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4.17. Internal Quality Audits |
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You must carry out a comprehensive review of your organization to verify the effectiveness of your quality system and compliance with the ISO 9000 standard. This review should take the form of scheduled audits of the various areas, based on the relative importance of the operations and activities. Audits are to be conducted in accordance with your documented procedures by trained individuals. The results of the audits must be documented and presented to management personnel for timely corrective action of any nonconformances cited, and tracked to ensure follow-through. Follow-up audits must be conducted to confirm the corrective action. Audit frequency will be determined based on experience as well as the importance to the products being produced. Generally, no more than one year should elapse between audits of the same area to maintain compliance. Audits are carried out according to a documented plan that will specify not only locations and time, but also the qualifications of the auditors, the output required, the method for conducting the audit, and who will receive the results. Audits shall be conducted by personnel independent of the operation being audited and trained in ISO 9000 requirements. For internal quality audits:
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