WEIGHTS AND MEASURES
Guidelines on the Appointment of UK
Notified Bodies for NAWI and MID
January 2013
Version 3
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1.
INTRODUCTION
1.1
The Secretary of State for the Department for Business, Innovation and Skills, BIS is
responsible for the appointment, or designation, of Notified Bodies to undertake duties as set
out in the Regulations.
1.2
These guidelines apply to the appointment of UK Notified Bodies to undertake
conformity assessment tasks under the codified Non Automatic Weighing Machines Directive
2009/23/EC and the Measuring Instruments Directive 2004/22/EC.
1.3
An organisation wishing to be designated as a Notified Body in the United Kingdom will
need to meet the criteria in the relevant Directive and the requirements in these guidelines.
These guidelines also provide information on how the relevant conformity assessment body
standards are used to assess the applicant body.
1.4
The Non-Automatic Weighing Instruments (NAWI) Directive was made in 1990 and
came into force in 1992. The UK implementing regulations are the Non-automatic Weighing
Instruments Regulations 2000 No. 3236 as amended by the Non-automatic Weighing
Instruments (Amendment) Regulations 2008 No. 738.
1.5
The Measuring Instruments Directive (MID) was made in 2004 and came into force in
2006. The UK implementing regulations are:
1. The Measuring Instruments (Non-Prescribed Instruments) Regulations 2006 No.1270
2. The Measuring Instruments (Automatic Gravimetric Filling Instruments) Regulations
2006 No. 1258
3. The Measuring Instruments (Beltweighers) Regulations 2006 no.1259
4. The Measuring Instruments (Capacity Serving Measures) Regulations 2006 No. 1264
5. The Measuring Instruments (Automatic Catchweighers) Regulations 2006 No. 1257
6. The Measuring Instruments (Cold-water Meters) Regulations 2006 No. 1268
7. The Measuring Instruments (Automatic Discontinuous Totalisers) Regulations 2006 No.
1255
8. The Measuring Instruments (Liquid Fuel and Lubricants) Regulations 2006 No. 1266
9. The Measuring Instruments (Liquid Fuel delivered from Road Tankers) Regulations 2006
no. 1269
10. The Measuring Instruments (Material Measures of Length) Regulations 2006 No. 1267
11. The Measuring Instruments (Automatic Rail Weighbridges) Regulations 2006 No. 1256
12. The Measuring Instruments (Active Electrical Energy Meters) Regulations 2006 No.
1679
13. The Measuring Instruments (Gas Meters) Regulations 2006 No. 2647
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1.6
Applications for taximeters and exhaust gas analysers should be directed to the
Department for Transport, Great Minister House, 76 Marsham Street, London, SW1P 4DR.
2.
BACKGROUND
2.1
These guidelines will outline the necessary criteria to become a Notified Body and the
process of application. They will not provide detail on how an organisation will undertake the
relevant tasks it proposes to be designated for and it is not intended as an interpretation guide
for the essential requirements. This information is contained in the Directive itself and will be
supplemented by harmonised standards and normative documents that assist with the
interpretation of the essential requirements.
2.2
The Secretary of State for BIS has appointed NMO to designate Notified Bodies under
the Non Automatic Weighing Instruments Directive and the Measuring Instruments Directive for
certain categories of instruments. NMO will make suitable designations based on the
organisations ability to meet the criteria laid down in Annex V of the NAWI Directive and Article
12 of the MID. Evidence of an organisation’s ability to meet these criteria must be established
by accreditation by UKAS against the appropriate harmonised standards.
2.3
For Notified Bodies wishing to deliver declarations of conformity based on product
verification in the Local Government Sector an alternative assessment can be made by NMO
recognising the other ongoing legal metrology responsibilities that some local authorities have
under the Weights and Measures Act 1985 and subordinate legislation. Details of this process
are available from NMO.
2.4
In all other cases an application should be made to UKAS in accordance with their
general procedures and the application associated with this document should be completed and
sent at the same time to NMO.
2.5
The flow chart on page 5 identifies the different categories of organisation that might
apply for Notified Body status. The main distinction is between those applying for the first time
and those that are seeking to extend their scope. In all cases the applicant will have to complete
the NMO application form MID 02. In the case of organisations outside of local government,
they are required to work with UKAS who will present evidence in the form of accreditation
certificates to NMO.
2.6
For instruments covered by the MID there is a transitional period where instruments can
be placed on the market under either existing national or the new national provisions
implementing the directive. This transitional period will last for the remainder of time on the type
approval certificate or 10 years whichever is the shorter. For those instruments that do not
require type approval e.g. capacity serving measures, they have been required to go through
the appropriate conformity assessment procedure since the 30th of October 2006 before being
placed on the market. Access to the wider European market during this transitional period will
only be available for instruments placed on the market under the provisions of the MID.
2.7
The Directives only deal with the placing of goods on the market and their conformity
assessment procedures only apply to this initial stage of an instruments life. The national
regulations also include provisions to ensure that instruments remain accurate and in
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compliance with their specification throughout their life. These provisions are not delivered by
Notified Bodies under these Directives. The Weights and Measures Act 1985 (“the Act”)
prescribes the controls on instruments in the applicable categories and those persons or
organisations that will undertake the in use supervision of instruments.
2.8
The Act identifies Local Weights and Measures Authorities as responsible for the
inspection and disqualification of instruments and the responsibility to re-verify (pass as fit for
use for trade, place back on the market) instruments that have been disqualified or are capable
of being disqualified.
2.9
The Act also identifies Approved Verifiers (manufacturers, installers and repairers) who,
once approved by the Secretary of State, are able to re-verify (pass as fit for use for trade, place
back on the market) instruments that will be first placed on the market under the Directives.
2.10 The application process for manufacturers, installers and repairers wishing to conduct
such activities is laid down in NMO publication “Approved Verification Guidance on Regulation
INT/05 March 2010” which can be found on the NMO website www.nmo.gov.uk.
2.11 For organisations approved to undertake conformity assessment procedures under
NAWI and MID the application process to be approved to undertake similar “in use” activities
will be significantly reduced as evidence of the organisations systems and competence are
already available.
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Notified Body Application Process Flow Chart
Existing Notified Bodies
New Notified Bodies
Eligable Organisations
Accreditation Required
Eligable Organisations
Already Accredited
Accreditation Required
COMPLETE APPLICATION NB01 AND SUBMIT TO NMO
Scope does
not cover
relevant
Directive
Scope
Covers
relevant
Directive
Complete UKAS application form
Complete UKAS application form
UKAS confirm Certification & Scope to NMO
UKAS confirm Certification & Scope to NMO
INITIAL ASSESSMENT BY NMO
Failed applicants sent
details
FINAL ASSESSMENT BY NMO
Amend existing or draw up new Letter of Designation
Notify Commission of New Body or Change of Scope
Issue Letter of Designation
ACCREDITED UKAS
ORGANISATION
Surveillance & Assessment in
accordance with UKAS Accreditation
Scheme
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Additional information may be sought
from applicant by NMO
3.
CRITERIA
3.1
The Core Criteria in the Directives
The core criteria for the NAWI Directive are contained in Annex V and are as follows:
‘1.
The bodies shall dispose of the necessary personnel, means and equipment.
2.
The personnel shall have technical competence and professional integrity.
3.
The bodies shall work independently of all circles, groups or persons having direct or
indirect interest in non-automatic weighing instruments regarding the carrying-out of the tests,
the preparation of reports, the issuing of the certificates and the surveillance requested by this
Directive.
4.
The personnel shall respect the professional secret.
5.
The bodies shall have taken out a civil liability insurance if their civil liability is not
covered by the state under national law.
The fulfilment of the conditions under points 1 and 2 shall be periodically verified by the member
states.’
The core criteria for the MI Directive are contained in Article 12 and are as follows:
‘1.
The body, its director and staff involved in conformity assessment tasks shall not be the
designer, manufacturer, supplier, installer or user of the instruments that they inspect, nor the
authorised representative of any of them. In addition, they may not be directly involved in the
design, manufacture, marketing or maintenance of the instruments, nor represent the parties
engaged in these activities. The preceding criterion does not, however, preclude in any way the
possibility of exchanges of technical information between the manufacturer and the body for the
purposes of conformity assessment.
2.
The body, its director and staff involved in conformity assessment tasks shall be free
from all pressures and inducements, in particular financial inducements that might influence
their judgement or the results of their conformity assessment, especially from persons or groups
of persons with an interest in the results of the assessments.
3.
The conformity assessment shall be carried out with the highest degree of professional
integrity and requisite competence in the field of metrology. Should the body sub-contract
specific tasks, it shall first ensure that the sub-contractor meets the requirements of these
Regulations, and in particular of this Schedule. The body shall keep the relevant documents
assessing the sub-contractor’s qualifications and the work carried out by him under these
Regulations at the disposal of the notifying authority.
4.
The body shall be capable of carrying out all the conformity assessment tasks for which
it has been designated, whether those tasks are carried out by the body itself or on its behalf
and under its responsibility. It shall have at its disposal the necessary staff and shall have
access to the necessary facilities for carrying out in a proper manner the technical and
administrative tasks entailed in conformity assessment.
5.
The body’s staff shall have—

sound technical and vocational training, covering all conformity assessment tasks
for which the body was designated;
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
satisfactory knowledge of the rules governing the tasks which it carries out, and
adequate experience of such tasks; and

the requisite ability to draw up the certificates, records and reports demonstrating
that the tasks have been carried out.
6.
The impartiality of the body, its director and staff shall be guaranteed. The remuneration
of the body shall not depend on the results of the tasks it carries out. The remuneration of the
body’s director and staff shall not depend on the number of tasks carried out or on the results of
such tasks.
7.
The body shall satisfy the Secretary of State that it has adequate civil liability insurance.
8.
The body’s director and staff shall be bound to observe professional secrecy with regard
to all information obtained in the performance of their duties pursuant to these Regulations,
except vis-à-vis the authority of the Member State.’
3.2
The Core Criteria and the Conformity Assessment Body Standards for the
Appointment of Notified Bodies
3.2.1 The applicant body shall demonstrate to NMO via accreditation by UKAS and additional
information that it meets the core criteria set out in the Directives (and reproduced in Section 3)
and the additional requirements in these guidelines.
3.2.2 Council Regulation 765/2008, among other things, set out the general framework for the
assessment of Notified Bodies and the policy that Member States should use harmonised
standards for the assessment of an applicant body against the core criteria. The ISO/IEC17000
series of harmonised standards that are relevant for these guidelines are listed below.
3.2.3 The conformity assessment body standards cover different types of body but in general
terms they have a similar structure, consisting of parts dealing with the organisation and
management of a body, and parts dealing with the technical requirements relating to the
operation of the body in the areas of testing, inspection, product certification and management
systems assessment. However, the Department will require compliance with these standards
only in so far as they relate to a Notified Body’s activities with regard to the conformity
assessment procedures and products in its scope of appointment.
BS EN ISO/IEC 17025:2005 General requirements for the competence of testing and calibration
laboratories
BS EN ISO/IEC 17020:2004 General criteria for the operation of various types of bodies
performing inspection
BS EN 45011:1998 General requirements for bodies operating product certification systems
BS EN ISO/IEC 17021:2006 Conformity assessment – Requirements for bodies providing audit
and certification of management systems.
EA-2/17:2009 Mandatory EA (European co-operation for Accreditation) Guidance on the
horizontal requirements for the accreditation of conformity assessment bodies for notification
purposes. This document contains horizontal criteria for conformity assessment bodies seeking
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accreditation for the purpose of notification, to carry out as notified bodies, third-party conformity
assessment tasks under community harmonisation legislation.
3.3
The conformity assessment procedures in the Directive and the conformity
assessment body standards
3.3.1 The basic correspondence between the conformity assessment procedures and the
conformity assessment body standards is shown in the table below. Where more than one
assessment standard is provided as an option for a particular procedure, the applicant body will
have the choice of deciding which standard to use.
Module
A1
Conformity assessment body standards applicable
ISO/IEC 17025 (including the ability to evaluate and decide on
conformity), or
ISO/IEC 17020 (ISO/IEC 17025 to be observed for testing required),
or
EN 45011 (ISO/IEC17025 to be observed for testing required)
B,
ISO/IEC 17020 (ISO/IEC 17025 to be observed for testing required),
or
EN 45011 (ISO/IEC 17025 to be observed of testing required)
D, D1
EN 17021 (+ product related knowledge)
E, E1
EN 17021 (+ product related knowledge)
F, F1
G
H
H1
ISO/IEC 17025 (including the ability to evaluate and decide on
conformity), or
ISO/IEC 17020 (ISO/IEC 17025 to be observed for testing required),
or
EN 45011 (ISO/IEC 17025 to be observed for testing required)
ISO/IEC 17020 (ISO/IEC 17025 to be observed for testing required),
or
EN 45011 (ISO/IEC 17025 to be observed for testing required)
EN 17021 (+ product related knowledge)
EN 17021 (+ product related knowledge) + (ISO/IEC 17020 or EN
45011)
3.3.2 Further advice on the assessment of Notified Bodies for MID has been developed by
WELMEC working group 8 and has been published as guide WELMEC 8.0, Generalities on the
Assessment and Operation of Notified Bodies performing Conformity Assessment available on
the WELMEC website www.welmec.org.
3.3.3 Where the applicant body’s proposed scope of appointment requires operation in
accordance with the requirements of more than one conformity assessment standard, it may
choose to base its systems on one selected core standard and deal with the relevant
requirements of the other standards as additions to its base system. The parts of the standards
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covering technical competence requirements however, such as facilities and equipment, training
and qualification of personnel, should be carried out on the basis of the requirements of each
standard.
3.4
Policy on accreditation
If an applicant body is already accredited by UKAS to one of the conformity assessment body
standards, for an appropriate scope, then any subsequent application for appointment as a
Notified Body for a directive with a similar scope, will involve the minimum of additional work for
the UKAS assessment.
4.
QUALITY MANUAL
4.1
The Notified Body should have a quality manual and associated documented
operational procedures, appropriate to the conformity assessment modules and instrument
type which it wishes to certify. The quality system set out in the documentation shall ensure
that all the requirements of the relevant standard(s) in the EN 17000 or EN 45000 series
are met plus any further requirements for accreditation and criteria for appointment and
operation as a Notified Body. The quality documentation shall contain policies and
procedures to include:
a) a statement on the training of staff engaged in the conformity assessment
process;
b) details of the documented procedures for assessing initial and audit product
testing;
c) a general statement on the range of testing and inspection facilities appropriate
to its activities;
d) details of documented procedures for the surveillance of a manufacturer’s quality
system;
e) a list of sub-contractors and details of the documented procedures for assessing
and monitoring their competence;
f)
details of appeals procedures and the procedure for ensuring that complaints to
the Notified Body are investigated to ensure that any shortcomings of the
certification activities are revealed;
g) a list of staff members responsible for investigating complaints and those having
the authority to take remedial action;
h) a copy of instructions to staff on confidentiality;
i)
a copy of the written undertaking by staff not to divulge any information gained
about the client to a third party;
j) a copy of the provisions in all sub-contracts to maintain confidentiality;
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4.2
The Notified Body will be required to inform the assessment body (UKAS) (and the
Secretary of State) immediately of any changes relating to its application or scope. This
includes any change in its status as an organisation.
5.
DOCUMENTATION TO BE RETAINED BY THE NOTIFIED BODY
5.1
The Notified Body is required to maintain an up to date record of all certifications/
notifications that it has issued, to whom it has been issued and to what it applies. These records
shall be retained by the Notified Body and made available on request to the Secretary of State,
or such other person as may be authorised by the Secretary of State, subject to the usual
provisions relating to confidentiality. A list of the relevant technical documentation must be
annexed to the certificate and a copy kept by the Notified Body. Where the Regulations do not
explicitly require a Notified Body to retain copies of the technical documentation for a certain
period of time, this is a matter of agreement between the Notified Body and its client. It is
suggested however, that the technical documentation relating to the certification issued should
be retained until the certificate is no longer valid or required either as a matter of contract or to
comply with requests from the enforcement authorities.
5.2
In the case of type approval certificates the technical documentation and the full
certificate and supporting certificates shall be retained until the certification is no longer valid.
5.3
Agencies responsible for the inspection and ongoing supervision of equipment need to
have access to certificates and supporting information. Notified Bodies will be required to
support information exchange and supply relevant certificates and information as required by
these agencies.
6.
INTERNAL AUDIT AND PERIODIC REVIEW
6.1
The Notified Body shall undertake internal audits and management reviews as
required by the particular EN 45000 and EN 17000 standards to which it is working. Audits
and reviews shall include checking compliance with the criteria for appointment as a
Notified Body and checking that the certification process is correctly and effectively
implemented.
7.
MISUSE OF CERTIFICATES AND CONFORMITY NUMBERS
7.1
The quality manual should state the Notified Body’s policy and procedure for
controlling the use of its certificates and conformity numbers. The Notified Body should
have documented procedures covering the control and use of its conformity number and
any associated mark(s). The Notified Body should not allow its mark(s) to be used without
its express permission.
7.2
If, for example, an irregularity or oversight is discovered it might be necessary to
withdraw the company’s approval. NMO must be informed immediately in such cases.
8.
PARTICIPATION IN CO-ORDINATION ACTIVITIES
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8.1
The Notified Body shall participate in the Notified Body co-ordination activities at the
national and European level. It shall demonstrate active participation by a record of frequent
attendance at UK meetings and it should also show that it has an effective means of providing
input and making itself aware of the outcome of co-ordination at the European level. The
Notified Body shall take account of Notified Body co-ordination decisions at the European level.
9.
CIRCUMSTANCES IN WHICH THE NOTIFIED BODY SHALL CONTACT THE
DEPARTMENT
9.1
The Notified Body shall inform NMO of the occurrence of the following events:
a) the withdrawal of an EC type/design examination certificate by the Notified Body
(including the reasons for doing so);
b) any changes which, in any way, have a bearing upon its status as a Notified Body, or its
ability to perform the duties and functions in its scope of appointment;
c) details of any defective harmonised standard and, if relevant, an inappropriate
application of harmonised standards. (Defective standards are those that do not fulfil the
mandate issued to the European Standards organisations by the Directive 98/34/EC
Article 5 committee, and/or do not fully address the essential requirements of the
Regulations.)
For point (b) the Notified Body shall also inform UKAS.
10.
CONFIDENTIALITY
10.1 Subject to any arrangements in respect of the release of information to other Notified
Bodies in accordance with the relevant conformity assessment procedures, the Notified Body
shall have adequate arrangements for ensuring confidentiality of information obtained in the
course of its certification activities between itself and its clients.
11.
INVOLVEMENT OF A NOTIFIED BODY IN CONFORMITY ASSESSMENT AT THE
REQUEST OF A MANUFACTURER THAT IS NOT COVERED BY THE REGULATIONS
11.1 A manufacturer may ask a Notified Body to become involved in a conformity assessment
procedure that is not required by the Regulations (e.g. carrying out testing as part of module
A1). In such circumstances the Notified Body shall have procedures to ensure that any marking
on the product, or certification provided by the Notified Body, shall be distinguishable from
marking on the product or certification that relates to the requirements in the Regulations.
12.
APPLICATION AND APPOINTMENT
12.1
Eligibility and legal identity
To be eligible for appointment as a United Kingdom Notified Body for the Regulations; the
applicant body shall be a legal entity1 and be established in the United Kingdom. It must carry
1 To be eligible, a body must have a legal identity but does not have to be formed according to UK law. It must be
established in the UK and thus come under its jurisdiction.
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out its conformity assessment functions within the jurisdiction although possible not the land
area of the UK and only issue certificates from an establishment in the UK. It may have staff
located outside the UK and it may conduct assessments of quality management systems, or
product tests and inspections, or have them conducted on its behalf, outside the UK.
12.2
Application to UKAS for accreditation, copy application to NMO
Organisations wishing to be appointed as a Notified Body should make an application in the first
instance to the United Kingdom Accreditation Service (UKAS) for accreditation using the
general UKAS Application Form and Form AC 6. Further information on the UKAS application
and assessment processes is given in UKAS document P-16. At the same time as it submits its
application to UKAS, the applicant body shall send copies of both forms plus NMO’s application
form NB01 completed to NMO and these will be taken to be the formal application to the
Secretary of State. No further action will be taken by NMO until UKAS provide the formal report
of the scope of any accreditation activities.
12.3
Overall process of accreditation by UKAS
UKAS will carry out an assessment of the applicant body on behalf of the Secretary of State
against the requirements set out in these guidelines and provide an accreditation report and
recommendation to the Secretary of State.
12.4
Agreement on the use of subcontracted UKAS assessors
UKAS will use suitably qualified assessors or assessment teams to undertake the assessment
and make clear to applicant bodies when sub-contracted assessors or technical experts are to
be used. Applicant bodies will have the right to object to specific assessors and experts where
there are concerns about potential conflicts of interest. UKAS has established procedures to
handle complaints or appeals associated with its assessment activities.
12.5
UKAS scale of charges
UKAS will quote and charge applicant bodies against its own standard scale of charges for its
assessment activities carried out under these guidelines.
12.6
Insurance
The applicant body shall provide evidence of its insurance cover to UKAS and to NMO before
any appointment is made. After any appointment, the Notified Body shall provide evidence of
continued appropriate insurance cover to UKAS at each annual surveillance exercise or
assessment directed by the Secretary of State if this route is selected.
12.7
Secretary of State’s decision
The Secretary of State will make a decision based on the recommendation and accompanying
accreditation from UKAS and any other relevant information that the Secretary of State will
request of the organisation. It should be noted that appointment is at the discretion of the
Secretary of State and it should not be assumed that, if an applicant body meets all the core
criteria, then an appointment will automatically follow if there are other circumstances relevant
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to the application that the Secretary of State might consider warrant delaying or refusing
appointment.
If the Secretary of State is minded not to appoint an applicant body, then the applicant body will
be informed in writing of the reasons for being so minded and given the opportunity of making
further representations within a period of 28 days of notice of this information. Such
representations will be further considered before a final decision is made.
However, if the Secretary of State is satisfied that the applicant body is suitable, and should be
designated, a letter of appointment will be issued to the applicant body.
12.8
Conditions of appointment
The precise terms of appointment will be set out in the individual letters of appointment,
but they will include conditions that the applicant agrees:
-
to take part in co-ordination activities at both UK and European level;
-
to surveillance annually or at whatever intervals are thought appropriate by the
Department (newly appointed Notified Bodies may be required to undergo an initial
surveillance after 6 months);
-
to a full reassessment every four years or at whatever intervals are thought
appropriate by the Department.
Once acceptance of the conditions of the letter of appointment has been received,
receipt of that acceptance will be confirmed and the Department will notify the European
Commission and the other member/EEA States of the appointment.
12.9 Notification of the appointment to the European Commission and other Member
States
When the applicant body has signed and returned the letter of appointment, the Department will
notify the appointment to the European Commission and other Member States. (The
appointment is said to have taken place when the signed letter is received by the Department.)
If the applicant body has not previously been assigned an identification number according to
another EC Directive, the Department will ask the Commission to assign such a number prior to
notification. The designated body may begin working when the appointment has taken place but
it shall not issue any certificates until the identification number has been assigned and it has
received confirmation from the Department of its notification. (Other Member States are only
obliged to provide free circulation to products, which are subject to conformity assessment
procedures requiring the involvement of a Notified Body, if they have received information about
the notification of any Notified Body involved.)
12.10 Reassessment and surveillance of Notified Bodies by UKAS
UKAS will carry out reassessment and surveillance of the Notified Body according to the
conditions in that body’s letter of appointment and send a report to the Secretary of State or
conduct assessments at the direction of the secretary of state if the chosen method of
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demonstrating compliance is by assessment rather than accreditation. The information in the
report will relate only to the Notified Body’s activities as a Notified Body and will not include any
other activity that is not relevant to the appointment. Reassessment and surveillance may also
be carried out by the Secretary of State. UKAS will advise the Department if it believes that a
Notified Body no longer complies with the terms of that body’s letter of appointment, including
compliance with the requirements in these guidelines.
12.11 Co-ordination of action between NMO and UKAS on suspension or withdrawal of
accreditation and withdrawal of appointment
The designation of a Notified Body is based on accreditation to the conformity assessment body
standards, UKAS will advise NMO if that accreditation is suspended, withdrawn, or is reduced in
scope in a way that is relevant to the appointment. When an appropriate appeals procedure has
been completed (if requested by the Notified Body) UKAS will advise NMO if it can no longer
support its recommendation for designation based on accreditation. UKAS will inform the
Department when an accreditation that supports notification is re-instated following suspension,
withdrawal, or a reduction in scope. In turn, NMO will advise UKAS if a Notified Body has
decided to suspend its activities pending rectification, or when an appointment and notification
has been withdrawn or terminated.
12.12 Existing Notified Bodies Wishing to Extend Their Scope
12.12.1 If your organisation has already been notified to the commission to undertake one or
more conformity assessment tasks associated with a new approach directive then the
application process can be different.
12.12.2 Your organisation will still be required to demonstrate that it meets the criteria in Article
12 of the MID and/or Annex V of the NAWI Directive but there will already be significant
evidence available to demonstrate most of the criteria.
12.12.3 The first stage of the application process is to discuss the scope of any accreditation
you may have with UKAS and ensure that your scope clearly covers the new areas in which you
intend to operate. You must demonstrate that your organisation meets the core criteria in a
directive through accreditation. This may well involve comprehensive audit activities depending
on your organisation’s previous accreditation reports. You may need to undertake a further
accreditation process. NMO will expect to see the scope of your application covered in a UKAS
recommendation schedule.
12.12.4 When you complete the application form, you must inform NMO of your existing
Notified Body number and the scope of any designations. NMO may seek additional information
relating to your application. Such information would cover the more specific measuring
instruments related criteria. For example; a request to demonstrate what competence criteria
would be required from the technical expert in an assessment team for Module D tasks, a
request to demonstrate how the Notified Body intends to calculate and record the results of its
testing (standard forms etc.) in Module F or B tasks or a request to demonstrate that any special
conditions in the letter of appointment can be met with.
12.12.5 Once NMO have been provided with supporting evidence from UKAS as to your
organisation’s ability to conduct a wider range of activities NMO will inform the commission of
any new scope and amend or issue a new letter of designation.
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13.
THE SCOPE OF APPOINTMENT
The scope of appointment of a Notified Body will be that outlined in the letter of appointment. A
Notified Body shall be capable of providing all the services associated with a single conformity
assessment task e.g. all the tasks identified in any one of the directives in the case of MID,
annexes A–H1. However, those services may be limited to particular instrument types and sub
categories. Such limitations should be clearly identified in the application process by using the
tick box element of the scope form which will form part of the letter of appointment.
The decision as to whether a particular sub category of instruments is appropriate bearing in
mind the purposes of the directive will rest with the Secretary of State.
14.
MUTUAL RECOGNITION AGREEMENTS
Applicants should note that the European Community has established Mutual Recognition
Agreements (MRAs) with key trading partners. Under these agreements, EC Notified Bodies
may be eligible to perform conformity assessments as required by these key trading partners’
laws. Similarly, those trading partners’ equivalents to EC Notified Bodies may be eligible to
perform conformity assessments under EC Directives. A Notified Body should inform the
Department if it wishes to be considered for appointment under the MRAs.
An MRA has been agreed with Switzerland and all EU Notified Bodies appointed for the specific
sectors covered by the MRA will automatically be included in the relevant lists of Notified
Bodies.
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ANNEX 1
CONTACT INFORMATION
Applications for appointment as described in these guidelines should be sent to:
United Kingdom Accreditation Service
21-47 High Street
Feltham
Middlesex
TW13 4UN
Tel: 0208 917 8400
Fax: 0208 917 8500
Email: info@ukas.com
Web site: www.ukas.com
And be copied to:
Notified Body Applications
National Measurement Office
Stanton Avenue
Teddington
Middlesex
TW11 0JZ
Tel: 020 8943 7272
Fax: 020 8943 7200
Email: notified.bodies@nmo.gov.uk
Web site: www.nmo.gov.uk
For taximeters and exhaust gas analysers contact:
Department for Transport
Great Minister House
76 Marsham Street
London
SW1P 4DR
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ANNEX 2
SOURCES OF INFORMATION AND RELEVANT DOCUMENTS

The Directives
The text of the codified Non Automatic Weighing Instruments Directive (2009/23/EC) is
available at:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:122:0006:0027:EN:PDF
The text of the Measuring Instruments Directive (2004/22/EC) is available at:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:135:0001:0080:EN:PDF
and a summary of the legislation:
http://europa.eu/legislation_summaries/internal_market/single_market_for_goods/technical_har
monisation/l21009b_en.htm

The UK Regulations
When the completed regulations are passed they can be obtained from:
The Stationery Office Ltd
PO Box 29
Norwich, NR3 IGN
Tel: 0870 600 5522
Fax: 0870 600 5533
Email: customer.services@tso.co.uk
Textphone: 0870 240 3701
or by direct download from:
Web: http://www.legislation.gov.uk/

European and national standards
Information on the EN 17000 and EN 45000 series of standards and the harmonised
standards is available from:
BSI British Standards
389 Chiswick High Road
London, W4 4AL
Tel: 0208 996 9001
Fax: 0208 996 7001
Web: http://www.bsi.group.com
Page 17 of 28
UKAS Publications
http://www.ukas.com

Applications to UKAS for accreditation for Notified Body status will require two forms (i) a
general form and (ii) AC 6 Approved or Notified Body form. Both forms should be
returned to UKAS and copied to the Department.
The following publications may also be of interest:




LAB 3 The conduct of UKAS Laboratory Assessments;
C1 General principles for the assessment of certification bodies for management
certification;
C2 General principles for the assessment of certification bodies for product certification;
E1 General principles for the assessment of inspection bodies by the United Kingdom
Accreditation Service.
European Commission
Notified Bodies notified by the UK and other Member States are listed in:
 NANDO Information system
http://europa.eu.int/comm/enterprise/nando-is/home/index.cfm
Explanations of the terminology that is used in directives and further background information
can be found in:
 The New Approach Guide
http://europa.eu.int/comm/enterprise/newapproach/legislation/guide/legislation.htm
European Accreditation (EA)
http://www.european-accreditation.org/
WELMEC Guides
http://www.welmec.org
Page 18 of 28
Annex 3
NB01
APPLICATION FORM FOR BODIES APPLYING TO BE APPOINTED AS A UNITED KINGDOM
NOTIFIED BODY UNDER THE NAWI AND/OR THE MI DIRECTIVES
1.
Applicant details
(A) Name of Body
(B) Liaison Officer
(C) Address (A)
Address (B)
Tel. Number:
E-mail:
Tel. Number:
E-mail:
Where applicant has already been designated as a Notified Body under other 'New Approach'
Directives please provide the following information:
(D) Applicable Legislation and Identification Number
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(E) Scope
For NAWI
E.g. 88/378/EEC (Toy safety), SI 1989/1275, EC type examination.
For MID – Please tick the boxes for the instrument/s and conformity assessment module/s you
wish to be appointed for
Annex
MI-
Measuring instrument
Scope of Application
Complete Conformity Assessment Modules
A
1
2
3
A1
B
C
C1
D
D1
E
"Water Meters" (clean water)
Cold Water
residential
commercial
light industrial
Warm Water
residential
commercial
light industrial
"Gas Meters"
residential
commercial
light industrial
Volume Conversion Devices
residential
commercial
light industrial
"Active Electrical Energy
Meters"
residential
commercial
light industrial
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E1
F
F1
G
H
H1
Other identifiable subcategory of equipment
4
"Heat Meters"
residential
commercial
light industrial
Reversed Heat Meters(Cooling
Meters)
Sub-assemblies:
5
Flow sensor
Temperature sensor pair
Calculator
"Measuring Systems for
Measurement of Quantities
of Liquids other than Water"
Fuel dispensers
Systems on Pipelines
Systems on loading ships
Systems on loading road
tankers
6
Systems for milk
Systems for refuelling aircraft
Systems for cryogenic liquids
Mechanical
"Automatic
Weighing Instruments"
Automatic catchweighers (Y)
Automatic checkweighers (x)
Automatic gravimetric filling
instruments
6
Discontinuous totalisers
Continuous totalisers
Automatic rail- weighbridges
Electromechanical
"Automatic
Weighing
Instruments"
Automatic catchweighers
Automatic gravimetric filling
instruments
6
Discontinuous totalisers
Continuous totalisers
Automatic rail- weighbridges
Electronic
systems
or
systems containing software
"Automatic
Weighing
Instruments"
Automatic catchweighers
Automatic gravimetric filling
instruments
Discontinuous totalisers
Continuous totalisers
Automatic rail- weighbridges
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8
"Material Measures"
Material measures of length
Capacity serving measures
Mechanical
and
electromechanical
"Dimensional
Measuring
Instruments"
9
Length measuring instruments
Area measuring Instruments
Multi-dimensional measuring
instruments
9
Electronic or
containing
"Dimensional
Instruments"
instruments
software
Measuring
Length measuring instruments
Area measuring Instruments
Multi-dimensional measuring
instruments
This form in its final format will be part of any letter of appointment.
Additional Information not covered above:
2.
UKAS Accreditation
(F) Accreditation Number and Date
(G) Scope of accreditation
(including SIC reference where applicable)
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3.
Use of suitably qualified assessors or assessment teams
(H) Inclusion of suitably qualified assessors or assessment teams in the examination and
evaluation of the quality system and EC surveillance teams - please acknowledge by ticking the
box below.
4.
Details of any Sub-Contracted Tasks
(I) Task/s sub-contracted, details of how the sub-contractor/s meets the requirements of the
Directive in particular Article 12, including references to procedures.
5.
Details of Insurance
(J) Name of Insurance Company(s), Policy Numbers and Summary of cover provided.
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(K) Reference to applicants quality manual/procedures
6.
Personnel statement
(L) Number of staff
(M) Technical competence
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7.
Statements of independence and impartiality
(N) Statement of conformance with sections 1 and 2 of Article 12
8.
Confidentiality statement
(O) Brief description of confidentiality arrangements
9.
DECLARATION
(P)
As an organisation prepared to carry out the tasks defined in section E) Scope of this
application I declare that
(insert name of organisation)
meets the core criteria as set out in the relevant Directive/s.
I agree to pay the prescribed fees and where designation is granted such fees as may be
prescribed for subsequent verification of compliance with the requirements.
..............................................................
(signature of Chief Executive)
..............................................................
(name in block capitals)
....................................
(date)
NMO
Stanton Avenue, Teddington, Middlesex TW11 0JZ
Tel No: 020 8943 7272 Fax No: 020 8943 7270
Page 25 of 28
Guidance on completion of the application form is provided by the following notes.
GUIDANCE NOTES
Please refer to the 'letters' against each entry on the application form to identify the relevant notes
for the following 'numbered' sections:1.
Applicant details
A
Enter the name of the organisation.
B
Enter the name of the officer to be contacted in the event of further information or
clarification being required.
C
Enter the official address of the organisation and, where different, the address of the
officer named in B above.
D
Enter the details of any designation the organisation has already been granted as a
Notified Body under other 'New Approach' Directives e.g. EC verification under Council Directive
90/384/EEC for NAWI. Also enter any details of any appointment held in relation to self
verification under the UK deregulation order 1999.
E
For NAWI enter the required designation task. For MID tick the box/es corresponding to
the instrument type and conformity assessment module you wish to be appointed for. Your
organisation will be assessed for this scope only and this scope will be included in the letter of
appointment.
2.
UKAS accreditation
This section is designed for those applicants that have already been accredited by UKAS for the
full scope of their application. If the applicant is applying for a scope for which UKAS has not yet
accredited them they should indicate that the UKAS application form has been completed and
sent to UKAS and a copy should be attached to this application.
F/G
Enter the accreditation number given by UKAS and provide details of the scope of the
accreditation together with the Standard Industry Code (SIC) reference where applicable. Also
enter any details of any accreditation held in relation to self verification under the UK deregulation
order 1999.
To be accepted, the accredited scope of the applicant body must cover the scope for which the
applicant body wishes to be appointed for:
In applying for designation the applicant body should undertake to verify
(i)
that where a supplier agrees to supply such an instrument in conformity with a design for
which he has type approval, his systems are such as to ensure conformity of the
instruments with the type and with the requirements of the Directive.
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(ii)
that where an EC mark e.g. CE mark and green M (or other symbol indicating compliance
to specified requirements) is placed on an instrument, the suppliers quality systems
ensure conformity of that instrument so marked, with the requirements indicated by the
mark.
A quality system certificate issued by an appointed Notified Body should refer to the supply or
manufacture of instruments complying with the terms of the relevant Directive.
3.
Use of suitably qualified assessors
H
UKAS will use suitably qualified assessors or assessment teams to undertake the
assessment and make clear to applicant bodies when sub-contracted assessors or technical
experts are to be used. Applicant bodies will have the right to object to specific assessors and
experts where there are concerns about potential conflicts of interest. UKAS has established
procedures to handle complaints or appeals associated with its assessment activities.
You are asked to indicate acceptance by placing a tick in the box provided.
4.
Details of any sub-contracted tasks
I
Enter a description of any specific tasks that are subcontracted by the applicant body to
any other organisation and what procedures are in place to ensure that the core requirements of
the relevant Directive are met.
5.
Details of insurance
J/K
A description of the arrangements made by the applicant body must be included with
specific reference to the policy number, the nature and extent of the cover provided in monetary
terms, whether there is any excess (and if so how much), whether the limit is per 'occurrence' or
otherwise, whether the applicant body will seek to limit liability with its customers (and if so a copy
of the relevant clause(s) should be appended to the application). In addition please provide
details of the appropriate references in your quality manual or procedures.
6.
Personnel Statement
L
Applicant bodies should enter the number of staff that will be involved in conformity
assessment and what level of qualifications and/or experience they have. Local Authorities
should enter the number of officers in post holding a certificate issued or deemed to have been
issued under Section 73 of the Weights and Measures Act 1985.
M
Briefly describe how the technical competence of staff is assured; this will need to include
reference to the maintenance of staff competence, quality management systems, management
supervision and review.
7.
Statements of independence and impartiality
N
The third criterion in Annex V of the NAWI Directive states that ‘The bodies shall work
independently of all circles, groups or persons having direct or indirect interest in non-automatic
weighing instruments regarding the carrying-out of the tests, the preparation of reports, the
Page 27 of 28
issuing of the certificates and the surveillance requested by this Directive.’ The first criterion in
Article 12 of the MI Directive prohibits the Notified Body from being any of the types of economic
operators listed, or from being directly involved in any of the activities listed. The second
criterion refers to the Notified Body being “….free from all pressures and inducements, in
particular financial inducements, that might influence their judgement or the results of their
conformity assessment……”. A statement of conformance with the criteria in the relevant
Directive/s should be entered by the applicant body.
8.
Confidentiality statement
O
Subject to any arrangements in respect of the release of information to other Notified
Bodies in accordance with the relevant conformity assessment procedures, the Notified Body
shall have adequate arrangements for ensuring confidentiality of information obtained in the
course of its certification activities between itself and its clients. The applicant body should
enter a brief description of its confidentiality arrangements.
9.
Declaration
P
Enter here the name of the organisation and have the form signed and dated by the Chief
Executive.
FEES
A fee plus additional expenses, if any, to cover the costs of considering the application will be due
and payable on completion of the consideration. The level of the fee is set out in NMO's Fees
Regulations.
Page 28 of 28