Do I need to change my SOPs? Transitioning to ISO 9001:2000 from the 1994 version

[sjrutland]

Hello again, as you all know by now I am new to the ISO world. I am trying to get my company tranformed over from ISO 9000 to ISO 9001:2000. My question is do I need to change my SOP's? I have written a new quality manual with the help of all the threads great advise out here but I bit concerned about the SOP's It appears we are in compliance with the ISO9001:2000 standards but just need to know if I need to change the SOP's or leave them as is. Any advise is appreaciated. Thank you all.

 

[SteelMaiden]

If they still reflect the way you are doing things, why change them? Save yourself the worry, you've got more important things to do. Good luck!

 

[Claes Gefvenberg]

I agree with Steel. If your SOP's are in compliance with the ISO9001:2000 std, you are ok. Save yourself the extra toil.

/Claes

 

[RoxaneB]

Hello again, as you all know by now I am new to the ISO world. I am trying to get my company tranformed over from ISO 9000 to ISO 9001:2000. My question is do I need to change my SOP's? I have written a new quality manual with the help of all the threads great advise out here but I bit concerned about the SOP's It appears we are in compliance with the ISO9001:2000 standards but just need to know if I need to change the SOP's or leave them as is. Any advise is appreaciated. Thank you all.

Like SteelMaiden and Claes, there should be no need to change your documentation if if does indeed:

• Reflect what you actually do;
• Address the requirements of ISO 9001:2000;and,
• Works for you.

To quote an old expression, "If it ain't broke, why fix it?"

However, being the cynical and jaded person that I am today ( ), there is almost always more to a story than we first hear about. Do you think your documentation needs to be changed, sjrutland? What is it about your documentation that prompted to you ask the question?

 

[sjrutland]

I ask the question because

I asked the question because I notice the SOP were numbered to follow the
ISO 9000 manual with a few extra's at the end. I feel we are in compliance but know some of the things listed are not required by ISO9001: I just wanted to know if I should take some of them out and them renumber them to match the ISO 9001 requirements. That is the reason for the first question.

 

[Cari Spears]

I reduced our number of documents, which were numbered like ISO9002:1994 before I got here, but I never changed the numbering. I merged procedures into others or eliminated them completely, but, for example, our Contract Review Procedure is still TCP.03.01 and all the resulting forms are TCF.03.whatever. The ".03" is just an arbitrary number now - it doesn't relate to the standard anymore.

Now we have a specific requirement in AS9100 that we have to take into account for clearly showing the relationship between the requirements of the standard and our documented procedures. I won't go through and change all of our document numbers - besides, so many things overlap, leaving you to choose which number it most fits. Phooey. Also, we prescribe to more than just ISO and soon AS9100, we also have Part 145 Repair Station stuff to consider in the very near futur.

I figure what I'll do is create a matrix listing our documented policies and procedures, with a column for each standard/regulation and just list the clause numbers that each procedure addresses. I can "save as" my Master Document List and add appropriate columns, but I haven't thought it all the way through yet.

As an ISO registered company, before all the AS and FAA stuff, I would have never sweated the way documents are numbered.

 

[Jeff Frost]

My company elected to keep the 20 element format and developed a matrix to link to ISO 9001:2000 and AS9100A (now B revision). One exercise that we did do was to obtain a copy of AS9101 QMS Assessment that registrars are required to use.

Using AS9101 we then performed a procedure audit to determine which procedure linked with the various Clauses of AS9100. This also helped use to identify what other process, procedure, document or a documented procedure (look up each meaning in ISO 9001:2000 to see the deference) would be needed to meet the requirements of the standard.
Once we understood how our system linked to the requirement of AS9100 (could also be ISO 9001) we then developed our quality manual which contains:

 Quality Manual - 4 pages
 List of procedures - required by AS
 Cross Reference Matrix - Requirements of standard to our QMS.

Now some would say why not completely re-due the documentation system and we respond with the following:

 Standard requires that QMS be developed to meet the companies needs and not the registrar's preference.
 The 20-element system is integrated into our build process and is understood by all our employees.
 We must meet deferring industry QMS requirements other than ISO or AS so we kept what works for us and we make the registrar's work a little harder for their money.

Hope this insight helps.

 

[M Greenaway]

Nice one Jeff.

Out of interest what did you do to address the requirements under the 'process approach' ?