Archive for May, 2008

Using outside companies as part of your Production Process in ISO9001:2000

Thursday, May 15th, 2008

One concern many people have regarding an ISO9001:2000 quality management system is if they can use outside companies to supply products or processes for their product or service. And the answer is yes, of course you can use outside companies as part of your production process. The key for passing your ISO9001 audit is to adequately control those processes or products, no matter where they come from.

If the other companies are ISO certified it does make your job a little easier, but if they’re not its still OK. Outside companies can supply product or services as part of your production process, you just have to make sure you adequately control the processes and can verify quality inspections. You’ll have to include these vendors, and all your product quality related vendors, in your vendor approval process of course.

You may want to specify in your quality manual that you conduct periodic inspections of these vendors, or that they have to be certified to a certain standard (ISO, UL, etc), or have to maintain specific kinds of equipment, or other requirements you might deem necessary to ensure their process/product meets your requirements. Its totally up to you how you do this, of course. Just keep in mind that whatever controls you specify had best be sufficient enough to pass muster with your auditor.

How many Corrective Action Requests are enough in ISO9001:2000?

Monday, May 5th, 2008

If you’ve read many of my posts compared them to most other ISO9001 consultants, you will probably notice that I’m a little more cynical than others. Many ISO types like to extoll the virtues of the quality management system and how it will increase customer satisfaction, decrease failures, etc. I don’t disagree with those benefits of ISO9001:2000. But the stark reality for most companies is that they MUST get ISO9001 certified in order to keep doing business. They don’t want to, mind you, but they must.

Keeping that in mind, one of the added tasks of an ISO quality system is to write, deal with, and record corrective action. I call them CAR’s, for Corrective Action Requests. CAR’s are a requirement of ISO9001:2000, and while certainly a valuable tool, they can be a pain in the rear to deal with.

You’ve got to do them if you want to keep your ISO9001:2000 certificate. So how many should you do? If you’ve got full time quality nazis on staff, they could easily turn corrective actions into a full time gig. I don’t think anyone wants that. Too many corrective action requests wastes everyone’s time, and pisses people off. Most people just want to do their jobs, not fill out extra paperwork because some quality person has a nit to pick.

It all depends on the size and complexity of your organization, of course. And also keep in mind this is only my opinion. I’m sure other ISO9001 professionals will tell you differently, and that’s fine with me. But for a company of under 20 people, I’d say that 1 or 2 CAR’s per month is sufficient. For a company of 21 to 100 people I would recommend at least 2 or 3 CAR’s per month. Only for much larger companies, with dedicated quality staff, would I recommend more than 3 corrective action requests per month. After all, you want to actually get work done, don’t you?