ISO 13485:2016 – Management Representative (Online Assessment)

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What is the primary purpose of ISO 13485:2016?

To establish environmental management systems

To define standards for information security management

To set requirements for a quality management system for medical devices

To provide guidelines for occupational health and safety management

None

Which of the following is a key requirement of ISO 13485:2016 regarding documentation?

Documentation must be handwritten

Documentation must be kept for at least 10 years

Documentation must include a quality manual

Documentation must be in multiple languages

None

Which process is essential for risk management as required by ISO 13485:2016?

Customer satisfaction surveys

Employee training programs

Risk analysis and mitigation

Market trend analysis

None

In the context of ISO 13485:2016, what is a corrective action?

A planned change to a product design

An action to eliminate the cause of a detected nonconformity

An audit process

A routine maintenance activity

None

A fictional company XYZ is preparing for an ISO 13485 audit. Which document is NOT required by the standard?

Quality policy

Marketing strategy

Quality objectives

Risk management procedures

None

What does ISO 13485:2016 require regarding the control of records?

Records must be publicly available

Records must be retained for at least 10 years

Records must be legible, identifiable, and retrievable

Records must be encrypted

None

During the implementation of ISO 13485:2016, a fictional company identifies a potential issue with supplier quality. What action should the company take according to the standard?

Ignore the issue and monitor it over time

Discontinue the use of the supplier immediately

Evaluate the supplier’s impact on product quality and take necessary actions

Increase the price of the product to cover potential defects

None

In the ISO 13485:2016 standard, what is meant by “continual improvement”?

Increasing the financial value of products annually

Constantly making improvements to the quality management system

Hiring new staff every year

Replacing equipment every 5 years

None

For a fictional company implementing ISO 13485:2016, which department is typically involved in verifying product conformity before release?

Sales Department

Quality Assurance Department

Marketing Department

Finance Department

None

What is the scope of ISO 13485:2016?

Applies to any organization regardless of size or type

Applies only to large multinational corporations

Applies only to manufacturers of electronic devices

Applies exclusively to hospitals and healthcare facilities

None

What is required from a company under ISO 13485:2016 regarding the management of suppliers?

Only use local suppliers

Conduct regular audits and evaluations of suppliers

Only use suppliers with an ISO 13485 certificate

Using suppliers is prohibited

None

Which of the following best describes a nonconformity in the context of ISO 13485:2016?

A minor error in product packaging

A deviation from a documented procedure or requirement

An innovative product design

A customer complaint

None

When implementing ISO 13485:2016, a fictional company decides to conduct internal audits. What is the purpose of these audits?

To detect underperforming employees

To identify areas for improvement and ensure compliance with the standard

To reduce production costs

To receive an ISO 13485 certificate

None

Under ISO 13485:2016, what must a company do if a nonconforming product is detected after delivery?

Ignore the issue if the customer has not complained

Recall the product if necessary and take corrective action

Blame the supplier for the defect

Offer a discount on the next purchase

None

What is the role of top management in an ISO 13485:2016 compliant organization?

To set sales targets and dismiss all employees who are underperforming

To provide leadership and support for the quality management system

To manage customer complaints directly

To design new products

None

What does ISO 13485:2016 specify about the control of monitoring and measuring equipment?

Equipment should be new

Equipment must be calibrated or verified at specified intervals

Equipment should be imported from specific countries

Equipment does not require calibration

None

A fictional company implementing ISO 13485:2016 discovers that its training records are incomplete. What should the company do?

Dismiss employees who lack training records

Update and complete the training records

Ignore the issue as training is not mandatory

Outsource training to another company

None

According to ISO 13485:2016, what is required for the management review process?

Only positive feedback should be documented

Reviews should occur annually and include assessing the effectiveness of the quality management system

Management reviews are optional

Only information about the safety and performance of medical devices must be reviewed

None

In a fictional company, which of the following activities is considered a preventive action under ISO 13485:2016?

Correct an incorrect work instruction before it is executed

Issuing a product recall

Reprimanding employees for mistakes

Developing a new product line

None

ISO 13485:2016 requires that a quality management system must be:

Flexible to avoid documenting every process

Documented, implemented, and maintained

The same as ISO 9001 in every detail

Approved by external auditors

None

What is the primary reason for performing design and development validation according to ISO 13485:2016?

To reduce production costs

To ensure the product meets user needs and intended use

To improve sales performance

To eliminate the need for further testing

None

In ISO 13485:2016, what is the significance of "product realization"?

It is the process of launching a product on social media

It encompasses the entire process from product design to delivery

It refers to the company's profit margins

It involves only the packaging of the product

None

Which clause in ISO 13485:2016 focuses on customer satisfaction?

Clause 5 - Management Responsibility

Clause 7 - Product Realization

Clause 8 - Measurement, Analysis, and Improvement

Clause 4 - Quality Management System

None

In the context of ISO 13485:2016, what does CAPA stand for?

Corrective Action and Product Assessment

Corrective and Preventive Action

Customer and Product Analysis

Calibration and Product Approval

None

A fictional company needs to implement ISO 13485:2016 and improve product traceability. What action should they take?

Increase the advertising budget

Ensure each product batch is uniquely identified and recorded

Only track products with defects

Ensure that products are not delivered by external suppliers

None

According to ISO 13485:2016, what is required when a change in the manufacturing process is planned?

No action is required if the product looks the same

Document the change, assess the impact, and obtain approvals

Inform only the manufacturing team

Stop production immediately

None

Under ISO 13485:2016, how often should an organization review its quality policy?

Every ten years

Annually or as necessary

Every time a new product is launched

Only when required by the regulatory authorities

None

A fictional company under ISO 13485:2016 must ensure competency of personnel. What is a key requirement?

Provide training records for all personnel

Have personnel work overtime regularly

Pay higher salaries to skilled workers

Rotate employees among departments frequently

None

Which of the following is NOT required by ISO 13485:2016?

Internal audits

Continuous product innovation

Risk management procedures

Design controls

None

According to ISO 13485:2016, what must be done when nonconforming products are detected?

Rework the product and continue production without documentation

Immediately destroy the product

Segregate, control, and document nonconforming products

Offer a discount to customers who purchase nonconforming products

None

For a fictional company complying with ISO 13485:2016, what is the purpose of the Management Review?

To discuss marketing strategies

To assess and improve the effectiveness of the quality management system

To celebrate annual achievements

To finalize financial statements

None

Which of the following is a key aspect of product design according to ISO 13485:2016?

Using the most robust materials available

Ensuring the design complies with regulatory requirements and customer needs

Involvement of only medical experts in product design

Avoiding the use of technology

None

In a company implementing ISO 13485:2016, who is responsible for reviewing and approving changes to documents?

Any employee

Only the CEO

Designated personnel with authority

External auditors

None

What is the goal of risk management as outlined in ISO 13485:2016?

To maximize profits

To identify, evaluate, and mitigate risks related to the safety and performance of medical devices

To enhance customer satisfaction

To identify, evaluate, and mitigate risks related to business and the durability of medical devices

None

Under ISO 13485:2016, how should a fictional company handle customer feedback?

Ignore all positive feedback

Document and use feedback to improve products and services

Only consider feedback from verified clients

Offer a refund for every feedback received

None

Which is an example of a control measure required by ISO 13485:2016 during product realization?

Hiring more employees

Using controlled conditions such as documented work instructions and monitoring

Launching a new advertising campaign

Offering discounts to loyal customers

None

What is the importance of the term “traceability” in ISO 13485:2016?

To increase production efficiency

To ensure the ability to trace the history, application, and location of a product

To provide marketing data

To ensure products have built-in tools for tracking and monitoring

None

A fictional company is preparing its final product for delivery under ISO 13485:2016. What should be checked before release?

The product’s market value

The product’s conformity to the design and regulatory requirements

Feedback from top management on the product

The product’s packaging design

None

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