Q: What is the difference between the ISO 9001:2008 and ISO 19011:2011 literature on your web site? Please provide a detailed explanation and their use.
A: I can see where the confusion might arise, as the numbers are very similar! But the contents are quite different.
ISO 9001 Quality management systems–Requirements is the mother of all quality management systems. It lays out the minimal requirements for an acceptable way of managing your business for quality. In the beginning, it was developed as a requirements document to lay on your suppliers. Then it became the foundation for registration (other countries might call this certification) of your own management approach to quality. About a decade ago, various business sectors – aerospace, automotive, medical devices, laboratories, etc., all used the ISO 9001 document as the base for their specific approaches. They didn’t take anything away, but added additional requirements. By far, the greatest use today is for registration/certification. This is somewhat sad, in that the standard itself is a beautiful way of managing the resources within the enterprise. Registration can get quite bureaucratic and not worth the expense.
ISO 19011:2011 Guidelines for the auditing management systems is the international auditing standard (my specialty). It was first developed as a means to get all the various registration agencies around the world to do their audits in a consistent manner. It also had support from the multinational companies that had factories – and thus registrations – all around the world and often with different cultures. Norms in Canada are not the same as China! Unfortunately, this registration emphasis in the standard made it somewhat hard for internal auditors and supplier auditors to use it. Plus, there is no requirement to use the standard, other than within the registration industry.
For these reasons, the U.S. wrote a supplement for the 2002 version of this standard, giving guidance on how to use the principles for internal audits and small organizations [note: development is underway to offer similar supplements for the ISO 19011:2011 version — anticipated end of 2012/early 2013.]. ASQ is the only place to get this version, which includes the supplement, along with the base document. As this auditing standard was revised, it picked up environmental auditing and safety auditing in the scope.
Dennis Arter
ASQ Fellow
The Audit Guy
Columbia Audit Resources
Kennewick, WA
http://auditguy.net