Download - QMS Audit (updated)
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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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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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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 judgementPeople Skills• Be a good listener and communicate clearly• Discuss issues without arguing • Maintain the self-esteem of all partiesPersonal AttributesBe 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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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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PKQA SERVICESPKQA SERVICESQuality Assurance Consultancy & ISO 17025 Auditing
Audit PlanningAddresses 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) ?
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Types of Audit : 1 Imagine a layered cake :-
Vertical Audit
(many elements)
Horizontal Audit
(single element)
etc
Booking In ProcessContract Review
Handling of ItemsEquipment Calibration
Item CalibrationRecording of the ResultsCertificate Formulation
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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 .
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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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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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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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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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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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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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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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Audit Summary (2)
Plan it
Do it
Report on it
Follow it up
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Presented by :-
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