MCT BEGINNING

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

• Technology environment
• Economic environment
• Products and services
• Corporate culture

1. The characteristics of a MD, relating to safety, concern:

• How the MD works
• Inteded use
• Reasonably foreseeable misuse
• Materials in contact with the patient
• User error

1. The ISO 27001 standard defines for an information security management system:

• The requirements
• Overview and vocabulary
• Reference control objectives and controls
• The risk management

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

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

2. Staff are made aware of, among other things:

• The importance of complying with the information security policy
• The importance of meeting the requirements of the ISMS
• The positive effectsof individual performance
• The consequences of non-compliance with ISMS policies
• Everyone's contribution to improving the performance of the ISMS
• The benefits of becoming an information security expert

2. The quantitative risk assessment appeared over the years:

• 1650
• 1792
• 2004
• 2009

3. Examples of interested parties:

• Law and regulations
• Customers
• Stockholders
• Neighbours

3. Staff are regularly made aware of:

• Information security risks
• The level of password security
• Disciplinary rules
• Updates to policies and procedures
• The scope of the ISMS

3. To evaluate the risks related to the saety of the medical device after the start of marketing:

• A risk management plan is used
• A production information collection system is used
• A system for collecting post-production information is used
• A production information review system is used
• A post-production information review system is used
• A post-market monitoring plan is used

4. Anticipating the needs and expectations of workers is:

• Identifying and reduce OH&S hazards
• Using SWOT analysis
• Preparing to address risks
• Seizing opportunities for improvement

4. Risk reduction is confirmed by:

• Checking the implementation of the control measure
• Verifying the effectiveness of the control measure
• Carrying out tests with users
• Recording the results of veryfying the effectiveness of control measures

4. The internal audit:

• Check staff competence
• Helps to raise awareness among staff
• Allows disciplinary actions to be taken
• Allows the compliance of the ISMS to be evaluated
• Allows the effectiveness of the ISMS to be evaluated
• Helps improve the effectiveness of the ISMS

5. Physical and environmental security can include:

• Secure areas
• Delivery areas
• Arrival and departure of visitors
• Indication of the purpose of the rooms
• External threats
• Classification of information

5. The number of requirements of ISO 45001 version 2018 is:

• Less than 200
• Over 200
• Over 300
• Less than 300

5. The risk analysis takes into account:

• The impact of risk
• The likelihood of the risk occurring
• Risk control measures
• The root causes of risk
• Interaction with other risks