New Quality Manual

Hello,

I was brought into a manufacturing company as a QA Manager with the need to implement a QMS and write the Quality Manual. For context the company was established about 20 years ago, grew rapidly, and was subsequently sold due to the need for a more structured approach opposed to the "Mom & Pop" shop system it had thrived off of in its younger years. The aspirations of top management is that we move to an ISO complaint system. Currently, we work to ASME for some of our products and are ASME code certified meaning we have an ASME Code Quality Manual. However, that doesn't cover a vast majority of what we do. We really need a Company Quality Manual that pertains to the non-code portions of manufacturing that we do. Under these circumstances, is it recommended to use a 2 Manual system? (ASME Code Quality Manual & Non-Code Company Quality Manual?)



Regards,

WC

 

What @Andy Nichols said

Good day @Will Carl and welcome to the site. I have been doing this for a long time ( 25 years +), buy I never have and still have no idea know what is meant by a "quality manual" and the purpose of it.
Oh, I know what the standard originally asked for (and the IATF...different subject, still bitterly clings to) . I've written many, and I understand what was "literally" required (I assume you are aware that ISO 9001 no longer requires a so called 'quality manual'.

The amount of "overthink" and effort which I see companies struggle through to create a "quality manual" that often provides no value to the organization, is disheartening.

Regardless, I would strongly counsel that any and ALL document your organization creates, is developed selfishly so as to add benefit to your organization and not created simply for the sake of an auditor. I would also counsel that all documentation your organization develops falls within the common governance of your systems and processes and is singular (i.e not separate/redundant, which will cause a document control nightmare and confusion for your teams. I've dealt with organizations who had separate documentation for multitude of standards/certifications instead of integrating and consolidating. This never ends well.

Hope this helps.
Be well.

 

If your intention is to define and describe the other non-code portions of the manufacturing processes of your organization, you may find it beneficial to merge them with the processes that are ASME compliant.

Your manual should not be structured against the clauses of a standard, which @Andy Nichols dissuade organizations to do. It's not even what ISO 9001 intends when it stated in its Introduction this statement "It is not the intent of this International Standard to imply the need for: alignment of documentation to the clause structure of this International Standard."

Map your processes (ASME coded and non-coded) and use this map as the basis for the structure or outline of your manual. This what ISO 9001 prescribes in its Annex A.1, which states "The structure and content of documented information related to a quality management system can often be more relevant to its users if it relates to both the processes operated by the organization and information maintained for other purposes."

Below is a sample of the outline of a quality manual that describes the three groups of processes of an organization's QMS:

 

My concern is the updating of a QC Manual. When updating an ASME QC Manual it must be approved by an AI Inspector prior to implementation. So, if I merge them together, is it required to have an AI approval to update sections of the manual that are not regulated by the ASME code?

KR,

WC