ISO9001:2000 Section 4.1 General Requirements Part 1

This is part one of a primer on the general requirements of the ISO9001:2000 quality management system. You can find these in section 4.1 of the standard.

1. Your organization or company must identify the processes needed for your quality management system, and you must also decide how these processes will be applied in your company.

What processes do you use (or will you use) in your quality management system? Do you have a procedure for handling sales orders? Purchase orders? You’ll probably need a written procedure on how to choose vendors, and a system of recording which vendors are approved. You might have an inspection at time of receiving, another in-process, and yet another at final shipment.

You must identify ALL of the processes used in your quality management system. It’s likely that you’ll have to create one or two processes to meet the requirements of the ISO9001:2000 quality standard. You might have no existing system for approving vendors, for example. Under ISO, you’ll not only have to develop a procedure for approving vendors, but you’ll also have to keep records of which vendors are approved, which have been disapproved, and you’ll also have to keep records of your vendors’ performance. There are a lot of records needed in an ISO9001:2000 quality system, get used to it!

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