Looking for some help. I have recently joined a company and have been given the task of handling the ISO 9001 system and have a question regarding change management. Does ISO 9001 specify you need a process flow on how you manage changes in the way you produce your product.
No, as others have said.
If so how detailed does it have to be.
Here's the right answer to whether you need one (or a procedure), and how detailed it has to be: it depends.
Here are a few of the variables:
- How complex is the product?
- How complex is the process?
- How many people are involved?
- How strong is the need for standardization?
- How experienced/well trained are the people involved?
- What are the consequences of doing it wrong?
A common strategy is to capture the high level flow and, sometimes, responsibilities in a flow chart; then, fill in any salient details with procedures/work instructions. If you can count on people to execute most of the steps in the flow chart, write documents to cover the tricky bits.