Fact or Fiction? The Truth about ISO 9001
There are some strange ideas out there about ISO 9001:2000. While we are certain that many people providing guidance have good intentions, it can be frustrating for companies trying to transition or implement a quality management system for the first time. Here are a few of the things we’ve heard, along with our answers:
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“Six Sigma Green Belt training is required for registration to ISO 9001:2000.”
Wrong! This must come from a consultant offering this training. It is usually expensive and is only “required” for companies that want to implement Six Sigma. Some training in statistical methods would be useful in meeting the requirements in the standard for collection and analysis of data, but it is quite a stretch to translate that into a requirement for Green Belt training. -
“ISO 9001:2000 requires that internal auditors take an accredited Lead Assessor’s course.”
Wrong again – the standard does not specifically say anything about auditor training. It does refer to ISO 10011 for guidance, but how auditors are trained is left up to the company. It may not be a bad idea for internal auditors to take such a course, but it is not a requirement. -
“Preventive action is done to prevent recurrence of a problem after corrective action is taken.”
This one has been around since the days of the 1994 version. ISO 9001:2000 clarifies preventive action even further by separating it into a different section and emphasizing the reference to potential nonconformities. In other words, you are eliminating the cause of something that hasn’t even happened yet. -
“ISO 9001:2000 is much more difficult to implement than ISO 9001:1994.”
This is either a consultant trying to convince a client that they need him/her for six months, or a management representative concerned about the fact that upper management actually has to be involved. OK, it has some additional requirements like continual improvement, measurable objectives, customer satisfaction and analysis of data, to name a few. But what company in business to make a profit would not want these things? -
“We have to rewrite all our documentation before we can transition to ISO 9001:2000.”
This is a variation of #4. The belief is that because the sections of the standard are numbered differently, the documentation must be rewritten. A rewrite of the quality system manual makes it easier for the registrar to follow, but the sections can also be mapped to the corresponding parts of the standard (refer to Annex B in the standard – Correspondence between ISO 9001:2000 and ISO 9001:1994). The new requirements do need to be addressed.