In this article we will take a deeper look at the following: All medical device companies wishing to sell their devices in the European Union (EU) must pass an ISO 13485:2016 audit that is conducted by a Notified Body. In the next section we will go through the characteristics of this compliance checklist.ISO 13485:2016 is the latest edition of ISO 13485, which, as we know is the principal international QMS (Quality Management System) standard for medical devices companies. Sometimes, to cover this specific requirement, the timing for the opening of a CAPA following an audit findings shall be defined in the Quality System Procedure this timing may be different based on the type findings which have been raised during audit (remarks, minor non-conformities, major non-conformities).įor an efficient and straightforward internal audit process according to ISO 13485:2016, or in the framework of the preparation of a specific Internal or External audit, the ISO 13485 Audit Checklist is Ann essential tool. This sentence includes a very important requirements related to the implementation of corrections and corrective action “ without undue delay“. 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. 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 Internal Audit Plan and reports shall be documented.The link between Internal Audits and CAPA process shall be properly demonstrated and documented.Independence of the auditors shall always be demonstrated.Quality Audits shall be performed to ensure compliance of the Quality System to the applicable regulatory requirements.The dates and results of quality audits and reaudits shall be documented.īased on this text of the regulation it is possible to basically summarise the key requirements for the internal audit process: A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. The text of the section is reported below:Įach manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality Audit requirements according FDA Quality System Regulation are reported in the section 21 CFR 820.22. Internal Audit Requirements According to 21 CFR 820
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