A frequently heard comment from anxious organisations is: ‘We will have to improve for ISO 9001:2000.’ But the reality is that it is the standard that has actually improved for contemporary business life.
Many additional requirements are already being met in modern organisations. All that may be needed is to put these into the ‘audit arena’ by presenting them in the form of procedures.
Putting these issues into the audit arena (ie enabling them to be audited) gives an opportunity to gain assurance that planned arrangements are being complied with. To appreciate this it is worthwhile looking at some aspects of the new standard that have been introduced or at least been given emphasis in comparison to the 1994 version.
The requirement to present processes and their interaction is not a useless activity. In doing this an organisation and other parties interested in its management system are able to clarify their understanding of the system.
Seeking the opinion of the customer base is something that any ambitious organisation should do and in many cases is probably already doing. For some, the insertion of the customer satisfaction requirement into ISO 9001:2000 (8.2.1), was neither shocking nor daunting.
Many sales and marketing functions already had existing processes for this requirement, with a view to gaining competitive advantage, but were not formally described for auditing.
In an effort to continually improve, all organisations have objectives relating to quality. These objectives can be of two types:
Therefore establishing quality objectives (5.4.1) is a requirement that should not induce fear. Once again, all that may be needed is some means of making these objectives visible in the described management system.
Many industry sectors have for many years been controlled by a regulatory framework. Examples can be found in water supply, food, pharmaceuticals and consumer products but there are many others.
The need to consider regulatory demands was mentioned in ISO 9001:1994 but the 2000 version gives great emphasis to it as part of product realisation (7.2.1) and any design/development inputs (7.3.2).
The lack of emphasis on consideration of legal drivers in the 1994 version did not mean that certified companies were ignoring them. The only shortfall was the lack of a description of how legal information was obtained, processed and applied to the realisation of a product. ISO 9001:2000 demands that these activities are made more visible to enable auditing.
ISO 9001:1994 gave the impression that the most reliable and auditable device for the presence of competence of personnel was the training record. Although records are still part of the picture this method obviously has limitations as a sole proof of competence.
The 2000 version gives greater emphasis to the concept of competence
(6.2.1 and 6.2.2) and so directs auditors to check that personnel
are competent to perform allocated tasks. The publication of the 2000
version has opened up human resource management to the audit process.
ISO 9001:2000 is not revolutionary. The examples given here are just
a few of several to illustrate a point. The latest version of the
standard has merely caught up with the reality of business life.
If these additional requirements are in existence then the only task for many stewards of management systems is to recognise and represent them in a way in which they can be audited.
About the author
David Powley is a principal lead IMS auditor for DNV Certification
Ltd. He is also a chartered chemist and member of the Royal Society
of Chemistry and the Institution of Occupational Safety and Health.
He is a principal environmental auditor with the Institute of Environmental
Management Assessment, a registered lead auditor with the IRCA scheme
for QMSs and a lead verifier for Eco Management and Audit Scheme.
For more information go to www.dnv.com