MCT Beginning

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 ISMS improvement opportunities to be found
• Are verifiable evidences

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

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

4. 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 programme to a qualified person

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

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