ISO 9001:2008 Clause 8.2.2 PR018 Internal Audit Procedure Strode Park Foundation Page 1 of 9
Approvals The signatures below certify that this procedure has been reviewed and accepted, and demonstrates that the signatories are aware of all the requirements contained herein and are committed to ensuring their provision. Name Signature Position Date Prepared by Jacky Moat HR Support 11/04/12 Reviewed by David Dye HR Director/Quality Manager 11/04/12 Approved by Quality Meeting 15/05/12 Amendment Record This procedure reviewed to ensure its continuing relevance to the systems and process that it describes. A record of contextual additions or omissions is given below: Page No. Context Revision Date Page 2 of 9
Contents CONTENTS 3 P018 INTERNAL AUDIT PROCEDURE 4 1. INTRODUCTION & PURPOSE 4 2. REFERENCES 4 3. TERMS & DEFINITIONS 4 4. APPLICATION & SCOPE 4 5. REQUIREMENTS 4 6. PROCESS 4 6.1 Audit Planning 5 6.2 Audit Preparation 5 6.3 On-site Audit 5 6.4 Wrap-up Meeting 6 6.5 Follow-up 6 6.6 Reporting 6 6.7 Review 6 6.8 Records 6 6.9 Audit Process Matrix 7 6.10 Internal Audit Process Map 9 Page 3 of 9
PR018 Internal Audit Procedure 1. Introduction & Purpose The purpose of this procedure is to define the Foundation s process for undertaking internal audits in order to assess the effectiveness of the application of ISO 9001:2008 and also to define the responsibilities for planning and conducting audits, reporting results and retaining associated records. 2. References Reference Title & Description 8.2.2 Quality System Manual F018-3 Internal Audit Check List F018-5 Internal Audit Report 3. Terms & Definitions Term ISO Clause Definition Non-conformity 3.6.2 Non-fulfilment of a requirement Preventive Action 3.6.4 Action taken to eliminate a potential non-conformity Corrective Action 3.6.5 Action taken to eliminate the cause of a non-conformity Audit 3.9.1 A systematic, independent documented process for obtaining and evaluating audit evidence objectively to determine the extent to which audit criteria are fulfilled 4. Application & Scope The scope of this procedure is focused on assessing the effectiveness of the Foundation s QMS. Where such processes are found to be deficient, the audit will lead to improvement in those processes. By applying the principles of auditing, outlined by ISO 19011:2002, the Foundation ensures that all internal audits are conducted with due professional care, integrity and independence. All conclusions derived from the audit are based upon objective and traceable evidence. 5. Requirements An audit of the QMS is conducted at planned intervals to: Determine whether the QMS conforms to planned arrangements Determine whether the QMS is properly implemented and maintained Provide information on the results of audits to Top Management 6. Process Internal auditing is undertaken at least once annually. The maximum interval between audits is 12 months on an annual cycle with all departments audited. Audits may be completed with a greater frequency if determined by the Quality Management Representative or as determined by: Page 4 of 9
ISO 9001 requirements Customer complaint QMS requirements Quality objectives/policy Corrective actions Statutory/legal requirements Management decisions Concerns raised by 3 rd parties Results of 3rd party audits Employee concerns Management Review concerns 6.1 Audit Planning The Quality Management Representative is required to: Establish and communicate internal audit schedule Establish and implement internal audit plan Appoint audit team leader where required Select audit team, see 6.1.1 below Assign audit duties to the auditor team 6.1.1 Audit Team Evaluation & Selection To ensure impartiality and objectivity, the audit team will include personnel from departments not directly associated with the area/department being audited. Audit team members are selected on the basis of: Education: secondary or higher Relevant work or other Experience Relevant Training: provided in-house or externally Audit Experience: demonstrable knowledge/skills 6.2 Audit Preparation The Audit Team is required to: Review relevant management system documents and records Determine their adequacy with respect to the audit criteria and with ISO 9001:2008 Review and prepare the internal audit checklist Arrange audit appointment Issue the audit checklist to the responsible manager 6.3 On-site Audit The Audit Team is required to: Conduct opening meeting Page 5 of 9
Sample and observe process inputs/outputs Record objective evidence to verify process compliance or non-conformance Generate audit findings 6.4 Wrap-up Meeting The Audit Team Leader and responsible manager are required to: Review audit conclusions and discuss recommendations for improvement Decide whether any non-conformances observed should be included in correction reports or solved immediately Minor areas of non-conformance are taken care of immediately Prepare an audit report Review audit report with the responsible manager Corrective actions are reviewed by the responsible manager and close out action is agreed upon The audit leader and responsible manager sign off audit report 6.5 Follow-up The Auditee/Responsible Manager is required to: Ensure corrective actions are implemented and are closed-out within the agreed timeframe Ensure non-conformances are closed-out within the agreed timeframe Ensure the status of corrective actions and any non-conformances are kept up-to-date 6.6 Reporting The Quality Management Representative is required to: Review audit conclusions Indentify trends Make recommendations for improvement Finalise the internal audit report Issue internal audit report to Top Management 6.7 Review Top Management is required to: Consider and act upon audit findings during the management review process Use the internal audit report to promote best practice Ensure records are maintained 6.8 Records All documentation and records generated by the internal audit process are managed in accordance with ISO 9001:2008 Clauses 4.2.3 & 4.2.4. Page 6 of 9
6.5 Follow-up 6.4 Wrap-up meeting 6.3 Audit 6.2 Preparation 6.1 Planning 20121104 Internal Audit Procedure PR018 6.9 Audit Process Matrix Action Responsibility Output Establish and communicate internal audit schedule Establish and implement internal audit plan Quality Management Representative Appoint the audit team leader where required Select the audit team Assign audit duties to the auditor F018-3 Review relevant QMS documents and records Audit Team Determine their adequacy with respect to the audit criteria Review relevant requirements of ISO 9001:2008 Review and prepare the internal audit checklist Arrange audit appointment Sample and observe necessary process inputs/outputs Audit Team Record objective evidence to verify process compliance Generate and record audit findings Decide whether any non-conformance observed should be included in correction reports or whether they can be solved immediately Minor areas of non-conformance are taken care of immediately, while a conclusion for the audit as a whole is written down Audit Team Leader and Responsible Manager An audit report is prepared which is examined together with the manager responsible for the area in question F018-5 Corrective actions are reviewed by the manager responsible and close out action is agreed upon The audit leader and responsible manager sign off audit report The reports are given to the QMR & the responsible manager Ensure corrective actions are closed-out within the agreed timeframe Responsible Manager Ensure non-conformances are closed-out within the agreed timeframe Ensure status of corrective actions and non-conformances communicated to the QMR Provide feedback on the audit process Page 7 of 9
6.7 Review 6.6 Reporting 20121104 Internal Audit Procedure PR018 Action Responsibility Output Review audit conclusions Indentify trends Quality Management Representative Make recommendations for improvement Finalise internal audit report Issue internal audit report to Top Management Consider and act upon audit findings during Management Review Top Management Use the internal audit report to promote best practice Page 8 of 9
6.10 Internal Audit Process Map Quality Management Representative Audit Team Responsible Manager Top Management Audit Considerations ISO 9001 requirements Customer feedback QMS requirements Quality objectives/policy Corrective actions Statutory/legal requirements Management decisions 3 rd party concerns Results of 3rd party audits Employee concerns Management Review Additional Considerations Status Importance Frequency Document review Prepare audit schedule Prepare audit checklist Devise audit plan Conduct audit Provide feedback on audit Assign audit duties F018-3 Noncompliance found? YES Initiate corrective actions NO Review audit findings Prepare audit report F018-5 Close-out corrective actions UPDATE Recommendations for improvement Verify close-out at follow-up meeting Management review Page 9 of 9