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? :bonk:

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 ! :bigwave:

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) (http://elsmar55.tempdomainname.com/Forums/showthread.php?threadid=6419) .

4.2.2:

The organization shall establish and maintain a quality manual that includesa) 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, andc) 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

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? :bonk:

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.

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. :lick:

Thanks guys,
fox

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

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".

---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. :lick:

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

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!

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

Claes
---X---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!

Glad to hear it Cari, :agree:

...and I'm looking forward to seeing the result. Well, it worked for us, but others may be better off doing it another way. Like a fellow Cove dweller says: One size does not fit all.

And Rick: That sounds like a good template for a manual. :agree:

/Claes

What does qualitymanual scope means?

1.- Facility/ Company which QM applies? ( ex, Quality manual applies to MWC de Mexico, Agua Prieta, Sonora, Mexico manufacturing facilities and to Douglas, AZ warehouse)
2.- What are the processes covered by QMS,( ex. manufacturing, inspection, testing and delivering of wiring harnesses).

Thanks all.

What does qualitymanual scope means?

1.- Facility/ Company which QM applies? ( ex, Quality manual applies to MWC de Mexico, Agua Prieta, Sonora, Mexico manufacturing facilities and to Douglas, AZ warehouse)
2.- What are the processes covered by QMS,( ex. manufacturing, inspection, testing and delivering of wiring harnesses).

Thanks all.

Well the scope is basically what your company does. Take for example the company I work for manufactures non-automotive thermoformed products (but has the ability to do automotive). So the scope here is:

"The quality management system applies to the manufacturing of plastic thermoformed products by the XYZ Co.
II. Exclusions:
1. XYZ Co.is not responsible for the design of any product, therefore claims exemption to clause 7.3.
2. XYZ Co.does not provide service after sale of its product, therefore claims exemption to any requirements for servicing."

As for your question about the processes covered, well, that is everything that falls under the umbrella of your QMS. For instance we have Management review, contract review, purchasing, maintenance, calibration, product manufacturing, shipping, and the list goes on. But hopefully that gives you some idea.

Regards,
fox

Well the scope is basically what your company does. Take for example the company I work for manufactures non-automotive thermoformed products (but has the ability to do automotive). So the scope here is:

"The quality management system applies to the manufacturing of plastic thermoformed products by the XYZ Co.
II. Exclusions:
1. XYZ Co.is not responsible for the design of any product, therefore claims exemption to clause 7.3.
2. XYZ Co.does not provide service after sale of its product, therefore claims exemption to any requirements for servicing."

As for your question about the processes covered, well, that is everything that falls under the umbrella of your QMS. For instance we have Management review, contract review, purchasing, maintenance, calibration, product manufacturing, shipping, and the list goes on. But hopefully that gives you some idea.

Regards,
fox

Thnaks Fox for your input; I will combine two statements as in our QMS manual.
I

I'm a little late getting in on this thread but we recently had our transition audit and the auditor stated that we had our QM "worded too much like the standard". Granted there were some very basic wording but my whole take on it was that our procedures were what our main focus was. These procedure explained the who, what, where , how, and when for our company.
Am I wrong in this or is the auditor just looking for a reason to write something?

"4.2.2 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."

IMO as long as you have the above three elements covered you should be ok. Did the auditor write this up as an observation or finding? I would like to know because we have our 2000 audit coming up next month and our current QManual sounds much the same as yours.

But on another note….kinda: our Registrar didn’t even request we send it in to them for approval. Is that normal SOP with Registrars?

"4.2.2 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."

IMO as long as you have the above three elements covered you should be ok. Did the auditor write this up as an observation or finding? I would like to know because we have our 2000 audit coming up next month and our current QManual sounds much the same as yours.

But on another note….kinda: our Registrar didn’t even request we send it in to them for approval. Is that normal SOP with Registrars?

No, we hadn't have a ISO9K2K or TS2K Certification audit yet, we are planning to move from ISO9002:1994 to ISO/TS16949:2002.

As I know, UL, BSI, TUV, QCB, DNV require to have a manual before the initial audit.

The auditor wrote it up as a observation. This was done on his audit to the new standard.

But on another note….kinda: our Registrar didn’t even request we send it in to them for approval. Is that normal SOP with Registrars?
All of the registrars I've worked with do a quality manual review offsite prior to the certification audit.

Am I wrong in this or is the auditor just looking for a reason to write something?
You're right. You've met the requirements, and the auditor was making a subjective statement. Keep in mind who the users of the quality manual typically are - people implementing the system, internal auditors, external auditors, and customers. If it meets their needs, it's done its job.

Look db

Brad is from the show me the shall state. ;)

Good one. :vfunny:

All of the registrars I've worked with do a quality manual review offsite prior to the certification audit.

That is what I thought. So much for an value added Certification audit :(

It's going to be one auditor...one day...and we have about 200 employees.
:mad:

From both sides of the fence I keep asking the same question - what does your manual give you and I am critical of manuals that are phrased around "the company shall ".... nobody speaks like that! The only adequate reason I get for this form of manual is that it will satisfy the auditors ... well sod that!

The only decent manuals I have seen are ones used by companies as promotional material, written by the marketing department or some other wordsmith (although I am sad to say rarely the QM). The whole idea is to describe the controls in place that will ensure the customer gets what they want and in a manner of words that people can read, the best ones now aren't written as manuals but as web sites where people can follow a train of thought.

Keep in mind who the users of the quality manual typically are
External auditors and potential customers.
IMO a QM is the biggest waste of time and effort. Nobody looked at those things, unless they were dusting the office. I think the only thing less read than a QM are the ads that come attached to the comic page in Sunday news papers, well either that or the Detroit Tigers box score. :biglaugh:

Look db

Brad is from the show me the shall state. ;)

Can you believe I just now got that? :eek:

I'm gettin slow in my old age.

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!

Cari,

I was performing a search and read through this thread. Looked for your completed manual. Did you post it? I would be interested in seeing how you handled the "documented procedures established for the quality management system." Under the old procedural /element approach I had no problem listing my level 2 - System Procedures because they were fairly stable. But with the newer Process Approach where I have a number of process flows, do I now have to reference the level 3 - Work Instructions and Inspection & Test Procedures. How did you make this work for your system?

Thanks,
Doug