REPUBLIC OF CROATIA STATE OFFICE FOR METROLOGY Conformity Assessment Procedures of the „New Approach“ of EU illustrated by the Measuring Instruments Directive.

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REPUBLIC OF CROATIA STATE OFFICE FOR METROLOGY Conformity Assessment Procedures of the „New Approach“ of EU illustrated by the Measuring Instruments Directive 2004/22/EC (MID) Harry Stolz PTB GERMANY Certification Body Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November 2010

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Aim of Legal Metrology

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Legal Metrology in Germany before implementation of the Measuring Instruments Directive (MID) on 30 October 2006 Type approval PTB Initial Verification Verification Authorities and authorized Test Labs Use of measuring instrument Expiry of verification validity ? no Re-verification yes Verification Authorities and authorized Test Labs

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Legal Metrology in Germany since implementation of Measuring Instruments Directive (MID) on 30 October 2006 Phase Development Production Bringing onto the market Putting into use Use Responsible Manufacturer Verification Authority User Verification Auth., auth. Test Labs Verification Authority Activity Conformity Assessment Declaration of conformity Market Surveillance Support, Service Re-verification Surveillance of users

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Typical procedure at a manufacturer Market introduction of new measuring instruments Market research Concept, Customer requirement specifications Development Construction 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 Speciments, Type tests, Design validation Development Verification Distribution, Start-up, service, maintenance Purchase Supplier

Initial Verification Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Legal inspections according to the old German verification law (before MID) Type Approval Distribution, Start-up, service, maintenance Market Research Concept, Customer requirement specifications Development Construction 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 Speciments, Type tests, Design validation Development Verification Purchase Supplier

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Measuring Instruments Directive 2004/22/EC (MID) Organisation of the Measuring Instruments Directive MID Annexes MI MI-010 Requirements, specific to measuring instrument categories Annexes MI MI-010 Requirements, specific to measuring instrument categories Articles 1 to 23 Articles 1 to 23 Annexes I and A -H1 Conformity assessment procedures Annexes I and A -H1 Conformity assessment procedures Annex I Basic Require- ments Annex I Basic Require- ments General description of the „modules“ possible „modules“

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Possible Conformity assessment procedures 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 metersB+D, B+F, H1 MI-004, Heat metersB+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 SW:B+D, B+F, G, H1 MI-007, TaximetersB+D, B+F, H1 MI-008, Material measures I – Material measure of lengthB+D, D1, F1, G, H II – Capacity serving measuresA1, 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 analysersB+D, B+F, H1 An. A Internal production control An. F1 Product verification by N.B. (if so, statistic. verific.) An. C Internal production control An. D Assess- ment + surveillance of QMS production by N.B. An. E Assess- ment and surveillance of QMS product by N.B. An. F Product verification by N.B. (if so, statistic. verific.) An. C1 Internal production control + product testing by N.B. An. D1 Assess- ment and surveillance of QMS production by N.B. An. E1 Assess- ment and surveillance of QMS product by N.B. An. H1 Assess- ment and surveillance of full Quality Assu- rance + Design examination by N.B. An. G Unit verification by N.B. An. H Assess- ment and surveillance of full Quality Assu- rance by N.B. An. B Type examination by N.B. (Notified Body) An. A1 Internal production control + product testing by N.B. Technical documentation of the manufacturer

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Module A: Conformity Declaration on base of internal production control of manufacturer (without notified body) Not scheduled for MID so far!!! Alternatives of conformity assessment according to MID (Modules) Distribution, Start-up, service, maintenance Market research Concept, Customer requirement specifications Development Construction 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 Purchase Supplier M10 xxxx Declaration of conformity

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Sample Verification Module A1: Internal production control of manufacturer + Sample Verification of final products Only for Capacity Serving Measures MI-008-II Alternatives of conformity assessment according to MID (Modules) Distribution, Start-up, service, maintenance Market research Concept, Customer requirement specifications Development Construction 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 Purchase Supplier M10 xxxx Declaration of conformity Future module A2

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Alternatives of conformity assessment according to MID (Modules) Complete unit examination (100%) Module G: Unit verification of each single instrument Applicable for non-mass-produced single instruments MI-005, MI-006, MI-008, MI-009 Distribution, Start-up, service, maintenance Market research Concept, Customer requirement specifications Development Construction 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 Purchase Supplier M10 xxxx Declaration of conformity

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Modules B+C: Type examination (B) and internal production control (C) of manufacturer Module C not scheduled for MID so far!!! Alternatives of conformity assessment according to MID (Modules) Distribution, Start-up, service, maintenance Market research Concept, Customer requirement specifications Development Construction 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 Purchase Supplier M10 xxxx Declaration of conformity Type Examination

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Modules B+C1: Type examination (B) and Sample Verification (C1) Sample Verification Module C1 not scheduled for MID so far !!! Alternatives of conformity assessment according to MID (Modules) Distribution, Start-up, service, maintenance Market research Concept, Customer requirement specifications Development Construction 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 Purchase Supplier M10 xxxx Declaration of conformity Type Examination Future module C2

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Modules B+F: Type Examination (B) and Product Verification (F) Product Verification (100% or statistical) Applicable for small batch production of instruments MI-001 bis MI-007, MI-009, MI-010 (corresponds to former type approval and initial verification) Alternatives of conformity assessment according to MID (Modules) Distribution, Start-up, service, maintenance Market research Concept, Customer requirement specifications Development Construction 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 Purchase Supplier M10 xxxx Declaration of conformity Type Examination

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Module F1: Product Verification (F1) - see F without Type Examination Product Verification (100% or statistical) Applicable for „simple“ products MI-006 (mech.), MI-008, MI-009 (el.mech.) Alternatives of conformity assessment according to MID (Modules) Distribution, Start-up, service, maintenance Market research Concept, Customer requirement specifications Development Construction 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 Purchase Supplier M10 xxxx Declaration of conformity

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November 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 Audit + surveillance Alternatives of conformity assessment according to MID (Modules) Distribution, Start-up, service, maintenance Market research Concept, Customer requirement specifications Development Construction 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 Purchase Supplier M10 xxxx Declaration of conformity Type Examination

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Module D1: Approval of quality system for production (D1) – see D without B – Applicable for „simple“ large batch production with ISO 9001-certificate MI-006 (mech.), MI-008, MI-009 (mech., el.mech.) Audit + surveillance Alternatives of conformity assessment according to MID (Modules) Distribution, Start-up, service, maintenance Market research Concept, Customer requirement specifications Development Construction 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 Purchase Supplier M10 xxxx Declaration of conformity

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Modules B+E: Type Examination (B) and Approval of Quality System for final examination (E) Only applicable, if final examination meets all characteristics, relevant to MID MI-006 (mech., el.mech.), MI-008-II, MI-009 (mech., el.mech.) Audit + surveillance Alternatives of conformity assessment according to MID (Modules) Distribution, Start-up, service, maintenance Market research Concept, Customer requirement specifications Development Construction 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 Purchase Supplier M10 xxxx Declaration of conformity Type Examination

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Module E1: Approval of Quality System for final examination (E1) – see E without B – Simple measuring instruments, if final examination meets all attributes, relevant to MID MI-008-II, MI-009 (mech., el.mech.) Audit + surveillance Alternatives of conformity assessment according to MID (Modules) Distribution, Start-up, service, maintenance Market research Concept, Customer requirement specifications Development Construction 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 Purchase Supplier M10 xxxx Declaration of conformity

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Global Audit + surveillance Module H: Approval of quality system for development and production Only for Material Measures and simple length measuring instruments MI-008-I, MI-008-II, MI-009 (mech., el.mech) Alternatives of conformity assessment according to MID (Modules) Distribution, Start-up, service, maintenance Market research Concept, Customer requirement specifications Development Construction 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 Speciments, Type tests, Design validation Development Verification Purchase Supplier M10 xxxx Declaration of conformity

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Module H1: Approval of quality management system for development and production + Design examination MI-001…MI-007, MI-009, MI-010 Global Audit + surveillance Applicable for manufacturers with own type test equipment and ISO 9001-certificate Alternatives of conformity assessment according to MID (Modules) Distribution, Start-up, service, maintenance Market research Concept, Customer requirement specifications Development Construction 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 Speciments, Type tests, Design validation Development Verification Purchase Supplier M10 xxxx Declaration of conformity Design Examination

Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November Possible Conformity assessment procedures 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 metersB+D, B+F, H1 MI-004, Heat metersB+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 SW:B+D, B+F, G, H1 MI-007, TaximetersB+D, B+F, H1 MI-008, Material measures I – Material measure of lengthB+D, D1, F1, G, H II – Capacity serving measuresA1, 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 analysersB+D, B+F, H1 An. A Internal production control An. F1 Product verification by N.B. (if so, statistic. verific.) An. C Internal production control An. D Assess- ment + surveillance of QMS production by N.B. An. E Assess- ment and surveillance of QMS product by N.B. An. F Product verification by N.B. (if so, statistic. verific.) An. C1 Internal production control + product testing by N.B. An. D1 Assess- ment and surveillance of QMS production by N.B. An. E1 Assess- ment and surveillance of QMS product by N.B. An. H1 Assess- ment and surveillance of full Quality Assu- rance + Design examination by N.B. An. G Unit verification by N.B. An. H Assess- ment and surveillance of full Quality Assu- rance by N.B. An. B Type examination by N.B. (Notified Body) An. A1 Internal production control + product testing by N.B. Technical documentation of the manufacturer

H. Stolz, May Consequences for previous Metrology Authorities The manufacturer is solely responsible for the conformity of measuring instruments put to the market Notified bodies are conformity assessment service providers for manufacturers Monopoly loss (Notified Bodies shall coordinate at a European level !!!) Conformity assessment of notified bodies are private services in spite of administrative act (-> General term and conditions of certification, certification contract) The authorisation of notified bodies is limited to the contractual agreement with the manufacturer, it is restricted until putting into the market. (Possible form of pressure: refusal or withdrawal of certificates) Market surveillance is independent of notified bodies (A granted certificate does not ensure successful access to the market) Notified bodies shall follow the respective conformity assessment standards: EN (->ISO/IEC 17065), ISO/IEC 17025, ISO/IEC 17020, ISO/IEC Separation of conformity assessment services as a notified body and official (legal) tasks of Metrology Authorities (e.g. market surveillance)

REPUBLIC OF CROATIA STATE OFFICE FOR METROLOGY Seminar “ Legal Metrology & EU directives, New Legislative Framework” Zagreb, Croatia, 3 – 4 November 2010 Further Information New approach of EU: products/new-legislative-framework/ Notified Bodies(NANDO-Database): EU-Webpage Measuring Instruments: WELMEC: Thank you for your attention !!!