A few months back, I wrote about the choices an organization makes regarding its quality management system (QMS). At that time, I talked about the overall system, with particular focus on management’s investment and support.

Today I’d like to spend some time talking about the choices within the requirements of the quality management system. Once you’ve decided that you are going to conform to the requirements of ISO 9001 or a comparable QMS standard, you still have many options to consider. It’s not just a matter of whether or not you’ll conform to ISO 9001, but how you’ll do it. How will you implement your system?

The answer is encompassed in two sentences that carry within them challenge and constraint. “It depends.” and “You decide.” The method of implementation is dependent on the multiple variables of your unique organization. And the application is the outcome of your decision-making process, based on an assessment of those variables.

You have the obligation and the right to select how requirements will be applied in your organization. Once you’ve agreed that you’ll utilize a QMS model, you get to choose how it’ll manifest itself. But you also have to devote adequate resources to that decision making process.

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