ISO 9001:2008 Mandatory Procedures in Quality Manual

[toto2010]

Hi Everyone,

I have an enquiry. I am developing ISO 9001 Quality Manual.
I have incorporated the 6 mandatory documented procedures into my quality manual. However, my consultant said that the documented procedures cannot be in the Quality Manual. He said that they must be separated from the quality manual. Just like to know which clause states that they cannot be in the QM.

Hope to hear some advices. Have a nice day.
Thank you very much.

Regards,
Toto2010

 

[t.PoN]

Re: ISO 9001:2008 mandatory procedures

ISO 9001:2008
4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
b) the documented procedures established for the quality management system, or reference to them,

Wait, you can make it part of the Quality Manual!!!! i guess your consultant is wrong..

You can make it part of the Quality manual or make it separate documents

 

[Colin]

I completely agree with t.PoN when he says it is up to you where you put the procedures (any of them that is, not just the mandatory ones), clause 4.2.2 states that the manual must include ... or make reference to the procedures.

Just a thought, do consider that sometimes you might be asked to send a copy of the quality manual to customers and if the procedures are in there, you are handing over all of the system virtually. This may or may not be a concern for you.

 

[Randy]

You can carve your procedures in the bark of a tree if that's what you choose to do as long as you can effectively control them and folks that need to can access them.

Have you verified the competency of your consultant like 6.2.1 requires? (He should have more than some shake and bake training course)

 

[PaulJSmith]

Yes, unfortunately your consultant is incorrect. You might ask him to re-read clause 4.2.2.b, and then explain to you why he's telling you that you cannot do something that is clearly prescribed by the standard. If he cannot, then you may want to find another consultant.

Colin also makes a very good point about including it there, though. Something to consider.

 

[Claes Gefvenberg]

Just like to know which clause states that they cannot be in the QM.

We are all agreed: There is no such clause. Your manual must include scope of your system, plus justification for any exclusions and a description of the interaction of your processes.

Apart from that, clause 4.2.2b allows for a manual covering:

• your entire system,
• none of it, or
• anything in between.

 

[Golfman25]

Sounds to me like a semantic argument. What really is a "quality manual?" Most of us in the real world call that binder with all the quality stuff in it a quality manual. My guess is your consultant is advising you to keep procedures separate so you have a convenient quality manual to send to customers who request it.

 

[t.PoN]

What really is a "quality manual?"

ISO 9000:
quality manual: document specifying the quality management system of an organization.

If he wants to separate the procedure for any purpose (better document control, confidentiality issues ....etc) then he should state that clearly. His customer may have a better idea.

he should not say 'because the ISO 9001 says so".

I am afraid that the consultant is following a practice rather than requirements

 

[Sennayagi]

Hi,
The consultant was not wrong. As per the Documentation requirements we defined as 4 level of documents like Level 1 for quality manual , Level 2 for Documented procedure manual , Level 3 for Department procedures and work instructions and Level 4 for formats and documents


That?s why the consultant advised to separate the procedures from Quality manual.


Why because the quality manual is 1 level documents but documented procedure is 2 level documents.


So keep it separate.


Hope it will clear your query.


Thanks
SEN

 

[Colin]

Sen, you are correct in common practice and I normally use a tiered approach to building the QMS but strictly speaking, it is not a requirement, just a preference.

I know that the modern approach is to minimise the quality manual and we suspect that there will not even be a requirement for such a document when the 2015 version arrives but I will most likely recommend to my clients to keep it.

I use it as an interface between the organisation, who are unique and the standard, which is generic. We have 1 standard trying to address every type of organisation, of every size and in many languages. So I use the manual to customise the interpretation of the standard for each organisation - or maybe I am just an 'old git' who is stuck in his ways!!