ISO 9001 Clauses - Using only 23 of 62 Clauses

[Marc]

Yup - The requirements of each clause can be in separate documents and they do not have to reference the clause, either. They don't have to be in the quality manual. But... Most companies have, at the least, a matrix which points to the document(s) which fulfill each applicable clause of the standard so it's very clear each of the clauses is addressed in their quality system. Back in the 1990's it was sort of expected that the quality manual had to address every clause in the standard. These days a quality manual can consist of little more than a high level flow chart.

 

[TPMB4]

An old thread but I thought I would bring this up as I have seen a few threads and sample manuals that basically mirror the ISO9001:2008 standard.
I'm planning to totally update our manual as it is highly dated in look and even substance even if it does allow us to be certified and pass our 3rd party audits. Being new to the Quality representative role I've obviously looked around for ideas and there seems to be a lot who just regurgitate the standard. I've seen countless examples that in the first three sections even show the PDCA diagrams. Why?

That is why I see those 2 page manuals and think something closer to that end is better than creating an ISO 9001 standard clone.

Please correct me if I'm wrong but the whole QMS manual is about documenting what YOU do and whilst reference to particular clausesmight be useful to those who don't know them the auditor should be able to work out what clause a particular section or procedure is about.

Sorry if I sound a but angry but as someone who is really working from a low knowledge level I took some time to realize that these regurgitations are not needed. I have wasted a lot of time already trying to produce my own version of this.

Of course if I am wrong about this please correct me. I am willing and very keen to know. Correction of my mistake or misunderstanding (if that is what this is) would be a valued service to me.

Unless someone convinces me that I am wrong I will chart the processes in the company I work in and produce something from that. Basically document the processes that all work well and tidy up those that don't. Think I prefer the KISS approach but not quite down to 2 pages...yet!

BTW I already know our 3rd party auditor is supposed to be keen on simple systems where possible after he was told we were re-writing our manual and procedures. So provided I don't miss anything a simple manual should put us in good stead. Might actually be read by people other than the directors and me!!

 

[Jim Wynne]

An old thread but I thought I would bring this up as I have seen a few threads and sample manuals that basically mirror the ISO9001:2008 standard.
I'm planning to totally update our manual as it is highly dated in look and even substance even if it does allow us to be certified and pass our 3rd party audits. Being new to the Quality representative role I've obviously looked around for ideas and there seems to be a lot who just regurgitate the standard. I've seen countless examples that in the first three sections even show the PDCA diagrams. Why?

That is why I see those 2 page manuals and think something closer to that end is better than creating an ISO 9001 standard clone.

Please correct me if I'm wrong but the whole QMS manual is about documenting what YOU do and whilst reference to particular clausesmight be useful to those who don't know them the auditor should be able to work out what clause a particular section or procedure is about.

Sorry if I sound a but angry but as someone who is really working from a low knowledge level I took some time to realize that these regurgitations are not needed. I have wasted a lot of time already trying to produce my own version of this.

Of course if I am wrong about this please correct me. I am willing and very keen to know. Correction of my mistake or misunderstanding (if that is what this is) would be a valued service to me.

Unless someone convinces me that I am wrong I will chart the processes in the company I work in and produce something from that. Basically document the processes that all work well and tidy up those that don't. Think I prefer the KISS approach but not quite down to 2 pages...yet!

BTW I already know our 3rd party auditor is supposed to be keen on simple systems where possible after he was told we were re-writing our manual and procedures. So provided I don't miss anything a simple manual should put us in good stead. Might actually be read by people other than the directors and me!!

I agree with you completely. There's a lot of discussion here in the Cove on the subject. For example, have a look at Boss Wants a 4 Page Manual for starters.

 

[somashekar]

Unless someone convinces me that I am wrong I will chart the processes in the company I work in and produce something from that. Basically document the processes that all work well and tidy up those that don't. Think I prefer the KISS approach but not quite down to 2 pages...yet!

Yes, you have to map what you do with the standard, and then find gaps if any and bridge them, and not the other way round, mapping standard to what you do.
Apart from keeping what the standard requires in your quality manual, you can add more if that makes any use to you. It is certainly not about 2 page or 20 page manual.

 

[TPMB4]

Thanks for that. I did wonder if I was a bit mad. To me I could not see why things need to be that complicated. You have a company, it's not a big, multi-site corporation, it has procedures that are robust and well maintained. As a company it works so why make it bigger than it is.

I reckon I will write something out based on less than a page for policy, objectives and the scope (we don't design nor service so that is excluded). Then we have a small handful of processes that could be simply written up. Think I will try for less than 10 pages with the content spread out only for ease of reading. Although I will not dictate a page number before it is written.

Just one question for procedures. Are flowcharts or written procedures best these days? I mean do flowcharts look old hat for procedures? I've seen written ones with inputs/outputs, entry/exit criteria, etc. What is best?

 

[Jim Wynne]

Thanks for that. I did wonder if I was a bit mad. To me I could not see why things need to be that complicated. You have a company, it's not a big, multi-site corporation, it has procedures that are robust and well maintained. As a company it works so why make it bigger than it is.

I reckon I will write something out based on less than a page for policy, objectives and the scope (we don't design nor service so that is excluded). Then we have a small handful of processes that could be simply written up. Think I will try for less than 10 pages with the content spread out only for ease of reading. Although I will not dictate a page number before it is written.

Just one question for procedures. Are flowcharts or written procedures best these days? I mean do flowcharts look old hat for procedures? I've seen written ones with inputs/outputs, entry/exit criteria, etc. What is best?

What's best is what accomplishes the mission with the least amount of trouble. Less is more, in most cases. Flowcharts are fine so long as they convey the requirements clearly.

 

[TPMB4]

Yes, you have to map what you do with the standard, and then find gaps if any and bridge them, and not the other way round, mapping standard to what you do.
Apart from keeping what the standard requires in your quality manual, you can add more if that makes any use to you. It is certainly not about 2 page or 20 page manual.

But the manual does not have to look like the standard or even refer to it. i have the idea that the manual is a record of what you do. The 3rd party auditor knows what the standard requires and must be able to recognize what your process/procedure covers in the standard's clauses / requirements. He/she assesses the manual and system to determine if it is capable of covering those clauses or requirements then he/she audits the company to see that they actually do what is recorded in the manual.

In my mind the manual does not have to refer to the standard at any point. It just has to meet the requirementsto enable the auditor to certify (if you do what you say that is and that is another matter competely).

From my view I intend to do less than 10 pages if I can and still have not decided whether for internal use to actually quote the clauses for each process/procedure. I suspect I will since I have generated audit checklists based on the clauses so should reference them somewhere in the manual, perhaps in a flowchart of the processes. I won't create sections 4, 4.1, 4.2, 4.2.1, 4.2.2, etc. and write in what we do for those clauses.

I will at least find it interesting come next 3rd party audit as it is the 3 yearly re-certification one.

 

[Randy Lefferts]

What you put in the quality manual is up to you as long as it meets :

4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.

I created a 2 page quality manual after seeing an example in this thread. Post #9, by DrM2u, contains an example.

 

[Rickser]

One of the "catch phrases" I use when working with processes, procedures and quality manuals is: "Say what you do, do it, and document that you did it". That has worked well for me, especially when getting employees to write processes. Clauses and the number of clauses do not matter as long as you meet the requirements of the ISO standard. You can combine requirements into one process. You can spread requirements out over more than one process (though I can't figure out why anyone would).