QMS Audit (updated)

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AN INTRODUCTION TO THE

AUDITING OF THE ISO 17025

QUALITY MANAGEMENT

SYSTEM (QMS)

Quality Assurance Consultancy & ISO 17025 Auditing

PKQA SERVICESPKQA SERVICES

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



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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PKQA SERVICESPKQA SERVICESQuality Assurance Consultancy & ISO 17025 Auditing

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 …




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


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)



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)



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


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)



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



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



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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Technology

QMS Audit (updated)