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Implementation

Although “implementation” is indicated as simply one block on the flowchart, the concept has many facets. Most of these will be specific to each company. However, there are some aspects of implementation that are important for all companies.

COMMUNICATION

The single most important aspect of implementation is communication with all who are affected by the changes. Of course there is a requirement in ISO 13485 that communication should take place regarding the effectiveness of the QMS. However, the communication is more important than simply fulfilling a requirement. In fact, the success of the quality plan to put in place ...

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