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How to start ISO 13485 implementation project

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Guest user Created:   Apr 23, 2018 Last commented:   Apr 23, 2018

How to start ISO 13485 implementation project

How to start the project of ISO 13485 after getting the management approval?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Strahinja Stojanovic Apr 23, 2018

Answer:

Once you have the top management support for the project, sou should conduct a gap analysis to determine to what extent your organization is already compliant with ISO 13485 and what needs to be done to achieve full compliance. After determining the gaps, you can define the project plan for the implementation where you will define the activities, documents to be developed, responsibilities and deadlines.

Usually, the first step in the project is defining the procedure for document and record control, and then the quality policy. The next step is to identify the processes and resource management. Then you can conduct risk assessment and define controls for the processes.

Once your processes are set up, you can perform internal audit and management review and you will be ready for the certification audit.
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Apr 23, 2018

Apr 23, 2018

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