MCT Beginning T 35

1. The objectives of an audit program are influenced by:

• Quality procedures
• Expectations of top management
• QMS requirements
• Statutory and regulatory requirements
• Risks identified

2. The implementation of the audit program requires:

• Its approval by top management
• Its communication to the concerned parties
• Audit plans to be followed
• Audit follow-up

3. 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

4. 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

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

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