Changes to ISO 9000

Changes in titles
The titles have changed – moving away from models to requirements andguidance.

Changes in scope
The scope of the standard has changed from those activities that impact theproduct to embrace all activities
in an organization that serve the satisfaction of customers. This leaves little if any activity of an organization that would be
outside the scope of the quality management system.

Changes in structure

By far the most significant change is the change in structure – away from 20elements to a model based on five elements.
The ISO 9000:2000 family of standard is based on a process model.
Changes in content
The content has changed from 20 elements organized on the basis of whatcould go wrong to four groups of requirements
that focus on elements of process management. It is however, not the fact that the original elements have
been placed onto a new structure, but that the principles upon which the standard has been based have changed.
Changes in intent
The intent of ISO 9001 has changed from a model for quality assurance to a setof requirements for an effective quality
management. The standard is now based on eight management principles not on what requirements were
necessary to prevent failures that experience had shown led to poor product quality.
The forgotten standard ISO 8402 is brought into the family of ISO 9000 thus making it more likely that people will use it.
However, in the author ’s opinion, all three standards should have been merged into one standard thus
ensuring that everyone who possessed the requirements also possessed the concepts, terminology and
guidelines to refer to as necessary.
Much damage can be done when the requirements of ISO 9000 are taken out
of context, taken in isolation and taken literally. ISO 9000 is not a productstandard therefore it is subject to
interpretation as appropriate to the conditions
in which it is being used. Whatever the initial understanding of a requirement
of ISO 9001 might be, the intent is that:
organizations design and manage their processes effectively to achievecorporate objectives, not that they create functional
silos that compete for resources.
organizations choose the right things to do based on an objective analysis of
the environment in which they operate, not slavishly follow procedures that
serve no practical purpose.
management create an environment in which people will be motivated, not
create bureaucratic systems of documentation that stifle initiative and
creativity.
Changes in language
The language in ISO 9000 has changed to reflect pressure from the usercommunity for a user-friendlier standard.
In some cases the changes are insignificant but in others the changes have a wider impact as indicated
below:
Subcontractor has changed to supplier and supplier changed to organizationso that there is now a supply
chain represented by customer – organization – supplier.
In ISO 9001 the term customer is used but in ISO 9004 the term, interested party
is used in order to embrace customers, employees, investors and otherparties.
Executive management has been changed to Top Management indicating thatwhen the standard uses
the term management responsibility it is the people who direct the organization that should address
these requirements.
Specified requirements have changed to customer and regulatory require-ments or product requirements
depending on the context.
Procedures have not exactly been changed to processes but presented in adifferent way that makes
procedures only one element of managing an effective process. Procedures have lost their dominance in
the standard to be replaced by the concept of managed processes.
Changes in requirement
ISO 9001 still contains 136 ‘shall’ statements, 2 less than the 1994 version so insome respects it is no different.
There were roughly 323 requirements in ISO 9001:1994 (Hoyle, David, 1996)6 . In ISO 9001:2000 there are roughly 250
requirements. This is still too many especially if we are trying to get across the
fundamental requirements of the standard. The following summarizes the
requirement of ISO 9001 at two levels: firstly as a single requirement, secondly
as a series of generic requirements.