I worked as Quality Engineer for 3 yrs, and now I got a new offer as Quality Manager to implement ISO 9001:2000 for a Manufacturing company(150 employee) in 1-2 yrs time frame. They never had a Quality dept before. I am the Start for Quality and they also gave me an opportunity to hire some body else under me. I am kind a hesitant to take the Job offer because of the Toughness of the Job. But Management is real cooperative to accomplish my task, they are willing to give whatever i ask for. Please advice what you think about ISO Implementation. Can I go ahead & take the offer?

My approch is writing Quality Manual first then Operating Procedures, Work Instructions & Forms tieing into the above three. Hire a good ISO Consultant who can guide the company to accomplish the goal.

Customer Requirements, Comapany Goals, Management Meetings, Planning & Product realization, Design & Development, Monitoring and Measurment, Corrective Actions & Preventative Actions, Continuos Improvement through internal auditing. I am familiar with the above topics but I had never implemented an ISO system before.

Congratulations on the opportunity.

Let me suggest you may have the cart before the horse in writing the Quality Manual first.

If it were I with the opportunity, first, I'd look at what the organization actually does. Surprisingly, many organization already do a lot of "right" things, even though they've never heard of ISO, simply because many of the precepts of ISO Quality Management Systems are merely restatements of what good organizations do in their best practices.

Once I had a good understanding of what the organization already does, I'd include a bunch of folks in helping to perform a Gap Analysis, always aiming to be INCLUSIVE, rather than exclusive, emphasizing the fact we are aiming toward "best practices" and only incidentally meeting basic requirements of ISO.

With the gap analysis in hand, you have a road map to what the organization does now and what it may need to add or change for the future. Then, and only then, would I start writing a Quality Manual which reflects what we do and what we hope to do.

Procedures are written and established merely to document what the organization does so you have a yardstick to measure for deviations or for possible improvement in the future.

Being "familiar with" ISO is a far cry from knowing about actually implementing a compliant system. Kind of like the difference between knowing how to drive a car versus knowing how to build one.

As part of your search for an ISO consultant, make sure you get one who will help folks understand the business purposes underlying the ISO Standards and is willing and able to see that YOU get up to speed so you can identify areas for change and/or improvement.

I vaguely remember two threads where you talked about applying for this or a similar job. It might be valuable for you to revisit those threads and look at some of the tips you received.

I am familiar with the above topics but I had never implemented an ISO system before.

From the standpoint of an auditor...KIASAP (Keep It As Simple As Possible)

I agree with Randy KISS

I would not bother with a consultant other than top maybe train Auditors and the management team. You have a great opportunity to build a system for YOUR company rather than the norm where people build systems for the 'Standard'.

I'd review current SOPs, Training manuals, Forms etc (if any) and then map out the entire process, ensuring that the operators and management had a large part to play. Adult learners need to understand how they fit into the picture, what the benefits will be (for them) and have a hand in the changes, for this to work. You have two glorious years whereas many of us had a LOT less so there was usually more pain in implementing things rapidly.

I'd write the documents about what the company does NOW and then see how they fit the standard rather than the other way around as people tend to try and make the company fit and it should never work this way. I could go on and on but it would confuse you m,ore than my lame post. Good luck and please come back with specific questions and feel free to use the search engine within this site. There is some marvelous stuff here. Here are some ice breakers I use to convey the QA picture and change.

Apes and Culture (http://elsmar.com/Forums/attachment.php?attachmentid=709&d=1049176962). This deals with Change, especially from the NORM or what we do everyday. We want [people to look at what is now and WHY it is like this. Could it be better if we stepped back and looked at NEW ways to do things rather than the Same old and
What is a QMS (http://elsmar.com/Forums/attachment.php?attachmentid=2176&d=1085445550). This Illustrates why we need a QA system and compares it to Safety and Environment Systems. It has teacher notes attached at the operators/students have to give the answers rather than US teaching THEM. These are my favorite presentations and go down really well. Good Luck

You also might want to read through this: Quality Management System
(QMS) Implementation (http://elsmar.com/Imp/).

While the following is TS 16949 focused, it is excellent reading: A TS 16949 Implementation through Registration Project Diary - Automotive (http://elsmar.com/Forums/showthread.php?t=8664)

Cognizant

This sounds like a very good position. 1-2 years time frame for implementation is wide open, too.

I think the hardest part would be to educate everyone in management and get them participating and contributing to management based on the standard.

My patent pending description of ISO 9001:2000 is "an effective system of formalized, documented management that is continually improved as a process." Pretty neat, huh?

There are pleeeeenty of misconceptions about what ISO 9000 is like and what it is for. It's also notable that the requirements are difficult to interpret and understand even when they're right in front of you.

I'd like to suggest a few first steps of implementation

Purchase a copy of the standard, ISO 9001:2000 -and- ISO 9000:2005, the latter contains definitions of terms and concepts used in ISO 9001.
Purchase a good book on ISO 9001:2000's requirements. I recommend David Hoyle's ISO 9000 Quality Systems Handbook. This book answers three questions about every requirement of ISO 9001, what does it mean? why is it necessary? how is it implemented?
Create a process map, or maps, of some shape or kind that will allow you to establish key performance measures and key quality objectives for each process. I recommend something like the attachment followed with turtle diagrams for each process.I have no affiliation with that book, except that it has educated me on the standard. So has The Cove.

****, I wish it was me!! I would love that challenge :biglaugh:

From the standpoint of someone who has never implemented an ISO system: Make sure that the persons affected by the policies, procedures and instructions are involved in writing them, or at least let them have a good saying about it. You will have a hard time implementing something that smells of writing "from behind a desk".

I wish you the best of luck.

I think you've already started-off on the right foot by registering as an Elsmar Cove visitor/user. This is a great site for sharing ideas, concepts and answering some of those nasty "how-to" types' of questions. I have recently acheived certification under very similar circumstances to your own.

I'm not one to plug ISO products, but not having much experience in the ISO areana, I purchased an ISO Guide (step-by-step program) with example Quality Manuals, procedures, forms, etc. This combined with much help from the Elsmar folks really got me across the line. Here is a link to the site if you want more info. For my 2 cents worth, it was the best $130 dollars I ever spent. Good Luck:rolleyes:

http://www.iso-9000.co.uk/d-commerce/

I worked as Quality Engineer for 3 yrs, and now I got a new offer as Quality Manager to implement ISO 9001:2000 for a Manufacturing company(150 employee) in 1-2 yrs time frame. They never had a Quality dept before. I am the Start for Quality and they also gave me an opportunity to hire some body else under me. I am kind a hesitant to take the Job offer because of the Toughness of the Job. But Management is real cooperative to accomplish my task, they are willing to give whatever i ask for. Please advice what you think about ISO Implementation. Can I go ahead & take the offer?

My approch is writing Quality Manual first then Operating Procedures, Work Instructions & Forms tieing into the above three. Hire a good ISO Consultant who can guide the company to accomplish the goal.

Customer Requirements, Comapany Goals, Management Meetings, Planning & Product realization, Design & Development, Monitoring and Measurment, Corrective Actions & Preventative Actions, Continuos Improvement through internal auditing. I am familiar with the above topics but I had never implemented an ISO system before.


Cognizant,

Everyone that has posted responses to your questions are valid points. Wes's comment regarding writing the manual first in my opinion, is understanding the requirements (I agree with Wes). The next step would to review your current processes, flow chart the processes, document the current way that your business is run, than after fully understanding, the requirements, the company, and their processes, then develop the Policy. Always try to get everyone involved while developing policy and/or procedures.

Consultant? I don't feel the need to have a consultant (I have nothing against consultants. So please any consultants that may review this post I am not hammering the use of Consultants). Once the QMS has been accomplished than your company would feel that they (the company) have developed the QMS on how they do business.

Marc has also provided good links to threads that have been posted that might also assist you in your endevor. Recommend that you do a search in this forum for other posts and responses.


Coury Ferguson

Congratulations Cognizant!

I was in nearly same boat in 2000 when I left a QA Engineer job (after 3 years) in injection/blow molding to become QA Manger for a contract packager.
The differences were that I was more concerned with FDA cGMP for food and drugs, kosher certification, and Procter & Gamble's 19 Key elements than ISO9000.
But I did model the QMS on ISO9000:2000.
Tremendous experience. I wish I knew about The Cove back then.

In addition to what everyone else said I would recommend that you get a copy of MS Project to help manage the tasks, have frequent meetings with the top managers to discuss the plan and your resource needs, and set up an "implementation team" of key stakeholders.

If the company is willing to spring for a consultant be wary of the guys that claim they'll have you "registered in a year". They'll just dump some generic manual on you that is meaningless to the business. As Greg B suggested: Use consultants for training... training people in process mapping, procedure writing, project management, internal auditing. Not for writing your procedures.

Wow, sounds like a cool job to me. Another tip for considering this position, check the article posted in this thread

Letter to your CEO on Quality (http://elsmar.com/Forums/showthread.php?t=17342&highlight=ceo)

and see if you can picture yourself discussing this with the management team of the company. If you feel they would giggle at you and send you off to get them some coffee, think again, if not, go for it!

My approch is writing Quality Manual firstThat was actually the very last thing I did... When everything else was in place.

/Claes

Thank you all for your valuable responses..I am taking the challenging job ...

Hi Cognizant,

I see from elsewhere in this thread that you decided to take the job, so maybe my question's too late, but I'll pose it anyway in the hope that it might lead to some helpful ideas.

In your original question you say, "I am kind a hesitant to take the Job offer because of the Toughness of the Job. But Management is real cooperative to accomplish my task, they are willing to give whatever i ask for."

Now pardon me for picking your words apart, but if management are really cooperative and will really give you whatever you ask for, it aint' gonna be tough ;-)

(But, I have yet to see a management team deliver on such a promise, so I think you're right, it will get tough.)

So my first question would be, to whom do you report? Senior enough, I hope, to give you the clout to bring people together to write processes, to get corrective actions closed and to facilitate meaningful management reviews. If you're not senior enough, I would advise either locating some good political friends that will sponsor your work or, if it's not too late, getting the role defined so you have the power you need.

Second, I'd ask if you have budget, written down with the CFO's approval, or just a verbal promise of "whatever you need." If the latter, I'd advise setting out a decent budget early.

On consultants: yes, (I write as a consultant) you should do without them -- us -- as far as is possible, as other posters have noted. If you do feel a need for one, I'd suggest you select one that understands your business sector, who listens more than he or she talks, and who facilitates you inventing your own processes rather than imposes processes that won't work -- and carefully walks off with your money before you realise: make sure they're in it with you for the long haul.

One role we can play, by the way, is to deliver uncomfortable messages to your management team without getting you fired; good auditors do that, too. (Well-written major non-conformances are often code for, "Your process sucks, gentlemen.")

Here's how seasoned quality managers orchestrate it: invite the consultant or external auditor to do an assessment. Plan it ahead with the auditor. Without saying so (for to say so would be to prejudice the assessor's independent findings) engineer it such that they meet cooperative managers and departments early, recalcitrants later. If they're awake, they'll point the findings at the recalcitrants with business rationale noted in the objective evidence ("Corrective action not being performed on non-conforming product: the factory has a stack of non-conforming product worth $5M.") The seasoned quality manager never tells you the tough message she wants delivered; she just makes sure you see all the evidence of the mess and draw your own conclusions, which you report as your own so she doesn't get fired.

... Not that quality managers ever get fired for delivering bad news, of course ;-)

Hope this helps,
Patrick

... Not that quality managers ever get fired for delivering bad news, of course ;-)Something to keep in mind. They sometimes shoot the mesenger.

Thank you all for your valuable responses..I am taking the challenging job ...I wish you good luck with your quest. :agree:

/Claes

Thank you all for your valuable responses..I am taking the challenging job ...

Good luck and remember what the Boy Scouts say "Be prepared."

Coury Ferguson

Cognizant,
Everyone that has posted responses to your questions are valid points. Wes's comment regarding writing the manual first in my opinion, is understanding the requirements (I agree with Wes). The next step would to review your current processes, flow chart the processes, document the current way that your business is run, than after fully understanding, the requirements, the company, and their processes, then develop the Policy. Always try to get everyone involved while developing policy and/or procedures.

IMHO, I don't understand how anyone could write the Quality Manual BEFORE understanding any of the processes, unless it is regurgitating the standard and inserting the companies name every now and again. I would really like to see all of the processes documented (This is how we do things here) and then go and adapt the Manualo to what we axctually do bnot the other way around.

Consultant? I don't feel the need to have a consultant (I have nothing against consultants. So please any consultants that may review this post I am not hammering the use of Consultants). Once the QMS has been accomplished than your company would feel that they (the company) have developed the QMS on how they do business.. TOTALLY AGREE!

If you feel they would giggle at you and send you off to get them some coffee, think again, if not, go for it!

WELL SAID!!!

Cognizant,

This is exactly what i am doing now. I was hired to implement a QMS and there was nothing in place when I came on board. We are not going for ISO certification at this time but I am designing our system according to ISO standards since it is a good known standard. The task is monumental but the challenge and self satifaction that will be achieved is well worth it.

Something to keep in mind. They sometimes shoot the mesenger.

been there. been shot. :mad:

actually, it was more of a purge. I was the last to go in the purge so at least I saw it coming.