ISO 13485

• Company Name

• Location
  Address

• Date

  Date

• Scope of Audit

• Auditor(s)

• Audit Summary

• Audit Conclusions

• Critical

  Off

  On
Observation

• Major

  Off

  On
Observation

• Minor

  Off

  On
Observation

• Recommendations

General Requirements

• 4.1.1 - Is the Quality Management System (QMS):

• established?

  Yes

  No

  N/A

• fully documented?

  Yes

  No

  N/A

• effectively implemented?

  Yes

  No

  N/A

• effectively maintained?

  Yes

  No

  N/A

• 4.1 a) - Have all the processes needed for the QMS and the way they apply to the organisation been determined?

  Yes

  No

  N/A

• 4.1 b) 1 - Are the sequences of the processes defined?

  Yes

  No

  N/A

• 4.1 b) 2 - Is there a clear definition of how the processes interact with each other?

  Yes

  No

  N/A

• 4.1 c) - Is there a clear definition of the criteria and methods needed for:

• effective operation of the processes?

  Yes

  No

  N/A

• effective control of the processes?

  Yes

  No

  N/A