What is acceptable quality manual content? How much detail to put in here?

[cleverfox]

What is acceptable quality manual content?

I am writing the transition quality manual and am unsure how much detail to put in here. Is the quality manual just the shalls redressed? Or is it a declaration of how the organization plans on meeting those requirements.

Take this requirement, "5.5.3 Internal communication - Top managament shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the" QMS.

Example1 - Top management at XYZ Corp. ensures that appropriate communication processes are established and that communication takes place regarding the effectiveness of its QMS.

Example2 - Top management reports on the effectiveness of the QMS through team briefings, notification boards, and other management led discussions.

We all know that some processes are too varied to detail in a quality manual, so is it better to just say that the organization will do it and let the auditor ask how we do it and show them, or say how it intends to do it more specifically?

What are your thoughts?

 

[noboxwine]

Waste of Time IMHO

In my many moons of doing this, I have always just copied the standard, added a company logo and controlled it. Never before have I seen a use or value for a Quality Manual in house----it's just a waste of time used for registrstion compliance purposes only. If you see some value, structure it the way you'd like and go for it----but dont set yourself up for audit findings. Let us know and good luck !

 

[Claes Gefvenberg]

Hullo fox,

I suggest you begin by taking a look in ISO 9001:2000 clause 4.2.2 and then proceed to the thread Help - Tips on updating Manual (1994 - 2000) .

4.2.2:

The organization shall establish and maintain a quality manual that includes​

a) the scope of the qualityman agement 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.​

If you already have the have the system up and running all you have to do in order to comply with b) is to put in a reference to your system. If so, the manual can be very brief indeed.​

/Claes​

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[db]

I am writing the transition quality manual and am unsure how much detail to put in here. Is the quality manual just the shalls redressed? Or is it a declaration of how the organization plans on meeting those requirements.

Take this requirement, "5.5.3 Internal communication - Top managament shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the" QMS.

Example1 - Top management at XYZ Corp. ensures that appropriate communication processes are established and that communication takes place regarding the effectiveness of its QMS.

Example2 - Top management reports on the effectiveness of the QMS through team briefings, notification boards, and other management led discussions.

We all know that some processes are too varied to detail in a quality manual, so is it better to just say that the organization will do it and let the auditor ask how we do it and show them, or say how it intends to do it more specifically?

What are your thoughts?

I like example 2 better. It shows that you have read, understand and are applying the standard. Also, there is no requirement for Level 1 docs anyway. All you have to do for your QM is just what Claes suggests. Remember, if you need to document things for control, then document them. Other than that, you only need to document what absolutely aligns with a "shall". Make the system work for you and don't build a monster you can't feed.

 

[cleverfox]

Thank you NOBOXWINE, Claes and Dave B. I think I will go both ways. I will restate the shalls and when it is not too constricting I will try to add some value and show the auditor that we (I) have read and understand the standard.

I really enjoy getting feedback from my peers so quickly. I think that we all usually know what needs to be done, but need re-iteration from others who have been through this. Kind of like sticking our toe in the water before jumping in completely.

Thanks guys,
fox

 

[everest]

Internal Communications and QM

We simply placed a flowchart into the QM to address internal communications.

 

[Cari Spears]

Myself, I started out rehashing the standard and adding more text to make the document useful, then completely changed my mind later. I posted my rough draft @ "Is your company registered to ISO9001:2000" and received a lot of feedback from the forum (thanks everyone!).

I also searched these forums and did an internet search and looked at dozens of examples. I just searched for "Quality Policy Manual".

 

[Claes Gefvenberg]

---X---I really enjoy getting feedback from my peers so quickly. I think that we all usually know what needs to be done, but need re-iteration from others who have been through this. Kind of like sticking our toe in the water before jumping in completely.

Thanks guys,
fox

Exactly... If the Cove is good for anything, that must be it... Being able to discuss your work with others in the same situation really is a tremendeous help. A real confidence builder if you ask me.

/Claes

 

[Cari Spears]

Claes

In the thread that you referenced above, you described how you created the policy manual after your system was in place and kept it to the minimum.

This was one of the trains of thought that changed my mind about my manual in progress. I was determined not to rehash the standard, but in writing our manual IAW the standard, I ended up doing just that in the end anyway.

Your comment got me thinking - if I write IAW our system, then the manual will be truly useful. I'm following your advice and keeping it very simple and ensuring that the requirements in 4.2.2 are included. I'll post my completed manual in (hopefully) the next couple of weeks.

Thanks!

 

[Rick Goodson]

Claes

In the thread that you referenced above, you described how you created the policy manual after your system was in place and kept it to the minimum.

This was one of the trains of thought that changed my mind about my manual in progress. I was determined not to rehash the standard, but in writing our manual IAW the standard, I ended up doing just that in the end anyway.

Your comment got me thinking - if I write IAW our system, then the manual will be truly useful. I'm following your advice and keeping it very simple and ensuring that the requirements in 4.2.2 are included. I'll post my completed manual in (hopefully) the next couple of weeks.

Thanks!

Just another thought. I have been writing Q manuals under 1994 and 2000 that are basically the same. In 1994 I usually had to rehash the shalls, but that was in addition to the basic concept. The manual starts with a description of the business and the markets it services. Then we add the Q policy and Q objectives. Next we add a statement saying we meet all of the requirements of the standard, or what we exclude, and any other standards we adher to. The balance of the manual is divided into the business functions such as Sales, Purchasing, Engineering, Human Resources, etc. Under each section we add how that department/function works and how it meets the ISO9001 requirements. For example, if HR is responsible for internal communication and has a news letter, bulletin boards, quarterly meetings; we state that. Under purchasing we describe how we select and control suppliers. Finally we include a matrix in the appendix that crosses the ISO 9001 elements to pages in the manual where we address them and the procedures, flowcharts, etc that support individual requirements. The manual (without the appendix) is a useful sale/marketing tool and with the appendix passes muster with the registrar.

One of the nice things about this style of manual is you do not rewrite when the standard changes. You simply aadd the new requirements references and redo the appendix matrix.

Rick