I am currently working with a medical manufacturer to help them implement Teamcenter software so that they can be FDA compliant. Their focus is ISO13485 [which encompasses ISO9001]. They need to have many procedures in place.
Over-simplifying, to be compliant with ISO9001 a company needs to be able to show written documentation as to how they design and manufacture their product. Then they need to be able to prove that they follow those procedures.
ISO13485 calls for a risk management procedure. In 2015, ISO9001 added risk management to their list of procedures. Risk management procedures may seem obvious, but do you have a written procedure to manage risk?
PLM Software and Procedures
The great thing about PLM software is that it can manage your processes for you. You still have to write the procedures, but you can configure your PLM software to manage them for you.
PLM software simplifies your ISO9001 audits. Show your auditor your procedure and then show them how the PLM software makes sure that all of the steps take place. Show them the documents, approvals and signatures.
This audit that used to take most of a week, will now take only a matter of hours.
With the addition of risk management, you will need to write another procedure and it will likely be complex. I can almost guarantee that you will be editing [improving] it over time beginning with the first time you attempt to follow it. Your PLM software will provide control and visibility to your Risk Management process.
ISO9001 compliance is a good reason for PLM software. Interested in learning more, drop me a note…