Answers: What’s Your ISO 13485 IQ?

By MedTech Intelligence Staff
February 28, 2017


• Categories: 05-Quality/Regulatory, RC - Medtech Regulatory Resource Center

Last week we posted the ISO 13485 IQ Test for our readers to assess their basic knowledge of the standard. Below are the results. Do they surprise you? Stay tuned for Part II, which will be posted within the next couple of weeks!

Didn’t take the test? Click here to test your ISO 13485 IQ.

Results

1. Please choose the accurate statement about ISO 13485:
   1. US FDA Requires manufacturers to comply with ISO 13485
   2. It is the basis for the Health Canada CMDCAS program. – ANSWER. 63% answered correctly.
      
   3. It is the management system defining the process for risk management
   4. It is the same as ISO 9001
2. (T/F) ISO 13485:2016 Requires ISO 14971. – FALSE. 48% answered correctly.
   
3. (T/F) The latest Version of ISO 13485 was published in 2016. – TRUE. Congrats–93% knew this one.
   
4. (T/F) Certification to ISO 13485 requires a preliminary assessment and a registration assessment. – TRUE. 67% answered correctly.
   
5. ISO 13485 accrediting bodies include:
   1. SCC
   2. UKAS
   3. JAB
   4. ANAB
   5. All of the above – ANSWER. 78% answered correctly.