I am working with a medical manufacturer to help them get into compliance with ISO13485. Simply put, ISO13485 provides a list of procedures that you are to have in place. These procedures are written documents so that you could be compliant without the use of software.
Maintaining procedures is complicated enough without adding a person to manage a ‘vault’ with its needs for security, versioning, changing, etc. As I look at this, a company could possibly use business process management software or product lifecycle management software.
Business Process Management
The focus of Business Process Management [BPM] software has always been the process.
They came from the process side, so even if they have some form of document management it will not be as sophisticated as that found in PLM software.
Yes process is extremely important for ISO13485, but managing the documents [procedures] is also important.
Product Lifecycle Management
The focus of Product Lifecycle Management [PLM] software has always been the document.
PLM software grew up from document management software. They really understand the principles of a vault. It all starts with security – who can have access; who can see it; who can change it; etc.
They got a lot of push from their customer base to come up with a ‘workflow’ component that would manage the process of managing engineering changes. Over the years, this has kept improving.
An ISO13485 Solution
Your best solution for compliance to ISO13485 should include a strong process management component and a strong document management component. It will make your life much easier over the years.
Need some help, give me a call?