S1: Overview MID and NAWID 2012-10-31 1 Physikalisch-Technische Bundesanstalt Workshop on MID and NAWID for interested Serbian manufacturers of measuring

S1: Overview MID and NAWID 2012-10-311

Physikalisch-Technische Bundesanstalt

Workshop on MID and NAWID

for interested Serbian manufacturers of measuring instruments, stakeholders and DMDM staff

Peter Ulbig, Harry Stolz

Belgrade, 31 October 2012

MID +

NAWID


PTB = Germanys National Metrology Institute

Braunschweig

Berlin

BESSYin Berlin


Brief introduction

Dr. Peter Ulbig

Head of Division Q of

„Scientific-technical cross-sectional tasks“

Chairperson of the

Deutsche Kalibrierdienst

(association of PTB with accr. calibr. labs)

Responsible for legal metrology, accreditation in metrology,

international technical cooperation in metrology


Brief introduction

Dr. Harry Stolz

Head of the certification body

Project leader of an EU Twinning project

with Georgia dealing with metrology and

standardisation

Responsible for all certification systems at PTB.Expert in legal metrology, accreditation in metrology, international technical cooperation in metrology



Why this workshop ?

because Serbia likes to join the EU

because Serbia aims to align to European legislation

because European legislation is not easy!

but to make it easy for you to understand the philosophy behind

to give you an overview over the most relevant parts

to prepare you for the very next future!

and …



… you are not alone!Many countries are interested in the MID and NAWIDor even try right now to integrate them in national laws:

Balkan countries,

Russia, Belarussia, Kazakhstan, …

Jordan, Egypt

Tunesia, Algeria, Morocco, Mauretania

…


What are we talking about?

MID = Measuring Instruments Directive (Directive EC/2004/22)

NAWID = Non-Automatic Weighing Instruments Directive (Directive EC/2009/23, formerly 90/384/EC)

80 pages + 1000 pages (WELMEC guides)

22 pages + 200 pages (WELMEC guides)


MID + NAWID + European legislation

MIDNAWID

764 765

768


Where to be found?


Where to be found?


History

before 1971:

• only national

type approvals

• costs time and money

• sometimes different

requirements

• time to place

instruments on the

market relatively long


History

Non-automatic

weighing instruments

(NAWID)

• since 1990

(1990/384/EC)

for different NAWIs

• more or less

„New Approach“-direct.

• European type approv.


History

„blue guide“ (1999):

• how to place goods in the EC-market and how to put them into use

• responsibilities (manufacturer, user …)

• EC declaration of conformity (CE marking)

• notified bodies

• market surveillance


History

New Approach principles:

• Harmonisation is limited to essential requirements.

• Only products fulfilling the essential requirements may be placed on the market and put into use.

• Harmonised standards, which have been published in the Official EU-Journal and which have been transposed into national standards, are presumed to be conform to the corresponding essential requirements.


History

New Approach principles:

• Application of harmonised standards or other technical specifications remains voluntary, and manufacturers are free to choose any technical solution that provides compliance with the essential requirements.

• Manufacturers may choose between different

conformity assessment procedures provided

for in the corresponding directive

(„Global Approach“).


History

The “Global Approach”:

– is a modular approach, offering harmonised conformity assessment procedures to the manufacturers

– opens the possibility to take into account the manufacturers internal design and production control activities

– allows a complete assessment until placing a measuring instrument on the market / putting into use

– should provide a high level of confidence to the product

MID: The conformity assessment procedures must be performed under the responsibility of a Notified Body, who is under the surveillance of a member state


History

Basis: European harmonised standards

Presumption of conformity with the essential requirementsin full or in part if the instrument complies with :

– Harmonised European Standard (CEN/CENELEC)

– Normative Documents, e.g.drawn up by OIML,

in full or in part referenced in the C series of the Official Journal of the European Communities

Where an instrument not complies with referenced standards or documents, the Notified Body is in charge thatthe instrument meets the provisions of the Directive


History

Simplified flow chart of conformity assessment procedures (Global Approach)

(“Blue Guide”: www.newapproach.org)


History

Comparison old and new approach:

1. Type approval

2. Initial verification

3. subsequent verification

Conformity

assessment

subsequentverification


History

Comparison old and new approach (example):

1. Type approval

2. Initial verification


1. Conformity

assessment

(of the type)

2. Conformity to type



History

www.newapproach.org


History

Directive of the European Parliament and

of the Council on Measuring Instruments

relevant for 31 European countries (2004/22/EC)

=Measuring Instruments Directive = MID


History

Measuring Instruments

Directive (MID)

• since 2004

(2004/22/EC)

for 10 meas. instruments

• based on the

„New Approach“

• conformity assessment

(modules)


History

Some bad experiences with „New Approach“:

• small and medium enterprises are more or less

producing for a local market (not european-wide)

• market surveillance doesn‘t work in the EC

(no concepts, no harmonisation)

• accreditation procedures are very different in

the different member states (e.g. too many

accreditation bodies)


History

„New Legal Framework“ (Decision 768/2008):


History

Improvement of the „New Approach“:

• regulation shall be reduced to make it easier

for small and medium enterprises

• member states have to develop market surveillance

concepts and shall protect consumers much more

especially in the case of unsafe products from

third countries

• there has to be only one accreditation body

in each member state from 1st January 2010 on


2008 - 2012

Consequences of the „New legal framework“:

revision of european guide lines („OMNIBUS-procedure“)

to make it easy for everyone

New approach

omnibus

Dir1

Dir2

Dir3

Dir4

Dir5

unification of

directives


2008 - 2012



Directive (MID)

Non-automatic


(NAWID)

revision of european guide lines („OMNIBUS-procedure“)

many changes ! only some changes !

process finished more or less in 2012


2013 -



Directive (MID)

Non-automatic


(NAWID)

same definitions of e. g. „manufacturer“, „importer“ etc.

same conformity assessment modules


Definitions given by Decision 768/2008


Definitions given by Decision 768/2008


Obligations of manufacturers


Obligations of manufacturers


Conformity assessment

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

Speciments, Type tests,Design validation

DevelopmentValidation

Distribution,Start-up, service,maintenance

Purchase

SupplierTypical procedure at a manufacturerTypical procedure at a manufacturer


Old approach

Marketresearch




Production



Process planning




Purchase

SupplierTypical procedure at a manufacturerTypical procedure at a manufacturer

Initial VerificationType Approval


Structure of the Measuring Instruments Directive

MIDAnnexes

MI-001...MI-010

Requirements, specific to measuring instrument categories

Annexes MI-001...MI-010

Requirements, specific to measuring instrument categories

Articles1 to 23

Articles1 to 23

Annexes I and A-H1

Conformity assessmentprocedures

Annexes I and A-H1

Conformity assessmentprocedures

Annex IBasic

Require-ments

Annex IBasic

Require-ments

General descriptionof the „modules“

possible „modules“



MI-001 Water Meters

MI-002 Gas Meters and Volume Conversion Devices

MI-003 Active Electrical Energy Meters

MI-004 Heat Meters

(MI-001 to MI-004: for utility measuring purposes)

MI-005 Measuring Systems for the Measurement of Quantities of Liquids other than Water

MI-006 Automatic Weighing Instruments

MI-007 Taximeters

MI-008 Material Measures (length, capacity measure)

MI-009 Dimensional Measuring Instruments (e.g. area)

MI-010 Exhaust Gas Analysers



Basic Principle:

Regulations for legally controlled instruments are limited until “placing on the market” and/or “putting into use”

– Member states remain responsible for their legal metrological control (choice of controlled instruments, market surveillance), but

– National metrological control shall not lead to barriers for free movement of measuring instruments and

– Directives have to be implemented into national legislation.



What is regulated in the Member States? (Regulated Instruments in % of Member States):

Resid.I Com.I Industr. Utility meters (consumer protection)

100%, 97 % , 97 % MI-003 Active Electrical Energy Meters

93 % , 83 % , 74 % MI-001 Clean cold Water Meters

93 % , 93 % , 93 % MI-002 Gas Meters

89 % , 85 % , 85 % MI-001 Clean warm Water Meters

85 % , 89 %, 89 % MI-002 Volume conversion devices

82 % , 78 % , 78 % MI-004 Heat Meters (Resid.= residential use, Com. = commercial use, Industr. = industrial use)



Regulated Instruments in % Member States:

100 % MI-005 Fuel Dispensers (consum. prot.)

97 % MI-006 Automatic Weighing Instrum. (fair trade)

97 % MI-005 Systems on Road Tankers (fair trade)

93 % MI-005 Systems for Milk (fair trade)

89 % MI-007 Taximeters (consum. prot.)

85 % MI-010 Exhaust Gas Analysers (environment)

82 % MI-008 Material Measures: Length (consum.prot.)

74 % MI-008 Capacity measures (taxes)

70 % MI-009 Dimensional Measuring Instruments



Structure of the MID:

1) Articles, regulating the procedures: Definitions, Procedures for implementation, obligations, regulations, Criteria to be satisfied by the notified bodies, Necessary technical documentation from manufacturer, Safeguard clause in the case of non conformity, Changes and further development of the MID

2) General Essential Requirements (Annex I)

3) Conformity Assessment Procedures (Annexes A - H1)

4) Instrument Specific Essential Requirements (Annexes MI-001 to MI-010)



Essential Requirements: All instruments (Annex I) Correct measurement: maximum permissible errors, durability

Influence quantities: mechanic, climatic, electromagnetic

Suitability for use, reproducibility

Verifiability: Metrolog. relevant parts, also for instruments in use

Additional functionalities, not under legal control

Protection against corruption (Hard- and Software)

Easy identification of metrological relevant Hard- and Software

Information to accompany the instruments

Indication of the result: (Metrologically controlled display for the consumer as the basis of the price to pay)

Further processing of data to conclude trading transaction



Instrument specific Essential Requirements(Annexes MI-001 to MI-010)

Rated operating conditions (climatic, mechan., electromagn.)

Maximum permissible Errors (MPE) at rated operating cond.

Permissible effects of disturbances

Indication of the result

Allowed Conformity Assessment Procedures

If applicable:

Accuracy classes

Conditions for putting into use

Suitability / Durability

Requirements for sub assemblies with conformity assessment


•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 SW: 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, H1 electronic 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

Internal pro-duction control + product testing by N.B.

An. D1


of QMS pro-duction by N.B.

An. E1


of QMS product by N.B.

An. H1


of full Quality Assu-rance

+

Design exami-nation by N.B.

An. G

Unit verifi-cationby N.B.

An. H


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

Conformity assessment modules



Marketresearch




Production



Process planning




Purchase

Supplier

M10 xxxx

Declaration of conformity

Module A: Conformity Declaration on base of internal production control of manufacturer (without notified body)

Not scheduled for MID so far!!!


Marketresearch




Production



Process planning




Purchase

Supplier


Sample Verification

Module A1: Internal production control of manufacturer + Sample Verification of final products

Future module A2

M10 xxxx



Marketresearch




Production



Process planning




Purchase

Supplier


M10 xxxx


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


Marketresearch




Production



Process planning




Purchase

Supplier

M10 xxxx


Modules B+C: Type examination (B) and internal production control (C) of manufacturer

Type Examination

Module C not scheduled for MID so far!!!



Marketresearch




Production



Process planning




Purchase

Supplier

M10 xxxx


Modules B+C1: Type examination (B) and Sample Verification (C1)

Module C1 not scheduled for MID so far !!!Future module C2

Type Examination

Sample Verification



Marketresearch




Production



Process planning




Purchase

Supplier


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)

M10 xxxx


Type Examination

Product Verification

100 % or statistical


Audit + surveillance

Marketresearch




Production



Process planning




Purchase

Supplier


M10 xxxx


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

Type Examination



Purchase

Supplier

Marketresearch




Production



Process planning





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.)

M10 xxxx




Marketresearch




Production

Components,Final products,

Final inspection


Process planning




Purchase

Supplier


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 MIDMI-006 (mech., el.mech.), MI-008-II, MI-009 (mech., el.mech.)

Type Examination

M10 xxxx




Marketresearch




Production

Components,Final products,

Final inspection


Process planning




Purchase

Supplier


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.)

M10 xxxx



Global Audit + surveillance

Marketresearch




Production



Process planning




Purchase

Supplier


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)

M10 xxxx



Global Audit + surveillance

Marketresearch




Production



Process planning

Speciments,

Type tests,Design validation



Purchase

Supplier


M10 xxxx


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

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

Design Examination



Ticket for the EC-Market since 30th October 2006:

M 06 0102

M = Conformity to the legal metrology Directive 2004/22/EC

= Conformity to applicable technical harmonisation Directives

06 = Year of affixing the CE- and the metrology marking

0102 = Identification no. of the notified body, responsible for the conformity assessment procedure for ‘placing on the market’ and/or ‘putting into use’


CE-mark


Consequences

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(The manufacturer is free to choose a Notified Body on a European level !!!)


Nando Database


Conformity assessments of notified bodies are private services in spite of administrative acts( General terms and conditions of certification, ´ certification contract)

The authorisation of notified bodies is limited to the contractual agreement with the manufacturer, it is restricted until placing on the market.(Possible kind 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)

Consequences


Notified bodies shall follow the respective conformity assessment standards:

EN 45011 ( ISO/IEC 17065), ISO/IEC 17025, ISO/IEC 17020, ISO/IEC 17021

Separation of conformity assessment services as a notified body from the official (legal) tasks of metrology authorities (e.g. market surveillance)

In case of a national metrology institute:independent units for conformity assessment and market surveillance

Consequences


Links

Further Information

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