MCT QMS T 22

1. The procedure control of documents ensures for documents their:

• Approval
• Updating
• Disposal
• Verification

2. The procedure control of records ensures for records:

• Updating
• Identification
• Retention time
• Verification
• Disposal

3. The processes are:

• Named
• Identified
• Their interactions determined
• Monitored
• Their objectives established and analysed

4. Control of records related to quality:

• Is a mandatory procedure
• Requires that these records be at least in paper form
• Provides evidence of conformity and effectiveness of the QMS
• Requests that records be made available to interested parties

5. The level of risk of the processes is identified in relation to:

• Effectiveness of the QMS
• Impact on the safety of medical devices
• Impact on the performance of medical devices
• Impact on regulatory conformity