Clause no 6.3 - Planning of changes

We are following a change management process in which whatever changes are there is recorded except ECRN changes which design department does it separate. The change management which we follow consists of all the changes like 4M changes operational changes etc.
Can I include QMS changes as per 6.3 in the same sheet which I use for Operational change tracking .
Also can I use any document change, tracking in the same sheet . Can I keep a single sheet for all the changes mentioned in ISO9001 :2015 . Will there be any Problem ?
Can anyone suggest me a format to track Changes related to QMS which can also show a linkage to operational changes .
Can I show my auditor that all the changes I track is In one sheet only & this is OK as per standard .

 

The ECRN satisfies the requirement of 8.3.6 since this clause requires organization to "retain documented information on design/development changes". The 4M change form, if used for design/development, can also satisfy 8.3.6. If the 4M change form is used for purpose of production or service provision, it satisfies 8.5.6 since there is a requirement to "retain documented information describing the results of the review of changes" pertaining to changes on production or service provision. The standard has categorically specify to "retain documented information" on both clauses.

Clause 6.3 has no specific requirement to "retain documented information" so it will be up to any organization to ensure that changes to the QMS are implemented in a planned manner. Not every clause in the standard requires retaining of specific documented information. If an auditor is asking how your organization carries out changes in the QMS "in a planned manner", show any information that your organization deems appropriate. It doesn't have to be in one form.

A good reference when being asked by auditors for evidence is the ISO 9001 Auditing Practices Group Guidance on Evidence Collection. According to this guidance document:

"Auditors should be aware that objective evidence does not necessarily depend on the existence of documented information, except where specifically mentioned in ISO 9001. In other cases, it is up to the organization to determine what documented information is necessary in order to provide this objective evidence."​

 

Welcome to the site @Baner ;

I actually counsel most of my clients to exactly what you describe. Making "QMS" a separate thing....different from the organization's typical processes is not the intent. I fact, the standard requires us to "integrate" into the business.
I counsel that your organization does not hold "ISO" in the left hand and "Business" in the right hand. Instead, I counsel that the QMS should be a seamless part of your organization's fabric. Simply a foundation for how your organization manages its business processes.

In fact, if your organization simply has a change management process (Change Point Control...or whatever you determine to call it), is it still appropriate to refer to that process as "ECR" ? (Generally applying to Engineering Change Request? ) Does that possibly pigeon-hole the use? Pollute the concept of what you are apparently working towards?

Food for thought.

Be well.

John

 

Thank you everyone ..... & I am lucky that I was able to join this Forum