MCT Beginning T 35

1. The extent of the audit program, among other things, depends on:

• Process complexity
• Risks identified
• Follow-up of previous audits
• Commercial policy
• Essential characteristics of products

2. The results of the process internal audit:

• Are management review outputs
• Are management review inputs
• Allow QMS improvement opportunities to be found
• Are verifiable evidences

3. An internal audit is initiated, for example:

• When it is scheduled in the audit program
• Following the request of a department manager
• After a dysfunction in an activity
• Following a major evolution of a process

4. The records related to the audits, among other things, contain the:

• Audit plan
• Audit report
• Audit procedure
• Evaluation of auditor competence
• Audit team members

5. The audit procedure contains, at minimum, instructions on how to:

• Plan the audits
• Conduct the audits
• Ensure auditor competence
• Assign the responsibility for managing the audit program to a qualified person