Let’s first define what is change — a change is any modification to an element in the QMS or to a combination of several elements that may affect the quality of the product or the service. There are numerous events and files that are subject to change in the quality management system. For example, customer feedback and complaints, product failure, determining risk, internal audit results, etc.
The quality management system faces various changes during the lifecycle of your product regularly. And the point here is to handle that change effectively because it’s one of the most important functions in QMS. And what else very important is to document those changes.
4 clauses in ISO 9001:2015 are talking about changes, and they are:
· 6.3 Planning of changes
· 8.1 Operational planning and control
· 8.3.6 Design and development changes
· 8.5.6 Control of changes
But as you know, in any QMS, it’s crucial to control your changes. You need to carry them out in a planned manner. As in Planning of changes — lecture is said, changes have to be beneficial, but also relevant and achievable.
Steps when planning and controlling changes
Before we discover what is needed to document changes, it would be beneficial to understand its purpose first. The purpose of a change refers to the anticipated outcome of the change, and it guides your planned actions.
When is it needed to control and document changes? And which changes are needed to be documented? Each time a change may affect the activity that the documented information supports (internal and external).
ISO 9001 advises you to create your method for documenting and controlling changes. There are just a few requirements that you must consider, and that is that you have to identify it, describe the change in detail, then identify affected documents. Afterward, when change is implemented, it has to be authorized by a designated person, and last but not least important when it is going to take effect.
And now we can talk about steps — The key steps of the change management process are planning, evaluation, documentation, review, approval, communication, implementation, and post-implementation review.
You have to document changes and update them throughout the change management process.
Nowadays, most companies use change management software to manage change requests, review, and approval workflows.
Smaller companies with resource limitations may still use simple Change Request Forms to manage manually the change requests, reviews, and approval processes. Important information must be taken for each change request, regardless of the change management tool (sophisticated software or Change Request Forms). It requires the mandated information for adequate review by others (approvers and change control review board) for approving the requested change.
Documenting change easily
It might seem complicated now to you, but it is not if you use the right tool. qmsWrapper has everything you need. How? Since you can create any module you need, you can create a Document Change Management module. Purpose-built to work the way your company works whether it change requests of existing current content or change orders forms of revised documents.
qmsWrapper can help you:
· Get approvals to change current content with change requests
· Manage changes to multiple documents with a change order so they are reviewed, approved, and made current as a synchronized group
· Identify the reference documents
· Document the reason for the change
· Create a thorough description of the changes to your documents
· Add comments to support the review and approval
· Attach affected documents
How to do it exactly you can read it in use case: Document change request process.