Showing posts from August, 2018

How Will ISO 13485:2016 Impact Your Relationship With Suppliers & Why You Should Be Using ISO 13485:2016 CERTIFIED Suppliers From Now On

The 2016 revision to ISO 13485 may have profound implications for the medical device industry. The updated standard will alter the way device makers interact with suppliers, from supplier selection to the management of supplier relationships. Speaking as the Quality Systems Director of CrossWind Machining (component manufacturer for the medical device industry) and just completing our ISO 13485:2016 Certification, the new 2016 revision (from 2003) is all about mitigating risk from every aspect of the medical device manufacturing process. And with ISO 13485:2003 no longer being valid after 2019, suppliers are having to decide how much time & money they are willing to put into separating themselves.

What the new Standard Says About RiskOne particularlynotable change with ISO 13485:2016is the addition of more explicit risk management requirements. Companies will be required to consider the risk associated with a device from conception through its use. Device makers must plan and imple…