Implementation of ISO 13485

Answer:

Implementation process of ISO 13485 is not so different from other management system standards. After obtaining management support for the implementation, you need to conduct GAP analysis to determine to what extent your company is already compliant with ISO 13485 and determine what needs to be done to achieve full compliance with the standard.

Next step is to develop project plan where you will define all activities to be taken and documents to be created, as well as responsibilities, resources and deadlines. Then you can start implementing new processes and changing existing ones and creating necessary documentation.

Once you implement the standard, you need to conduct internal audit and management review to make sure that your system is compliant with the standard and finally you can hire certification body to conduct certification audit and issue your company the certific ate. For more information, see: Diagram of ISO 13485:2016 Implementation Process https://advisera.com/9001academy/free-downloads//