We are an ISO 9001:2000 company. When we got the certification originally, it was for ISO 9002, but last year we moved to ISO 9001. We had lots of laboratory testing methods, manufacturing procedures and formulae etc., basically confidential information from our production and quality control/assurance area as part of our SOPs. Now ISO 9001 includes industry regulatory requirements (like GMP) whereas it didn't previously.

Our QA manager, who is now also the MR, wants to take out all our 'confidential' manufacturing formulas and testing methods (around 200 SOPs) out of the ISO net and keep the documentation separately, and just wants to have one SOP saying that products are manufactured according to available and documented procedures and tested according to available and documented testing methods.

Is there any problem with that? What are the advantages and disadvantages of taking these out (considering we've been externally audited multiple times with these same procedures in there). He believes that will lighten the ISO load and that formulae and methods are internal company business and shouldn't be shown to the external auditor (but can be displayed if asked, to show we are documenting these things). Any guidance would be appreciated. Thanks!

-Adil

IMO, sections 4.2.1 and 4.2.3 are pretty straight forward.

I think you need to control these documents as part of the QMS.

Section 4.2.1 states:

“The QMS documentation shall include documents needed by the organization to ensure the effective planning, operation, and control of its processes.”

I agree with BadgerMan. If the documents are used for the planning, operation, or control of your processes, they're part of the QMS and are fair game to be audited no matter what document control system they are hidden in.

How will changing control of those documents from one system to another "lighten the load?" It sounds like the QA manager believes that the QMS is not part of the company's business operations. It's a bad idea to separate your quality system from your business.

It's a bad idea to separate your quality system from your business.

Exactly! That's why many are renaming their QMS by calling it their BMS (Business Management System).