ISO 9001-2015 Clause 9.2 Internal Audit PDF

9. Performance evaluation 9.2 Internal audit Does the organization conduct internal audits at planned intervals to provide information on whether the quality management system: a)       conforms to: 1)       the organization’s own requirements for its quality management...

9. Performance evaluation 9.2 Internal audit Does the organization conduct internal audits at planned intervals to provide information on whether the quality management system: a)       conforms to: 1)       the organization’s own requirements for its quality management system? AS9100-D NOTE: The organization’s own requirements should include customer and applicable statutory and regulatory quality management system requirements. 2)       the requirements of ISO 9001? 9.2.1 b)       is effectively implemented and maintained? AS9100-D NOTE: When conducting internal audits, performance indicators can be evaluated to determine whether the quality management system is effectively implemented and maintained. DIRECTIVE 2014/68/EU Module D 3-2: The quality system documentation shall contain the means of monitoring the achievement of the required quality and the effective operation of the quality system. Does the organization: a)       plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which take into consideration the importance of the processes concerned, customer feedback, changes affecting the organisation, and the results of previous audits? b)       define the audit criteria and scope for each audit? c)       select auditors and conduct audits to ensure objectivity and the impartiality of the audit process? d)       ensure that the results of the audits are reported to relevant management? e)       take appropriate correction and corrective actions without undue delay? f)        retain documented information as evidence of the implementation of the audit programme and the audit results? NOTE See ISO 19011 for guidance. NQA-1 / 10 CFR Part 50-Appendix B: XVIII Audits. A comprehensive system of planned and periodic audits shall be carried out to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program. The audits shall be performed in accordance with the written procedures or check lists by appropriately trained personnel not having direct responsibilities in the areas being audited. Audit results shall be documented and reviewed by management having responsibility in the area audited. Follow up action, including reaudit of deficient areas, shall be taken where indicated. 9.2.2 a. Audits are performed at proper frequency. b. An audit plan is developed for each audit, which identifies the audit scope, requirements, audit personnel, activities to be audited, organizations to be notified, c. The audit team is identified prior to beginning the audit, and consists of one or more Auditors; one of which is the Lead Auditor who organizes and directs the audit. d. Audit team members have experience and training commensurate with the scope, complexity and nature of the audit, have no direct responsibility in the areas audited and have sufficient authority and organizational freedom to make the audit process meaningful and effective. e. Procedures / checklist(s) adequately cover the program elements being assessed, elements selected for audit are evaluated against specified requirements, and objective evidence is examined to the depth necessary to determine if these elements are implemented effectively. f. Conditions requiring prompt corrective action are required to be reported immediately to management of the audited organization. g. An audit report identifying the audit scope, Auditors, persons contacted, results, including a statement of effectiveness, and findings is endorsed by the Lead Auditor and issued to the audited organization. h. Audit responses are evaluated by or for the audited organization that that follow-up action, including re-audit of deficient areas, is taken where needed. i. Audit plans, reports, written replies, and records of completed corrective actions are maintained. Measures exist to ensure management of the audited organization or activity investigates adverse audit findings, schedules corrective action, including measures to prevent recurrence of significant conditions adverse to quality, and notifies the appropriate organization in writing of action taken or planned. ISO 9001-2015 Clause Requirements 9. Performance evaluation EN ISO / IEC 80079-34: a) The audit program shall address the effectiveness of the elements of the quality management system as described in this document to ensure that the Ex products are in conformity with the certificate. The maximum period between audits shall not exceed 14 months. b)       One method of demonstrating effectiveness is the use of vertical auditing whereby an Ex Product awaiting dispatch is used to prove the system. The auditor examines all aspects of the system associated with the production of that Ex Product from a certification viewpoint. This normally includes appropriate documentation 9.2.2 (drawings, inspection checklists, test records, material certificates etc.), Ex Product identification, handling, storage, training of staff and any other elements of the system which can affect the compliance of the Ex Product to the certification parameters. c)       For those manufacturers that employ checklists to assist in their internal audit programs, the inclusion of the requirements of this document into the appropriate checklists, and the retention of internal audit records, is an alternative method of addressing this requirement. Manufacturers may employ either method or some other equivalent method. ISO 9001-2015 Clause Requirements