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 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
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
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-conformitiespage / of
Item Reference from activity sheet / Level of non-conformity / Description of non-conformity / Proposed corrective action / Date corrective action completed
Auditor Signature
Annex 3
EXAMPLES OF MAJOR/MINOR NON-CONFORMITIES
From paragraph 3.7 of the Auditing Protocol
Area/Activity audited
/Description of non-conformity
/Major/Minor non-conformity
EC Verifications / Equipment has not been correctly verified / MajorTest result sheet not correctly completed / Major
Incorrect markings placed onto instrument / Major
Appeals / 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
Certificates of Conformity (C of C) / 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
Training Records / 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
Organisation Structure / Not identified clearly / Major
Structure out of date or not accurate / Major
Joint Arrangements / Individual Local Authorities within the group not working to a common QS / Major
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.