posted 25 March 2000 11:29 PM               

From: Charley Scalies [email protected]

> From: Karen Siegel [email protected]
>
> We have decided to go for the ISO9000 2000 when it is out. We will
> begin meeting the draft requirements now as they appear to also meet
> FDA's requirements. I found a company that sells ISO 9000 forms that
> they claim will greatly help with the process. Their product includes 27
> SOP's and 22 forms. Am I wasting my time and money here? Is anyone
> familiar with these sorts of products?

Rule # 1 - ISO isn't about documenting. It's about doing the things the standard requires. Documentation (procedures, etc.) prescribes the methods you use for getting them done. If the documentation is your focus, you will wind up like the guy who built a beautiful boat in his basement only to find he had no way to get it out into the water.

Rule # 2 - Copying No. Benchmarking Si. There are many sample procedures that provide good insight into how "someone" might implement and document a particular requirement. (I sell them as do many other consultants.) But, except for a very few ISO elements, where firms might have absolutely no established practices, e.g. internal auditing, you must be extremely careful not to ADOPT foreign practices. They almost never translate well. Instead, if they look like a good, efficient method for your operation, then learn from them and ADAPT them to the way you do business. That's part of what "Benchmarking" is all about.

> Is there something better?

Rule # 3 - Spend to Save Get help from someone who has been through the process before. (The more often the better.) If nothing else, it will buy you practicality. That person can define the intent of each requirement as it applies to you, compare your current methods and practices to the requirements (a gap analysis) and guide you to implement new/changed practices that will help you close the gap in ways that will work best for you.

posted 28 March 2000 12:51 PM               

The only exceptions i have had to this is;
Calibration Equipment Lists
Document Matrixs (which i will not use in future).
Acceptable Supplier Lists
etc

I find that canned forms try to cater for too many possibilities and end up too complex.