Implementing ISO9001

Are you ready to implement your ISO9001 quality management sytem? Every business is unique, and has its own set of processes. If you’re thinking of implementing ISO9001, but you think it will be a lot of work and useless paperwork, you may be surprised at how relatively easy it is to implement an ISO9001 quality management system.

First you’ll have to decide if you want to implement the current version, which is ISO9001-2008, or wait to implement the upcoming version, ISO9001-2015. ISO9001-2015 is due to be unleashed on us late in 2015. If you have a customer breathing down your neck to implement ISO9001 right away, I’d recommend implementing the 2008 version. ISO9001-2008 will be valid and recognized for 3 years after the 2015 version is released. This gives us plenty of time to make the changes that will be needed in ISO9001-2015. However if you’re not in any hurry, you might consider waiting until the new version is released, as it’s just a few months away as I write this.

If your company is well organized and has some sort of quality system, chances are good that you’re already doing much of what’s required in ISO9001-2008. Things like having authorized people approve sales orders, purchase orders, receiving inspection, things like that. Do you have positive control over the documents necessary to run your business? It’s a good idea to have control over documents to make sure that everyone in your organization is on the same page, literally and figuratively.

In my experience, the biggest changes needed by most companies are in the areas of internal auditing and corrective actions. Every company already finds mistakes and corrects them, but few companies have a documented process for handling corrective actions. Having a system for dealing with corrective actions in an organized way, doing the root cause analysis and keeping the relevant records may seem cumbersome and not worth your time. But keep in mind that ISO9001 does not have any specific requirement on how many corrective actions you do in a particular year. The quantity of corrective actions you have in your files is up to you, although you should keep in mind that your records will have to satisfy your auditor. In my experience if you do one corrective action per month, in a small company, most auditors will think that is fine.

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2 Responses to “Implementing ISO9001”

  1. AKhila says:

    Simple and Nice article

    Management Review meetings and corresponding actions were a mandatory stuff in 2008 version. I think some changes have happened on that clause in 2015 version. Can you explain on that?

  2. Timothy says:

    Thank you. As of today the 2015 version has not yet been released, so any discussion would only be speculation. We’ll have to wait a couple more weeks.

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