iso 9001 implementation and action plan

Andy asking for Context is important, but from my understanding and experience it's the following (Please correct me if I'm wrong)

3.3.10
change control
<configuration management> activities for control of the output after formal approval of its product configuration information.

Translates roughly into:

Any proposals for change, evaluation & approval of change, implementation of change & verification of change are adequately captured and 'documented*' or tracked* (*What ever the context of your question is).

It's dictating that any changes/modifications made to product/process/service are thoroughly managed & recorded some where. This will help to maintain and align the products design/configuration information throughout the entire process. Basically, the changes exist within a well established process that is controlled, captured & monitored.

In the context of my experience, this is an Engineering change request, or "ECR". A change is requested to a design, some one evaluates that change on an individual basis or assessing the changes impact on the overall design. They approve or disapprove. The approval is flowed down to an Engineer who makes the relevant changes, Modelling, CAD, other technical outputs etc. Then a prototype is produced and validated/verified before final implementation.

 

Thanks @monster, if i take your example of modifying something in design then it will require a documentational evidence to capture the change but what if a new design is introduced to the system, i guess that will also requires a documentation right?

 

yeah Andy i am on it (Going through it), Thanks

 

For a new design, you would be looking at 9001 "8.3.3 Design and development inputs". Orgs may have some sort of project scope document that captures all relevant 'inputs'*, produced for review before any commitment to a new project takes place. 9001 requires that these inputs SHALL be documented. *9001/9002 give advice for what these inputs might be.

As for documentation, don't take a narrow view on it. It could be a document for the proposal of a new design/service/process that has relevant items to consider, it could just be the minutes captures from a meeting to discuss, a recorded phone call with a customer. Just make sure it's captured in some way.

It's important that you capture these initial inputs, because if you don't - how will you measure the success of the outputs?


ISO 9000 gives the following definition:

3.8.5
document
information and the medium on which it is contained

 

Andy, i am not concerned about design i just took this as an example, my point is if anything introduced to the system for the first time does this also follows this clause, i guess not, as you said 8.3 describe the whole thing for it.

By the way thanks for your value adding points..

 

Got your point clearly thanks for clarifying @Monster