MCT General requirements

1. The process mapping allows us to:

• Identify the beneficiary
• Plan the MS (management system)
• Identify the interactions
• Manage inspection means
• Obtain a global vision

2. Risk:

• Is inevitable
• Is intrinsic to any activity
• Can be eliminated
• Cannot be eliminated
• Can be reduced

3. The requirements of ISO 14971 version 2019 are:

• 134
• 309
• 416

4. The cost of risk management during production is:

• Between 10 to 100 times higher than during design
• Between 1,000 to 10,000 times higher than during design
• Between 100 to 100,000 times higher than during development

5. According to ISO 14971 version 2019 the risk is:

• Effect of uncertainty on the achievement of objectives
• Combination of the probability of an event and its consequence
• Combination of the probability of occurrence of harm and the severity of that harm
• Effect of uncertainty