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Assembling Your Quality Manual

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 so.

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?

Answer: 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.


Assembling your quality manual