![]() ![]() The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. ![]() #ISO 13485 INTERNAL AUDIT CHECKLIST ISO#in fact, the text of the iso standard reports: moreover, it definitely makes sense to include the specific audit criteria for each specific process to be audited.Īlso within iso 13485 there is the requirements associated to the link between the internal audit process and the capa process. in the audit plan, the specific processes to be audited need to be mentioned along with the timing on when that specific audit is planned. It is very important to document an audit plan which takes in consideration the internal audits to be performed through the whole year. this is very important and it can be included in the framework of those requirements that go in the direction of the implementation of risk management principles in the quality management system of an organization. in fact, iso 13485 requires internal audits to be planned “ taking into consideration the status and importance of the processes and area to be audited, as well as the results of previous audits“. Specifically, one of the most important requirement is the risk-based approach in the planning of the internal audits. however, in addition to what has already be mentioned in the previous paragraph, there are some additional requirements which is important to mention. there are mainly the same requirements already explained in the previous section related to fda quality system regulation. ![]() The section related to internal audit within iso 13485:2016 is the clause 8.2. Internal audit requirements according to iso 13485:2016
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