Change Management System - Does ISO 9001 specify you need a process flow?

[Jameson4]

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. If so how detailed does it have to be.

 

[Duke Okes]

Re: Change Management System

It is not necessary but if it is a complex process it might be useful as a way to summarize the related procedure.

 

[antoine.dias]

Re: Change Management System - ISO 9001

Hello and welcome to the Cove.

In 9001, several locations are found with reference to changes :

4.2.3.c
5.4.2.b
5.6.1
5.6.2
7.2.2 ( x3 )
7.3.7 ( x5 )

Although it is not directly required in the standard it is best that you manage the way changes are incorporated in you company.
If you have this documented is up to you.

Best regards,

Antoine

 

[Kales Veggie]

Re: Change Management System

The ISO 9000 standard requires only a handful of documented procedures and a quality manual.

I agree with other Covers here. It would be in your best interest to document/flow chart your process. The complexity of your documentation would depend on the complexity of your product and potential impact on your company and your customer (making a change to a complex engine is different from making a change to a bolt).

Do it for the good of your company and customer, not for the standard.

 

[CliffK]

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.

 

[Jameson4]

Thanks for all the replies. It looks like I'll be a frequent user.

 

[CliffK]

Thanks for all the replies. It looks like I'll be a frequent user.

You're welcome.

Welcome to the Cove, too. (Where have my manners gone?)

Look around. You will find loads of resources and advice.

 

[AngLow]

Does anyone have an example flowchart of procedure for management of change that i could reference?

thanks

 

[JaneB]

Does anyone have an example flowchart of procedure for management of change that i could reference?

thanks

How about you tell us more about:
1. What kind of product/s you produce now
2. What kind of workflow /processes are involved ?
3. Do you have any flowcharts that show this?

Without better information, it's slow guessing to try and figure out what you might be after.

Alternatively, try searching the Posts Attachments List (see green button at screen top).

 

[somashekar]

Hi Jameson ...
Take a look at the Note 1 of 7.1

NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract can be referred to as a quality plan.

and then ISO 10005:2005, Quality management systems — Guidelines for quality plans.

Does ISO 9001 specify you need a process flow on how you manage changes in the way you produce your product. If so how detailed does it have to be.

It can be as detailed as you wish to have and maintain. All that it has got to be is really really useful to you. Any change can be first addressed from the quality plan document which will drive down further to the areas requiring changes.