ISO 17025 Auditing - PowerPoint PPT Presentation

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ISO 17025 Auditing

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Internal auditing of ISO 17025 accredited laboratories – PowerPoint PPT presentation

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Title: ISO 17025 Auditing


1
PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing
AN INTRODUCTION TO THE AUDITING OF THE ISO
17025 QUALITY MANAGEMENT SYSTEM (QMS)
2
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

3
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

4
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 .

5
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


6
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

7
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

8
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) ?
9
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
10
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 .

11
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

12
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

13
PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing
The Audit Plan (2)
14
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

15
PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing
The Audit Checklist (2)
16
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

17
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

18
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

19
PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing
The Audit Forms (2)
20
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

21
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

22
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

23
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

24
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

25
PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing
Audit Summary (2)

Plan it
Do it
Report on it
Follow it up
26
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

27
PKQA SERVICES
Quality Assurance Consultancy ISO 17025
Auditing
 
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