Tiêu đề Internal Audit QP 8.8.pdf ✅

INTERNAL AUDIT PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V: 01 Code: QP 8.8 controlled E copy pg. 1 INTERNAL AUDIT PROCEDURE QP-8.8 Author Prepared by Reviewed and approved by Name Mohamed Abdelaziz Shaik aldien Function /position Quality Lead / Senior Quality Supervisor lab Manager Signature Date All rights reserved. These materials are confidential and proprietary to Conformity Assurance. No part of these materials should be reproduced, published in any form by any means (electronic or mechanical, including photocopy or any information storage or retrieval system), nor should the materials be disclosed to third parties without the express written authorization of Conformity Assurance
INTERNAL AUDIT PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V: 01 Code: QP 8.8 controlled E copy pg. 2 1. Purpose The purpose of internal audit procedure is to ensure that: 1.1. The laboratory management system documentation adequately defines the laboratory management system requirements including the requirements of ISO/IEC 17025:2017 1.2. The laboratory management system is effectively implemented and maintained. 2. Scope This procedure is applicable to all activities of Conformity Assurance laboratory management system. 3. Definitions 3.1. Audit Systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled 3.2. Audit program Set of one or more audits planned for a specific time frame and directed towards a specific purpose 3.3. Audit scope Extent and boundaries of an audit 3.4. Audit plan Description of the activities and arrangements for an audit 3.5. Audit criteria Set of policies, procedures or requirements used as a reference against which objective evidence is compared 3.6. Audit evidence Records, statements of fact or other information, which are relevant to the audit criteria and verifiable 3.7. Audit findings Results of the evaluation of the collected audit evidence against audit criteria 3.8. Audit conclusion Outcome of an audit after consideration of the audit objectives and all audit findings 3.9. Auditee Organization being audited 3.10. Guide Person appointed by the auditee to assist the audit team 3.11. Audit team One or more persons conducting an audit , supported if needed by technical experts
INTERNAL AUDIT PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V: 01 Code: QP 8.8 controlled E copy pg. 3 3.12. Auditor Person who conducts an audit 4. References 4.1. ISO 9000:2015 Quality management systems - Fundamentals and vocabulary 4.2. ISO 9001:2015 Quality management systems — Requirements 4.3. ISO IEC 17025:2017 General requirements for the competence of testing and calibration laboratories 5. Responsibilities 5.1. Quality manager 5.2. Lab Manager 5.3. Lab Analyst 6. Process 6.1. Audit planning 6.1.1.The quality manager is responsible to plan for internal audits on annual basis using internal audit plan form no. QF-8.8-1. 6.1.2.The audit plan will cover all aspects and elements of the laboratory management system including testing activities at least once a year.’ 6.1.3.The audit plan will leave opportunities for unscheduled audits in response to: 6.1.3.1. anticipated problem areas. 6.1.3.2. actual problems. 6.1.3.3. requests from Management; and 6.1.3.4. unforeseen changes in circumstances. 6.1.4.The audit plan will define in each audit the following aspects: 6.1.4.1. Process / activity which will be audited. 6.1.4.2. Trained, qualified auditor and independent of the activity to be audited. 6.1.4.3. Process / Activity to be audited; and
INTERNAL AUDIT PROCEDURE Conformity assurance Electrical lab – Dammam Issue date: 01.04.2024 V: 01 Code: QP 8.8 controlled E copy pg. 4 6.1.4.4. the audit dates. 6.2. Audit Preparation 6.2.1.The auditor will prepare for each audit as follows: 6.2.1.1. Review the previous audit report covering the same area (in order that previous problem areas can be examined in more details, or that areas previously unexamined can be looked more closely). 6.2.1.2. Get familiar with the requirements of ISO/IEC 17025:2017 and the local standards (quality manual, procedures, test methods, work instructions, etc.....). re-read the standards (quality manual, procedures, test methods, work instructions...............etc). 6.2.1.3. Contacting the auditee and confirming the date/time for the audit. 6.2.1.4. Preparing an audit checklist or similar aide-memoir. 6.3. Auditing 6.3.1.During the audit, the auditor will: 6.3.1.1. make use of standard auditing techniques to collect objective evidences concerning the subject being audited. 6.3.1.2. not respond to rumor and hearsay. 6.3.1.3. avoid confrontational situations and arguments. 6.3.1.4. makes notes to aid the writing of the audit report. 6.3.1.5. collect documentary evidence of conformity or nonconformity. 6.3.1.6. note where current procedures could be improved; and 6.3.1.7. keep the auditee informed as to the progress of the audit and any findings. 6.3.2.During the audit time the auditor will evaluate the collected objective evidence against the requirements and decide as following: 6.3.2.1. Acceptable: satisfies the laboratory management system requirements including the requirements of ISO/IEC 17025:2017 (E), the laboratory's own policies, manual, procedures, .... etc. 6.3.2.2. major: Major fails to satisfy the laboratory management system requirements including the requirements of ISO/IEC 17025:2017 (E), the laboratory's own policies, manual, procedures, .... etc.