Medtech question

Test your ISO 13485 IQ: Part II

By MedTech Intelligence Staff
1 Comment
Medtech question

Part II of the ISO 13485 IQ test digs a little bit deeper into the standard.

Part I of our ISO 13485 test dealt with the basics of the standard. Test takers did fairly well (view results) and Part II is an opportunity to go a bit further in testing your knowledge of the standard. We’ll post the results in a couple of weeks. Good luck!

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  1. John Ruhl

    Hello, I just completed your 2nd quiz on ISO13485. There was a question regarding whether or not a organization was required to complete inspection of material from a sister site. I realize that Purchased Product now includes all product received outside a organizations Quality Management System regardless of there being a financial or commercial agreement. However, I feel the answer to this question could be true if the sister company is outside the organizations quality management system, but false if the sister company is a part of the organizations umbrella certification. Not sure what answer you will determine to be correct for this question. I look forward to seeing the answers.

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