1 AN INTRODUCTION TO THE AUDITING OF A QUALITY MANAGEMENT SYSTEM (QMS) Quality Assurance Consultancy & ISO 17025 Auditing What is a Quality Audit ? •An audit is a systematic , independent , and documented process of obtaining and evaluating evidence in order to determine the extent to which agreed criteria have been fulfilled •An audit program will address all elements of the QMS to ensure its continued compliance with relevant National and International standards •An audit is NOT intended to criticise or apportion blame Quality Assurance Consultancy & ISO 17025 Auditing
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AN INTRODUCTION TO THE
AUDITING OF A
QUALITY MANAGEMENT
SYSTEM (QMS)
Quality Assurance Consultancy & ISO 17025 Auditing
What is a Quality Audit ?•An audit is a systematic , independent , and documented process of obtaining and evaluating evidence in order to determine the extent to which agreed criteria have been fulfilled
•An audit program will address all elements of the QMS to ensure its continued compliance with relevant National and International standards
•An audit is NOT intended to criticise or apportion blame
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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 simplification or additions to procedures
•To identify opportunities for improvement
•To provide confidence that the QMS is effective
Quality Assurance Consultancy & ISO 17025 Auditing
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 will also be non-critical , responsible , and accountable for his actions .
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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 under audit NOT the Auditee
Quality Assurance Consultancy & ISO 17025 Auditing
Depths / Scope of the Audit
Quality Manual
Operational Procedures
and Work Instructions
Records and Evidence
Who ….. What ..… When ..… Where ….. How ..…
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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
Quality Assurance Consultancy & ISO 17025 Auditing
The Audit Plan (2)
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The Audit Checklist (1)•A series of questions based on the QMS element(s) being audited , and prepared prior to the audit itself .
•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 sample can be seen on the next slide
Quality Assurance Consultancy & ISO 17025 Auditing
The Audit Checklist (2)Quality Assurance Consultancy & ISO 17025 Auditing
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The Audit Itself•Interviewing and questioning staff directly involved in the process
•Observation of activities and processes
•Viewing and witnessing records
•Determination of Observations or Non-compliances
•Recording results and findings/conclusions
Quality Assurance Consultancy & ISO 17025 Auditing
The Audit Forms (1)•1. An Audit Report form :
To record the evidence of the audit and used in conjunction with the Audit Checklist
•2. 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)Quality Assurance Consultancy & ISO 17025 Auditing
The Audit Forms (3)The Audit Report Form : -
•A narrative of the audit checklist
•Documented evidence that the procedure / process
has been followed completely and correctly
•Is itself auditable itself via Quality Records audit
•A communication tool for management
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The Audit Forms (4)The Non-Compliance Form Form :-
•Identifies any violations of policies , procedures , or work instructions
•Identifies what Corrective Action is to be taken
•Decides / agrees when the Corrective Action and any follow-up audit is scheduled for completion/discharge
Quality Assurance Consultancy & ISO 17025 Auditing
Post Audit Discussions•The audit report must provide conclusive evidence to show that the facility has demonstrated compliance with the Standard (or reported otherwise if not) .
•If a Non-Compliance is raised , it should be fully documented , with agreed discharge dates
•It should be noted that an Observation is purely the opinion 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 to verify discharge of any non-compliances raised during the audit , plan a re-audit of this one , or plan a future new audit
Quality Assurance Consultancy & ISO 17025 Auditing
Audit Summary (1)Procedural Requirements for an ISO 17025 Audit
•The Quality Manual
•Operational Procedures
•Work / Calibration Instructions
•An Audit Plan
•An Audit Checklist
•An Audit Report and Non-Compliance Form
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Audit Summary (2)Quality Assurance Consultancy & ISO 17025 Auditing
Plan it
Do it
Report on it
Follow it up
Quality Assurance Consultancy & ISO 17025 Auditing
