Whether your company must comply with ISO9001, ISO13485 or other regulations, it is your responsibility to maintain compliance.
I have knowledge of one company that, for one reason or another, did not maintain their compliance. The ‘regulators’ pulled their license to sell their product. They were not able to renew their compliance for 6 months. An expensive oversight…
What can we learn?
Knowledge is the key. Your company needs to be aware of all changes to the regulations pertaining to your business. Just like in a courtroom, ‘ignorance of the law is no excuse.’
Someone or some people in your company need to stay on top of these regulations. They can become a member that can help shape the regulations. They can attend conferences [both real and virtual]. They can get on distribution lists.
If you choose to go with one person, you are subject to ‘their view of the regulation’. Choosing more than one person or selecting some kind of rotating strategy will provide you with less chance of an error.
When they become aware of a pending regulation change, they must create an internal change request to alter their processes to get into compliance with the new regulations.
Not being in compliance can be expensive. The process of staying in compliance is extremely important, give it that kind of attention.
Need some help?