Both ISO9001 & ISO13485 stress process management.
Business Process Management is a discipline [it is not software]. ISO compliance is accomplished with a centralized, common, collaborative environment that gives you visibility into your quality efforts making you an active participant and a quality champion.
ISO calls for your company to have written procedures. You need to follow those procedures and you need to be able to show that you are following them. It does not tell you what those procedures need to look like. It doesn’t tell you how to do your job. It just tells you to do it.
Your solution can be paper based, electronic or some kind of hybrid solution.
In each case, you will need a quality manual. You will need to have your procedures documented. You will need to show that your employees follow those written procedures. You will be managing lots of documentation.
I am sure that there are still companies out there that have paper copies of their documentation [quality manual, procedures, approvals, etc.] stored in binders. In many cases, they will have a person or persons tracking and documenting processes being followed in their company. They will make sure that the latest approved [released] documents are available to those with proper access authority.
In this solution, everything is done in software. Some kind of document management software will manage all of the documentation. Companies will have software to manage their processes [procedures] collecting documentation, approvals and movement from one step to the next. The software will provide access control.
This could be any kind of ‘mash-up’ of the two strategies.
Selecting the Right Path
The selection always comes down to – ‘how can I do the best job for the least cost?’ That said, be sure to perform a risk analysis on your alternatives. That may point you in the right direction.
Contact me if you would like some help…