Experience folding your QC Manual for ASME Section VIII, Division 1 into ISO 9000?

[warren]

Anyone have any experience folding their QC Manual for ASME Section VIII, Division 1 into ISO 9000? I would be interested in how you went about it. Seems like I would not want to end up with two documents at the end, and that performing the ISO exercise would satisfy the ASME requirements. Thoughts?

WRW

[CarolX]

Hello Warren - Welcome to the Cove

I am not familiar with the ASME spec. But, I would recommend combining both into your quality system. Nothing in ISO9K prevents you from exceeding the requirements. Compare the two specs and pick the tighter requirement and use it.

Good Luck!

CarolX

[HFowler]

Warren,

I have been a Quality Assurance Manager for a couple of companies that manufactured pressure relief valve to ASME Code Sections I, IV & VIII (Divisions 1 & 2) over a (10) year period. I have written a few manuals in ISO 9001 format that also included ASME requirements.

You can purchase a copy of Boiler Inspector's Code (NB-23) from The National Board of Boiler & Pressure Vessel Inspectors. It has guidelines for developing an ASME compliant Quality Manual. The National Board also sometimes does a seminar on writing a Quality Manual to comply with ISO 9001 and ASME Code.

I have had several ASME Shop Reviews and never a problem. I wrote my manuals just like I would for ISO 9001 and added the following to satisfy ASME.

Title Page must include company name and address just as it appears on your ASME Certificates. I also included the sections of the ASME Code that we were authorized to.

Next page was a Log of Revisions page that had a place at the bottom for signatures of the person with executive responsibility, the Quality Assurance Manager and the ASME Designee (or National Board Acceptance).

At the beginning of the manual, I had a Scope of Work Page that listed the test media, (air, water & steam) and the test pressure capability range for each media. On the same page, under a heading called Approved Materials of Construction, I listed the relevant paragraphs of ASME Code for each section that dealt with that topic.
For example: Engineering refers to the following document when specifying materials to be used in the manufacture of Safety and Safety Relief Valves:
Section VIII, Paragraph UG-136 (b) (3)
(NOTE) Always check the latest revision of the ASME Code for requirements!!!

Under the Section - Responsibility & Authority - ASME & The National Board always expect to see a description of the organizational structure with functional responsibility. You will need to include an organizational chart. You need to include a paragraph that states who is responsible for the review of Industry & National Standards, ASME Code Editions, Addenda and revisions, etc. You will also need a signed letter on company letterhead from the President, or someone with executive responsibility, that states that the Quality Assurance Manager, irrespective of other responsibilities, has responsibility, authority and organizational freedom to carry out the Quality Program.

Under Control of Documents - You must state that a controlled copy of the Quality Manual will br kept on file with The National Board of Boiler & Pressure Vessel Inspectors. Also state that The National Board has free access at all times to all documentation and locations within the organization where Code activities are performed. Include a statement regarding how changes to the Quality Manual are handled and that a copy is sent to The National Board for review and acceptance.

ASME and The National Board expect to see an Approved Suppliers List which I always mentioned under the Purchasing section of my manual.

The NB-23 that I mentioned earlier has a section regarding "special processes", such as welding, heat treating and nondestructive testing, etc. You must address this in your manual. If you don't perform any special processes, then state that, otherwise tell how welders are qualified, weld procedures are controlled, etc.

You have to describe how your ASME Code symbols are controlled and used. In this section, also describe nameplates that bear ASME Code symbols, such as UV in the case of Section VIII.

The last thisg I can think of, off the top of my head is, that ASME and The National Board expects to see samples of completed forms associated with processes affecting quality, engineering drawings, purchase orders, inspection sheets, etc. I usually included these in an appendix to the manual.

They will also want to see a copy of your associated procedures when they come for a Shop Review to approve or renew you ASME Certificates of Authorization.

I hope this helps. I know it was wordy, but it's not as bad as it sounds.

Best Regards,
Hank

[warren]

Thanks for the welcome wagon!

I pretty well have the ASME and Nat'l Board requirements well in hand. We are a pressure vessel shop with the "U","UM", and "R" stamps.

My confusion (a seemingly terminal state) comes out of the ISO side and incorporating what I already have for ASME into the ISO9001 format, and having the same document survive audits from each angle. I rather expect to get much help from my Authorized Inspection Agency since they will also be my Registrar for ISO (and Notified Body for CE purposes).

The purpose of my post was to solicit "real world" answers from those who've been there before. Hank, your approach seems to be fair and straightforward, utilizing the ISO form and inserting the ASME. I guess my trepidation is based on abandoning my "QC Manual for ASME" (my baby!) for another form with a much wider scope, and bringing all my control documents into line with ISO.

Cheers, WRW

[HFowler]

Warren,

You don't have to abandon your "QC Manual for ASME". As a matter of fact, your Authorized Inspector will appreciate being able to find all of his concerns easily. My experience has been that they are sometimes frustratred by having to find areas of the manual that they are particularly interested in buried in all the "ISO stuff".

I think its easier, from a document management standpoint, to pick a format that's understood by the majority and include the other statutory and regulatory requirements. When you start working with your Notified Body on CE Mark Approval, you will be faced with the same dilema. He will have to review your manual as well as other documentation. As I remember the requirements of the Pressure Equipment Directive (PED), I would still opt for the ISO format for the long haul. My experience also included Licensing by the Chinese Boiler & Pressure Vessel Inspectors (CBPVI).

Of course, this is just my opinion. Good luck in you efforts.

Best Regards,
Hank