9.2 Internal audit 9.2.1 The organization shall conduct Are internal audits being internal audits at planned intervals conducted at planned intervals? to provide information on whether Do they determine whether the the quality management system; QMS conforms to the a) conforms to: requirements of ISO 9001 and to 1) the own the other requirements established organization’s 9.2.1 requirements for its quality by Organization? (Review records q1 management system; to demonstrate conformance) 2) the requirements of this Do they determine whether the International Standard; QMS is effectively implemented b) Is effectively implemented and and maintained? (Review records) maintained. 9.2.2 The organization shall: Can you show me audit Documented information of the audit a) plan, establish, implement and programme(s) that takes into programme and results maintain an audit programme(s) consideration the quality including the frequency, methods, objectives, importance of the responsibilities, planning processes, customer feedback, requirements and reporting, which changes impacting the shall take into consideration the organization and the results of quality objectives, the importance previous audits? of the processes concerned, Where are the audit criteria and customer feedback, changes scope for each audit? impacting on the organization, and Can you demonstrate that the results of previous audits; selection of auditors and the b) define the audit criteria and conduct of audits are objective scope for each audit; and impartial and that auditors 9.2.2 c) select auditors and conduct audit their own work? don’t q1 audits to ensure objectivity and the How are audit results reported to impartiality of the audit process; relevant management? d) ensure that the results of the Can you demonstrate that audits are reported to relevant necessary correction and management; corrective actions are taken e) take necessary correction and without undue delay? corrective actions without undue Can you show me documented delay; information of the audit f) Retain documented information programme and the audit results? as evidence of the implementation of the audit programme and the audit results. NOTE See ISO 19011 for guidance. 9.3 Management Review 9.3.1 Top management shall review the What is the frequency that top organization's quality management reviews the management system, at planned organization's QMS? How is the 9.3.1 intervals, to ensure its continuing QMS deemed suitable, adequate q1 suitability, adequacy, and and effective? effectiveness.
9.2 Internal audit 9.2.1 9.2.1 q1 The organization shall 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; 2) the requirements of this International Standard; b) Is effectively implemented and maintained. Are internal audits being conducted at planned intervals? Do they determine whether the QMS conforms to the requirements of ISO 9001 and to the other requirements established by Organization? (Review records to demonstrate conformance) Do they determine whether the QMS is effectively implemented and maintained? (Review records) 9.2.2 9.2.2 q1 The organization shall: a) plan, establish, implement and maintain an audit programme(s) including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the quality objectives, the importance of the processes concerned, customer feedback, changes impacting on the organization, 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 necessary correction and corrective actions without undue delay; f) Retain documented information as evidence of the implementation of the audit programme and the audit results. Can you show me audit programme(s) that takes into consideration the quality objectives, importance of the processes, customer feedback, changes impacting the organization and the results of previous audits? Where are the audit criteria and scope for each audit? Can you demonstrate that selection of auditors and the conduct of audits are objective and impartial and that auditors don’t audit their own work? How are audit results reported to relevant management? Can you demonstrate that necessary correction and corrective actions are taken without undue delay? Can you show me documented information of the audit programme and the audit results? Documented information of the audit programme and results NOTE See ISO 19011 for guidance. 9.3 Management Review 9.3.1 9.3.1 q1 Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy, and effectiveness. What is the frequency that top management reviews the organization's QMS? How is the QMS deemed suitable, adequate and effective?
Portrait-Audit-Checklist.docx