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

[ab001]

Why not consider the process an Improvement Process
You need to know where you are now to be able to get to where you want to be (certified)
Make sure you define who supplies you with inputs to this process, and what outputs you deliver to the customer of this process to.

You can choose a 4-step, 5-step, 6-step, (7 step), 8-step, ...

I know 4 step-
PDCA [google that, or wikipedia that]
Plan - say what you do
Do - do what you say
Check - prove it
Act - improve it

5-step
DMAIC
Define your problem
Measure it's impact
Analyse your results and design improvements
Implement your improvements
Control - check your results

6,7 - similar to the first two

8 step - i've heard Covers talk about it but never seen it defined (i think it's something done in the auto industry)

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

 

[Raffy]

Hi Welcome to the Cove.
You can start aligning your process with regard to the requirements of ISO9001:2008 through the following:
Create a gap analysis versus the requirements of ISO9001:2008. Identify what do you lack or what do you need in order to satisfy the requirements of ISO. Document and implement. Verify the effectivess of the implementation through audit.
The easiest i think is to paraphrase the requirements of the standard however, please be careful in doing so because you might end up
putting yourself in a tight position in adapting the said requirements.
hope this helps.
best regards,
raffy

 

[qusys]

To pursue a certification application ( To ISO 9001 or others), it needs a strong sponsorship of Top Management because it is a strategical choice to embrance a certain standard of QMS.
Top management and managers should have clear how means to have a QMS certified vs ISO 9001 and so be aware of it and how to proceed.
Said that, I respond to your question.
In my opinion , the approach could be different.
A gap assessment of the organization could be primarily performed, then identify processes of QMS, understand the relationship, then try to document them and so no.
Organization shall live the path towards certification, trying to work in team and it is important create interesta and involvement since the first step.
They do not see it as an obligation or a burden but as something that improve and facilitate the way of working and doing business.
Quality manual realization is the final step where the organization have clear and consolidate their own process.
You could facilitate the process but it is fundamental to work in team to realize it as well as all the requested mandatory procedures.
The Quality manual belongs to the organization and so all can contribute, based upon their roles and responsibilities.
In this sense the role of Management representative is very kep in this start up phase.
I advice to have a project plan according to which to proceed.
Hope I helped.

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

 

[Vic de Beer]

I Have just come accross a very interesting situation.
An Organization has presented a QMS Manual and I have attached the first page of this manual.
The simple response to all my questions was: it meets the requirements of ISO 9001.
What is the forums reaction to this? View attachment Manual page.doc

 

[AndyN]

Scary....but people have been doing pretty much the same thing for years really, Vic...

 

[Brunetta]

I Have just come accross a very interesting situation.
An Organization has presented a QMS Manual and I have attached the first page of this manual.
The simple response to all my questions was: it meets the requirements of ISO 9001.
What is the forums reaction to this? View attachment 11972

Okay, going out on a limb here...but I feel compelled to share why I think that a manual like this as a starting point may not be such a bad idea.
Before you throw rocks at me, let me tell you about my experience.

Before I arrived at my current position, the company had a Quality Manual that specifically did not mention any part of the ISO 9001 standard. It was flashy, wordy and in the end unfortunately, in the attempt to describe what we do it ended up containing some hidden requirements that were better placed in Work Instructions. Because of this (and some other serious issues) we promptly went SPLAT on at our first certification audit.

It took a year to resolve all of our nonconformities. I had to find out about the organization, and learn about the standard's requirements. Being faced with an elephant, all I could do was take it one bite at a time and I ended up starting from the bottom up.

Long story short ...
(because it is a long story filled with we think ISO 9k wants us to do this when we really do this SPLAT SPLAT SPLAT and me asking why why why)

The next audit was coming around and the time it took to literally "where applicable" rebuild and reconnect the processes of the QMS left little time to address the Quality Manual and those pesky hidden requirements that tripped us up.

We ended up with one of "those" Quality Manuals and as a result all the hidden requirements were removed and management breathed a sigh of relief. Does anyone use the Quality Manual aside from our auditors (both internal and external) sadly no. Is this something I am happy with? Absolutely not, but we are still evolving from an organization with a few heroic people/tribal knowledge centric view.

Sometimes you need someplace to start before you can improve.

Sometimes you need to understand why the organization chose to mimic the ISO 9001 requirements in their quality manual, it may be just an interim step toward their continual improvement.

~Brunetta

 

[Marc]

Over the years I have approached this simply - A Quality Manual is developed at the same time as the procedures are being analyzed.

I have never approached quality manual development as distinct from, and done either before or after, existing procedures are being analyzed. Like the APQP process, there are interactions that take place simultaneously.

Start the quality manual, start procedure analysis, and as time proceeds they will come together.

As to whether the text of the quality manual, whether it is in part a 'regurgitation of the standard' is a personal preference - Nothing more and nothing less. A quality manual is nothing more than a way to tie together and explain the systems and their interactions much like a map.

I think people make much too big of a deal out of some things like this.

 

[dtr18c]

I Have just come accross a very interesting situation.
An Organization has presented a QMS Manual and I have attached the first page of this manual.
The simple response to all my questions was: it meets the requirements of ISO 9001.
What is the forums reaction to this?Manual page.doc

Is this by chance a "cookie cutter" quality manual(purchased)?

Does anyone have an example of a really good quality manual format to compare to?

 

[AndyN]

Is this by chance a "cookie cutter" quality manual(purchased)?

Does anyone have an example of a really good quality manual format to compare to?

Did you have a chance to click on the green 'Post Attachments List' button up top, by the lighthouse?

 

[dtr18c]

Did you have a chance to click on the green 'Post Attachments List' button up top, by the lighthouse?

I found this: Post Attachment List search for Quality Manual