MCT Beginning T 16

1. External issues that may affect the company's performance, among others, are:

• Social environment
• Regulatory environment
• Corporate culture
• Products and services

2. Leadership of top management should:

• Manage the company's processes
• Fully assume responsibility for the effectiveness of the QMS
• Define the purpose of the company
• Lead by example in the field
• Support continual improvement

3. Planning the QMS means taking into account:

• The commitment of top management
• External and internal issues
• The requirements of interested parties
• The QMS processes

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

• Inputs
• Owner
• Strategy
• Purpose

5. Operational control is present wherever a risk is identified in:

• The design of workstations
• The maintenance of equipement and machines
• The operation of the equipment
• The prevention plan