As internal audit is the second important tool in ISO 9001 used to gauge the health of the QMS, Rockpower has a documented procedure for our internal audit process addressing each of the following control requirements: The scope of our internal audit program must cover the: Audit of product realization processes -to determine conformity of both product and product realization processes to customer and applicable regulatory requirements. Audit of the QMS - to determine conformity to the ISO 9001 standard Audit of the QMS - to determine conformity to organizational requirements Audit of QMS processes and their interaction - to determine if the QMS has been effectively implemented and maintained. The time frame during which the audits specified above will be conducted Rockpower’s time frame is one year. But we also consider adjusting the audit frequency (and perhaps even the audit scope), of specific processes or group of processes, when: - We experience internal or external nonconformities - Get customer complaints - Have critical or high risk processes - Have frequent or significant changes to processes and product Our internal audit program will consider the following: - Input from audited area and related areas - Key customer oriented processes - Process and product performance results and expectations - Opportunities for continual improvement - Feedback from customers Audit criteria, refers to the specific QMS policies, objectives; ISO requirements; documentation; customer and regulatory requirements, etc., that the audit is referenced to or conducted against. Audit criteria may relate to the whole audit program as well as eachindividual audit. Audit methods refer to the specific techniques that auditors use to gather objective audit evidence that can be evaluated to determine conformity to audit criteria. Examples of audit methods include - interview of personnel, observation of activities; review of documents and records; etc. Rockpower define the minimum qualification requirements for internal auditors. These requirements include knowledge of -QMS processes and their interaction; related QMS controls; customer requirements; applicable regulatory requirements; the ISO 9001 standard;the audit process and audit techniques. Auditor Independence - Auditors can audit their own department provided their objectivity and impartiality is not compromised, but they cannot audit their own work. Rockpower ensure auditor independence when assigning personnel to specific audits. Process owners of Rockpower must take timely corrective action on nonconformities found in their area as per the corrective action procedure to determine root cause, take appropriate action and follow-up to determine if results indicate that the root cause has been eliminated. Audit results must be summarized and reported for management review . The Management Representative must also report any opportunities for QMS improvement . The MR of Rockpower must analyze the results of each audit as well as the annual audit program to determine strengths and weaknesses in QMS processes, interactions, functions,products, etc., to identify and prioritize opportunities for improvement. Audit records include -annual audit schedule; audit planning- (criteria, scope, frequency, methods,auditor selection and assignment, etc); auditor competence and training; audit checklists and forms; audit notes and other evidence gathered; audit findings;nonconformity reports; audit reports; corrective actions and follow-up of internal audit nonconformities; analysis of audit program performance indicators and trends; and identified improvement opportunities.
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