ISO9001-2008 fantasy vs reality

In the document control procedure of one of my clients is a requirement that every document be reviewed and revised, or reapproved, a minimum of every 2 years. Someone said this was an arbitrary amount of time, that documents should be reviewed and reapproved a lot more often than every 2 years. He’s right, of course. In a perfect world people would actually look at quality system documentation on a regular basis. They would take some time to consider what was written, and give some thought to its accuracy, and make revisions when necessary. Maybe every year would be better. Maybe every 6 months.

Another client, with about 100 people in the company, writes up 20 to 30 corrective actions, and 3 to 5 preventive actions, each year. A very minor nonconformance occurred, a simple human error. Someone questioned whether or not we ought to write up corrective actions for every minor issue. Such issues would likely add another 15 or 20 CAR’s to the annual list, and would also add about 40 to 80 man-hours of work each year, with little benefit realized.

The reality in many organizations is that people are too busy getting product designed, produced, inspected and shipped. Sales orders and purchase orders need to be negotiated, processed and followed up.

In the case of the first company, writing an arbitrary time of 2 years was done to make sure documents get revised at least that often. The company’s quality manager knows that, with their level of business and manpower, if that arbitrary time period wasn’t written into the manual, the documents might go for 3 or 4 or 5 years until someone got around to reviewing them. Is this a perfect solution? No, of course not. But it works for their company.

The ISO9001-2008 quality standard does not specify how many corrective actions you must write. It doesn’t specify how often you revise your documents. It’s up to you to decide what’s appropriate for your company. Your third-party auditor may have thoughts and suggestions as to how you run your quality management system. As long as you are meeting the requirements of the standard, and meeting the requirements you’ve written in your quality system documents, you’ll be fine.

Similar Posts:

Leave a Reply