuselein [email protected]

Other CABs:Domestic:http://www.adkbs.ptb.de/

European: http://ec.europa.eu/growth/tools-databases/nando/

General questions on conformity assessment services of PTB:Office PTB-CAB (9.22)

Dr. Stolz [email protected]

http://www.adkbs.ptb.de/

http://ec.europa.eu/growth/tools-databases/nando/

Physikalisch-Technische Bundesanstalt

Braunschweig und Berlin

Conformity Assessment Body

Evaluation of Quality Systems of Measuring Instruments Manufacturers

Bundesallee 100

38116 Braunschweig



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