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Course 2: Legal Metrology in Detail

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0% found this document useful (0 votes)
71 views17 pages

Course 2: Legal Metrology in Detail

Uploaded by

Bima Sakti
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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COURSE 2

Legal Metrology in detail

Module 9
OIML Certificate Systems and
Engagement with the OIML and
RLMOs

Project funded by the European Union


at the request of the ACP Group
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

OIML Certificate Systems and Engagement


with the OIML and RLMOs
Dr. Predrag Vukadin

Abstract

The OIML has two Certificate Systems: the Basic System and the Mutual Acceptance Arrangement (MAA)
which are voluntary systems for issuing, registering and using OIML Certificates of Conformity and
associated OIML Type Evaluation Reports for measuring instrument types based on the requirements of
OIML Recommendations. Their aim is to facilitate, accelerate and harmonize the work of national and
regional bodies that approve types of measuring instruments subject to legal control. Both of these systems
are presented and discussed in this paper. 2

Note A new OIML Certification System (OIML-CS) is being developed that will come into effect from the 1
January 2018. The new OIML-CS will replace the OIML Basic and MAA Certificate Systems at that time.
Information on the Framework for the new OIML-CS can be found in OIML Basic Publication B 18:2016.

Relations and engagements between National Legal Metrology Organizations (NLMOs), Regional Legal
Metrology Organizations (RLMOs) and OIML are also presented and discussed.

Introduction

The need to ensure international consistency of trade and regulatory measurements, and to “resolve
internationally the technical and administrative problems raised by the use of measuring instruments”, led
to the establishment in 1955 of a second Metrology Treaty Organization, the International Organization of
Legal Metrology (OIML).
Many applications of metrology have a legal aspect, such as when there is a social need to protect both the
buyer and seller in a commercial exchange of a commodity (trade) or a service provided, or where
measurements are used to apply a sanction.
Legal metrology is the practice and the process of applying regulatory structure and enforcement to
metrology. It comprises all activities for which legal requirements are prescribed, units of measurement,
measuring instruments or systems and methods of measurement. These activities are performed by or on
behalf of government authorities, in order to ensure an appropriate level of confidence in measurement
results in the national regulatory environment.
In order to facilitate administrative procedures and lower the costs associated with international trade of
measuring instruments subject to legal requirements, the OIML Basic Certificate System for Measuring
Instruments was introduced in 1991.It is important to say that it is a voluntary system for issuing,
registering and using OIML Certificates of Conformity and associated OIML Type Evaluation Reports for
measuring instrument types based on the requirements of OIML Recommendations. The
Recommendations are prepared in such a way that may be useful for any state, no matter if it is an OIML
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

member or not. However, only those states which are members can have Issuing Authorities or Participants
for the issuing of OIML Basic or MAA Certificates respectively for Measuring Instruments. Recognition of
national certificates of conformity is usually provided by bilateral or multilateral agreements between
states.
In 2003 the OIML introduced the OIML Mutual Acceptance Arrangement (OIML MAA) as a tool to increase
the level of mutual confidence in OIML Certificates. It was implemented in January 2005 and its purpose
was to establish a worldwide multilateral arrangement which offers a wider scope than bilateral or regional
arrangements.

1. OIML Basic Certificate System

The OIML Basic Certificate System for OIML Type Evaluation of Measuring Instruments (hereafter referred
to as the “Basic System”) is a system for issuing, registering and using OIML Basic Certificates of Conformity
(hereafter referred to as “Basic Certificates”) and associated OIML Type Evaluation Reports for types of
measuring instruments (including families of measuring instruments, modules, or families of modules), 3
based on the requirements of Recommendations of the International Organization of Legal Metrology
(OIML). The rules and procedures for the operation of the Basic System are specified in OIML B 3.
The Basic System is a voluntary system and aims to facilitate, accelerate, and harmonize the work of
national and regional bodies that approve types of measuring instruments that are subject to legal
control within OIML Member States and Corresponding Members, or within regions including OIML
Member States and Corresponding Members. In the same way, instrument manufacturers, who are
required to obtain type approval in some countries in which they wish to sell their products, should benefit
from the Basic System as it provides evidence that their instrument type complies with the requirements of
the relevant OIML Recommendations. The Basic System may also help to promote the manufacture,
marketing, and use of measuring instruments that comply with OIML requirements for applications that are
not subject to legal control. A manufacturer or its representative from any country may apply for type
evaluation and a Basic Certificate to be issued by a designated Issuing Authority in any OIML Member State
that participates in the Basic System. Likewise, any Basic Certificate may be accepted and utilized by any
national metrology service or national responsible body in any country.

1.1 Scope

A Basic Certificate that is issued for a type of measuring instrument (including a family of instruments, a
module or a family of modules), attests to the conformity of that type - as represented by the sample(s)
submitted, tested, and examined - to the requirements of the relevant OIML Recommendation.
A Basic Certificate may be issued only for the categories of measuring instruments for which the relevant
Recommendation specifies:
• the metrological and technical requirements,
• the test procedures and,
• the OIML Type Evaluation Report Format.

Concerning families of instruments, modules and families of modules, the relevant Recommendation(s)
shall specify what can be considered as a family and/or a module as well as the specific metrological and
technical requirements and test procedures applicable to such families/modules.
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

Member States that choose to implement the Basic System shall ensure that documented procedures for
the operation, supervision, and control of the Basic System, including appeals, are established and are
consistent with national laws and with the requirements of the Basic System.

1.2 Terminology

The selection of the terms below has been adapted to the needs of this Module. Other terms which are
important for legal metrology may be found in Module 4 and VIML.

1.2.1 Category of instruments


Identification or classification of instruments according to unique metrological and technical characteristics
that may include the measured quantity, the measuring range, the principle or method of measurement
and the conditions of use.

1.2.2 Family of measuring instruments


Identifiable group of measuring instruments belonging to the same manufactured type within the same 4
category that have the same design features and metrological principles for measurement but which may
differ in some metrological and technical performance characteristics, as defined in the relevant
Recommendation.
Note The concept of a “family” primarily aims to reduce the testing required for OIML Type Evaluation. It
does not preclude the possibility of listing more than one family in one Certificate.

1.2.3 Module
Identifiable part of a measuring instrument or of a family of measuring instruments that performs a specific
function or functions and that can be separately evaluated according to prescribed metrological and
technical performance requirements in the relevant Recommendation.

1.2.4 Family of modules


Identifiable group of modules belonging to the same manufactured type that have similar design features
but may differ in some metrological and technical performance requirements as defined in the relevant
Recommendation.

1.2.5 OIML Type Evaluation


Type evaluation conducted on the basis of the relevant OIML Recommendation.

1.2.6 Examination
Official visual inspection of an instrument or device and relevant documentation to ensure that some
specified requirements are met.

1.2.7 OIML Basic Certificate of Conformity


Document issued under the rules of the Basic System by an OIML Issuing Authority providing confidence
that the identified type of measuring instrument or module is in conformity with the requirements of the
relevant Recommendation.
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

1.2.8 OIML Basic Type Evaluation Report


Report, issued by an OIML Issuing Authority (see 2.2.10), that assesses the conformity of the type of
measuring instrument or module to all of the requirements in the relevant Recommendation .

1.2.9 test report


Report issued by a Testing Laboratory, that includes results of tests and examinations it carried out on the
basis of the relevant OIML Recommendation during OIML Type Evaluation on identified sample(s) of a given
type of measuring instrument or module.

1.3 Processing a Basic Certificate

The start of the process is an application, which is provided from the manufacturer, or an authorized
representative of the manufacturer, of a type of measuring instrument to a designated OIML Issuing
Authority for a Basic Certificate. The content of the application can be found in OIML B 3:2011. Besides
these mandatory documents, the applicants may also submit their own test results, or those of a third
party laboratory, in support of the claim that the instruments or modules meet the requirements of the 5
relevant Recommendation.
The OIML Issuing Authority receiving the application shall review it and may request the applicant to
provide additional information and documents prior to further processing of the application. When the
applicant submits test results, the OIML Issuing Authority is not required to accept them. The OIML Issuing
Authority may refuse the application if any of the following conditions apply:
• the OIML Issuing Authority is unable to have the necessary tests conducted for the category of
instruments or module concerned;
• the type does not correspond to the category or module covered in the relevant Recommendation;
• the information required for the application (including any additional information and documents
requested) is incomplete;
• other clearly identified reasons.

In the first case mentioned above, the OIML Issuing Authority may, however, refer the applicant to an OIML
Issuing Authority in another Member State, which may be capable of conducting the OIML Type Evaluation,
without obligating the latter thereby.
The OIML Issuing Authority shall inform the applicant in writing of its decision concerning the acceptance or
refusal of an application. If the application is refused, the reason shall be given.

Note The OIML Issuing Authority may also request the applicant to provide any specialized equipment
necessary to conduct the tests.

If the application is accepted, the OIML Issuing Authority shall inform the applicant of the rules of the Basic
System and of the number of samples of the type that are required for testing. This number is usually
specified in the relevant Recommendation but, if not, it shall be mutually agreed upon by the Issuing
Authority and the applicant. In certain cases, the Issuing Authority may be satisfied with the results of test
reports of a previous OIML type evaluation and, therefore, it may not be necessary to test new sample(s) of
the type. The Issuing Authority, however, shall obtain evidence that the type for which a Certificate is
requested is identical to the previously evaluated type. If previous test results are accepted, the Type
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

Evaluation Report or accompanying document shall indicate which previous results were accepted and
utilized.
The OIML Issuing Authority shall inform the applicant of the fee for application, an estimate of the fees for
OIML Type Evaluation and issuing the Basic Certificate, and the exact amount of the BIML (Bureau
Internationale de Metrologie Legal) registration fee. The fees for testing and issuing Basic Certificates and
OIML Type Evaluation Reports shall be determined according to national practice, and the BIML fees for
registration shall be determined by the CIML. The Issuing Authority shall inform the applicant in writing of
the approximate time necessary to draw up the OIML Basic Type Evaluation Report and complete the type
evaluation.

1.4 Tests and Examinations

The tests and examinations for OIML type evaluation shall be performed in the Testing Laboratories. These
laboratories shall comply with the requirements in international guides or standards on testing, such as in
ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories” and
other relevant guides and publications (e.g. OIML D 30). 6
It is recommended that the competence of the testing laboratory, which performs the test of conformity,
be assessed by a body within a national accreditation system, by peers, or by other means. The assessment
team utilized shall include at least one member who is an expert in legal metrology for the relevant
category of measuring instruments or devices.
The test procedures shall be consistent with those described in the relevant OIML Recommendation. The
applicant may provide test results to the Issuing Authority. The test results provided by applicants, and
their sources, shall be clearly identified in the OIML Basic Type Evaluation Report.

1.5 Test Report(s)

The Testing Laboratory conducting tests according to the relevant Recommendation shall issue a Test
Report. In case there are several Testing Laboratories conducting such tests, each Testing Laboratory shall
issue a Test Report which includes the results of the tests it has conducted. All the test reports will then be
included in the OIML Basic Type Evaluation Report issued by the OIML Issuing Authority. Each Test Report
shall give, as appropriate, the results of the various tests and examinations obtained for samples of the
type. The content of Test Report may be found in OIML B 3. The Test Report shall be dated, signed, and
provided with a unique identification number by the responsible person of the Testing Laboratory who
authorizes the report. The Test Report shall be in English and shall not bear any OIML logo.

1.6 OIML Basic Type Evaluation Report

The OIML Basic Type Evaluation Report is prepared according to the Format specified in the relevant OIML
Recommendation, and includes all the relevant Test Report(s). The content of the Evaluation Report may
be found in OIML B 3. The OIML Basic Type Evaluation Report shall be dated, signed by the responsible
persons (e.g. evaluator and supervisors according to OIML D 29) of the OIML Issuing Authority that
performed the OIML Type Evaluation, and provided with a unique identification number. The OIML logo
shall be affixed on the OIML Basic Type Evaluation Report. The OIML Basic Type Evaluation Report shall be
in English.
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

The OIML Issuing Authority shall keep on file a copy of the OIML Basic Type Evaluation Report and the
information provided with the application. By agreement with the applicant, the tested samples may be
kept by the OIML Issuing Authority, the Testing Laboratory(ies), or the applicant, the decision taking into
account the size and, if appropriate, the commercial value of those samples.
In a declaration of the conformity of the type, the following apply:
• if it is concluded that the samples meet all the requirements of the Recommendation, a Certificate
shall be issued;
• if the samples do not meet the requirements, the applicant shall be informed in writing of the
reason for the failure, and the OIML Type Evaluation Report shall be given to the applicant, if
requested.

In the event that the samples failed a previous evaluation, the applicant may submit a new application with
samples of a modified or newly identified type. New tests may be conducted but may be limited to those
requirements for which the previous type was found not to comply only if evidence provided supports the
conclusion that the instrument’s performance for all other requirements is not likely to have been affected
by the modification of the type.
Fees for type evaluation and testing shall be collected in accordance with the national practice. 7

2. OIML MAA Certificate System

2.1 Scope

The operating rules and procedures for the OIML MAA are defined in OIML B 10 Framework for a Mutual
Acceptance Arrangement on OIML Type Evaluations. Within the OIML MAA, confidence in test and
examination results that are included in the OIML MAA Type Evaluation Report is reinforced by a formal
and mandatory evaluation process of Testing Laboratories involved in tests and examinations.
The objectives of the OIML Mutual Acceptance Arrangement (MAA) are:
• to establish rules and procedures for fostering mutual confidence among participating OIML
Member States and Corresponding Members in the results of type evaluations that indicate
conformity of measuring instruments and/or modules, under legal metrological control, to OIML
metrological and technical requirements and, when included, any agreed upon additional
national/regional requirements;
• to promote the global harmonization, uniform interpretation, and implementation of legal
metrological requirements for measuring instruments and/or modules;
• to promote efficiency in time and cost of national type evaluations and approvals, or recognition of
measuring instruments and/or modules under legal metrological control, while achieving and
maintaining confidence in the results in support of facilitating global trade of individual
instruments; and
• to offer a viable alternative to countries for which no test facilities are available.

The OIML MAA, as per the OIML Basic Certificate System, is a voluntary system. OIML Members States and
Corresponding Members are free to participate or not.
Participating in a Declaration of Mutual Confidence (DoMC) commits in principle the Participants to accept
and use OIML MAA Evaluation Reports issued by Issuing Participants.
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

The implementation of the OIML MAA leads to the establishment of a Declaration of Mutual Confidence
for each category of measuring instruments. Depending on the relevant OIML Recommendation, modules
of measuring instruments may also be included in the Declaration of Mutual Confidence. OIML B 10
provides procedures to establish, operate and maintain a Declaration of Mutual Confidence, and for
Participants to appeal and resolve issues concerning their participation.
The OIML MAA covers all items defined in the scope of the relevant DoMC for a category of measuring
instruments or a module. OIML B 10 identifies supplementary and/or other requirements applicable to the
implementation of the OIML MAA.
OIML Issuing Authorities, National Issuing Authorities and/or National Responsible Bodies of OIML Member
States or Corresponding Members may participate in the OIML MAA.
There are three categories of Participants:
• Issuing Participants are participants from Member States that issue OIML MAA Type Evaluation
Reports and OIML MAA Certificates and that utilize those issued by other Issuing Participants.
• Utilizing Participants are participants from OIML Member States that do not issue OIML MAA Type
Evaluation Reports or OIML MAA Certificates, but that utilize those issued by Issuing Participants.
8
• Associates are participants from OIML Corresponding Members that are willing to utilize OIML MAA
Type Evaluation Reports or OIML MAA Certificates. Associates do not have voting rights in the
review process.

The OIML MAA is applicable to three categories of measuring instruments covered by the OIML
Recommendations R 49 (water meters), R 60 (load cells) and R 76 (non-automatic weighing instruments).

2.2 Terminology

For better understanding, a few selected terms are presented in addition to those in OIML B 3 (see section
2.2 above).

2.2.1 National Issuing Authority


It is a certifying body or person in an OIML Member State or Corresponding Member that is responsible for
national type approval and that issues national/regional Type Approval Certificates (VIML, 3.2) for specific
categories of measuring instruments or modules on the basis of examination and testing under its own
control.

2.2.2 National Responsible Body


It is an organization within an OIML Member State or Corresponding Member that does not conduct type
evaluation (OIML B 3, 3.7) but is responsible for the metrological control of measuring instruments and/or
modules.

2.2.3 OIML Mutual Acceptance Arrangement (OIML MAA)


It is a framework agreement that, in principle, commits Participants to accepting and utilizing OIML MAA
Type Evaluation Reports issued by other Participants under a particular DoMC, after having established
mutual confidence among them through assessment of competence.
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

2.2.4 OIML MAA Certificate of Conformity


It is a document issued under the rules of the MAA by an Issuing Participant in a DoMC, providing
confidence that the identified type of measuring instrument or module is in conformity with the
requirements of the relevant Recommendation, taking into account the exclusions mentioned in the scope
of the DoMC, if applicable.

2.2.5 Peer assessment (from ISO/IEC 17000, 4.5)


It is an assessment of a body against specified requirements by representatives of other bodies in, or
candidates for, an agreement group.

Note Within the MAA implementation, this is the procedure by which agreed upon legal metrology
experts assess, against specified requirements, on site, the competence of Testing Laboratories
requested by Issuing Participants to be registered in a DoMC.

2.2.6 Audit (from ISO/IEC 17000, 4.4)


It is a systematic, independent, documented process for obtaining records, statements of fact or other 9
relevant information and assessing them objectively to determine the extent to which specified
requirements are fulfilled.

Note Audits may be internal or external. Internal audits are supposed to be conducted by the relevant
personnel provided that it is not responsible for the activity which is audited. External audits are
conducted by third-party bodies.

2.3 Declaration of Mutual Confidence

A Declaration of Mutual Confidence (DoMC) is a declaration by Participants that they have achieved a
voluntary mutual arrangement with regard to type evaluation, for a specified category of measuring
instruments, to accept and utilize OIML MAA Type Evaluation Reports issued by Issuing Participants.
Anyone may submit a request to launch a DoMC through the BIML, which will forward the request to the
CIML. The decision to launch a DoMC is made by the CIML. The BIML will report annually to the CIML on the
status of the MAA implementation. In general, one DoMC covers the relevant OIML Recommendation.
A DoMC may be established for categories of measuring instruments (including families and modules as
appropriate) that are included in the OIML Basic Certificate System (OIML B 3, 2.2). At least three
Participants, preferably from different regions, shall be required in order to establish a DoMC. At least two
of them must be Issuing Participants. The scope of a DoMC is defined by the Committee on Participation
Review (CPR) on the basis of the tests and examinations for which detailed procedures are defined in the
appropriate OIML Recommendation, and on the basis of additional national requirements submitted by
the Participants and for which detailed testing procedures have been provided. Issuing Participants shall
apply for the registration of Testing Laboratories (internal and/or subcontracting) that will be responsible
for issuing Test Reports that will be utilized in MAA Type Evaluation Reports. In addition to its internal
and/or subcontracting Testing Laboratories, an Issuing Participant may register one or more MTLs
(Manufacturer’s Testing Laboratory), the test results of which are to be utilized. All Testing Laboratories
shall be assessed either by accreditation or shall be included in the scope of the peer assessment of the
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

corresponding Issuing Participant using requirements that comply with ISO/IEC 17025 and OIML D 30 for
the scope of the DoMC.
In order to address potential conflicts of interest the MTL shall operate under the controlled supervision of
at least one Issuing Participant that is identified in the DoMC. In order to ensure sufficient independence
and impartiality of the MTL as part of a larger organization (company) the quality manual and other
supporting documents of the organization shall demonstrate that there are suitable provisions that ensure
that the MTL’s personnel are free from any undue commercial, financial or other pressures which might
influence their technical judgment.

2.4 Application for participation in a DoMC

Applications for participation in DoMC shall be sent to the relevant CIML Member or contact person of
Corresponding Members, who is responsible for submitting them to the BIML. Applications shall be
accompanied by the following information:
For potential Issuing Participants, Utilizing Participants and Associates: 10
• an official letter confirming participation in the MAA and the type of participation (Issuing
Participant or Utilizing Participant or Associate);
• information about additional tests and examinations required for national type approval that
Participants would potentially be willing to include in the scope of the DoMC - in such a case, the
detailed testing procedures shall be provided to be examined by the CPR.

For potential Issuing Participants only:


• information about its competence as defined in OIML B 3;
• a list of all Testing Laboratories (internal, subcontracting and MTLs) indicating, for each one, which
tests and examinations of the relevant OIML Recommendation and of additional national
requirements included in the scope of the DoMC, if applicable, it performs;
• information about its type testing capabilities (including those of its registered subcontracting
Testing Laboratories and MTLs, if any);
• in the case of an MTL: the procedures between the Issuing Participant and the MTL to manage the
controlled supervision;
• in the case of accreditation, the certificate(s) of accreditation of the Testing Laboratories and their
most recent accreditation assessment report(s) which includes the relevant scope of the DoMC and
enough information that an assessment of the legal metrology aspects of the accreditation can be
determined, if accreditation applies;
• the most recent internal audit of each Testing Laboratory (whether it is accredited or not)
conducted on the basis of ISO/IEC 17025 and OIML D 30 for the relevant scope of the DoMC;
• the results of intercomparisons conducted in the relevant field, if any;
• a copy of the most recent OIML Basic Type Evaluation Report issued for the considered category in
the event that the potential Issuing Participant is already an OIML Issuing Authority (OIML B
03:2011) for the relevant category.
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

2.5 Review of application for participation in a DoMC

2.5.1 CPR establishment and operating rules


A CPR shall be set up for the purpose of:
• reviewing the documentation submitted by potential Participants;
• deciding for which Testing Laboratory a peer assessment shall be conducted and in that case
defining the scope of the peer assessment or requesting an extension of the scope of accreditation,
if appropriate;
• validating the scope of the DoMC;
• reviewing the accreditation reports and peer assessment reports of the potential Issuing
Participants;
• deciding, in case a new edition of an OIML Recommendation is included in the DoMC, whether an
extension of accreditation (for accredited Testing Laboratories) or a new peer assessment (for non-
accredited Testing Laboratories) is necessary;
• validating the candidacies submitted by technical and metrological experts who will participate in
the assessments of the Testing Laboratories; 11
• preparing a report based on all information received, including peer assessments when conducted,
on the competence of each potential Issuing Participant in the DoMC to be used for the decision on
participation;
• establishing, expanding and maintaining the appropriate DoMC;
• proposing to the CIML the deadline after which it will no longer be possible to issue OIML Basic
Certificates for the relevant category (see OIML B 3, 11.1).

Generally, one CPR per DoMC is established. Nevertheless, one CPR may be established for several DoMCs
if their scopes are similar. In such a case, the CPR may be composed of several representatives of the same
Participant to ensure the necessary degree of competence.
Before a DoMC is signed, a provisional CPR is established with representtaives of those potential
Participants who have applied for participation. After the DoMC is signed, the definitive CPR is established
and a representative of each Participant is approved.
Decisions in the CPR are considered valid if two-thirds of the votes cast by the CPR members having voting
rights are in favour of them.) the following steps are:

2.5.2 Approval of Issuing Participants


When a DoMC is first being established, all potential Participants shall independently review the report
drawn up by the CPR. Each potential Participant shall initially submit its agreement or reservations on the
participation of Issuing Participants to the BIML representative on the CPR. Responses from at least 80 % of
the potential Participants shall be received. Each Issuing Participant is accepted provided that at least 80 %
of the potential Participants agree on its participation.

2.5.3 Admission of Utilizing Participants and Associates


Potential Utilizing Participants or Associates who apply for participation and who do not require additional
national requirements to be included in the DoMC are automatically accepted, and the CPR’s composition
is modified consequently to take into account the newly appointed members.
In the event that a potential Utilizing Participant or Associate requires additional national requirements to
be included in the DoMC, the BIML consults the CPR for the acceptance of these additional national
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

requirements and for a decision on conducting any additional necessary assessments for those Issuing
Participants wishing to perform the tests according to the additional national requirements.

2.6 Assessments of Testing Laboratories

The accreditation body that carries out an assessment of a Testing Laboratory of a Participant in a DoMC
shall participate in a mutual recognition arrangement among accrediting bodies (regional or international),
for instance the ILAC MRA (International Laboratory Accreditation Cooperation Mutual Recognition
Arrangement). The assessment team shall include at least one technical and metrological expert
validated by the CPR for at least one of the surveillance assessments which covers the scope of the DoMC
within the accreditation renewal cycle. The peer assessment shall be carried out by a team of experts,
including at least one technical and metrological expert validated by the CPR and at least one expert
knowledgeable in assessing quality management systems of Testing Laboratories on the basis of ISO/IEC
17025.
Note: A lead assessor of an accreditation body as defined in the Memorandum of Understanding signed
between ILAC, IAF and the OIML fulfills this last requirement. 12

2.7 Record of participation

Each accepted Participant shall sign in duplicate a registration form drawn up according to the format
defined in Annex C of OMIL B 10.
The BIML is responsible for making a synthesis of the registration forms (Annex B of OIML B 10) containing
the necessary information on the participants, available to the public. This synthesis represents the official
registration of the DoMC by the BIML and shall be available on the OIML web site. The synthesis includes, if
appropriate, the additional testing procedures and test report.

2.8 Initiation and maintenance of a DoMC

Each DoMC becomes effective on the date that it is recorded by the BIML. From this date, Issuing
Participants shall issue only OIML MAA Type Evaluation Reports and MAA Certificates for the relevant
category of measuring instruments as soon as they perform tests and examinations that are included in the
scope of the DoMC.
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

13

2.9 Processing an OIML MAA Type Evaluation Report and an MAA Certificate

The manufacturer of a type of instrument or module, or an authorized representative of the manufacturer,


shall apply to an Issuing Participant in the relevant DoMC for an OIML MAA Type Evaluation Report and an
MAA Certificate.
The application shall include the information listed in OIML B 3, 5.1.2. If results of previous type evaluation
reports are provided, they shall come from an OIML MAA Type Evaluation Report.
The tests and examinations for OIML type evaluation shall be performed in the Testing Laboratories of the
Issuing Participant registered in the relevant DoMC.
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

The test procedures shall be consistent with those described in the relevant Recommendation and/or the
additional testing procedures annexed to the DoMC for the additional national requirements included in
the scope of the DoMC.
The test procedures may be abbreviated or omitted if the Issuing Participant considers that the conclusions
necessary for issuing the OIML MAA Type Evaluation Report may be drawn from a previous OIML MAA
Type Evaluation Report.
All the Test Reports will then be included in the OIML MAA Type Evaluation Report issued by the Issuing
Participant.
The OIML MAA Type Evaluation Report is prepared by the Issuing Participant according to the format
specified in the relevant OIML Recommendation, and includes all the relevant Test Report(s).
The OIML MAA logo shall be affixed on the OIML MAA Type Evaluation Report.
The MAA Certificate shall be drawn up according to the model given in OIML B 3, Annex A. It shall be signed
by the Issuing Participant and bear the OIML MAA logo.
In the event that tests according to the additional national requirements included in the DoMC have been
conducted, a letter issued by the Issuing Participant may validate the conformity of the instrument to these
requirements. A copy of such a letter shall be sent to the BIML with the MAA Certificate.
14
For registration of MAA Certificates, the provisions defined in OIML B 3 are applied.
Use of OIML MAA Type Evaluation Reports, appeals, resolution of complaints and disputes are elaborated
in OIML B 10, 13 and 14. OIML B 10 also contains informative and mandatory annexes to be used in the
OIML MAA process of Type Approval.
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

3. Concluding Remarks

OIML Basic Certificates are issued by Issuing Authorities designated by OIML Member States. The OIML
Basic Certificate will be issued after completing all the tests, evaluations and examinations specified in the
relevant OIML Recommendation and after it is demonstrated that the type complies with the requirements
of the Recommendation. OIML Basic Certificates are accompanied by an OIML Evaluation Report. The list of
Issuing Authorities for Basic Certificates, together with the list of Recommendations for which each Issuing
Authority is authorized to issue Basic Certificates, is maintained by the BIML and published on the OIML
website. Manufacturers may apply for an OIML Basic Certificate from any of the Issuing Authorities on this
list.
The CIML Member in a given Member State may designate one or more OIML Issuing Authorities in that
State per category of instruments. An OIML Issuing Authority that issues OIML Basic Certificates may or
may not be the same organization as the national body that issues national type approval certificates and
whose responsibilities are governed by national regulations. An OIML Issuing Authority should demonstrate
its competence to issue Basic Certificates and associated OIML Type Evaluation Reports according to the
requirements specified in OIML Publication B 3 and in the relevant Recommendation, and in particular that 15
it complies with the requirements in international standards on certification, notably in ISO/IEC
17065 Conformity assessment - Requirements for bodies certifying products, processes and services.
The tests and examinations for OIML type evaluations shall be performed in Testing Laboratories that
comply with the requirements in international guides or standards on testing, such as in ISO/IEC
17025 General requirements for the competence of testing and calibration laboratories and other
relevant guides and publications. The evaluation of the competence of the OIML Issuing Authority is the
responsibility of the Member State. Under the OIML Basic System there is no formal peer evaluation of
competence of the Issuing Authority or its associated Testing Laboratories.
Under the OIML MAA, confidence in test and examination results is reinforced by a formal and mandatory
peer evaluation process. This process verifies the compliance of the Issuing Authorities and their
associated Testing Laboratories with the respective Standards, and also the capability of the testing
laboratories to perform the tests. To prove this compliance, the Issuing Authorities and their associated
Testing Laboratories must be accredited for the field covered by the respective OIML Recommendations or
undergo peer assessment.
The list of Recommendations for which OIML MAA Type Evaluation Reports and OIML MAA Certificates are
issued and the lists of participants in the agreement are maintained by the BIML in documents called
“Declarations of Mutual Confidence” (DoMC) and published on the OIML website. Manufacturers may
apply for an OIML MAA Certificate from any of the Issuing Participants on these lists.
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

Literature

• OIML web-site: https://www.oiml.org/


• OIML Basic Certificate System for OIML Type Evaluation of Measuring Instruments, OIML Basic
Publication B3:2011
• Framework for a Mutual Acceptance Arrangement on OIML Type Evaluations, OIML Basic Publication
B10: 2011 (including changes in the 2012 Amendment)

16
OIML Certificate Systems and Engagement with the OIML and RLMOs MODULE 9

Course: Legal Metrology in Detail


Module: OIML Certificate Systems and Engagement with the OIML and RLMOs
Developed by AFRIMETS, CROSQ and OIML and facilitated by the ACP-EU TBT Programme
Author: Dr. Predrag Vukadin
Team Leader: Dr. Konstantinos Athanasiadis
Project funded by the European Union at the request of the ACP Group.

First edition
Copyright© 2016 ACP-EU TBT Programme

This work is licensed under a Creative Commons Attribution-Non-Commercial-NoDerivatives 4.0


International License.

Attribution-NonCommercial-NoDerivatives 17
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production of translations, requires the writ -ten approval of ACP-EU TBT Programme.

AFRIMETS CROSQ OIML


Intra-Africa Metrology System CARICOM Regional Organisation Organisation INternationale de
Private Bag X34 for Standards and Quality Métrologie Légale
Lynnwood Ridge 0040 South Africa 2nd Floor Baobab Towers, 11, rue Turgot - 75009 Paris -
Tel +27 128413898 Warrens, St. Michael, Barbados France
Fax +27 128413382 +1-246-622-7670 Tel +33 1 48 78 12 82
www.afrimets.org +1-246-622-7677 Fax +33 1 42 82 17 27
[email protected]

ACP-EU TBT Programme Management Unit


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