MCT Beginning T 39

1. Improving the audit program takes into account the:

• Rate of implementation of the audit plan
• Percentage of trained persons as internal auditors
• Trends of audits
• Proper application of procedures

1. The scope of the ISO 19011 standard, among other things, contains the:

• Audit program
• Audit requirements
• Auditor competence
• Audit activities

2. Auditor principles to be followed, among other things, are:

• Factual approach
• Professional ethics
• Professional integrity
• Remaining available
• Confidentiality

2. The person managing the audit program, among other things, will:

• Establish the objectives and scope of the audit program
• Write the audit procedure
• Obtain the availability of auditors
• Determine participation and responsibilities
• Verify that the audit procedure is approved

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

• QSE procedures
• Expectations of top management
• IMS requirements
• Legal and other requirements (compliance obligations)
• Risks identified

3. The results of the process internal audit:

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

4. Auditee principles to follow include:

• Curiosity
• Confidentiality
• Remaining available
• Being benevolent and cooperative

4. 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

5. Internal audit can be of:

• A process
• A product
• A customer
• A supplier

5. The auditor has knowledge and controls the application of:

• Audit priciples
• Process approach
• Management principles
• Applicable requirements
• Organizing the team