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
S1: Overview MID and NAWID 2012-10-312
PTB = Germanys National Metrology Institute
Braunschweig
Berlin
BESSYin Berlin
S1: Overview MID and NAWID 2012-10-313
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
S1: Overview MID and NAWID 2012-10-314
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
S1: Overview MID and NAWID 2012-10-315
Workshop on MID and NAWID
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 …
S1: Overview MID and NAWID 2012-10-316
Workshop on MID and NAWID
… 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
…
S1: Overview MID and NAWID 2012-10-317
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)
S1: Overview MID and NAWID 2012-10-318
MID + NAWID + European legislation
MIDNAWID
764 765
768
S1: Overview MID and NAWID 2012-10-319
Where to be found?
S1: Overview MID and NAWID 2012-10-3110
Where to be found?
S1: Overview MID and NAWID 2012-10-3111
History
before 1971:
• only national
type approvals
• costs time and money
• sometimes different
requirements
• time to place
instruments on the
market relatively long
S1: Overview MID and NAWID 2012-10-3112
History
Non-automatic
weighing instruments
(NAWID)
• since 1990
(1990/384/EC)
for different NAWIs
• more or less
„New Approach“-direct.
• European type approv.
S1: Overview MID and NAWID 2012-10-3113
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
S1: Overview MID and NAWID 2012-10-3114
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.
S1: Overview MID and NAWID 2012-10-3115
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“).
S1: Overview MID and NAWID 2012-10-3116
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
S1: Overview MID and NAWID 2012-10-3117
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
S1: Overview MID and NAWID 2012-10-3118
History
Simplified flow chart of conformity assessment procedures (Global Approach)
(“Blue Guide”: www.newapproach.org)
S1: Overview MID and NAWID 2012-10-3119
History
Comparison old and new approach:
1. Type approval
2. Initial verification
3. subsequent verification
Conformity
assessment
subsequentverification
S1: Overview MID and NAWID 2012-10-3120
History
Comparison old and new approach (example):
1. Type approval
2. Initial verification
3. subsequent verification
1. Conformity
assessment
(of the type)
2. Conformity to type
3. subsequent verification
S1: Overview MID and NAWID 2012-10-3121
History
www.newapproach.org
S1: Overview MID and NAWID 2012-10-3122
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
S1: Overview MID and NAWID 2012-10-3123
History
Measuring Instruments
Directive (MID)
• since 2004
(2004/22/EC)
for 10 meas. instruments
• based on the
„New Approach“
• conformity assessment
(modules)
S1: Overview MID and NAWID 2012-10-3124
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)
S1: Overview MID and NAWID 2012-10-3125
History
„New Legal Framework“ (Decision 768/2008):
S1: Overview MID and NAWID 2012-10-3126
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
S1: Overview MID and NAWID 2012-10-3127
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
S1: Overview MID and NAWID 2012-10-3128
2008 - 2012
Consequences of the „New legal framework“:
Measuring Instruments
Directive (MID)
Non-automatic
weighing instruments
(NAWID)
revision of european guide lines („OMNIBUS-procedure“)
many changes ! only some changes !
process finished more or less in 2012
S1: Overview MID and NAWID 2012-10-3129
2013 -
Consequences of the „New legal framework“:
Measuring Instruments
Directive (MID)
Non-automatic
weighing instruments
(NAWID)
same definitions of e. g. „manufacturer“, „importer“ etc.
same conformity assessment modules
S1: Overview MID and NAWID 2012-10-3130
Definitions given by Decision 768/2008
S1: Overview MID and NAWID 2012-10-3131
Definitions given by Decision 768/2008
S1: Overview MID and NAWID 2012-10-3132
Obligations of manufacturers
S1: Overview MID and NAWID 2012-10-3133
Obligations of manufacturers
S1: Overview MID and NAWID 2012-10-3134
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
S1: Overview MID and NAWID 2012-10-3135
Old approach
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
Initial VerificationType Approval
S1: Overview MID and NAWID 2012-10-3136
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“
S1: Overview MID and NAWID 2012-10-3137
Structure of the Measuring Instruments Directive
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
S1: Overview MID and NAWID 2012-10-3138
Structure of the Measuring Instruments Directive
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.
S1: Overview MID and NAWID 2012-10-3139
Structure of the Measuring Instruments Directive
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)
S1: Overview MID and NAWID 2012-10-3140
Structure of the Measuring Instruments Directive
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
S1: Overview MID and NAWID 2012-10-3141
Structure of the Measuring Instruments Directive
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)
S1: Overview MID and NAWID 2012-10-3142
Structure of the Measuring Instruments Directive
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
S1: Overview MID and NAWID 2012-10-3143
Structure of the Measuring Instruments Directive
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
S1: Overview MID and NAWID 2012-10-3144
•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
Internal pro-duction control
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
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
Internal pro-duction control
+ product testing by N.B.
Technical documentation of the manufacturer
Conformity assessment modules
S1: Overview MID and NAWID 2012-10-3145
Conformity assessment modules
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
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!!!
S1: Overview MID and NAWID 2012-10-3146
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
Supplier
Conformity assessment modules
Sample Verification
Module A1: Internal production control of manufacturer + Sample Verification of final products
Future module A2
M10 xxxx
Declaration of conformity
S1: Overview MID and NAWID 2012-10-3147
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
Supplier
Conformity assessment modules
M10 xxxx
Declaration of conformity
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
S1: Overview MID and NAWID 2012-10-3148
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
Supplier
M10 xxxx
Declaration of conformity
Modules B+C: Type examination (B) and internal production control (C) of manufacturer
Type Examination
Module C not scheduled for MID so far!!!
Conformity assessment modules
S1: Overview MID and NAWID 2012-10-3149
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
Supplier
M10 xxxx
Declaration of conformity
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
Conformity assessment modules
S1: Overview MID and NAWID 2012-10-3150
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
Supplier
Conformity assessment modules
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
Declaration of conformity
Type Examination
Product Verification
100 % or statistical
S1: Overview MID and NAWID 2012-10-3151
Audit + surveillance
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
Supplier
Conformity assessment modules
M10 xxxx
Declaration of conformity
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
S1: Overview MID and NAWID 2012-10-3152
Audit + surveillance
Purchase
Supplier
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
Conformity assessment modules
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
Declaration of conformity
S1: Overview MID and NAWID 2012-10-3153
Audit + surveillance
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
Supplier
Conformity assessment modules
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
Declaration of conformity
S1: Overview MID and NAWID 2012-10-3154
Audit + surveillance
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
Supplier
Conformity assessment modules
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
Declaration of conformity
S1: Overview MID and NAWID 2012-10-3155
Global Audit + surveillance
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
Supplier
Conformity assessment modules
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
Declaration of conformity
S1: Overview MID and NAWID 2012-10-3156
Global Audit + surveillance
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
Supplier
Conformity assessment modules
M10 xxxx
Declaration of conformity
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
S1: Overview MID and NAWID 2012-10-3157
Conformity assessment modules
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’
S1: Overview MID and NAWID 2012-10-3158
CE-mark
S1: Overview MID and NAWID 2012-10-3159
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 !!!)
S1: Overview MID and NAWID 2012-10-3160
Nando Database
S1: Overview MID and NAWID 2012-10-3161
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
S1: Overview MID and NAWID 2012-10-3162
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
S1: Overview MID and NAWID 2012-10-3163
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