ISO 9001:2008 QMS Internal Auditor Refresher Course

1. ISO 9001:2008 QMS Internal Auditor Refresher Course Delivered by: Kobe K. Motlhatlhedi Gaborone International Convention Centre February 5th – 6th 2014

2. Introductions Name Department/Function Job Title Duration of Employment QMS Audit Experience (Duration)

3. General Information about the Course

4. What the Course will Cover Overview of ISO 9001:2008 Principles of Management System Auditing Importance of Internal QMS auditors and their Responsibilities Conducting an Effective QMS Audit Corrective action Verifying the effectiveness of CA Characteristics/skills/traits of Auditors Examination Review of the Examination

5. Continual Improvement Management Responsibility Measurement, Analysis, Improvement Satisfaction Resource Management CUSTOMER CUSTOMER Requirements Product Realization Over view of ISO 9001:2008 PLAN/ACT PLAN CHECK DO Outputs Inputs PRODUCT Key: Value-adding activities Information flow

6. Principles of Management System Auditing Why Audit is essential? A management tool for monitoring and verifying the effective implementation of an organization’s Quality Management System To identify areas of conformity and nonconformity against customer requirements, applicable statutory and regulatory requirements, and established planned arrangements in the QMS To provide a systematic discipline for corrective or preventive actions if actual or potential nonconformities are found

7. Principles of Management System Auditing Why Audit is essential? To provide information on which an organization can act to improve its performance (identify opportunities for continual improvements) It is an essential part of conformity assessment activities such as 3rd party certification

8. Principles of Management System Auditing Internal Quality Audits are essential… … to determine, by an unbiased means and through factual information on quality performance, whether the quality system is effective in maintaining control by checking that prescribed quality objectives are being achieved and the resultant products and services meet specified customer and regulatory requirements.

9. Principles of Management System Auditing Likely effects on QMS of a weak IQA System Inadequate review of the Quality Management System vs. the requirements Conclusions not reliable basis for Top Management to evaluate the effectiveness of QMS implementation Diminished people’s full support to the Quality Management System.

10. Principles of Management System Auditing Important terms and definitions: Audit A systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.

11. Principles of Management System Auditing Audit Criteria – Set of policies, procedures or requirements used as a reference against which audit evidence is compared. Audit Evidence – Records, statements of fact or other information, which are relevant to the audit criteria and verifiable.

12. Principles of Management System Auditing Audit findings– results of the evaluation of the collected audit evidence against audit criteria Audit Conclusion– outcome of an audit provided by an audit team after consideration of the audit objectives and all audit findings Auditor– person with competence to conduct an audit

13. Principles of Management System Auditing Audit Scope– extent and boundaries of an audit; generally includes a description of the physical locations, organizational units, activities and processes, as well as the time period covered. Audit Program – set of one or more audits, planned for a specific timeframe and directed towards a specific purpose.

14. Principles of Management System Auditing Audit Plan – description of the activities and arrangements for an audit Auditee – organization being audited Audit client – organization or person requesting an audit Competence – demonstrated personal attributes and demonstrated ability to apply knowledge and skills

15. Refresher Break

16. Exercises 1 and 2

17. General Auditor Responsibilities Dedicate time to preparing for audit assignments, including researching information re: process/area to be audited and preparing an audit checklist Communicate effectively with all levels and associates within your organization Summarize audit information in an objective manner Adapt to auditing situations

18. Auditors Management’s mirror for observing the business Objective Prepared Professional Ethical Honest Inquisitive

19. Auditor Responsibilities Conduct audits per audit schedule Contact appropriate personnel in the area being audited to establish specific date/time and agenda for audit Review information related to the area being audited Prepare a checklist of questions to guide the audit process Collect objective evidence to support audit findings Report the results of the audit in a timely manner Organize verification of corrective actions to audit non-conformances

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