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ISO 9001: 2008 Implementation - Quality Manual First -> Questionable approach

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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#22
IMHO - no! It's certainly not compliant and, since it merely follows the sequence of the ISO/TS requirements, listing the various procedures etc, I'd rather doubt management would be able to describe its usefulness!
I beg to differ. It *is* compliant. You may not like it but you really should be more tolerant of formats you personally do not like. I have seen thousands of companies with simple manuals like this that are registered to ISO 9001. To state it is not compliant without seeing related documentation is misleading to say the least.

As to its usefulness, again an opinion. It doesn't matter what format a quality manual is in, a company can have a useless manual. It's how the company uses the manual, not the format of the manual, which determines its usefulness.

My advice to dtr18c is to look at several different quality manual formats and decide what is best for his/her company.

A more complete listing of quality manuals to look over: Quality Manual Examples
 
#23
I beg to differ. It *is* compliant. You may not like it but you really should be more tolerant of formats you personally do not like. I have seen thousands of companies with simple manuals like this that are registered to ISO 9001. To state it is not compliant without seeing related documentation is misleading to say the least.

As to its usefulness, again an opinion. It doesn't matter what format a quality manual is in, a company can have a useless manual. It's how the company uses the manual, not the format of the manual, which determines its usefulness.

My advice to dtr18c is to look at several different quality manual formats and decide what is best for his/her company.

A more complete listing of quality manuals to look over: Quality Manual Examples
I clearly stated it was my opinion, which is based on 20 years of doing this stuff and living with the results! The manual doesn't, in my experience, clearly identify the 'sequence and interaction' of the processes - despite the fact that they copied this text right out of the standard! A listing of the requirements isn't the sequence or interaction of the organization's processes and it would take about 5 - 10 minutes after an opening meeting (at a 'Stage 1' audit) to discover that the top management team couldn't describe their business operations that way...I'd put money on it!

This is the most common nc found at a 'Stage 1' audit - an inadequate description of the sequence and interactions of the processes (not requirements) of the QMS.

I fully understand, Marc, that Quality Manuals don't 'float your boat' and you are entitled to your opinions and comments too. What floats mine is the creation of a document which management can actually see the use for, and what they are paying someone to produce, distribute and maintain. IMHO, the example is only useful in gathering dust and getting out once a year to placate an auditor...

I believe that management not putting some pain and effort into the creation of a useful manual is part of the reason for the diatribe in another thread about the 'process approach'...
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#24
<snip> It's certainly not compliant <snip>
Your words exactly. As a quality manual within its self it *is* compliant.

A quality manual is just one part of system of documents. Like I said - Tens, if not hundreds, of thousands of companies have simple manuals just like the one linked to. To restate my position: Too many people place too much emphasis on the format of a quality manual when it is the documentation of systems as a whole and their content which is the important part. The requirement to show the interactions of processes does not have to be done in the quality manual in detail, or in the quality manual alone. It can be done in a multiple documents.

AndyN<snip> This is the most common nc found at a 'Stage 1' audit - an inadequate description of the sequence and interactions of the processes (not requirements) of the QMS. <snip>[/quote said:
Which is related to understanding the requirements of the standard which is not related to the content of a quality manual.

Understanding the requirements of the standard is why many people come here and is also why some companies hire consultants.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#25
<snip> based on 20 years of doing this stuff and living with the results! <snip>
Same here - With clients as diverse as Motorola to Borg Warner to Harley Davidson (etc., etc.) I have been in the business since 1990 with every client successfully registered first audit. Not to mention QS-9000, TS 16949, ISO 14001 (etc., etc.).
 
J

John Martinez

#26
Hello Cove Members!

I'm working for a non-profit community agency that is starting the process of ISO 9001: 2008 certification. We have about 140 regular employees and 9 different service oriented programs that have a focus on resolving community issues. We recieve our funding through different charities but mainly through municiple, regional, and federal funding(Canadian). Recently we were given a mandate to become ISO 9001: 2008 certified by 2011.

Some background about me.

I am a 4th year Mechanical Engineering Student who has had engineering experience working for a team of engineers in a factory setting. I have never delt with quality management systems.

I am the only employee in the organization who is mainly focused on this ISO 9001: 2008 implimentaiton. So far I've done some high level process maps, and I was thinking of starting to write the Quality Assurance Manual. The approach I was thinking of taking was to write an ideal quality assurance manual that does not accuratley match our systems, then, with the help of management slowly begin to change our processes and systems to match the ideal.

I'm also thinking of making ideal process maps for some of the more unclear processes here, and again with the help of management begin to mold our processes to fit the ideal model.

What do you guys think? Any Input is greatly appreciated
Resist the urge to over engineer this...pun intended.

I can tell you what does not work. Cookie cutter manuals and procedures.

If you look at ISO 9001:2008 a manual can be a one page document. Fact is you need to develop the standard based upon YOUR PROCESSES as in 4.1 first, so I'm going to disagree with our distinguished host that these documents should be developed together.

Look at ISO 9001:2008. It stars with your PROCESSES and NOT the manual. Can't do 4.2.2 b until you decide what processes need to be documented by procedures. You can't do 4.2.2 c until you determine the processes and their interactions. For that matter, it's hard to do 4.2.2 a until you have a handle on what you do and what processes are included in what you do.

Unless you have identified the processes, determined the sequence and interaction, what makes these effective and THEN think about the documentation, in my opinion, this will be more money and effort than needed.

For procedures, identify process owners and develop procedures that reflect what they do and NOT what is ideal, standard requirements excepted. For work instructions, include the people who actually do the work.

I've been putting in systems since the 1987 Standard. I have been audited by the good, the bad, and yes the ugly.

Rule 1. Cookie cutter systems are ineffective. Rule 2. If you are considering a cookie cutter system, refer to Rule 1.
 
Last edited by a moderator:

Big Jim

Super Moderator
#27
Back to the very first question of where to start.

Forgive me if I missed it when reading through this thread.

In my opinion, the place to start is to learn the standard you wish to become registered to. Take a class. Although it may be even more than needed, I would recommend a five day lead auditor's course.

Until you understand the standard, you will never be able to figure out how to comply with it.
 
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