QMS Audit (updated)

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QMS Audit (updated)

  1. 1. 1 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 Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES
  2. 2. 2 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 Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES 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 . Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES
  3. 3. 3 PKQA SERVICESPKQA 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 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 Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES
  4. 4. 4 Depths / Scope of the Audit Quality Manual Operational Procedures and Work Instructions Records and Evidence Auditing is the Who … What … Where … When … and How … Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES PKQA SERVICESPKQA 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) ?
  5. 5. 5 PKQA SERVICESPKQA 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 PKQA SERVICESPKQA 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 .
  6. 6. 6 PKQA SERVICESPKQA 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 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 PKQA SERVICESPKQA SERVICES
  7. 7. 7 The Audit Plan (2) Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES 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 Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES
  8. 8. 8 The Audit Checklist (2) Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES 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 Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES
  9. 9. 9 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 PKQA SERVICESPKQA 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 Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES
  10. 10. 10 The Audit Forms (2) Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES 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 Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES
  11. 11. 11 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 Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES 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 Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES
  12. 12. 12 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 Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES 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 Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES
  13. 13. 13 Audit Summary (2) Plan it Do it Report on it Follow it up Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES Presented by :- Quality Assurance Consultancy & ISO 17025 Auditing PKQA SERVICESPKQA SERVICES

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