(ISO) Quality Manual Chat

Let’s say you own a small shop that manufactures spare parts. It is a sole proprietorship with you as the sole full time employee. You want to streamline your manual and procedures as much as possible, to include only the bare essentials to conform to ISO9001:2000. You’re the only person there, you need to maximize time making your product, but still have a quality system that satisfies customer requirements. What are the minimum requirements and how best to achieve them?

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.

Without knowing your particular operation it is difficult to give any more specific recommendations. If you have a question about a specific area of your business, please feel free to post it here.

If you’re under the gun from a customer’s demand that you get ISO9001:2000 registered, and you have lots of personnel resources at your disposal, you might be able to get it done in a couple of months. If you’re trying to implement the quality standard while you’re learning it, and you have no time constraint, I’d expect it to take you up to 6 or 7 months.

If your operations are complicated it will take longer, if you run a rather simple business, it will be quicker, of course. There is no correct answer here, everyone takes as long as they have.

Tell us about your particular situation. How long do you think it should take?

Continuing this blog, we know that some of the general requirements of an ISO9001:2000 quality management system include:

• identifying and documenting the processes and procedeures used in your quality management system
• determining and documenting the sequence of your processes, and how they interact with one another.
• determining and documenting your criteria needed to show your processes are effective and what methods you use to accomplish this.

If you choose to outsource any process that affects your product’s (or service’s) quality,
then you must also take steps to make sure that outsourced process is under your control.

For example, let’s say you produce an NAS- standard aluminum washer to be used on a military aircraft. In your shop you’ve got the machines needed to stamp out bolts and put threads on them. But the military specification calls for a hard anodizing, and you don’t have capability to perform plating in your shop. No problem, just find an anodizing shop, right?

It’s not quite that simple. Who are your customers for that washer? What are their requirements? If you want to sell the washer to Boeing, you probably have to use a plating shop that is also approved by Boeing. In addition to customer requirements, you have to go thru the process (there’s that word again…) of finding and approving the plating shop you’ll use. Are they also ISO9001:2000 certified? How about AS9100? Have you inspected their facility? Can you be reasonably certain they are not farming the work out to another vendor that isn’t approved?

Once you’ve followed your process and approved the plating shop as your vendor, there’s more work to do to ensure your product meets YOUR requirements. The military specification calls for a total thickness of .085 inches, and your company specifications and drawings do the same. It is not ultimately your vendor’s responsibility to ensure your product is in conformance with your specifications. This is YOUR responsibility. Every shipment of washers should be inspected upon receipt from your vendor. I’m not saying that every washer should be inspected, but a reasonable sampling should be measured before any parts can be used or sold.

Remember that you want to make sure your product conforms to your specifications, and also your customer requirements. Many industries and products require documentation to prove that the various processes used are also in conformance and were done by approved sources.

Not only does the product have to conform to satisfy your customer, but you’ve also got to satisfy your ISO auditor. Have you taken reasonable steps to ensure your product is always in conformance? Is it possible that, even tho your products so far are in conformance, that maybe you’ve just been lucky? How likely is it that something could go wrong? Will your process stand up to the scrutiny of an outside auditor?