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WEIGHTS AND MEASURESProtocol for Auditing of Local Authority Notified Bodies (LANB) for EU Verification
March 2017
Version 5
1
Protocol for Auditing of Local Authority Notified Bodies (LANB) for EU Verification
Table of Contents
1. Introduction______3
Four yearly re-assessments ______3
Yearly surveillance visits______4
2.Organisation______5
3.The audit process______7
4. Once completed______9
Annex 1 Audit checklist______11
Annex 2 Audit report______12
Annex 3 Examples of major/minor non-conformities______18
Version 1.0 / May 2001 / Original documentVersion 2.0 / January 2005 / MID included
Version 3.0 / September 2007 / Update of forms
Version 4.0 / December 2010 / New protocol to align with Decision 768/2008/EC
Version 5.0 / January 2017 / Update of organisation name, links, references to Directives 2014/31/EU and 2014/32/EU. Addition of 4.9 Recommended procedure for the submission of external reports and action plans
Introduction
1.1 This protocol lays down a framework through which Local Authorities wishing to operate as Notified Bodies for the task of EU verification under the non- automatic weighing instruments and measuring instruments directives can be independently audited. It also allows for the Regulatory Delivery Directorate (RD) on behalf of the Secretary of State (SoS) to be satisfied that the core criteria of Directive 2014/31/EU and 2014/32/EU 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 RD to establish whether the Notified Body continues to operate within the scope of its designation. The Notified Body also has a responsibility to inform RD 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 EU 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 with own authority)
•Group of Local Authorities (Local Authorities from within the group operating under joint arrangements) such as the Glamorgan Group
•Separate Legal Entity's such as SWERCOTS OR EESTA
1.3 The auditing process will be based around 4 yearly re-assessment audits using the audit checklist (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. (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 RD 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 RD, 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 RD 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 RD reserves the right 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, RD will remove the notified body designation.
2.2 This protocol facilitates a mechanism for inter-authority auditing to take place between LANBs. 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 RD aware of the selected auditor in advance. This person will be responsible for the audit report and recommendations made to RD. 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 RD prior to any audit taking place.
2.3 RD will require all LANBs to submit the name/s of the suitably qualified personnel who will conduct the 4 yearly re-assessments. RD will keep a master copy of the list and make it available on the GOV.UK website. LANBs will be required to ensure RD 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 RD 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. RD 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 RD to carry out the audit for a fee. For an organisation not currently designated as a notified body, RD will conduct the initial audit.
2.7 An audit schedule drawn up by RD, 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 RD at direct cost to the LANB or have their designation withdrawn.
2.8 LANBs will refer to the audit schedule on GOV.UK 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 RD (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.
Where no contact has been made, RD 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 RD 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 SoS. 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 17020:2012 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 17020:2012 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 EU 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:
Non-conformity –
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 non-conformity to be closed.
Non-conformity, Major –
1.The absence of, or the failure to implement and maintain all aspects of one or more requirements for certification/registration.
2.A number of minor non-conformities against one or more requirements, which when combined, can represent a breakdown of the organisation’s systems; or
3.A minor non-conformity that was previously issued and not addressed effectively.
Non-conformity, 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, cross-referenced to the non-conformities found and proposed corrective action. This report must record all areas audited, not just those areas where non-conformities were found.
4.2Major non-conformities 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 eight weeks 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 RD. Failure to complete corrective actions within eight weeks, may result in designations being withdrawn.
4.3The auditor is required to advise RD in writing when the auditing is complete and any outstanding corrective actions have been implemented. This advice together with copies of the completed audit report and yearly surveillance visits and supporting audit report(s) should be emailed to a word or pdf document. Where the time scale for completing the audit has been exceeded by more than eight weeks the auditor should advise RD of the current position.
4.4 Where the advice given is that the non-conformities cannot be corrected within the allotted time then RD 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 RD also contact the European Commission via NANDO input updates.
4.6 For each LANB audited a fee to cover RD 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 unless circumstances require a greater level of involvement from RD. Where RD 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.
4.8 Please ensure that attention is paid to the readability of the audit report submitted to RD alternatively send the audit report typed in electronic format. An electronic Protocol and audit form is available to download on the GOV.UK website.
4.9 Recommended procedure for the submission of external reports and action plans:
1.The re-assessment review or surveillance visit shall be conducted and the report completed by the auditor.
2.The report will need to be accepted and signed off by the LANB. It shall then be submitted to RD by the auditor within two weeks of the date of the audit visit. This should then be emailed to a word or pdf document.
3.The LANB then shall prepare an action plan to deal with the non-conformances and areas for improvement. The action plan shall be submitted to RD and the auditor within four weeks of the date of the audit visit.
4.The auditor should indicate to RD their acceptance, or otherwise, of the action plan and its ability to address the non-conformances within eight weeks of the date of the assessment visit.
5.RD then will make a decision, based on the degree of non-conformance, whether another visit should be made before the next annual visit is due and, if so, indicates this decision to the LANB within twelve weeks of the date of the assessment visit. These additional visits only review the implementation action plan and its effectiveness.
6.Where no extra surveillance visit is required the action plan and its effective implementation shall be assessed at the commencement of the next annual re-assessment review or surveillance visit.
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 (Article 21 NAWI Article 25 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 TEC 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 Metrology mark Notified Body Number Certificate of Conformity
7)Competence Evidence of staff training and knowledge Assessment of competence to undertake EU verification
Annex 2
Audit Report Cover sheet (only one cover sheet is needed per audit)
LA Notified Body auditedAudit 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 ……………………………… Signature of auditor
Date………………………………… ………………………………………………….
Signature of Authority representative
Print name ……………………………… Signature of representative
Date………………………………… ………………………………………………….
Agreed to carry out corrective action:
Print name ……………………………… Signature of responsible officer (LANB)
Job title………………………………… ………………………………………………….
Auditor satisfied corrective actions have been signed off and supplied with evidence corrective actions have been completed.
Print name ……………………………… Signature of auditor
Date………………………………… ………………………………………………….
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 / Notes / NC’s1) 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
Item reference / Notes / N/C’s
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
Item reference / Notes / N/C’s
5)Verification
TEC
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 M sticker
Notified body
Number
Certificate of Conformity
Item reference / Notes / N/C’s
7)Competence
Evidence of staff training and knowledge
Assessment of competence undertaken
Witness verification
Opportunities for Improvement
Details of non-conformities
page / of
Item Reference from activity sheet / Level of non-conformity / Description of non-conformity / Proposed corrective action / Date corrective action completed
Annex 3