Medical ISO13485:2016 Breakdown

Written by Marketing Manager Emily Waterhouse 07/13/2021

When you grew up did your parent(s) have a set of standards that you needed meet? Your room had to be at least this clean, or those dishes better be done before mom gets home, how about if your laundry wasn’t put away? 

Just like those standards our parents had for us growing up, here at Para-Coat we have standards that need to be met. That’s how and why we are ISO 13485:2016 certified. 

What is ISO13485:2016? 

ISO was designed to specify requirements (like mom telling you exactly how to dust the shelves) for a quality management system where an organization needs to demonstrate its ability to provide medical devices or related services that consistently and constantly meet customer and pertinent regulatory requirements. So basically, prove to clients you meet a set of medical standards every time! Mom would be so proud. 

Who can use ISO13485? 

ISO was made for any companies involved in with the design process, production, installation or servicing of a medical device or a related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. In simpler terms, ISO 13485 is for anyone who would come in contact with a medical device or medical service. 

There are revisions to ISO, why?  

Every ISO (medical, technology, environmental, etc.) gets revised after 5 years. This is to keep it current and relevant for their marketplaces. The new version of the medical ISO13485:2016 has a greater emphasis on risk management and risk-based decision making. As well as changes related to the growing regulatory requirements for companies within the supply chain. 

In conclusion..

In my personal opinion, I feel ISO13485:2016 is a great standard for organizations to live to up to. If it wasn’t in place just think about how bad medical devices / services could be. In comparison it’s like your bedroom again, if it wasn’t clean to a certain point was mom happy? No of course not! Would you be happy if those medical devices were, for lack of better terms, junky because there were no standards or expectations to live up to? I don’t think so. Some lives depend on them! What do you think about ISO 13485:2016, necessary expectations or unrealistic standards? 

Contact us today for more information!

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