ISO 13485:2016 - Test your knowledge

Are you familiar with ISO 13485, the globally recognized standard for medical devices - quality management systems? Or are you just starting to learn about it?

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Chapter 6: Resource Management:
What is the purpose of human resource management in the ISO 13485:2016 standard?

To ensure that personnel are available to implement the quality management system.

To ensure that personnel are competent on the basis of appropriate education, training, skills, and experience.

To ensure that personnel have enough resources to meet applicable regulatory requirements.

To ensure that personnel have adequate infrastructure to achieve conformity to product requirements.

Chapter 7: Product realization -> 7.4 Purchasing
What is the extent of verification activities based on?

The supplier evaluation results and proportionate to the risks associated with the purchased product.

The location of the supplier's premises.

The number of employees working for the supplier.

The supplier's marketing strategy.

Chapter 7: Product realization:
What does the organization need to plan and document arrangements for when communicating with customers?

Product information

Enquiries, contracts, or order handling

Customer feedback, including complaints

All of the above

8 Measurement, analysis, and improvement:
What is the purpose of preventive action in ISO 13485:2016?

To eliminate the causes of nonconformities in order to prevent recurrence

To determine any action(s) to eliminate the causes of potential nonconformities in order to prevent their occurrence

To plan and implement the monitoring, measurement, analysis and improvement processes needed to maintain the effectiveness of the quality management system

To ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery

Chapter 2 - Normative References:
How many normative references are listed in the ISO 13485:2016 standard?

Chapter 6: Resource Management:
What is the purpose of documenting requirements for control of contamination with microorganisms or particulate matter in the ISO 13485:2016 standard?

To ensure that personnel are competent on the basis of appropriate education, training, skills, and experience.

To ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are competent or supervised by a competent person.

To maintain the required cleanliness during assembly or packaging processes for sterile medical devices.

To prevent product mix-up and ensure orderly handling of product.

Chapter 6: Resource Management:
Which of the following is included in the infrastructure requirements for the ISO 13485:2016 standard?

Buildings and workspace only.

Buildings, workspace, and associated utilities.

Buildings, workspace, and process equipment (both hardware and software).

Buildings, workspace, and supporting services (such as transport, communication, or information systems).

Chapter 7: Product realization -> 7.5 Production and service provision
Does the organization need to document requirements for cleanliness of product or contamination control of product?

Yes, only if the product is supplied to be used non-sterile and its cleanliness is of significance in use.

Chapter 7: Product realization -> 7.5 Production and service provision
Does the organization need to maintain a record for each medical device or batch of medical devices that provides traceability to the extent specified in 7.5.9 and identifies the amount manufactured and amount approved for distribution?

Yes

Chapter 5. Management Responsibility:
What is the responsibility of the management representative?

To ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization

To ensure that everything needed for the quality management system is documented

To report to top management on the ineffectiveness of the quality management system and the need for improvement

None of the above

Time's up

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ISO 13485:2016 - Test your knowledge

About the Author: Jonatan M. Vinterbaek

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ISO 13485:2016 Quiz

- Test your knowledge about the standard: ISO 13485:2016 Medical devices - Quality management systems.

ISO 13485:2016 - Test your knowledge

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About the Author: Jonatan M. Vinterbaek

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