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 ……………………………..
Signature of representative
Date …………………………………….
………………………………………………
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 ……………………………..
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
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.