What Exclusions to the ISO 9001 standard are allowed? Clause 1.2

[samsung]

Re: Exclusions to the ISO standard

Statutory requirements usually relates to the technical specifications such as minimum required compressive strength at 28 days, maximum chloride content, setting characteristics and some others. How you design your product, test, manufacture, validate and others are entirely up to your own.

Over most part of the whole world, manufacturers either follow the practices of the Cement and concrete associations of America or UK.

Thanks a lot for your input. It is correct that statutory requirements relates to tech.specs. only & do not require 'validation' as defined by 9001. However, 3 & 7 days Compressive Strengths (even 1 day strength is also determined) & all previous checks at all points of production right from mining of limestone, may be used as supporting (objective) evidence of the process having been duly validated as planned.

Just curious ... have you checked with other manufacturers on how they tackle this "statutory" specification since its statutory, all manufacturers would be bound by this requirements ?

I have so far not checked with any other manufacturer but a good idea to have a try. I will also check with Cement & Concrete Association of US & UK.

Best regards,

 

[Big Jim]

Re: Exclusions to the ISO standard

I've come to the conclusion after studying our manual that I don't need to exclude anything. My shop process goes simply from order entry to shop to assy to test and on out the door. If field service is required that is covered as well. The only thing bothering me now is the statement:
"Where Premier chooses to outsource any process that affects product conformity with requirements, Premier ensures control over such processes. Controls of such outsourced processes are identified within our QMS.
note: Processes needed for the Quality Management System referred to above include processes for management activities, provision of resources, product realization and measurement"
The processes that are spoke of I think are procedural processes. This was worded to leave alot of gaps. Any thoughts?Help?
I really hate chasing after someone elses cheap work. sorry had to say it. just venting.

You are talking about two different things. Exclusions and Outsourcing. Exclusions are related to 1.2 and 4.2.2. As others have explained, you can take exclusion to things from element 7 only. You can only take exclusion if you don't do it and if you have no responsibility to do it in meeting customer requirements.

Outsourcing is addressed in the last part of 4.1 as you quoted. If you choose to outsource something, it has to be controlled and that control has to be part of your quality management system. Outsourcing is usually controlled in the purchasing process. You cannot claim exclusion for things that you outsource as you still need to control them.

 

[JaneB]

Re: Exclusions to the ISO standard

unforntunatly yes. A consltant wrote it back in 1994 or so. Its a been a bear to update.

The advice to chuck it away and start again is very sound advice.

Trying to work on one based around that 94 version will drive you bonkers, and is not likely to be productive. Out with the Ark and let's get with the 21st Century!

 

[JaneB]

Re: Exclusions to the ISO standard

You only need to put in an 'exclusion' clause if you want to exclude a particular clause. You can put the exclusion bit anywhere you want to. You can only exclude clauses from section 7, as stated.

To help you understand how to do it, there's a document you can get from ISO with a range of examples in it. It's not bad.

See the TC site, and get the document called Guidance on ISO 9001 Sub-clause 1.2 'Application'

If you read through the examples in the Appendix to that document, & look at the relevant clauses, this may help you to understand how it works.