Qms auditing powerpoint

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Qms auditing powerpoint

  1. 1. Quality Assurance Consultancy & ISO 17025 Auditing 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 documentedprocess of obtaining and evaluating evidence in order todetermine the extent to which agreed criteria have beenfulfilled•An audit program will address all elements of the QMS toensure its continued compliance with relevant National andInternational standards•An audit is NOT intended to criticise or apportion blame 1
  2. 2. 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 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 , andcommunicative . He will also be non-critical , responsible ,and accountable for his actions . 2
  3. 3. 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 under audit NOT the AuditeeQuality 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 ..… 3
  4. 4. 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 planQuality Assurance Consultancy & ISO 17025 Auditing The Audit Plan (2) 4
  5. 5. Quality Assurance Consultancy & ISO 17025 Auditing The Audit Checklist (1)•A series of questions based on the QMS element(s) beingaudited , 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 procedureand work / calibration instruction being audited A sample can be seen on the next slide Quality Assurance Consultancy & ISO 17025 Auditing The Audit Checklist (2) 5
  6. 6. Quality Assurance Consultancy & ISO 17025 Auditing The Audit Itself•Interviewing and questioning staff directly involved in theprocess•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 6
  7. 7. Quality Assurance Consultancy & ISO 17025 Auditing 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 7
  8. 8. 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 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 toshow that the facility has demonstrated compliance withthe Standard (or reported otherwise if not) .•If a Non-Compliance is raised , it should be fullydocumented , with agreed discharge dates•It should be noted that an Observation is purely theopinion of the auditor , and as such is not enforceable 8
  9. 9. Quality Assurance Consultancy & ISO 17025 Auditing Issue of Reports and Follow-up•Agree when the report(s) will be issued , to whom , andin what format•Agree a time scale•Agree a date for a follow-up meeting to verify dischargeof any non-compliances raised during the audit , plan are-audit of this one , or plan a future new auditQuality 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 9
  10. 10. Quality Assurance Consultancy & ISO 17025 Auditing Audit Summary (2) Plan it Do it Report on it Follow it upQuality Assurance Consultancy & ISO 17025 Auditing 10

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