ISO 17025 Auditing

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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing
AN INTRODUCTION TO THE AUDITING OF THE ISO
17025 QUALITY MANAGEMENT SYSTEM (QMS)
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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• 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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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• 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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PKQA SERVICES
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 should also be
  non-critical , and be responsible and accountable
  for his actions .

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PKQA SERVICES
Quality 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
  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

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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• 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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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• 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 SERVICES
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) ?
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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing
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
Certificate Formulation
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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• 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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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• 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

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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• 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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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing
The Audit Plan (2)
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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• 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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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing
The Audit Checklist (2)
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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• 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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PKQA SERVICES
Quality Assurance Consultancy ISO 17025 Auditing

• Difficult Situations -
• Dont 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 dont make it seem like an insult .
• If given evasive or indirect answers , ask for
  clarification

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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• 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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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing
The Audit Forms (2)
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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• The Audit Forms (3)
• The Audit Report Form -
• A narrative of the audit checklist . Dont 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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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• 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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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• 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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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• 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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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• 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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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing
Audit Summary (2)

Plan it
Do it
Report on it
Follow it up
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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing

• Conclusions
• A well-implemented QMS , augmented by efficient
  auditing can and will eliminate -
• Ineffectiveness of processes
• Inefficiencies in procedures and processes
• Problems , complaints , and non-compliances
• Mistakes and human errors
• Inconsistencies and poor reporting
• Malicious and non-validated practices
• Uncertainties
• Bad culture and poor housekeeping

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PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing
 
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