WEIGHTS AND MEASURES
Protocol for Auditing of Local Authority Notified Bodies (LANB)
for EC Verification
Guidance for Local Authorities
December 2010
Version 4
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Introduction
1.1 This protocol lays down a framework through which Local Authorities wishing to operate as
Notified Bodies (Approved Bodies) for the task of EC verification under the non automatic
weighing machines and measuring instruments directives can be independently audited. It
also allows for NMO on behalf of the Secretary of State to be satisfied that the core criteria of
Directive 2009/23/EC and 2004/22/EC continue to be adequately fulfilled.
1.2 Notified Bodies may, within the core criteria, be organised in a number of different ways and it
will be for the NMO to establish whether the Notified Body continues to operate within the
scope of its designation. The Notified Body also has a responsibility to inform NMO of any
changes which might affect its designation. Where personnel from other authorities operate
under the scope with the agreement of the Notified Body they must be accountable to the
Notified Body whenever the task of EC verification or activity associated with the task is being
carried out. This must include, inter alia, documentation/document control, training records,
the use of appropriate local and working standards and appropriate insurance cover. The
Notified Body may take one of the following forms whose structure and accountability must be
identified within the Quality System (QS) documentation which, although may evolve over
time, must remain within the scope of the designation:
Single Local Authority (personnel solely from within own authority)
Group of Local Authorities (Local Authorities from within the group operating under joint
arrangements) e.g. Glamorgan Group
Separate Legal Entity’s e.g. SWERCOTS or EETSA
1.3 The auditing process will be based around 4 yearly re-assessment audits using the audit
checklist (see Annex 1), of the entire quality system that each Notified Body operates. The 4
yearly audits will be interspersed with yearly surveillance visits which will focus on 3 random
aspects from the audit checklist ensuring that all aspects are covered over the 3 year period.
(see Annex 1). The system will continue to be run on a peer auditing system.
Four Yearly Re-assessments
1.4 These will consist of a complete audit of the entire quality system and the results will be
formally submitted to NMO by the auditor whereby an administration charge will be made at a
cost of £225 to the audited authority. The re-assessment audits are to be a comprehensive
check of the Notified Body with the auditor making a decision if the audited Authority is still
suitable to maintain notified body status.
This audit will based on all seven of the points in the audit check list (Annex 1)
Yearly Surveillance Visits
1.5 These will consist of a spot check of three out of the seven points in the audit checklist
(Annex 1). With a write up (Annex 2) to be submitted to NMO, no charges will be made for
this process. All seven aspects must be covered at least once in any of the three surveillance
visits in any four yearly re-assessment cycle.
Organisation
2.1 NMO will have an administrative role in each surveillance audit as well as coordinating the
overall planning of the audits by acting as overseer of the protocol. Should suitable
arrangements not be made in the time frames set out in this protocol NMO reserves the right
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to conduct audits themselves at direct hourly cost to the Notified Body involved or withdraw
designations. If audits are not up to date and if the situation remains un-rectified, NMO will
remove the notified body designation.
2.2 This protocol facilitates a mechanism for inter-authority auditing to take place between
LANB’s. It is not recommended that reciprocal auditing arrangements take place on more
than 2 occasions for the 4 yearly reassessment audits, However, for Regional Groups and
Surveillance visits reciprocal arrangements may take place.
The LANB must designate an auditor for the 4 yearly assessments and make NMO aware of
the selected auditor in advance. This person will be responsible for the audit report and
recommendations made to NMO. In the case of Groups of Local Authorities the production of
an audit plan to ensure all aspects of the notified body activities are assessed over time will
need to be submitted to NMO prior to any audit taking place.
2.3 NMO will require all LANBs to submit the name/s of the suitably qualified personnel who will
conduct the 4 yearly re-assessments. NMO will keep a master copy of the list and make it
available on the NMO website. LANBs will be required to ensure NMO are kept up to date of
any changes in personnel, failure to do so will result in non-conformities being raised.
2.4 Criteria for the auditors who carry out the 4 yearly re-assessments are as follows: Auditors
will have attended and passed a recognised lead auditor course, have experience of internal
and external assessments, have experience in management of teams for internal or external
assessment activities and have a current and proactive interest in metrology. They will not be
required to be on the IRCA Register (International Register of Certificated Auditors).
For surveillance visits the requirements will be those studying towards auditing qualifications
that possess experience of internal auditing and have an interest and relevant knowledge of
metrology.
2.5 Where inter-authority auditing is carried out NMO reserves the right to witness such audits at
no additional cost to the LANB. This is unlikely to take place for more than 5% of the LANBs
audited. NMO would inform the LANB in due time where this is to take place.
2.6 As an alternative to inter-authority auditing a LANB may invite NMO to carry out the audit for
a fee. For an organisation not currently designated as a notified body, NMO will conduct the
initial audit.
2.7 An audit schedule drawn up by NMO, based primarily on the date of designation and taking
into account other related issues e.g. local government re-organisation and actual work load,
will set out those authorities to be audited. All designated LANBs who fail to make suitable
arrangements within the time schedules set out in this protocol will either be audited by the
NMO at direct cost to the LANB or have their designation withdrawn.
2.8 LANBs will refer to the audit schedule on NMO’s website for information on audit dates.
2.9 The LANB should provide the auditor with a copy of their completed application form and/or
designation letter issued by NMO (plus any amendments) where the LANB is being audited
for the first time. For subsequent audits the LANB should provide details of any amendments
to the designation since the previous audit and details of the previous audit report if
requested by the auditor.
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Where no contact has been made, NMO will contact the LANBs one month before the
expected date of completion of the audit to remind them of the obligation for the audit to take
place. It is for the LANB to inform NMO the name of the auditor and the local authority they
are from.
2.10 If the LANB designation is withdrawn then the LANB may make an appeal to the Secretary of
State, SoS regarding this withdrawal. The SoS will consider the appeal and provide a formal
response to the LANB concerned within 10 working days.
The Audit Process
3.1 The audit process will be based on the following:
3.2 Auditors will conduct the audits on a similar basis to an ISO 9001 audit. The audit must
include all the conditions referred to in the core criteria of the Directives. These points may be
satisfied by the application of the appropriate requirements of the relevant harmonized
standards i.e. BS EN ISO/IEC 17020:2004 General criteria for the operation of various types
of bodies performing inspection and BS EN ISO/IEC 17025:2005 General requirements for
the competence of testing and calibration laboratories.
For a checklist of the essential elements to be included within the audit see Annex 1.
3.3 If the LANB being audited is already accredited to ISO 9001, BS EN ISO/IEC 17020:2004
and/or BS EN ISO/IEC 17025:2005 then these aspects of the audit will not need to be
duplicated, the audit will merely check to ensure the validity of the accreditation.
3.4 Where the Notified Body being audited covers more than one Local Authority (joint
arrangements) then the auditor must consider the most appropriate method for carrying out
the audit which ensures the adequacy of the audit both at the strategic and operational levels
i.e. head office and at individual Local Authority level. When auditing a Notified Body
covering more than one Local Authority the auditor must ensure that each Local Authority
audited is operating to the Notified Body’s documented quality system and that such an
integrated system exists which meets the requirements of the core criteria and the relevant
standard. An action plan must be in place to ensure that all the Local Authorities and all
elements of the QMS are audited on a planned basis over successive audits.
3.5 Named person/s will also have to prove/demonstrate competence in verification testing. They
will need to be able to satisfy the auditor that they can competently carry out EC verification
testing they are authorised to carry out. This may be done by way of a simulated
demonstration if necessary.
3.6 Non-conformities (NC) will be identified as:
Nonconformity –
1. Non-fulfilment of a requirement (ISO 9000:2005)
2. Breakdown in the quality system which requires a written corrective action and has
to be satisfactorily implemented and verified in order for the nonconformity to be
closed.
Nonconformity, Major –
1. The absence of, or the failure to implement and maintain all aspects of one or more
requirements for certification/registration.
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2. A number of minor nonconformities against one or more requirements, which when
combined, can represent a breakdown of the organisation’s systems; or
3. A minor nonconformity that was previously issued and not addressed effectively.
Nonconformity, Minor –
An observed lapse in the organisation’s quality system potentially impacting on the quality
of the product delivered to the customer.
Opportunities for Improvement –
Documented statements that may identify areas for potential improvement in the
organisation’s system, but shall not include specific recommendations nor require action
by the organisation.
3.7 Examples of what might constitute a major or minor non-conformity can be found at Annex 3.
The “level” of any non-conformity found must be indicated in the audit report in the space
provided.
Once Completed
4.1 The auditor will be required to produce a report in the form of Annex 2 of the findings, crossreferenced to the NCs found and proposed corrective action. This report must record all
areas audited, not just those areas where NCs were found.
4.2 Major nonconformities will usually result in the Notified Body ceasing all Notification activities
until the corrective actions have been signed off. The auditor may make an exception to this,
or require only a partial suspension, if there are exceptional extenuating circumstances. Any
corrective action must be completed within 2 months of the audit having taken place, with
proof that the actions have been addressed sent to the auditor. Once completed the audit and
evidence of corrective actions have been sent to the auditor, the final report can be sent to
NMO. Failure to complete corrective actions within 2 month, may result in designations being
withdrawn.
4.3 The auditor is required to advise NMO in writing when the auditing is complete and any
outstanding corrective actions have been implemented. This advice together with hard copies
of the completed audit report and yearly surveillance visits and supporting audit report(s)
should be emailed to notified.bodies@nmo.gov.uk as a word or pdf document. Where the
time scale for completing the audit has been exceeded by more than 1 month the auditor
should advise NMO of the current position.
4.4 Where the advice given is that the NCs cannot be corrected within the allotted time then NMO
will, following consultation with the LANB and where a satisfactory outcome cannot be
achieved, advise the LANB that the designation may be terminated.
4.5 In the case of any designation being terminated NMO also contact the European Commission
via NANDO input updates.
4.6 For each LANB audited a fee to cover NMO administrative costs including assessment,
moderation and notification to the Commission and other associated activities will be
charged. It is estimated that this should not exceed £225 for the financial year 2011/12,
unless circumstances require a greater level of involvement from NMO. Where NMO is
directly involved in the actual auditing then the associated costs would be charged in addition.
4.7 For a quick reference to the steps necessary for LANB auditing see Annex 3.
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4.8 Please ensure that attention is paid to the readability of the audit report submitted to NMO.
Alternatively send the audit report typed in electronic format to notified.bodies@nmo.gov.uk.
An electronic Protocol and audit form is available to download on our website at
http://www.nmo.bis.gov.uk/content.aspx?SC_ID=526
Document Control
Version
No.
0.0
1.0
2.0
3.0
Date of
change
May 2001
January 2005
September
2007
December
2010
Substantive changes
Original document
MID included
Update of forms
New protocol to align with Decision 768/2008/EC
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Annex 1
AUDIT CHECKLIST (Essential elements to be included within the audit)
1)
Designation letter (review conditions)
Designated name
Local Authority/group of Local Authorities
Personnel operating under designation
Scope of designation
Review scope and class of instruments
Conformity assessment tasks
Types of instrument / sub categories of instrument
2)
Essential Requirements
Sub-contracting arrangements
Testing by others
Calibration by others
Core criteria in the directives (annex V NAWI article 12 MID)
Met at time of application
Met on a continuing basis
Independence and Insurance
3)
Quality system
Manual
Procedures
Plans
Where a Notified Body is formed of a group of Local Authorities, are they operating to a
common quality system?
4)
Standards
Local standards, working standards, test weights, EEC Directive weights
Calibration, EEC verification of weights and other standards
Standards maintained in-house, hired-in, other arrangements
Range of standards available
5)
Verification
TAC and TC where appropriate
Assessment of conformity to type
Declaration of Conformity
Certificate of 1st stage verification (if applicable)
Verification tests
Recording of the results (It is especially important that test sheets are correctly completed).
6)
Application of the marks
Manufacturer i.e. CE marking and Green Metrology Sticker
Approved Body i.e. Notified Body Number
Certificate of Conformity
7)
Competence
Evidence of staff training and knowledge
Assessment of competence to undertake EC verification
Annex 2
Audit Report
Cover sheet (only one cover sheet is needed per audit)
LA Notified
Body audited
Audit Officer
LA Notified Body No.
Telephone
No. of auditor
Date audited
Supporting Audit Report e.g. ISO 9000 or UKAS (See auditing Protocol 3.3)
Title
Number
Auditor’s signature/date
Print name ……………………………..
Date …………………………………….
Signature of auditor
………………………………………………
Signature of Authority representative
Print name ……………………………..
Date …………………………………….
Signature of representative
………………………………………………
Agreed to carry out corrective action:
Print name ………………………………
Job title …………………………………
Signature of responsible officer (LANB)
……………………………………………..
Auditor Satisfied corrective actions have been signed off and supplied with evidence corrective
actions have been completed.
Print name ……………………………..
Date …………………………………….
Signature of auditor
………………………………………………
Detail of activities
Please use the audit checklist when conducting the audit ensuring all points are
covered
e.g. quality manual, procedures, plans or other documents
Item reference
1) Designation
Letter
Designated name
Scope of
designation
2) Essential
Requirements
Sub-contracting
arrangements
Core criteria in the
Directives being
met
Independence and
Insurance
3) Quality System
Manual
Procedures
Notes
NC’s
Item reference
Plan
Groups of
LANB all operate
from same QS
4) Standards
Local & Working
Standards, test
weights, EEC
directive
weights
Calibration
Maintenance of
Standards
Standards
maintained in
house, hired in
other
arrangement
Range of
standards
available
Notes
N/C’s
Item reference
5) Verification
TAC & TC
Assessment of
Conformity to
Type
Declaration of
Conformity
Certificate of 1st
stage
verification
Verification
tests
Recording of
results
6) Application
of Marks
Manufacturer
i.e. CE marking
Green M sticker
Approved body
Number
Certificate of
Conformity
Notes
N/C’s
Item reference
7) Competence
Evidence of
staff training
and knowledge
Assessment of
competence
undertaken
Witness
verification
Opportunities for Improvement
Notes
N/C’s
Details of non-conformities
page
of
Item
Reference
from activity
sheet
Level of
nonconformity
Description of non-conformity
Proposed corrective action
Auditor Signature
Date corrective
action
completed
Annex 3
EXAMPLES OF MAJOR/MINOR NON-CONFORMITIES
From paragraph 3.7 of the Auditing Protocol
Area/Activity audited
EC Verifications
Description of non-conformity
Major/Minor nonconformity
Equipment has not been correctly verified
Major
Test result sheet not correctly completed
Major
Incorrect markings placed onto instrument
Major
No procedure to cover Appeals in relation to
verification activities
Minor
Procedure exists but not addressed within QS for
EC verification of NAWI/MID
Minor
Procedure exists however where refused
submitter not made aware of right to appeal
Minor
No requirement within the procedure for the
issue of C of C
Major
In procedure but no C of C’s have been issued
against any of the EC verifications carried out
Major
Individual case of C of C not issued
Major
No training record in place for a member of staff
performing EC verifications
Major
Training activity non-existent on all training files
Major
Training activity for member of staff not included
on training record
Minor
Competence
Staff unable to competently demonstrate
verification testing
Major
Internal Audits
No procedure or audit programme in place
Major
Procedure/programme in place, no audits
conducted
Major
Not identified clearly
Major
Structure out of date or not accurate
Major
Individual Local Authorities within the group not
working to a common QS
Major
Appeals
Certificates of Conformity
(C of C)
Training Records
Organisation Structure
Joint Arrangements
Opportunities for Improvement
The aim of this is to allow the auditor scope to offer the authority, group suggestions for areas that
might be improved upon. These will not go against the overall assessment, however allows the auditor
to point out those areas that perhaps are not so serious to be awarded a major or minor nonconformity
but are noteworthy to the auditing process.