M Mandy Involved In Discussions Nov 5, 2017 #1 Nov 5, 2017 #1 Does the nonconforming product mentioned in Section 8.3 of ISO 13485 relate to reagents and disposables, or only to the company's manufactured product? Thanks
Does the nonconforming product mentioned in Section 8.3 of ISO 13485 relate to reagents and disposables, or only to the company's manufactured product? Thanks
Sidney Vianna Post Responsibly Staff member Admin Nov 5, 2017 #2 Nov 5, 2017 #2 In part, it does. But they are more appropriately handled in 7.4.3 of ISO 13485:2016. Personally, I think the new definition of "product" in ISO 13485:2016 and ISO 9000:2015 is a botched definition. Previous one was much better.
In part, it does. But they are more appropriately handled in 7.4.3 of ISO 13485:2016. Personally, I think the new definition of "product" in ISO 13485:2016 and ISO 9000:2015 is a botched definition. Previous one was much better.