ISO 13485:2016 prior knowledge quiz

Question 1 of 10

According to ISO 13485, what is the minimum period of time that records relating to the manufacture of medical devices must be retained?

2 years

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Lifetime of device

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2 years or the lifetime of the device

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Defined by national regulations

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Question 2 of 10

When was ISO 13485 last updated?

2012

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2015

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2016

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2018

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Question 3 of 10

Which European Directives are referenced by ISO 13845?

90/385

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93/42

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98/79

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All of these

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Question 4 of 10

What is the name of the body which underwrites auditor training and accreditation in the UK?

UKAS

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IRCA

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ISO

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MHRA

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Question 5 of 10

If an organisation wished to indicate that some aspects of ISO 13485 were not applicable in their circumstances, where would this be stated?

Quality Policy

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Management review minutes

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External audit report

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Scope statement

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Question 6 of 10

Which sort of organisation is authorised to conduct external audits of medical device manufacturers? Select as many as you think apply.

Certification Body

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Notified Body

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Question 7 of 10

What phrase within ISO 13485 is associated with the use of risk based thinking?

"as appropriate"

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"proportionate to"

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"establish and maintain"

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"effectiveness"

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Question 8 of 10

How often does a Management Review need to take place?

At planned intervals

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Monthly

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Quarterly

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Annually

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Question 9 of 10

Is it sufficient for software used during measurement of a medical device to be verified, or does it also need to be validated?

Verified

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Validated

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Both

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Neither

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Question 10 of 10

Which ISO standard applies to the risk management of medical devices?

ISO 9001

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ISO 14698

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ISO 17021

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ISO 14971

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