Engineering SOPs

sberg0408

Registered
I recently started as Quality Manager at a facility. They have not ever had a dedicated quality manager who could evaluate their ISO system and guide them through audits. They currently have very few SOPs and work instructions for the general work force here, but they have a huge book of Engineering Standards - SOPs - that they follow for guidelines on inspections, purchasing, receiving...basically everything you would normally have an ISO SOP for, except none of them are noted in the Quality Manual or list of company SOPs. Since they are the guidelines virtually all of the departments are using for guidance, should they be tied to ISO? I have never worked for a company that has so few ISO procedures, work instructions, or processes, but has a huge library of Engineering SOPs. I believe that in the past for audits, they were just not mentioned. They are "open" to having them integrated into the QMS - which is a whole other ball of yarn here, but am I opening a can of worms that does not need to be opened?
 

Golfman25

Trusted Information Resource
Why make such a distinction? To me, the biggest mistake Quality types make is talking about quality, ISO, etc. as if it's something separate. Every company has procedures and processes, some documented, some not. Who cares what they are "called." The only question is whether they are sufficient to satisfy an ISO clause. Sounds to me like these engineering standards go a long way to complying with the parts of any standard. I would map them to the standard and see what you have got to work with.
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Welcome to The Cove!

"ISO procedures" became a thing of the past with ISO 9001:2015, as the six procedures required in ISO 9001:2008 are no longer listed.

Now it says documented information, which the organization decides is needed unless some regulators or customers decide it for them. So I think it is encouraging to hear you have engineering SOPs, they need to be accurate and readily available to those who need them. Document control methods are of the organization's process design too. ISO 9001:2015 was purposely vague on those requirements so as to allow organizations the freedom to do what serves them and their interested parties best.
 

Mike S.

Happy to be Alive
Trusted Information Resource
How large of an organization is this? Are they certified to any standard? If yes, to what standard and by whom?

If someone took that huge book of Engineering Standards - SOPs and tossed it in the dumpster, would it matter? If yes, they should be controlled and part of the QMS.
 

Sidney Vianna

Post Responsibly
Leader
Admin
ISO procedures
There is no such a thing. There are no ISO manuals, no ISO procedures, no ISO forms, no ISO system, etc. Anyone that thinks they need ISO this and ISO that, outside of the organization’s business processes and day to day operations, has not understood what a quality system really is.

The advice already offered in this thread is pretty wise.

Good luck.
 

Randy

Super Moderator
I have never worked for a company that has so few ISO procedures,
As bad as it tastes, I stand with Sidney on this. Just like him and maybe one or two others here, we've been in this business a long, long time working from the 3rd party certification side of the house and even our respective employers don't have ISO procedures, manuals, manuals, forms or records, and neither do our clients. There are Management System documents such as procedures, manuals, forms, records, procedures and all that giz, but sadly, no ISO thingies................Now the ISO itself, in Switzerland might have one or two or ten, but they're probably the only ones.

So start from the git-go, you have a Quality Management System, not an ISO system, and then go from there.
 

sberg0408

Registered
How large of an organization is this? Are they certified to any standard? If yes, to what standard and by whom?

If someone took that huge book of Engineering Standards - SOPs and tossed it in the dumpster, would it matter? If yes, they should be controlled and part of the QMS.
We have roughly 45 employees. We are ISO 9001:2015 certified. I do not really care if they are engineering standards or quality standards, I just want to make sure our next audit (April - recertification), that we have our ducks in a row. If the standards were thrown out, it would matter a lot. Like I said these are their guidelines for everything - from what material to order, to how to design our parts, to our part structure requirements.
 

sberg0408

Registered
There is no such a thing. There are no ISO manuals, no ISO procedures, no ISO forms, no ISO system, etc. Anyone that thinks they need ISO this and ISO that, outside of the organization’s business processes and day to day operations, has not understood what a quality system really is.

The advice already offered in this thread is pretty wise.

Good luck.
I understand, I am just used to what I am used to! :) I like the fact that they have already established what works for them as far as documentation, my only concern was how it tied to the QMS since right now, they are not. They are kept hush hush and not shown to auditors.
 

sberg0408

Registered
As bad as it tastes, I stand with Sidney on this. Just like him and maybe one or two others here, we've been in this business a long, long time working from the 3rd party certification side of the house and even our respective employers don't have ISO procedures, manuals, manuals, forms or records, and neither do our clients. There are Management System documents such as procedures, manuals, forms, records, procedures and all that giz, but sadly, no ISO thingies................Now the ISO itself, in Switzerland might have one or two or ten, but they're probably the only ones.

So start from the git-go, you have a Quality Management System, not an ISO system, and then go from there.
I think that is part of the problem. They see the QMS as Quality only....not the whole business structure. So they exclude the Engineering standards because they are not part of quality. They got the certification because it was suggested they do so by their customers (many government), and they got an auditor who was their buddy and passed their audits for them. Now, we are getting new auditors, and are getting dinged for things in the audits. So I guess my biggest problem is trying to make them understand the difference between Management system and ISO.
 
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