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ISO 13485:2016 prior knowledge quiz
Question 1 of 10
Which European Directives are referenced by ISO 13845?
90/385
93/42
98/79
All of these
Question 2 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
Notified Body
Question 3 of 10
What is the name of the body which underwrites auditor training and accreditation in the UK?
UKAS
IRCA
ISO
MHRA
Question 4 of 10
When was ISO 13485 last updated?
2012
2015
2016
2018
Question 5 of 10
Which ISO standard applies to the risk management of medical devices?
ISO 9001
ISO 14698
ISO 17021
ISO 14971
Question 6 of 10
What phrase within ISO 13485 is associated with the use of risk based thinking?
"as appropriate"
"proportionate to"
"establish and maintain"
"effectiveness"
Question 7 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
Validated
Both
Neither
Question 8 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
Management review minutes
External audit report
Scope statement
Question 9 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
Lifetime of device
2 years or the lifetime of the device
Defined by national regulations
Question 10 of 10
How often does a Management Review need to take place?
At planned intervals
Monthly
Quarterly
Annually
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