Process Interaction Chart example as required by ISO 13485 2003

Marc

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#11
Can anyone in medical devices answer the last post above about organization chart requirements? Thanks in advance.
 
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yodon

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#12
Can anyone in medical devices answer the last post above about organization chart requirements? Thanks in advance.
As the last post asked about FDA expectations, I think the (probably) relevant clauses from 820 are:

(b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.

(1) Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.


(3) Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: ...

None specifically *requires* names associated but when the FDA comes in, they expect the roles, responsibility, & authority to be well defined. They want to know who the MR is, who the individual with overall accountability is, etc.

I wouldn't suggest it's advisable to present a 'generic' org chart - that may not get things off to the best start (from my experience, the org chart is pretty much the first thing they ask for).
 
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