1. 1
AN INTRODUCTION TO THE
AUDITING OF THE ISO 17025
QUALITY MANAGEMENT
SYSTEM (QMS)
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What is a Quality Audit ?
• An audit program will address all elements of the QMS to
ensure its continued compliance to relevant National and
International standards
• An audit is NOT intended to criticise or apportion blame
• An audit is a systematic , independent , and documented
process of obtaining and evaluating evidence in order to
determine the extent to which agreed procedures and
criteria have been fulfilled
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2. 2
Why Audit ?
• To ensure compliance with relevant standards
• To ensure that activities are performed and recorded
• To ensure contractual obligations are fulfilled
• To identify the simplification of or addition to procedures
• To identify any opportunities for improvement
• To provide confidence that the QMS is effective
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The Auditor :-
• Ideally be independent of the facility being audited
• Should have relative training / qualifications
• Should have an agreed agenda / checklist
• Should work to an agreed company audit plan
• Will be fair , truthful , discreet , inquisitive , and
communicative . He should also be non-critical , and be
responsible and accountable for his actions .
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3. 3
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The Auditor should possess :-
Professional Skills
• Be detail oriented , maintain independence and objectivity
• Work in a systematic and investigative manner
• Relate to all levels of personnel , and use sound judgement
People Skills
• Be a good listener and communicate clearly
• Discuss issues without arguing
• Maintain the self-esteem of all parties
Personal Attributes
Be diplomatic , tactful , decisive , fair , honest , and ethical
The Auditee(s) :-
• Ideally a team member of the facility being audited
• Should have relative training / qualifications
• Should be sincere , open , willing , and decisive
• Should be able to offer a constructive opinion
• Remember , the QMS is being audited NOT the Auditee
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4. 4
Depths / Scope of the Audit
Quality Manual
Operational Procedures
and Work Instructions
Records and Evidence
Auditing is the Who … What … Where … When … and How …
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Quality Assurance Consultancy & ISO 17025 Auditing
Audit Planning
Addresses the specific aspects of who ,what , where ,
when , and how :-
Who is the auditee ?
What are the audit objectives/outcome ?
Where will the audit be conducted ie , its scope ?
When will the audit occur and how long will it take ?
How will the audit be conducted (the audit procedure and
checklist) ?

5. 5
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Types of Audit : 1
Imagine a layered cake :-
Vertical Audit
(many elements)
Horizontal Audit
(single element)
etc
Booking In Process
Contract Review
Handling of Items
Equipment Calibration
Item Calibration
Recording of the Results
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Types of Audit : 2
• Horizontal :-
Looks at a single section of the QMS , but in greater depth
than a Vertical Audit . Particularly beneficial if there have
been historic non-compliances with the section
• Vertical :-
Looks at multiple sections of the QMS , but perhaps not to
the same depth as that of a Horizontal Audit . The Vertical
Audit looks at the ‘trail’ of linked , but separate elements .

6. 6
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Types of Audit : 3
• First Party :-
Usually undertaken by personnel from within the
organisation , but independent of the function being audited
•Second Party :-
Usually carried out by external auditors / consultants / clients
•Third Party :-
Carried out by Accreditation or Certification bodies
The Audit Plan (1)
• Be agreed with senior management / Quality Manager
• Should list all (relevant) sections of ISO 17025
• Should cover each section of ISO 17025 at least annually
(workload permitting)
• Ideally be phased over a 12 month period
See next slide for a typical annual plan
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7. 7
The Audit Plan (2)
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The Audit Checklist (1)
• Can only address statements within the relative section(s)
of ISO 17025 , and to those of the operational procedure
and work / calibration instruction being audited
• A series of questions based on the QMS element(s) being
audited , and prepared prior to the audit itself .
A sample can be seen on the next slide
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8. 8
The Audit Checklist (2)
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The Audit Itself Involves :
• Witnessing the process , procedure , document or instruction
relative to the audit and ensuring compliance is maintained by :-
• Interviewing and questioning staff directly involved in the
process
• Observation of activities and processes
• Viewing and witnessing records
• Determination of any Observations or Non-compliances
• Recording the results and findings / conclusions
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9. 9
Difficult Situations :-
 Don’t lose your temper or argue at any time . Auditees may
argue , but auditors discuss .
 Smile and relax the auditee . Show a sense of humor ; it
will build bridges between you and the auditee .
 Avoid time wasting , unrelated conversations , long lunch
breaks , and other breaks . Identify these diversions and
address them politely and diplomatically . This can be a
little difficult , so don’t make it seem like an insult .
 If given evasive or indirect answers , ask for clarification
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The Audit Forms (1)
• An Audit Report form :
To record the evidence of the audit and used in
conjunction with the Audit Checklist
• A Non-compliance / Corrective Action Form :
To record non-compliances arising from the audit
which may require a follow-up audit
Samples of both can be seen on the next slide
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10. 10
The Audit Forms (2)
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The Audit Forms (3)
The Audit Report Form : -
• A narrative of the audit checklist . Don’t drown in detail .
• Documented evidence that the procedure / process
has been followed completely and correctly
• Is auditable itself during the Quality Records audit
• A communication tool for the management review
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11. 11
The Audit Forms (4)
The Non-Compliance Form Form :-
• Identifies any violations of policies , procedures , or work
instructions
• Identifies any Observations made by the auditor
• Identifies if any Corrective Action(s) are necessary
• Decides and agrees the completion date for any Corrective
Action(s) , and whether a follow-up audit is necessary for
their discharge
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Post Audit Discussions
• The audit report (when issued) must provide conclusive
evidence to show that the facility has demonstrated its
compliance with the Standard , procedure , or process (and
reported otherwise if not)
• If a Non-Compliance is raised , it should be fully documented ,
with an agreed discharge date and/or a follow up audit
• It should be noted that an Observation is purely the
OPPINION of the auditor , and as such is not enforceable
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12. 12
Issue of Reports and Follow-up
• Agree when the report(s) will be issued , to whom , and
in what format
• Agree a time scale
• Agree a date for a follow-up meeting (or the forwarding
of evidence) to verify discharge of any non-compliances
raised during the audit . The meeting can also be used to
arrange a re-audit (if necessary) or to plan a future new
audit of the facility
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Audit Summary (1)
Clients documents required for an ISO 17025 Audit are :-
• The Quality Manual
• Operational Procedures
• Work / Calibration Instructions
• Audit Plan plus other supplementary forms / records
Also required and usually supplied by the Auditor are :-
• Audit Checklist and Audit Report Forms
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13. 13
Audit Summary (2)
Plan it
Do it
Report on it
Follow it up
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Presented by :-
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