MCT Process approach T 23

1. A process creates, among other things:

• Added value
• Potential nuisances
• Quality
• Continual improvement

1. The first edition of ISO 22716 appeared in:

• 2007
• 2008
• 2009

2. The 7 principles of quality management include:

• The quality approach
• The process approach
• Improvement
• Customer focus
• The quality policy
• Risk-based thinking

2. The process mapping allows us, among other things, to:

• Identify the beneficiary
• Identify the interactions
• Plan
• Control inspection means
• Obtain a global vision

3. The acronym ANSM stands for:

• National Agency for the Safety of Medicines and Public Health
• National Drug Safety Agency
• National Drug Safety Association

3. The process approach, among other things:

• Relies on process management
• Allows roles and responsibilites to be clarified
• Ensures document control
• Allows reducing costs, delays and waste

4. A process is determined, among other things, by its:

• Inputs
• Strategy
• Purpose
• Owner

4. The latest version of Cosmetic Regulation EC 1223/2009 entered into force in:

• 2009
• 2013
• 2015

5. ISO stands for:

• International Standard Organization
• International Organization for Standardization
• International Superior Organization

5. The sell and purchase processes are:

• Management processes
• Realization processes
• Support processes