ISO13485 Review

[greg-westnine]

Review ISO13485 and make amendments to policies or technical file accordingly.

[greg-westnine]

Points so far:

• [ ] Write a Quality Manual (4.2.1 b) which defines management responsibility (5) (5.3) and audit (8, 8.2.4) *Now in draft
• [ ] Check that every controlled document has a reference included in it which relates back to the register *sub-register now has references included
• [ ] Define a retention period policy in the Document Policy (4.2.4)
• [ ] Establish and create evidence of management review (5.6.1)
• [ ] Create a HR policy (6.1)
• [ ] Consider a Communications Policy (7.2.3)
• [ ] Consider a Purchasing and Supplier Evaluation Policy (7.4)
• [ ] Either add content to Dev policy, or create a separate policy to cover service provision (7.5), which can include monitoring and measuring of production environment (7.6)
• [ ] Add Complaint Handling to CI Policy (8.2.2)
• [ ] Add Preventative Action to CI Policy (8.5.3)

[joereddington]

It's increasingly clear to me that we should be working on the documents here for medical device registration as one repository...

Action points:

• Joe to handle the controlled documents mapping
• Greg to populate repostory with existing files.