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

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. Yes, this is destined to fail. What you want to have is a manual, process map, documents, etc. which describe how the processes are supposed to be operating. Not an ideal, unrealistic, perfect process.

Wishful thinking is a common failure mode for people defining processes.

Also, If my approach is completely backwards, let me know so I can do some more research and come back with some better questions.:o

Thanks again,

Shawn

Hey Sidney,

Sorry if I wan't clear. In this context, I was equating the ideal process with how the process should work.

For instance, right now our organization does not have a defined process for the control of design and development changes. My plan was to create such a process, get it approved by management, place it in the Quality Assurance Manual, then begin to impliment it with the support of management.

Is that a reasonable approach?

P.S. Thanks for the input

Start with what you have and work from there. You may not have a "defined" process but there is likely to be some unspoken rules and if you start re-defining them without input from the people involved in the process, you will get resistance.

Have you done a gap analysis to identify holes in the system?

I came into a new company last year to install a ISO 22000 system and luckily they had just done a Gap Analysis with an external service (they did it for free since it was their first venture into ISO 22000). It provided me a great road map for what was already strong and where things needed the most attention.

I also found it easier to write the manual and SOP to what was being done (with help from the people) and than suggest improvements. In the end, you will find most people already know what is missing, they just never had a resource to help them fix it.

For instance, right now our organization does not have a defined process for the control of design and development changes. My plan was to create such a process, get it approved by management, place it in the Quality Assurance Manual, then begin to impliment it with the support of management.

Is that a reasonable approach?


Shawn:

It does have a process doesn't it? Even if not 'defined' - BTW that doesn't necessarily mean documented, the Engineering manager might be able to verbalize it, that's 'defined'......

So, you run a big risk. You can invest a lot of time and effort and they will not thank you and you will have your document treated like the 'honkin' great binder' in the Dilbert cartoons! No-one will go near it!

I'd suggest that the business processes of your organization can be articulated to you, by a team, and you should capture them in a process mapping exercise........you simply facilitate, to keep them on task etc.

Any order you decide to work is OK. Some lessons I've learned over the years include (simply) to document what you actually do and do what you document. A quality manual is a good start. You may simply want that document to identify how you will meet each of the requirements of the standard. A quality policy document may also help to focus the efforts of your organization. Should you need examples, the internet is filled with numerous examples of quality policies and quality manuals from many industries; you can probably search for "non-profit quality policy" (or manual) and still get many examples. I would also recommend that you start with what is important to your organization, and start with what is required by the standard.

tsmith7858 raises a good point about the gap analysis :agree1:... If you have the time, and based on your target date of 2011, it appears you do, the gap analysis (gap audit) may be the way to go. We have done gap analysis for some of the standards we have been asked to comply with and the lessons you learn there may make your life a lot easier in the coming months. The sooner you get the gap analysis done, the sooner your system will be up to par. Of course, to conduct the gap analysis, you may first need to select a registrar. Most registrar's will offer the gap analysis service.

Good luck and keep us posted.

Thanks again guys,

I'm going to start with what I have here, and bring in management and affected personnel when I need to change a process or policy to meet the ISO 9001: 2008 standard, so the transition is more smooth.

Good Advice:D

Both Sidney and Andy & others have given good advice.

One of your biggest pieces of learning is going to be wrapping your head around the difference between a service organisation (and a non-profit at that!) vs the more standard manufacturing/engineering types of model - the majority of docs in the Cove (and a majority of posters, in my experience) are focussed on the latter. Another reason for NOT using your original suggestion-that way lies madness and failure (I can't think of a less effective approach).

Start with what they actually do.

i usually start on the ff order in their current process:
process flow summary
detailed flow
detials of each process and the links in work instructions and guidelines.

:bigwave::2cents:

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

Hi Welcome to the Cove. :bigwave:
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 :cool:

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