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Iso 9001 2000 requirement


Iso 9001 2000 requirement

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									Iso 9001 2000 requirement

The ISO9001:2000 quality standard gives you a tremendous amount of flexibility in how
you prepare your quality system, including the documentation required. I encourage you
to keep your quality system documentation as simple as possible. You want to make sure
that your quality system documentation meets the minimum requirements of the
ISO9001:2000 quality standard, and you also want to make sure your documentation
meets the quality needs of your company. However by going far above and beyond the
requirements of ISO and your company, you may be making things more complicated
and difficult than they need to be.

By making your quality system overly complicated, you make it more difficult to use,
difficult to keep updated, and you will give an auditor more things to check and find fault
with. And by making it overly complex, you and others at your company will need to
spend more time to learn and maintain your quality system. The more time people need to
spend learning and maintaining your quality system, the less they will be inclined to do

Requirements for Sole Proprietor

Let's say I own a machine shop that manufactures spare parts for the military. It is a sole
proprietorship with me as the sole full time employee. I used some ISO templates and
customized them to my company but still need to streamline my manual to include only
the bare essentials to conform to ISO 9001/2000. Since all duties fall on me, I need to
maximize my time producing product and still have a quality system that satisfies my
QAR (Quality Assurance Representative.) How would I best meet the minimum
requirements and what's the best way to achieve them in this situation?


There are six required procedures in ISO9001:2000. They are as follows:

1. Document control

2. Control of Records

3. Control of non-conforming material

4. Internal audit

5. Corrective Actions

6. Preventive Actions
Beyond these, any additional procedures are optional. Sometimes you can get away with
satisfying a requirement in your manual, without writing a separate procedure for it. For
example, while it is a requirement that you have a periodic management review, it is not a
requirement that you have a separate procedure for management review. You can
document your management review method in your manual.

You have to make sure you follow all the requirements of the ISO9001:2000 quality
standard. I assume you have a copy of the standard, or a good book that tells you all the
requirements. If not, I recommend a book by Charles Cianfrani titled "ISO9001:2000
Explained". This book contains all the elements of the quality standard, with very good
explanations. It's easy to read and I have found it invaluable for new clients.

There are many ways to keep it as simple as possible. For one thing, your quality manual
sections and procedures should probably be 2 to 3 pages maximum. Any more than that
and I'd guess you're doing too much work.

I would also recommend you combine Corrective Actions and Preventive Actions, since
they are so similar. You can use one form for both procedures, with just a check box on
the form to denote whether it is a "corrective" or "preventive" action request. You may
find that you can streamline other forms in a similar manner.

You want to strive to find the lowest level of complexity that still fleshes out your
company's operations.

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Best regards

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