What processes should be audited in your ISO9001-2008 quality management system?

What processes should be included in your ISO9001-2008 internal audit program? If you want to get, or maintain, your ISO9001-2008 certification, having an internal audit program is one of the things that the standard says you “shall” do. There’s no way out of it.

So what should be audited? According to the ISO9001-2008 standard, internal audits should determine whether the quality management system conforms to the planned arrangements you’ve made in regards to product realization. Also, internal audits should tell you if your quality system conforms to the ISO9001 standard, conforms to the requirements you’ve spelled out in your quality manual and procedures, and if it’s effective.

Like many things in the ISO9001-2008 standard, you’re largely left to your own devices to figure out what this means for you. Should you audit your purchasing process? Probably. Should you audit your process of hiring and firing personnel? An argument could be made for auditing the Human Resources process in your company, since section 6.2 of the standard deals with issues related to Human Resources. I recommend you keep your audit of HR processes limited strictly to those issues brought up in ISO9001. You want to make sure all your people are properly trained, and that you have good records. You want to make sure you have determined necessary competence for people whose work affects your product quality. However, I see no need to look into people’s personnel records regarding how often they’re late, or what punishments may have been doled out in their careers.

Should you audit the process of housekeeping? If your product, for example, requires assembly in a clean room, and cleaning is done per a schedule, auditing this process is probably a good idea. However if your business is processing consumer loans, auditing your housekeeping is likely a waste of time.

Don’t let some auditor tell you that you need to do more internal audits just because they said so. Give it some thought. Have you had any problems with that process, that affected product quality or customer satisfaction? If yes, then an audit program may be warranted. However if adding internal audits doesn’t add any value to your company’s operations, you may wish to ignore the “advice” of your auditor.

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