Saso Oiml D34 2020 e

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AF SASO OIML D 34:2020

OIML D 34:2019
Conformity to Type (CTT) – Pre-market conformity

assessment of measuring instruments
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ICS : 01.060
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Saudi Standards, Metrology and Quality Org (SASO)

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this document is a draft saudi standard circulated for comment. it is, therefore
subject to change and may not be referred to as a saudi standard until approved by
the board of directors.
Foreword
The Saudi Standards ,Metrology and Quality Organization (SASO)has

adopted the International standard No. ISO OIML D 34:-3:2019
“Conformity to Type (CTT) – Pre-market conformity assessment of
measuring instruments ” issued by (OIML). The text of this international
standard has been translated into Arabic so as to be approved as a Saudi
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standard.
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SAUDI STANDADR SASO OIML D 34: 2020
Contents
1 Introduction .................................................................................................................................... 5
2 Scope .............................................................................................................................................. 6
3 Terminology and abbreviations...................................................................................................... 6
3.1 Definitions............................................................................................................................... 6
3.2 Abbreviations and acronyms................................................................................................... 8
4 Considerations for a CTT program .............................................................................................. 10
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4.1 General .................................................................................................................................. 10
4.2 Legal metrological control systems ...................................................................................... 10
4.3 Elements to be considered..................................................................................................... 14
5 Issues identified and possible mitigation strategies ..................................................................... 14
6 Examples of existing CTT programs in the field of legal metrology ........................................... 15
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6.1 NTEP VCAP in the US ......................................................................................................... 15
6.2 The European Directives: NAWID and MID ....................................................................... 15
Annex 1 The ISO/IEC 17000 series (Informative) .......................................................................... 17
A1.1 Conformity assessment — the ISO/IEC 17000 series ............................................................. 17
A1.2 The ISO/IEC 17000 series standards with relevance to CTT .................................................. 17
Annex 2 The IEC Conformity Assessment (CA) systems (Informative) ........................................ 18
Annex 3 MID conformity assessment modules B, D and F (Informative) ...................................... 20
A3.1 Module B: EU-type examination ...................................................................................... 20
A3.2 Module D: Conformity to type based on quality assurance of the production process..... 22
A3.3 Module F: Conformity to type based on product verification........................................... 25
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Annex 4 NTEP/VCAP requirements and procedures (Informative) ............................................... 27
Annex 5 MID conformity assessment module H1 (Informative) .................................................... 30
Annex 6 Technical documentation (informative) ............................................................................ 35
Annex 7 The relationship with ‘market surveillance’ (Informative) ............................................... 37
Annex 8 References ......................................................................................................................... 39
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Pre-market conformity assessment of measuring instruments
1 Introduction
1.1 Generally, measuring instruments under legal control are subjected to conformity assessment
before they may be legally used. Traditionally, such conformity assessment comprises type
evaluation and type approval followed by verification.
1.2 At type evaluation, one or more instruments are subjected to examination and a wide range of
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tests (temperature, electromagnetic compatibility, etc.) that often require specialised and
expensive test facilities and can only be meaningfully performed in a laboratory. The
instruments submitted for type evaluation shall be representative of the final production of the
type of instrument. On completion of the type evaluation, a type evaluation report is issued
which will be reviewed when making the decision on type approval and the issuing of a type
approval certificate.
1.3 At verification, each individual instrument from the production is subjected to a limited set of
1.4
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tests, typically at ambient temperature only, to verify whether the instrument performs within
maximum permissible errors. Verification may also include an assessment of the compliance
of the design of the instrument with the approved type, as described in the type approval
certificate and the technical documentation, before it is put into use for regulated purposes.
This system of type evaluation, type approval and verification has been established in many
countries and regions and it has worked well to ensure that measuring instruments under legal
control comply with applicable technical and metrological requirements.
1.5 However, a range of factors is impacting on the ability to ensure that instruments are in
conformity with the approved type, for instance:
• new technologies make it difficult and often impossible to verify whether hardware
components in production instruments have the same function or the same specifications
as those in the samples that were tested for type approval;
•
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software can be downloaded remotely;
• as a result of globalisation and increasingly complex supply chains, instruments may be
issued with a type approval certificate in one country, produced in another country with
components from different sources, and verified and used in yet another country.
1.6 The issues arising from these factors are further exacerbated by the increased use of test results
obtained under bilateral and multilateral acceptance arrangements, such as the OIML
Certification System (OIML-CS) for measuring instruments [1].
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1.7 Consequently, it is becoming increasingly difficult to ascertain whether the instrument that is
being verified is in conformance with the design as described in the type approval certificate,
or in compliance with all of the applicable technical and metrological legal requirements.
1.8 The problem may be formulated in the following way: “Traditional conformity assessment in
legal metrology (i.e. type evaluation and type approval, followed by verification) may not
provide a sufficient level of assurance that verified instruments comply with all applicable
requirements”.
1.9 This could potentially result in the exposure of manufacturers to unfair competition from non-
compliant instruments, and countries and economies from potentially having non-conforming
products placed on their market.
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1.10 This problem is illustrated by the following issues identified in an OIML Member State where
the final products did not conform to the approved type:
• load cells lacking temperature compensation;
• NAWI instruments with different power supplies; and
• EMC components missing from instruments.
1.11 Different solutions to overcome the problems described above have been proposed, some of
which have been implemented and are presented in this Document as “good practice”. These
solutions include elements such as surveillance of the production by the body that issued the
type approval certificate and much more detailed requirements for the documentation to be
provided by the manufacturer when applying for type approval.
1.12 It should also be recognised that the implementation and certification of quality management
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systems by manufacturers of measuring instruments greatly contributes to improving the
situation, as it provides confidence that manufacturers are able to consistently produce
measuring instruments in conformity with the approved type.
2 Scope
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This Document provides considerations for countries and economies, or Regional Legal Metrology
Organisations (RLMOs), that are planning to develop conformity to type (CTT) programs in the field
of legal metrology. This Document also provides illustrative examples of CTT programs currently in
operation.
3 Terminology and abbreviations
For the purposes of this Document, the following definitions and abbreviations apply.
3.1 Definitions
3.1.1
accreditation (from ISO/IEC 17000:2004, 5.6 [2] and VIML, A.19 [3])
third-party attestation related to a conformity assessment body conveying formal demonstration of its
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competence to carry out specific conformity assessment tasks
3.1.2
certification (from ISO/IEC 17000:2004, 5.5 [2] and VIML, A.18 [3])
third-party attestation related to products, processes, systems or persons
3.1.3
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conformity assessment (from ISO/IEC 17000:2004, 2.1 [2] and VIML, A.1 [3])
demonstration that specified requirements relating to a product, process, system, person or body are
fulfilled
3.1.4
conformity to type (CTT)
conformity assessment procedure focused on the assessment of measuring instruments to give assurance
that manufactured (or production) instruments meet the approved type
Note: The concept of CTT as considered in this Document refers to a systematic pre-market
conformity assessment procedure applicable to measuring instruments. It should not be
confused with ‘market surveillance’ activities, which are sometimes performed as part of a
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systematic program but often are performed ad-hoc by public authorities based on risk
assessment and market intelligence, e.g. user complaints. ‘Market surveillance’ is further
discussed in Annex 7.
3.1.5
conformity to type (CTT) program
entity of a national or regional framework for implementing the concept of CTT
3.1.6
initial verification (from VIML, 2.12 [3])
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verification of a measuring instrument which has not been verified previously
3.1.7
inspection (from ISO/IEC 17000:2004, 4.3 [2] and VIML, A.11 [3])
examination of a product design, product, process or installation and determination of its conformity
with specific requirements or, on the basis of professional judgment, with general requirements
3.1.8
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legal metrological control (from VIML, 2.01 [3])
the whole of legal metrology activities
Note: Legal metrological control includes
• legal control of measuring instruments,
• metrological supervision, and
• all the operations for the purpose of examining and demonstrating, e.g. to testify in a court
of law, the condition of a measuring instrument and to determine its metrological
properties, amongst others by reference to the relevant statutory requirements.
3.1.9
legal metrology (from VIML, 1.01 [3])
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practice and process of applying statutory and regulatory structure and enforcement to metrology
3.1.10
metrological authority (from VIML, 1.05 [3])
legal entity designated by law or by the government to be responsible for specified legal metrology
activities
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3.1.11
placing on the market (from VIML, 2.2.4 [3])
the first making available of a measuring instrument or a prepackage on the market
Note: In the context of this Document, this definition applies to individual instruments rather than an
approved type of a measuring instrument.
3.1.12
subsequent verification (from VIML, 2.13 [3])
verification of a measuring instrument after a previous verification
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3.1.13
surveillance (from ISO/IEC 17000:2004, 6.1 [2] and VIML, A.20 [3])
systematic iteration of conformity assessment activities as a basis for maintaining the validity of the
statement of conformity
3.1.14
testing (from ISO/IEC 17000:2004, 4.2 [2] and VIML, A.10 [3])
determination of one or more characteristics of an object of conformity assessment, according to a
procedure
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3.1.15
type approval (from VIML, 2.05 [3])
decision of legal relevance, based on the review of the type evaluation report, that the type of a
measuring instrument complies with the relevant statutory requirements and results in the issuance of
the type approval certificate
3.1.16
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type evaluation (from VIML, 2.04 [3])
conformity assessment procedure on one or more specimens of an identified type (pattern) of measuring
instruments which results in an evaluation report and / or an evaluation certificate
Note: “Pattern” is used in legal metrology with the same meaning as “type”.
3.1.17
verification (from VIM, 2.44 [4])
provision of objective evidence that a given item fulfils specified requirements
3.1.18
verification of a measuring instrument (from VIML, 2.09 [3])
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conformity assessment procedure (other than type evaluation) which results in the affixing of a
verification mark and/or issuing of a verification certificate
3.1.19
verification mark (from VIML, 3.04 [3])
mark applied to a measuring instrument in a conspicuous manner certifying that the verification of the
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measuring instrument was carried out and compliance with statutory requirements was confirmed
3.2 Abbreviations and acronyms
ANAB ANSI-ASQ National Accreditation Board

ANSI American National Standards Institute
ASQ American Society for Quality
CAC Conformity assessment certificate
CAR Conformity assessment report
CASCO ISO Committee on Conformity Assessment
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CB Certification body
CC Certificate of conformance
CE Symbol, used to indicate conformity. Not an official abbreviation
CIML International Committee of Legal Metrology
CTT Conformity to type
EEA European Economic Area
EMC Electro-magnetic compatibility
EMS Environmental management system
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EU European Union
IEC International Electrotechnical Commission
IECEE IEC system for conformity testing and certification of electrotechnical equipment and
components
IECEx IEC system for certification to standards relating to equipment for use in explosive
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IECQ IEC quality assessment system for electronic components
IECRE IEC system for certification to standards relating to equipment for use in renewable
energy applications
ISO International Organization for Standardization
MID Measuring instruments directive
MSC Metrologically significant component
NAWI Non-automatic weighing instruments
NAWID Non-automatic weighing instruments directive
NCB National certification body
NCWM National Conference on Weights and Measures
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NIST National Institute of Standards and Technology
NTEP National type evaluation program
OIML-CS OIML Certification System
QMS Quality management system
RAPEX RAPid EXchange 1
RLMO Regional Legal Metrology Organisation
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SIC Standard industry classification

UNECE United Nations Economic Commission for Europe
US United States of America
VCAP Verified conformity assessment program
VIM International vocabulary of metrology
1RAPEX is the EU’s system for rapid exchange of information on dangers arising from the use of products.
See section 7.5.2 in [5].
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4 Considerations for a CTT program
4.1 General
4.1.1 In order to address the issues identified in the Introduction, a CTT program should be an integral
part of legal metrological control for measuring instruments for which national legislation
requires type evaluation and type approval followed by initial verification before such
instruments may be placed on the market.
4.1.2 Legal metrological control systems may be considered as consisting of a sequence of

conformity assessment procedures covering the various phases of the life cycle of measuring
instruments: the design phase, the production phase, the distribution phase, the installation
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phase and the in-service phase. It is during the production phase when CTT takes place and
during the distribution phase when market surveillance typically takes place.
4.1.3 Legal metrological control systems may exist in different forms, i.e. consist of different
conformity assessment procedures. Accordingly, CTT may appear as a separate conformity
assessment procedure, or be part of another conformity assessment procedure (e.g. initial
verification, surveillance). It will, however, always be applied in the production phase. This is
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illustrated by considering four different legal metrological control systems: A, B, C and D (see
Figure 1).
4.2 Legal metrological control systems
4.2.1 Depending on the place of conformity to type in the legal metrological control system, three
main systems may be distinguished:
A. CTT as an integral part of verification;
B. CTT as a separate conformity assessment procedure, in between type approval and
verification;
C. CTT linked to type approval through surveillance of the production by the body that issued
the type approval certificate or by a body different from the body that issued the type
approval certificate;
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D. CTT and verification as separate, independent activities.
4.2.2 Following installation of the measuring instrument and a period of service in the field, the legal
metrological control systems may include post-market activities such as market surveillance
(Annex 7), inspections, and subsequent verification (as shown in Figure 1). These post-market
activities provide assurances that measuring instruments and systems are operating as intended;
they also have the potential to provide significant information concerning the long-term
performance of the instruments and the prevalence of non-conforming instruments to
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manufacturers, CTT bodies, regulators, and customers.
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4.2.3 System A
4.2.3.1 System A includes
• type evaluation, with tests and examinations performed on one or more specimen
instruments, followed by type approval resulting in the issuing of a national or regional
type approval certificate 2;
• verification, where individual instruments are assessed for compliance with the technical
and metrological requirements that apply to them and resulting in the application of a
verification mark on the instruments. For those requirements for which compliance
cannot be assessed during verification, the assessment of the conformity of the instrument
with the approved type (i.e. CTT) should ensure that the instrument complies with those
requirements;
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• conformity assessment procedures after placing on the market, as part of market
surveillance and in-service inspection by metrological authorities, or subsequent
verification.
4.2.3.2 Examples of a ‘System A’ legal metrological control:
AF• traditional type evaluation, type approval and verification procedures for measuring
instruments used for trade: weighing instruments, petrol pumps, etc. where the
verification is considered to ensure CTT;
• European Measuring Instruments Directive (MID) [6] or Non-automatic Weighing
Instruments Directive (NAWID) [7] conformity assessment Module B: EU-type
examination plus Module F: Conformity to type based on product verification. See 6.2
and Annex 3 for details.
4.2.3.3 A variation of System A is the case where the manufacturer has a certified quality system
covering the production phase and is authorised under the control of the certified quality system
to apply a verification mark. In this case, CTT is part of the certified quality system.
4.2.4 System B
4.2.4.1 System B includes
• type evaluation and type approval, as in System A;
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• CTT as a separate conformity assessment procedure, resulting in the affixing of a
conformity marking on the instrument;
• verification, where the conformity of the instrument to the approved type is demonstrated
by the conformity marking on the instrument, resulting in the application of a verification
mark on the instrument;
• conformity assessment procedures after placing on the market, as in System A.
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4.2.4.2 This system may apply to a regionally based conformance system where a conformity mark is
agreed and utilised by participating economies. Typically, the type approval would take place
in one jurisdiction and production (and initial verification) in another. This could result in the
need for a conformity mark.
Note: To date, the OIML is not aware of an example of a ‘System B’ in legal metrology.
2 The evaluation may take account of the results of tests and examinations obtained by other bodies under
a mutual acceptance arrangement, for instance an OIML Certificate and/or OIML type evaluation report
issued by an OIML Issuing Authority under the OIML-CS.
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4.2.5 System C
4.2.5.1 System C includes
type evaluation and type approval, as in system A, and surveillance of the production by
the body that issued the type approval certificate. Here, CTT would be part of the
surveillance. A conformity marking would be affixed during the production of the
instruments,
verification, as in System B,
conformity assessment procedures after placing on the market, as in Systems A and B.
4.2.5.2 Example of System C:
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The National Type Evaluation Program (NTEP) Verified Conformity Assessment
Program (VCAP) administered by the National Conference on Weights and Measures
(NCWM) in the US. For details, see 6.1 and Annex 4.
4.2.5.3 A variation of System C is the case where the manufacturer has a certified quality system
covering both the design and production phases and is authorised to apply a verification mark.
In this case, CTT is part of the certified quality management system.
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Example:
The European Measuring Instruments Directive (MID) [6], conformity assessment
Module H1: Conformity based on full quality assurance plus design examination. For
details see 6.2 and Annex 5.
4.2.5.4 Other variations of the systems considered here may exist. For instance: verification may be
performed either by metrological authorities, or, under certain conditions, by authorised
manufacturers, installers, and/or private verification bodies. Such variations, however, do not
affect the role of CTT.
4.2.6 System D
4.2.6.1 System D includes
Type evaluation and type approval, as in System A,
CTT as a separate conformity assessment procedure. The system may include the use of
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a conformity mark indicating participation in a CTT program,
Verification as a separate conformity assessment procedure. Here verification provides
no evidence or assessment of CTT,
Conformity assessment procedures after placing on the market, as in Systems A, B and C.
4.2.6.2 This system allows for verification and CTT to be undertaken as independent activities. This
system may be implemented with or without the use of a CTT conformity mark on instruments.
Where there is no mark, conformity may be established through certificates or sharing of test
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results.
Example:
WSA 16 – 2013 Water Services Association of Australia (WSAA): Water Meter Pattern
Compliance and Data Sharing Code of Practice3.
3 https://www.wsaa.asn.au/shop/product/5536
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Legal metrological control systems
Stage A B C D
Type Evaluation Type Evaluation Type Evaluation & Type Evaluation

Surveillance
OIML Certificate OIML Certificate OIML Certificate OIML Certificate
National or National or National or National or
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Regional Regional Regional Regional
Type Approval Type Approval Type Approval Type Approval
Certificate Certificate Certificate Certificate
Production
to Type
Conformity
Verification
Initial
AF Initial Verification Conformity to Type Surveillance
Conformity to Type Conformity Mark Conformity to Type
Pre-market
Verification Mark
Conformity Mark
Initial Verification Initial Verification
Verification Mark Verification Mark Verification Mark
Use - Market - Market - Market - Market

surveillance surveillance surveillance surveillance
- Inspections - Inspections - Inspections - Inspections
- Subsequent - Subsequent - Subsequent - Subsequent
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verification verification verification verification
Post-
market
Figure 1 Legal metrological control systems
Note 1: “OIML Certificate” indicates any acceptable certificate and/or type evaluation report issued by
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other bodies and which may be taken into account during type evaluation.
Note 2:‘Surveillance’ during the production phase in System C is performed as part of the certification
(type evaluation and type approval) process where non-compliances may lead to the withdrawal
of the type approval certificate. It should not be confused with ‘market surveillance’ performed
by authorities. See also Annex 7.
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4.3 Elements to be considered

4.3.1 Elements to be considered for inclusion in a CTT program:
• comparing production instruments with the design of the approved type as described in
the type approval certificate and documentation (for an example of requirements for type
approval documentation, see Annex 6);
• repeating (part of the) type evaluation tests on one or more production instruments, as
part of a surveillance and sampling program. The sampling may be ad-hoc, or based on
a statistical sampling plan. The extent of such a program may be based on a risk
assessment, a specific critical influence quantity (e.g. extreme humidity in an economy),
or take account of the number of instruments placed on the market;
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• production of instruments under an appropriate certified quality management system;
• affixing a mark on the instrument to declare its conformity to the approved type;
• sealing of the instrument to ensure that it cannot be modified until verification;
• linking the renewal of a type approval certificate (sunset clause) to the testing of
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• regionally or internationally sharing the results of conformity to type surveillance and
testing.
5 Issues identified and possible mitigation strategies
a) The description of the approved type in the type approval certificate may not be detailed enough
to identify critical parts or components of the instrument:
 Provide guidance on the details of the description of the type in the type approval
certificate.
b) Possible conflicts of interest where private bodies perform CTT that are paid for by the
manufacturer:
 Develop an industry code of practice (voluntary) for the manufacturer to sign up to,
clearly defining roles and responsibilities, including requirements on sharing of
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information.
c) Funding of CTT programs may be unavailable or insufficient:
 Start small; prove benefits to manufacturers and legal metrology regulatory authorities.
Consider starting with a national, bilateral or regional approach. Focus on specific types
of instrument or industry (e.g. water meter code of practice developed in New
Zealand 4).
d) Sharing of information between regulators on a national and international basis raises privacy
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issues and issues to do with securing intellectual property rights:

 Set up an information sharing system such as RAPEX in Europe (see section 7.5.2 in
[5]), sharing information using templates and limiting access to participating issuing
authorities and regulators nominated by the CIML Member. Operation based on a code
of practice with voluntary participation.
4 New Zealand Water and Waste Association (NZWWA): Water meter code of Practice, 2003, see:
http://www.nzwwa.org.nz/Folder?Action=View%20File&Folder_id=101&File=110118_water_meter_cop
.pdf
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e) Lack of market surveillance, so that existing CTT programs cannot be adequately evaluated for
their effectiveness:
 Increase sharing and coordination of market surveillance activities between authorities
f) Impact of CTT on time to market and the supply of production instruments. Like other
regulatory controls, CTT could increase the time delay for manufacturers to bring new products
to market or the time it takes to supply production instruments:
 Where CTT involves type evaluation tests, consider a risk-based approach when
determining sample sizes and relevant influence and disturbance tests. Also consider
implementing corresponding changes to related regulatory controls. For instance,
regulatory bodies may consider changes to type approval requirements such as
accepting manufacturers’ test results provided manufacturers participate in a CTT
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program.
g) Market surveillance uncovers performance flaws associated with field installation and
calibration:
 CTT program encourages an industry code of practice whereby the manufacturer
ensures technicians, engineers, or installers are properly trained to install and calibrate
devices to perform to legal requirements.
6.1
6.1.1
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Examples of existing CTT programs in the field of legal metrology
NTEP VCAP in the US
In the US, the National Conference on Weights and Measures (NCWM) administers the
National Type Evaluation Program (NTEP). NTEP performs type evaluations of measuring
instruments and issues Certificates of Conformance. In addition, NTEP has developed
conformity assessment procedures to ensure conformance of production instruments with their
approved type. One of the elements is the NTEP Verified Conformity Assessment Program
(VCAP). The scope of this program is currently restricted to weighing equipment.
Manufacturers of instruments or components within the scope of VCAP and which are subject
to influence factors as defined in NIST Handbook 44 [8], must have a VCAP in place to ensure
that these instruments and components are produced at a level consistent with that of the
previously certified instrument or component.
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6.1.2 The VCAP requirements are detailed in NCWM/NTEP Publication 14: Administrative policy,
Section 21: Conformity Assessment Process [9] (See Annex 4).
6.1.3 Non-compliance with the VCAP requirements may result in the Certificate of Conformance
becoming “inactive”.
6.2 The European Directives: NAWID and MID

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6.2.1 The Member States of the European Union are required to implement the European Non-
automatic Weighing Instruments Directive (NAWID) [7] and the European Measuring
Instruments Directive (MID) [6] when exercising legal control on measuring instruments for
the applications mentioned in those Directives.
6.2.2 The NAWID [7] and the MID [6] provide for the affixing of the CE marking and the
supplementary metrology marking (M) on the measuring instruments within their scope that
will be placed on the market of the European Economic Area (EEA) 5 and Turkey.
5 The EEA consists of the European Union Member States, Norway, Iceland and Lichtenstein.
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6.2.3 The manufacturer is responsible for the conformity of the instruments with the provisions of all
applicable European Union legislation and for the affixing of the CE marking. By affixing the
CE marking, a manufacturer is declaring conformity, irrespective of whether or not a third party
has been involved in the conformity assessment process.
6.2.4 Conformity assessment procedures are composed of one or two conformity assessment
modules, covering both design and production phases. For more information about the
conformity assessment procedures for products by European legislation providing for the
affixing of the CE marking, see paragraph 5.1 of the 2016 edition of the “Blue Guide” [5] on
the implementation of EU product rules.
6.2.5 Manufacturers generally may choose one from several alternative conformity assessment
procedures. The procedures most frequently provided for in the MID [6] are
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• module B (EU-type examination) followed by module D (Conformity to type based on
quality assurance of the production process), see Annex 2,
• module B (EU-type examination) followed by module F (Conformity to type based on
product verification), see Annex 2,
AF• module G (Conformity based on unit verification), and

• module H1 (Conformity based on full quality assurance plus design examination), see
Annex 5.
6.2.6 In all cases, CTT is assessed on the basis of the technical documentation that the manufacturer
has submitted to the notified body6 for the purpose of type (or design) examination and that has
been included or referenced in the EU-type (or design) examination certificate.
6.2.7 The requirements for the technical documentation are contained in article 18 of the MID [6]
(see Annex 6).
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6A notified body is a certification body designated by national authorities to perform certain certification
activities prescribed in European legislation (such as the NAWID and the MID) and subsequently notified
according to a procedure detailed in the appropriate European legislation..
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Annex 1
The ISO/IEC 17000 series
(Informative)
A1.1 Conformity assessment — the ISO/IEC 17000 series

Conformity assessment is defined as: demonstration that specified requirements relating to a product,
process, system, person or body are fulfilled. Typical conformity assessment activities include: testing,
certification and inspection. Accreditation is also considered conformity assessment (of conformity
assessment bodies), while the concept of testing very often includes calibration and measurement, and
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‘certification’ may relate to products/processes/services, management systems and persons.
ISO and the IEC have developed a series of international standards for conformity assessment. The
development of these standards is managed by ISO/CASCO, which is the ISO Conformity Assessment
Committee. These standards are mainly applicable to type evaluation, but some are relevant to
conformity to type. Examples are listed below.
For the majority of measuring instruments under legal control, the applicable legislation specifies
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conformity assessment procedures involving third party attestation, even if the manufacturer, or another
body is authorised to perform certain activities that were traditionally performed by metrological
authorities. In such cases, the authorisation is the third party attestation.
A1.2 The ISO/IEC 17000 series standards with relevance to CTT

ISO Guide 27:1983 Guidelines for corrective action to be taken by a certification body in
the event of misuse of its mark of conformity
ISO/IEC Guide 60:2004 Conformity assessment -- Code of good practice
ISO/IEC 17011:2017 Conformity assessment -- Requirements for accreditation bodies
accrediting conformity assessment bodies
ISO/IEC 17020:2012 Conformity assessment -- Requirements for the operation of various
types of bodies performing inspection
ISO/IEC 17021-1:2015 Conformity assessment -- Requirements for bodies providing audit
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and certification of management systems – Part 1: Requirements
ISO/IEC 17025:2017 General requirements for the competence of testing and calibration
laboratories
ISO/IEC TR 17026 Conformity assessment – Example of a certification scheme for
tangible products
ISO/IEC 17030:2003 Conformity assessment -- General requirements for third-party marks
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of conformity
ISO/IEC 17065:2012 Conformity assessment -- Requirements for bodies certifying
products, processes and services
ISO/IEC 17067:2013 Conformity assessment -- Fundamentals of product certification and
guidelines for product certification schemes
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Annex 2
The IEC Conformity Assessment (CA) systems
(Informative)
The IEC operates four CA Systems:

(1) the IECEE which is a certification scheme for products and equipment for the home, office and
industry;
(2) IECEx which covers certification of equipment, services and personnel competencies in the
explosive atmosphere environments;
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(3) IECQ for component certification, supply chain certification and hazardous substances process
management essentially in the electronics sector; and
(4) IECRE a renewable energy certification system currently covering wind energy, solar-PV energy
and marine energy.
To facilitate international trade in electrical equipment, primarily intended for use in homes, offices,
workshops, healthcare facilities and similar locations, for the benefit of consumers, industries,
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authorities etc., and to provide convenience for manufacturers and other users of the services provided
by various national certification bodies (NCBs), IECEE (IEC System for Conformity testing and
Certification of Electrotechnical Equipment and Components), operates the CB Scheme.
The CB Scheme is based on the principle of mutual recognition (reciprocal acceptance) by its members
of test results for obtaining certification or approval at national level.
Participation of the various NCBs within the CB Scheme is intended to facilitate certification or
approval according to IEC standards. Where national standards are not yet completely based on IEC
standards, declared national differences will be taken into account; however, successful operation of
the CB Scheme presupposes that national standards are reasonably harmonised with the corresponding
IEC standards.
Use of the CB Scheme to its fullest extent will promote the exchange of information necessary in
assisting manufacturers around the world to obtain certification or approval at national level.
The CB Scheme is based on the use of CB Test Certificates which provide evidence that representative
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specimens of the product have successfully passed tests to show compliance with the requirements of
the relevant IEC standard.
A supplementary report providing evidence of compliance with declared national differences in order
to obtain national certification or approval may also be attached to the CB Test Report.
The first step for an NCB intending to operate in the CB Scheme is to be accepted as a Recognising
NCB. Such an NCB is prepared to recognise CB Test Certificates as a basis for certification or approval
at national level for one or more categories of products.
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The second step for an NCB, which can be taken at the same time as the first step, is to be accepted as
an Issuing and Recognising NCB. Such an NCB is entitled to issue CB Test Certificates for the
categories of equipment for which it recognises CB Test Certificates. It should, however, be noted that
an NCB may recognise CB Test Certificates for more categories of equipment than for which it is
entitled to issue CB Test Certificates.
Both the IECEx and IECEE also operate Full Certification Schemes. These are Type 5 schemes as
defined in ISO/IEC 17067 [10], and include not only type-testing and certification of products, but also
audit, inspection and assessment of the manufacturer’s production facility and its quality management
system. In addition, periodic surveillance of the production facility is conducted unannounced, and
samples of the product may be taken from either the market or the point of production (or both) and
assessed for ongoing conformity.
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The IEC CA Systems are global conformity assessment systems. They operate worldwide. The IEC
does no testing or certification itself, but rather commercial companies that specialise in testing and
certification, come to participate in the IEC frameworks that are the IEC CA Systems. It is those
commercial companies that do the testing and certification. Although those companies may be
competitors, they cooperate within the IEC CA Systems to create value that is larger than the simple
sum of the parts. The essential nature of that value is consistency, comparability and believability of
the test results and the certificates based on those test results, no matter from where in the world they
come. The believability of the results creates confidence in the results which is the driver for a mutual
recognition agreement (MRA) that works worldwide.
The MRA works because the NCBs believe in the test results and certificates. Why this works is because
of two deliberate activities. Firstly, issuing NCBs, certification bodies and testing laboratories, all have
to be assessed for qualification to the CA System. The IEC uses peer assessment to qualify participants.
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The peer assessment does the equivalent of an accreditation assessment, which assesses the basic
capacity to conduct the required work. The peer assessment then goes on and assesses much more. It
also assesses the understanding and application of the CA Systems’ own rules and documented testing
and assessment methods. These rules and documented testing and assessment methods are the second
part of why the MRA works. All the participants in the CA System hold meetings to discuss and reach
common understanding and interpretation of the standards to which they are assessing conformity. They
then document this common understanding and any specific testing or assessment methodology. Peer
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assessment then checks that they are actually applying the common understanding and methodologies.
The MRA works because each issuing body knows it would obtain the same results if it were to do the
same testing on the same product.
Note: More detailed information about the IEC CA Systems may be obtained from the IEC web site
(www.iec.ch), or each of the individual CA System websites, as follows:
IECEE www.iecee.org
IECEx www.iecex.com
IECQ www.iecq.org
IECRE www.iecre.org
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Annex 3
MID conformity assessment modules B, D and F
(Informative)
A3.1 Module B: EU-type examination

1. ‘EU-type examination’ is the part of a conformity assessment procedure in which a notified body
examines the technical design of an instrument and verifies and attests that the technical design of the
instrument meets the requirements of this Directive that apply to it.
2. EU-type examination may be carried out in either of the following manners:
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(a) examination of a specimen, representative of the production envisaged, of the complete measuring
instrument (production type),
(b) assessment of the adequacy of the technical design of the instrument through examination of the
technical documentation and supporting evidence referred to in point 3, plus examination of specimens,
representative of the production envisaged, of one or more critical parts of the instrument (combination
of production type and design type);
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(c) assessment of the adequacy of the technical design of the instrument through examination of the
technical documentation and supporting evidence referred to in point 3, without examination of a
specimen (design type).
The notified body decides on the appropriate manner and the specimens required.
3. The manufacturer shall lodge an application for EU-type examination with a single notified body7 of
his choice.
The application shall include:
(a) the name and address of the manufacturer and, if the application is lodged by the authorised
representative, his name and address as well;
(b) a written declaration that the same application has not been lodged with any other notified body;
(c) the technical documentation as described in Article 18 8. The technical documentation shall make it
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possible to assess the instrument’s conformity with the applicable requirements of this Directive and
shall include an adequate analysis and assessment of the risk(s). The technical documentation shall
specify the applicable requirements and cover, as far as relevant for the assessment, the design,
manufacture and operation of the instrument.
The application shall in addition contain, wherever applicable:
(d) the specimens, representative of the production envisaged. The notified body may request further
specimens if needed for carrying out the test programme;
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(e) the supporting evidence for the adequacy of the technical design solution. This supporting evidence
shall mention any documents that have been used, in particular where the relevant harmonised
standards, and/or normative documents 9 have not been applied in full. The supporting evidence shall
7A notified body is a certification body designated by national authorities to perform certain certification
according to a procedure detailed in the appropriate European legislation.
8 See Annex 6.
9 Inthe context of the MID [6], a ‘normative document’ is an OIML Recommendation, the references of which
have been published in the Official Journal of the European Union as providing presumption of conformity
to the essential requirements of the MID for a specific category of instruments. See in [5], paragraph 4.1.3,
footnote 161.
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include, where necessary, the results of tests carried out in accordance with other relevant technical
specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his
behalf and under his responsibility.
4. The notified body shall:
For the instrument:
4.1. examine the technical documentation and supporting evidence to assess the adequacy of the
technical design of the instrument;
For the specimen(s):
4.2. verify that the specimen(s) have been manufactured in conformity with the technical documentation
and identify the elements which have been designed in accordance with the applicable provisions of the
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relevant harmonised standards and/or normative documents, as well as the elements which have been
designed in accordance with other relevant technical specifications;
4.3. carry out appropriate examinations and tests, or have them carried out, to check whether, where the
manufacturer has chosen to apply the solutions in the relevant harmonised standards and normative
documents, these have been applied correctly;
4.4. carry out appropriate examinations and tests, or have them carried out, to check whether, where the
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solutions in the relevant harmonised standards, and/or normative documents have not been applied, the
solutions adopted by the manufacturer applying other relevant technical specifications meet the
corresponding essential requirements of this Directive;
4.5. agree with the manufacturer on the location where the examinations and tests will be carried out.
For the other parts of the measuring instrument:
4.6. examine the technical documentation and supporting evidence to assess the adequacy of the
technical design of the other parts of the measuring instrument.
5. The notified body shall draw up an evaluation report that records the activities undertaken in
accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis, the notifying
authorities, the notified body shall release the content of that report, in full or in part, only with the
agreement of the manufacturer.
6. Where the type meets the requirements of this Directive, the notified body shall issue an EU-type
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examination certificate to the manufacturer. That certificate shall contain the name and address of the
manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the
necessary data for identification of the approved type. The EU-type examination certificate may have
one or more annexes attached.
The EU-type examination certificate and its annexes shall contain all relevant information to allow the
conformity of manufactured measuring instruments with the examined type to be evaluated and to allow
for in-service control. In particular, to allow the conformity of manufactured instruments to be evaluated
with the examined type regarding the reproducibility of their metrological performances, when they are
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properly adjusted using appropriate means, content shall include:

— the metrological characteristics of the type of instrument;
— measures required for ensuring the integrity of the instruments (sealing, identification of software,
etc.);
— information on other elements necessary for the identification of the instruments and to check their
visual external conformity to type;
— if appropriate, any specific information necessary to verify the characteristics of manufactured
instruments;
— in the case of a sub-assembly, all necessary information to ensure the compatibility with other sub-
assemblies or measuring instruments.
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The EU-type examination certificate shall have a validity of 10 years from the date of its issue, and may
be renewed for subsequent periods of 10 years each.
Where the type does not satisfy the applicable requirements of this Directive, the notified body shall
refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving
detailed reasons for its refusal.
7. The notified body shall keep itself appraised of any changes in the generally acknowledged state of
the art which indicate that the approved type may no longer comply with the applicable requirements
of this Directive, and shall determine whether such changes require further investigation. If so, the
notified body shall inform the manufacturer accordingly.
8. The manufacturer shall inform the notified body that holds the technical documentation relating to
the EU-type examination certificate of all modifications to the approved type that may affect the
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conformity of the instrument with the essential requirements of this Directive or the conditions for
validity of that certificate Such modifications shall require additional approval in the form of an addition
to the original EU-type examination certificate.
9. Each notified body shall inform its notifying authority concerning the EU-type examination
certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or
upon request, make available to its notifying authority the list of such certificates and/or any additions
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thereto refused, suspended or otherwise restricted.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of
the EU-type examination certificates and/or additions thereto. On request, the Commission and the
Member States may obtain a copy of the technical documentation and the results of the examinations
carried out by the notified body.
The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions,
as well as the technical file including the documentation submitted by the manufacturer until the expiry
of the validity of that certificate.
10. The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions
together with the technical documentation at the disposal of the national authorities for 10 years after
the instrument has been placed on the market.
11. The manufacturer’s authorised representative may lodge the application referred to in point 3 and
fulfil the obligations set out in points 8 and 10, provided that they are specified in the mandate.
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A3.2 Module D: Conformity to type based on quality assurance of the production process
1. Conformity to type based on quality assurance of the production process is the part of a conformity
assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and
ensures and declares on his sole responsibility that the measuring instruments concerned are in
conformity with the type described in the EU-type examination certificate and satisfy the requirements
of this Directive that apply to them.
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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 and shall be subject to
surveillance as specified in point 4.
3. Quality system
3.1. The manufacturer shall lodge an application for assessment of his quality system with a notified
body of his choice, for the measuring instruments concerned.
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representative, his name and address as well,
(b) a written declaration that the same application has not been lodged with any other notified body,
(c) all relevant information for the instrument category envisaged;
(d) the documentation concerning the quality system;
(e) the technical documentation of the approved type and a copy of the EU-type examination certificate.
3.2 The quality system shall ensure that the measuring instruments are in conformity with the type
described in the EU- type examination certificate and comply with the requirements of this Directive
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that apply to them.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a
systematic and orderly manner in the form of written policies, procedures and instructions. This quality
system documentation shall permit a consistent interpretation of the quality programmes, plans,
manuals and records.
It shall, in particular, contain an adequate description of:
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(a) the quality objectives and the organisational structure, responsibilities and powers of the
management with regard to product quality;
(b) the corresponding manufacturing, quality control and quality assurance techniques, processes and
systematic actions that will be used;
(c) the examinations and tests that will be carried out before, during, and after manufacture, and the
frequency with which they will be carried out;
(d) the quality records, such as inspection reports and test data, calibration data, qualification reports on
the personnel concerned;
(e) the means of monitoring the achievement of the required product quality and the effective operation
of the quality system.
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements
referred to in point 3.2.
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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.
In addition to experience in quality management systems, the auditing team 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 this Directive. The audit shall include an
assessment visit to the manufacturer’s premises.
The auditing team shall review the technical documentation referred to in point (e) of point 3.1, to verify
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the manufacturer’s ability to identify the relevant requirements of this Directive and to carry out the
necessary examinations with a view to ensuring compliance of the instrument with those requirements.
The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the
audit and the reasoned assessment decision.
3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as
approved and to maintain it so that it remains adequate and efficient.
3.5. The manufacturer shall keep the notified body that has approved the quality system informed of
any intended change of the quality system.
The notified body shall evaluate any proposed changes and decide whether the modified quality system
will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary.
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It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the
examination and the reasoned assessment decision.
4. Surveillance under the responsibility of the notified body
4.1. 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 notified body access to the manufacture,
inspection, testing and storage sites, and shall provide it with all necessary information, in particular:
(a) the quality system documentation;
(b) the quality records, such as inspection reports and test data, calibration data, qualification reports on
the personnel concerned.
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4.3. The notified 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 notified body may pay unexpected visits to the manufacturer. During such visits
the notified 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 notified body shall provide the manufacturer
with a visit report and, if tests have been carried out, with a test report.
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5. Conformity marking and EU declaration of conformity
5.1. The manufacturer shall affix the CE marking and the supplementary metrology marking set out in
this Directive, and, under the responsibility of the notified 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 EU-type examination certificate and satisfies the applicable requirements of this
Directive.
5.2. The manufacturer shall draw up a written EU declaration of conformity for each instrument model
and keep it at the disposal of the national authorities for 10 years after the instrument has been placed
on the market. The EU declaration of conformity shall identify the instrument model for which it has
been drawn up.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon
request.
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A copy of the EU declaration of conformity shall be supplied with each measuring instrument that is
placed on the market. However, this requirement may be interpreted as applying to a batch or
consignment rather than individual instruments in those cases where a large number of instruments is
delivered to a single user.
6. The manufacturer shall, for a period ending 10 years after the instrument has been placed on the
market, keep at the disposal of the national authorities:
(a) the documentation referred to in point 3.1,
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(b) the information relating to the change referred to in point 3.5, as approved;
(c) the decisions and reports from the notified body referred to in points 3.5, 4.3 and 4.4.
7. Each notified body shall inform its notifying authority of quality system approvals issued or
withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of
quality system approvals refused, suspended or otherwise restricted
8. Authorised representative
The manufacturer’s obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised
representative, on his behalf and under his responsibility, provided that they are specified in the
mandate.
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A3.3 Module F: Conformity to type based on product verification

1. Conformity to type based on product verification is the part of a conformity assessment procedure
whereby the manufacturer fulfils the obligations laid down in points 2, 5.1 and 6, and ensures and
declares on his sole responsibility that the measuring instruments concerned, which have been subject
to the provisions of point 3, are in conformity with the type described in the EU-type examination
certificate and satisfy the requirements of this Directive that apply to them.
2. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring
ensure conformity of the manufactured measuring instruments with the approved type described in the
EU-type examination certificate and with the requirements of this Directive that apply to them.
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3. Verification
A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests, or
have them carried out, to verify the conformity of the instruments with the type as described in the EU-
type examination certificate and the appropriate requirements of this Directive.
The examinations and tests to verify the conformity of the measuring instruments with the appropriate
requirements shall be carried out, at the choice of the manufacturer, either by examination and testing
of every instrument as specified in point 4, or by examination and testing of the measuring instruments
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on a statistical basis as specified in point 5.
4. Verification of conformity by examination and testing of every instrument
4.1. All measuring instruments shall be individually examined and appropriate tests set out in the
relevant harmonised standard(s) and/or normative documents, and/or equivalent tests set out in other
relevant technical specifications, shall be carried out in order to verify their conformity with the
approved type described in the EU-type examination certificate and with the appropriate requirements
of this Directive.
In the absence of a harmonised standard or normative document, the notified body concerned shall
decide on the appropriate tests to be carried out.
4.2. The notified body shall issue a certificate of conformity in respect of the examinations and tests
carried out, and shall affix its identification number to each approved instrument or have it affixed under
its responsibility.
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The manufacturer shall keep the certificates of conformity available for inspection by the national
authorities for 10 years after the instrument has been placed on the market.
5. Statistical verification of conformity
5.1. The manufacturer shall take all measures necessary so that the manufacturing process and its
monitoring ensure the homogeneity of each lot produced, and shall present his measuring instruments
for verification in the form of homogeneous lots.
5.2. A random sample shall be taken from each lot according to the requirements of point 5.3. All
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measuring instruments in a sample shall be individually examined and appropriate tests set out in the
relevant harmonised standard(s) and/or normative document(s), and/or equivalent tests set out in other
relevant technical specifications, shall be carried out in order to verify their conformity with the type
described in the EU-type examination certificate and with the applicable requirements of this Directive,
and to determine whether the lot is accepted or rejected. In the absence of such harmonised standard or
normative document, the notified body concerned shall decide on the appropriate tests to be carried out.
5.3. The statistical procedure shall meet the following requirements:
The statistical control will be based on attributes. The sampling system shall ensure:
(a) a level of quality corresponding to a probability of acceptance of 95 %, with a non-conformity of
less than 1 %;
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(b) a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity of less

than 7 %.
5.4. If a lot is accepted, all measuring instruments of the lot shall be considered approved, except for
those measuring instruments from the sample that have been found not to satisfy the tests.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried
out, and shall affix its identification number to each approved instrument or have it affixed under its
responsibility.
The manufacturer shall keep the certificates of conformity at the disposal of the national authorities for
10 years after the instrument has been placed on the market.
5.5. If a lot is rejected, the notified body shall take appropriate measures to prevent the placing on the
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market of that lot. In the event of frequent rejection of lots the notified body may suspend the statistical
verification and take appropriate measures.
this Directive, and, under the responsibility of the notified body referred to in point 3, the latter’s
identification number to each individual instrument that is in conformity with the approved type
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described in the EU-type examination certificate and satisfies the applicable requirements of this
Directive.
been drawn up.
request.
If the notified body referred to in point 3 agrees and under its responsibility, the manufacturer may also
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affix the notified body’s identification number to the measuring instruments.
7. If the notified body agrees and under its responsibility, the manufacturer may affix the notified body’s
identification number to the measuring instruments during the manufacturing process.
The manufacturer’s obligations may be fulfilled by his authorised representative, on his behalf and
under his responsibility, provided that they are specified in the mandate. An authorised representative
may not fulfil the manufacturer’s obligations set out in points 2 and 5.1.
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Annex 4
NTEP/VCAP requirements and procedures
(Informative)
National Conference on Weights and Measures / National Type Evaluation Program

Publication 14 Administrative policy [9]: Section 21. Conformity Assessment Process
Note: In the following, “(…)” indicates that text has been omitted.
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21. Conformity assessment process
(…)
21.1 Main elements

21.1.1. Initial verification
(…)
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[The tests performed at initial verification] offer an invaluable means to check production devices and
many, but not all, of their features against the current requirements of NIST Handbook 44 [8] and to
verify the information provided in the NTEP Certificate of Conformance is both accurate and correct.
NTEP will use [feedback from the initial verification] to assist in the process of verifying that
production devices remain in compliance and that the information on the NTEP Certificate of
Conformance remains accurate.
21.1.2. Administrative review of a NTEP Certificate of Conformance
The administrative review of all NTEP Certificates of Conformance will be periodically conducted by
NTEP.
(…)
21.1.3. NTEP Verified Conformity Assessment Program Procedures
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Introduction
Many NTEP certified devices must meet NIST Handbook 44 [8] requirements for influence factors. It
is not possible to verify these requirements during the initial verification in the field. Therefore,
manufacturers of metrological devices (instruments) and/or components (modules) which are subject
to influence factors, as defined in NIST Handbook 44 [8], must have a Verified Conformity Assessment
Program (VCAP) in place to ensure that these metrological devices and/or components are produced to
perform at a level consistent with that of the device and/or component previously certified.
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The Verified Conformity Assessment Program audit will be at one or more sites as required to verify
compliance.
For weighing devices that are subject to influence factors, NTEP will require an initial on-site audit of
the manufacturer’s quality system and on-site random testing and/or review of a production device(s)
(instrument(s)) by the Registrar to verify that all items listed below are currently implemented and
functioning to verify compliance to the appropriate sections of NIST Handbook 44 [8]. (…)
21.1.3.1 Devices that must meet this requirement are limited to the list below:
(…)
Requirements:
21.1.3.2 Requirements, The NTEP CC Holder’s control facility responsibilities:
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21.1.3.2.1 A documented Quality Management System governing the design and manufacturer
of the device. (…)
21.1.3.2.2 Identify the applicable Metrologically Significant Components (MSC’s) of the
device.
21.1.3.2.3 Appropriate statistical methods are implemented to ensure that the process is in
control as defined by the NTEP CC holder’s Quality Management System.
21.1.3.2.4 An appropriate sampling plan, and acceptance criteria is in place and operating. (…)
21.1.3.2.5 Required operator’s manuals and calibration procedures or other controlled
documentation for all appropriate devices and components (either manufacture or
purchased).
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21.1.3.2.6 A non-conforming material system to control non-conforming/noncompliant devices
and components (either manufactured or purchased). (…)
21.1.3.2.7 Adequate control over subcontractors and sub-tier suppliers shall be defined in the
NTEP CC holder’s quality management system. (…)
21.1.3.2.8 Appropriate corrective action system to deal with non-conforming/non-compliant
devices. (…)
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21.1.3.2.9
21.1.3.2.10
21.1.3.2.11
An engineering change system to control engineering/design changes affecting any
MSCs. (…)
A document and data control (including software and firmware) system to control
changes affecting any MSCs or components of the VCAP program. (…)
A production control system to control changes affecting any MSCs. (…)
21.1.3.2.12 An identification and traceability system (including serialization and lot/batch
control as applicable) applied, as a minimum, to MSCs.
21.1.3.2.13 Documentation that personnel have been properly trained.
21.1.3.2.14 If the NTEP CC holder contracts with an outside testing facility to conduct the
influence factor testing, that facility will be subject to all pertinent VCAP
requirements.
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21.1.3.2.15 The NTEP CC holder shall plan and implement a program of internal self-
assessment. (…)
21.1.3.2.16 Subsequent audits will be held on-site to verify conformance to these standards.
Subsequent audits will be conducted every three years until objective evidence is
obtained to move to a maximum of every five years. (…)
21.1.3.3 Certification Body’s Responsibilities:
21.1.3.3.1 The selected Certification Body is to be accredited by ANSI-ASQ National
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Accreditation Board (ANAB) or by a signatory of the International Laboratory

Accreditation Cooperation (ILAC) Mutual Recognition. The ANSI, ANAB and
ILAC are accreditation bodies for management systems. ANAB and ILAC accredit
certification bodies (CBs) for ISO 9001 quality management systems (QMS), ISO
17025 laboratory testing facilities and ISO 14001 environmental management
systems (EMS), as well as a number of industry-specific requirements.
21.1.3.3.2 With accreditation to Standard Industry Classification (SIC) codes (3596/3821) or
equivalent. (…)
21.1.3.3.3 The selected certification body shall have international auditors available.
21.1.3.3.4 The certification body is required to notify NCWM when a major breakdown of the
NTEP CC holder’s VCAP program is found.
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21.1.3.3.5 The certification body shall submit a completed “Systems Audit Checklist” to
NCWM. Submitted documents must contain a clear statement of compliance as a
result of the VCAP audit.
21.1.3.4 NCWM Responsibilities
21.1.3.4.1 For new certificate holders, ensure that VCAP certification has been completed,
within a one year cycle of the first maintenance fee, but not to exceed 18 months
(example: if NTEP certified in July 2011, VCAP certification would be required by
November 2012).
21.1.3.4.2 As part of annual maintenance, NCWM shall ensure that VCAP audit reports are on
file, current, and that all non-conformances have been addressed.
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21.1.3.4.3 Ensure that an appeals process is in place and made available to certificate holders.
21.1.3.5 Sample sizes
21.1.3.5.1 The following sample sizes are to be used based on annual production. (…)
NTEP Verified Conformity Assessment Program Procedures for Private Label Certificate
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Holders
Many NTEP certified devices must meet NIST Handbook 44, Specifications, Tolerances, and Other
Technical Requirements for Weighing and Measuring Devices [8], requirements for influence factors.
It is not possible to verify these requirements during the Initial Verification in the field. Therefore,
manufacturers of metrological devices (instruments) and/or components (modules), which are subject
to influence factors, as defined in NIST Handbook 44 [8], must have a Verified Conformity Assessment
Program (VCAP) in place to ensure that these metrological devices and/or components are produced to
perform at a level consistent with that of the device and/or component previously certified.
For weighing devices that are subject to influence factors, traceable to a private label NTEP Certificate
of Conformance, NTEP will require the private label certificate holder to verify that the parent
certificate holder has complied with VCAP requirements, has a current VCAP audit certificate, the
VCAP certification is traceable back to the parent NTEP certificate, and the parent certificate is active.
(…)
21.1.3.6 Devices that Must Meet this Requirement are Limited to the List Below:
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(…)
21.1.3.7 Requirements: The Private Label NTEP CC Holder’s Responsibilities:
(…)
21.1.3.8 Certification Body’s Responsibilities:
(…)
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21.1.3.9 NCWM Responsibilities:

(…)
21.2. Consequences
If a certificate holder fails to submit an application for the administrative review, when requested, by
the review date specified, the NTEP Certificate of Conformance will be inactive.
If a certificate holder of a device subject to influence factors fails to submit documentation, by the
required date, indicating that it has and continues to maintain a VCAP for influence factors, the NTEP
Certificate of Conformance will be inactive.
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Annex 5
MID conformity assessment module H1
(Informative)
Module H1: Conformity based on full quality assurance plus design examination
1. Conformity based on full quality assurance plus design examination is the conformity assessment
procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 6, and ensures and
declares on his sole responsibility that the measuring instruments concerned satisfy the requirements of
this Directive that apply to them.
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2. Manufacturing
The manufacturer shall operate an approved quality system for design, manufacture and final product
inspection and testing of the measuring instruments concerned as specified in point 3, and shall be
subject to surveillance as specified in point 5.
The adequacy of the technical design of the measuring instruments shall have been examined in
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accordance with point 4.
3. Quality system
3.1. The manufacturer shall lodge an application for assessment of the quality system with the notified
body 10 of his choice for the measuring instruments concerned.
representative, his name and address as well;
(b) all relevant information for the instrument category envisaged;
(c) the documentation concerning the quality system;
(d) a written declaration that the same application has not been lodged with any other notified body.
3.2. The quality system shall ensure compliance of the measuring instruments with the requirements of
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this Directive that apply to them.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a
systematic and orderly manner in the form of written policies, procedures and instructions. This quality
system documentation shall permit a consistent interpretation of the quality programmes, plans,
manuals and records.
It shall, in particular, contain an adequate description of:
(a) the quality objectives and the organisational structure, responsibilities and powers of the
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management with regard to design and product quality;

(b) the technical design specifications, including standards, that will be applied and, where the relevant
harmonised standards and/or normative documents will not be applied in full, the means that will be
used to ensure that the essential requirements of this Directive that apply to the measuring instruments
will be met, applying other relevant technical specifications;
(c) the design control and design verification techniques, processes and systematic actions that will be
used when designing the measuring instruments pertaining to the instrument category covered;
10
A notified body is a certification body designated by national authorities to perform certain certification
according to a procedure detailed in the appropriate European legislation.
29
(d) the corresponding manufacturing, quality control and quality assurance techniques, processes and
systematic actions that will be used;
(e) the examinations and tests that will be carried out before, during and after manufacture, and the
frequency with which they will be carried out;
(f) the quality records, such as inspection reports and test data, calibration data, qualification reports on
the personnel concerned;
(g) the means of monitoring the achievement of the required design and product quality and the effective
operation of the quality system.
3.3. The notified body shall assess the quality system to determine whether it satisfies the requirements
referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements
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of the quality system that comply with the corresponding specifications of the relevant harmonised
standard.
In addition to experience in quality management systems, the auditing team shall have at least one
member experienced as an assessor in the relevant instrument field and instrument technology
concerned, and knowledge of the applicable requirements of this Directive. The audit shall include an
assessment visit to the manufacturer’s premises.
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The manufacturer or his authorised representative shall be notified of the decision. The notification
shall contain the conclusions of the audit and the reasoned assessment decision.
3.4. The manufacturer shall undertake to fulfil the obligations arising out of the quality system as
approved and to maintain it so that it remains adequate and efficient.
3.5. The manufacturer shall keep the notified body that has approved the quality system informed of
any intended change to the quality system.
The notified body shall evaluate any proposed changes and decide whether the modified quality system
will continue to satisfy the requirements referred to in point 3.2 or whether a re-assessment is necessary.
It shall notify the manufacturer or his authorised representative of its decision. The notification shall
contain the conclusions of the examination and the reasoned assessment decision.
3.6. Each notified body shall inform its notifying authority of quality system approvals issued or
withdrawn, and shall periodically or upon request, make available to its notifying authority the list of
quality system approvals refused, suspended or otherwise restricted.
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4. Design examination
4.1. The manufacturer shall lodge an application for examination of the design with the notified body
referred to in point 3.1.
4.2. The application shall make it possible to understand the design, manufacture and operation of the
instrument, and to assess the conformity with the requirements of this Directive that apply to it.
It shall include:
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(a) the name and address of the manufacturer;

(b) a written declaration that the same application has not been lodged with any other notified body;
(c) the technical documentation as described in Article 18. The documentation shall make it possible to
assess the instrument’s conformity with the relevant requirements, and shall include an adequate
analysis and assessment of the risk(s). It shall, as far as relevant for such assessment, cover the design
and operation of the instrument;
(d) the supporting evidence for the adequacy of the technical design. This supporting evidence shall
mention any documents that have been used, in particular where the relevant harmonised standards
and/or normative documents have not been applied in full, and shall include, where necessary, the
results of tests carried out in accordance with other relevant technical specifications, by the appropriate
30
laboratory of the manufacturer, or by another testing laboratory on his behalf and under his
responsibility.
4.3. The notified body shall examine the application, and where the design meets the requirements of
this Directive that apply to the instrument it shall issue an EU design examination certificate to the
manufacturer. That certificate shall give the name and address of the manufacturer, the conclusions of
the examination, the conditions (if any) for its validity and the data necessary for identification of the
approved design. That certificate may have one or more annexes attached.
That certificate and its annexes shall contain all relevant information to allow the conformity of
manufactured measuring instruments with the examined design to be evaluated and to allow for in-
service control. It shall allow the evaluation of conformity of the manufactured instruments with the
examined design regarding the reproducibility of their metrological performances, when they are
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properly adjusted using appropriate means, including:
(a) the metrological characteristics of the design of the instrument;
(b) measures required for ensuring the integrity of the instruments (sealing, identification of software,
etc.);
(c) information on other elements necessary for the identification of the instrument and to check its
visual external conformity to the design;
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(d) if appropriate, any specific information necessary to verify the characteristics of manufactured
instruments;
(e) in the case of a sub-assembly, all necessary information to ensure the compatibility with other sub-
assemblies or measuring instruments.
The notified body shall establish an evaluation report in this regard and keep it at the disposal of the
Member State that designated it. Without prejudice to Article 27(10), the notified body shall release the
content of this report, in full or in part, only with the agreement of the manufacturer.
The certificate shall have a validity of 10 years from the date of its issue, and may be renewed for
subsequent periods of 10 years each.
Where the design does not satisfy the applicable requirements of this Directive, the notified body shall
refuse to issue an EU design examination certificate and shall inform the applicant accordingly, giving
detailed reasons for its refusal.
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4.4. The notified body shall keep itself apprised of any changes in the generally acknowledged state of
the art which indicate that the approved design may no longer comply with the applicable requirements
of this Directive, and shall determine whether such changes require further investigation. If so, the
notified body shall inform the manufacturer accordingly.
The manufacturer shall keep the notified body that has issued the EU design examination certificate
informed of any modification to the approved design that may affect the conformity with the essential
requirements of this Directive or the conditions for validity of the certificate. Such modifications shall
require additional approval – from the notified body that issued the EU design examination certificate
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– in the form of an addition to the original EU design examination certificate.

4.5. Each notified body shall inform its notifying authority of the EU design examination certificates
and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request,
make available to its notifying authority the list of certificates and/or any additions thereto refused,
suspended or otherwise restricted.
The Commission, the Member States and the other notified bodies may, on request, obtain a copy of
the EU design examination certificates and/or additions thereto. On request, the Commission and the
Member States may obtain a copy of the technical documentation and of the results of the examinations
carried out by the notified body.
31
The notified body shall keep a copy of the EU design examination certificate, its annexes and additions,
as well as the technical file including the documentation submitted by the manufacturer until the expiry
of the validity of the certificate.
4.6. The manufacturer shall keep a copy of the EU design examination certificate, its annexes and
additions with the technical documentation at the disposal of the national authorities for 10 years after
the instrument has been placed on the market.
5. Surveillance under the responsibility of the notified body
5.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising
out of the approved quality system.
5.2. The manufacturer shall, for assessment purposes, allow the notified body access to the design,
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manufacture, inspection, testing and storage sites, and shall provide it with all necessary information,
in particular:
(a) the quality system documentation;
(b) the quality records as provided for by the design part of the quality system, such as results of
analyses, calculations, tests, etc.;
(c) the quality records as provided for by the manufacturing part of the quality system, such as
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inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.
5.3. The notified 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.
5.4. In addition, the notified body may pay unexpected visits to the manufacturer. During such visits
the notified body may, if necessary, carry out instrument tests, or have them carried out, in order to
check the proper functioning of the quality system. It shall provide the manufacturer with a visit report
and, if tests have been carried out, with a test report.
this Directive, and, under the responsibility of the notified body referred to in point 3.1, the latter’s
identification number to each individual instrument that satisfies the applicable requirements of this
Directive.
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been drawn up and shall mention the number of the design examination certificate.
request.
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7. The manufacturer shall, for a period ending 10 years after the instrument has been placed on the
market, keep at the disposal of the national authorities:
(a) the documentation concerning the quality system referred to in point 3.1,
(b) the information relating to the change referred to in point 3.5, as approved;
(c) the decisions and reports of the notified body referred to in points 3.5, 5.3 and 5.4.
32
The manufacturer's authorised representative may lodge the application referred to in points 4.1 and
4.2 and fulfil the obligations set out in points 3.1, 3.5, 4.4, 4.6, 6 and 7, on his behalf and under his
responsibility, provided that they are specified in the mandate.
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Annex 6
Technical documentation
(Informative)
As an example of the requirements for technical documentation of a measuring instrument, refer to the
European MID (Measuring Instruments Directive) [6], Annex B (EU-type examination).
When applying for type (or design) examination, the manufacturer has to submit the technical
documentation as described in article 18 of the MID [6] (see below). The documentation shall enable
assessment of the conformity of the instrument and shall, as far as relevant for such assessment, cover
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the design, manufacture and operation of the instrument.
“Article 18
Technical Documentation
1. The technical documentation shall render the design, manufacture and operation of the measuring
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instrument intelligible and shall permit an assessment of its conformity with the applicable requirements
of this Directive.
2. The technical documentation shall be sufficiently detailed to ensure compliance with the following
requirements:
(a) the definition of the metrological characteristics;
(b) the reproducibility of the metrological performances of produced measuring instruments
when properly adjusted using appropriate intended means;
(c) the integrity of the measuring instrument.
3. The technical documentation shall insofar as relevant for assessment and identification of the type
and/or the measuring instrument include the following information:
(a) a general description of the measuring instrument;
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(b) conceptual design and manufacturing drawings and plans of components, sub-assemblies,
circuits, etc.;
(c) manufacturing procedures to ensure consistent production;
(d) if applicable, a description of the electronic devices with drawings, diagrams, flow diagrams
of the logic and general software information explaining their characteristics and operation;
(e) descriptions and explanations necessary for the understanding of the information referred to
in points (b), (c) and (d), including the operation of the measuring instrument;
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(f) a list of the harmonised standards and/or normative documents 11 referred to in Article 14,
applied in full or in part, the references of which have been published in the Official Journal of
the European Union;
(g) descriptions of the solutions adopted to meet the essential requirements where the
harmonised standards and/or normative documents referred to in Article 14 have not been
applied, including a list of other relevant technical specifications applied;
11In the context of the MID [6], a ‘normative document’ is an OIML Recommendation, the references of
which have been published in the Official Journal of the European Union as providing presumption of
conformity to the essential requirements of the MID for a specific category of instruments. See in [5],
paragraph 4.1.3, footnote 161.
34
(h) results of design calculations, examinations, etc.;

(i) the appropriate test results, where necessary, to demonstrate that the type and/or the
measuring instruments comply with the following:
— the requirements of this Directive under declared rated operating conditions and under
specified environmental disturbances,
— the durability specifications for gas-, water-, thermal energy-meters as well as for liquids
other than water;
(j) the EU-type examination certificates or EU design examination certificates in respect of
measuring instruments containing parts identical to those in the design.
4. The manufacturer shall specify where seals and markings have been applied.
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5. The manufacturer shall indicate the conditions for compatibility with interfaces and sub-assemblies,
where relevant.”
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Annex 7
The relationship with ‘market surveillance’
(Informative)
As is pointed out in the definition of CTT in 3.1.4, it is important that the CTT conformity assessment
procedures are not confused with ‘market surveillance’ activities which are sometimes performed as
part of a systematic program but often are performed ad-hoc by public authorities based on risk
assessment and market intelligence.
Such market surveillance activities arise from the role of governments to enforce their legislation, in
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particular regarding the compliance of products with legal requirements. They are well-established in
many areas of product regulation, especially in the European Union, and may include both pro-active
checking of products for compliance with regulations and making sure products do not endanger health,
safety or any other aspect of public interest (in case the regulations do not fully cover all these aspects).
These activities are performed either at the point of import or in the distribution chain after leaving the
manufacturer, as well as actions taken by enforcement authorities following complaints by purchasers
of a product or by competitors.
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Definitions
There is at present no definition of market surveillance in the International Vocabulary of Legal
Metrology (the “VIML”) [3]. The concept of market surveillance was developed as an element of the
so-called “new approach to technical harmonisation and standards” conceived in the early 1980’s in
Europe (see section 7 in [5]) and the definition used in EU legislation [Regulation (EC) No 765/2008]
now forms the basis on the definition in the UNECE Glossary of Market Surveillance Terms (see in
[11], page 22) which is:
“the activities carried out and measures taken by designated authorities to ensure that products comply
with the requirements set out in the relevant legislation and do not endanger health, safety or any other
aspect of public interest protection”
This does not explicitly refer only to activities carried out after a product has been placed on the market
or put into use, but that is the way it is always understood by market surveillance authorities.
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There is also a definition in OIML D 9 [12]:
A form of metrological supervision aimed at a measuring instrument and prepackage which is placed
on the market and/or put into service for the first time, to ensure that all the elements of the conformity
assessment system work properly and result in general compliance of the products with the provisions
of the applicable regulations across a country or free trade area.
This has the advantage of referring explicitly to controls applied after placing on the market or putting
into use. But neither this nor the UNECE definition make clear the relationship between market
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surveillance activities (which are directed at ensuring that a regulated product is designed and
manufactured to the relevant requirements) and legal metrology controls such as verification and in-
service inspections which are primarily aimed at ensuring that compliant measuring instruments are
correctly adjusted and are being used properly.
A definition of market surveillance which is readily applicable for legal metrology purposes still needs
to be developed. It is likely, however, that such a definition will have two elements:
1. It will apply only to activities to identify and deal with non-compliance of regulated measuring
instruments and prepackages after they have been placed on the market or put into service; and
2. It will not apply to activities carried out to ensure that a compliant measuring instrument has
been properly adjusted and is being used correctly while in service. However, when the
36
activities are carried out by persons who identify a non-compliant product and initiate
corrective actions, the activities may be regarded as being part of a market surveillance system.
Surveillance as a systematic process

The concept of surveillance found in the conformity to type procedures described in this Document,
namely
• surveillance of the production, as part of the certification, performed by the body that issued
the type approval certificate, and
• surveillance of the quality management system of the manufacturer,
follows the ISO definition of “surveillance” used in the context of conformity assessment:
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“systematic iteration of conformity assessment activities as a basis for maintaining the validity of the
statement of conformity” (ISO/IEC 17000:2004, 6.1 [2] and VIML, A.20 [3]).
In addition to these types of surveillance, which can be considered as systematic pre-market conformity
assessment procedures, the term “surveillance” is sometimes used in legal metrology, for the systematic
control of instruments in use, for instance by legal metrology inspectors. As already noted, this type of
surveillance is primarily concerned with the proper installation and use of these instruments. Therefore,
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this type of surveillance should, more appropriately, be referred to as “control of instruments in use” or
“in-service inspection”.
All of these systematic activities may be performed by authorities or private bodies, depending on
national legislation.
Market surveillance, on the other hand, is different in at least two respects:
• First, it is essentially a Government activity. In practice, it is often not possible for authorities
to exercise market surveillance activities at the time products are made available (placed) on
the market, so market surveillance authorities will also use information obtained from
conformity assessment activities during the production phase, or while products are in use. In
this way, pre-market conformity assessment procedures may have consequences for products
that are already in use, for instance when serious non-compliances would require a recall of
products. In addition, “control of instruments in use” or “in-service inspection” may yield
evidence of some non-conformity of measuring instruments to the requirements that apply to
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them, for instance absence of documentation, or documentation which does not match the
instrument or labelling requirements. Enforcement, however, in all cases will be for public
authorities.
• Second, while ideally these inspection and enforcement actions should form part of a well-
designed program based on risk assessment, they will in practice often not be carried out as a
systematic activity. This will be the case, for instance, where enforcement action follows
information provided through CTT programmes, received from customers and competitors, or
forwarded by verification officers or in-service inspectors.
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In summary: For the purposes of this Document, “surveillance” is a systematic activity that may be
performed by private bodies, while “market surveillance” is the responsibility of public authorities and
will not be systematic in all cases.
37
Annex 8
References
(Informative)
[1] OIML B 18:2018 Framework for the OIML Certification System (OIML-CS)
[2] ISO/IEC 17000:2004 Conformity assessment -- Vocabulary and general principles
[3] OIML V 1:2013 (E/F) International vocabulary of terms in legal metrology (VIML) 12
[4] OIML V 2-200:2012 (E/F) International Vocabulary of Metrology - Basic and General
Concepts and Associated Terms (VIM) (Edition 2010 with minor corrections) 13
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[5] European Commission – The ‘Blue Guide’ on the implementation of EU product rules 2016
(Available for download from the European Commission web site at:
https://ec.europa.eu/growth/content/%E2%80%98blue-guide%E2%80%99-implementation-
eu-product-rules-0_en)
[6] 2014/32/EU (MID) Directive 2014/32/EU of the European Parliament and of the Council of
26 February 2014 on the harmonisation of the laws of the Member States relating to the making
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available on the market of measuring instruments (recast)
[7] 2014/31/EU (NAWID) Directive 2014/31/EU of the European Parliament and of the Council
of 26 February 2014 on the harmonisation of the laws of the Member States relating to the
making available on the market of non-automatic weighing instruments (recast)
[8] NIST Handbook 44: Specifications, Tolerances, and Other Technical Requirements for
Weighing and Measuring Devices (http://www.nist.gov/pml/wmd/pubs/hb44.cfm)
[9] National Conference on Weights and Measures / National Type Evaluation Program -
Publication 14 Administrative policy: Section 21. Conformity Assessment Process
[10] ISO/IEC 17067:2013 - Conformity assessment -- Fundamentals of product certification and
guidelines for product certification schemes
[11] UNECE publication ECE/TRADE/389: A glossary of market surveillance terms
(http://www.unece.org/fileadmin/DAM/trade/Publications/WP6-MARS-Glossary-
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389_EFR.pdf)
[12] OIML D 9:2004 Principles of metrological supervision
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12
An online version of the VIML may be accessed from: http://viml.oiml.info/en/index.html
13
An online version of the VIM may be accessed from: http:// jcgm.bipm.org/vim/en/index.html
38

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AF SASO OIML D 34:2020

Conformity to Type (CTT) – Pre-market conformity

Saudi Standards, Metrology and Quality Org (SASO)

The Saudi Standards ,Metrology and Quality Organization (SASO)has

Pre-market conformity assessment of measuring instruments

3 Terminology and abbreviations

3.2 Abbreviations and acronyms

ANAB ANSI-ASQ National Accreditation Board

SIC Standard industry classification

4 Considerations for a CTT program

4.1.2 Legal metrological control systems may be considered as consisting of a sequence of

4.2 Legal metrological control systems

manufacturers, CTT bodies, regulators, and customers.

Legal metrological control systems

Type Evaluation Type Evaluation Type Evaluation & Type Evaluation

OIML Certificate OIML Certificate OIML Certificate OIML Certificate

National or National or National or National or

Conformity to Type Conformity Mark Conformity to Type

Verification Mark Verification Mark Verification Mark

Use - Market - Market - Market - Market

Figure 1 Legal metrological control systems

4.3 Elements to be considered

5 Issues identified and possible mitigation strategies

issues and issues to do with securing intellectual property rights:

NTEP VCAP in the US

6.2 The European Directives: NAWID and MID

AF• module G (Conformity based on unit verification), and

A1.1 Conformity assessment — the ISO/IEC 17000 series

A1.2 The ISO/IEC 17000 series standards with relevance to CTT

The IEC operates four CA Systems:

A3.1 Module B: EU-type examination

properly adjusted using appropriate means, content shall include:

The application shall include:

A3.3 Module F: Conformity to type based on product verification

(b) a limit quality corresponding to a probability of acceptance of 5 %, with a non-conformity of less

National Conference on Weights and Measures / National Type Evaluation Program

21.1 Main elements

Accreditation Board (ANAB) or by a signatory of the International Laboratory

21.1.3.9 NCWM Responsibilities:

management with regard to design and product quality;

(a) the name and address of the manufacturer;

– in the form of an addition to the original EU design examination certificate.

(h) results of design calculations, examinations, etc.;

Surveillance as a systematic process

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