IN ISO 13485 Certification in France the Documentation control is the primary task for many people who would prepare for before attending an upcoming audit. Earlier to any audit, we would also ensure that any changes made to the work procedures that are updated, we have to review the Quality Manual and Quality Management System documents, and to ensure that each process proprietor is aware of their individual roles and responsibilities. This is an eco-friendly that makes the fundamentals of good documentation control.

According to Section 4.2.4 (Control of documentation) of ISO 13485 Services in France the documents that are required by the Quality Management System (QMS) should be controlled and maintained to ensure their won usability, effectiveness, and adequacy for operation. The organization should hold the documents, based on the project which is very useful for the life of the medical science and device or according to national regulatory requirements – whichever is the longer one. ISO 13485 Implementation in France which requires that the documentation related to the testing or manufacturing of medical device should be retained for the lifetime of the device, but it does not take more than two years after the distribution of the device. The retention period must also meet the requirements of the regulatory authorities of the countries in which the devices are distributed. It is also important to adopt things on a risk-based approach when you make changes to the work procedures, the Quality Manual, and other related documents that might affect the Quality Management System.


What are the common mistakes when implementing Section 4.2.4 in ISO 13485 Certification in France?

In ISO 13485 Consultant in France there are many mistakes that are happening today, as we are going to discuss the common mistakes people make when working on this section of ISO 13485, as highlighted below:


Documents are used without previous existing approval and review this is the consequences that people do not follow the perfect procedures to perform their daily routine. For example, people make changes to the prescribed procedure when they perform a work. The result, as they use a procedure that is not updated and approved by the workers instructions. To avoid these above situations, it is highly recommended to perform a regular check on the status of procedures as documented in the system, as compared to the original procedure that is carried out in the work. In addition, as an alternative of using paper copies, each work station could use the computer screen that is tied up into the document control centre so that only the current work instruction could be called up. This needs to be done so that there is no illogical between what is written and executed. This can also help in identifying holes and improve the opportunities within the existing procedures in the Quality Management System.


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