Documenting a quality management system

The standard requires the organization to document a
quality management system in accordance with the
requirements of ISO 9001.

A document (according to ISO 9000 clause 2.7.1) is
information and its supporting medium. A page of
printed information, a CD ROM or a computer file is
a document, implying that recorded information is a
document and verbal information is not a document.
Clause 4.2 requires the management system doc-
umentation to include certain types of documents
and therefore does not limit the management system
documentation to the types of documents listed.

As a management system is the means to achieve
the organization’s objectives, and a system is a set of interrelated processes, it
follows that what has to be documented are all the processes that constitute the
system.

While there is a reduction in emphasis on documentation in ISO 9001:2008
compared with the 1994 version, it does not imply that organizations will need
less documentation to define their management system. What it does mean is
that the organization is left to decide the documentation necessary for effective
operation and control of its processes. If the absence of specific documentation
does not adversely affect operation and control of processes, such documenta-
tion is unnecessary.


Before ISO 9000 came along, organizations prospered without masses of
documentation and many still do. Those that have chosen not to pursue the
ISO 9000 path often only generate and maintain documents that have a useful

purpose and will not produce documents just for auditors unless there is a
legal requirement. Most of the documentation that is required in ISO 9000 came
about from hindsight – the traditional unscientific way organizations learn and
how management systems evolve.
ISO 9000 contains a list of valid reasons for why documents are necessary
and here is a list used in previous editions of this handbook.
To communicate requirements, intentions, instructions, methods and results
effectively
To convert solved problems into recorded knowledge so as to avoid having
to solve them repeatedly
To provide freedom for management and staff to maximize their contribu-
tion to the business
To free the business from reliance on particular individuals for its
effectiveness
To provide legitimacy and authority for the actions and decisions needed
To make responsibility clear and to create the conditions for self-control
To provide co-ordination for inter-departmental action
To provide consistency and predictability in carrying out repetitive tasks
To provide training and reference material for new and existing staff
To provide evidence to those concerned of your intentions and your
actions
To provide a basis for studying existing work practices and identifying
opportunities for improvement
To demonstrate after an incident the precautions which were taken or which
should have been taken to prevent it or minimize its occurrence
If only one of these reasons make sense in a particular situation, the
information should be documented. In some organizations, they take the
view that it is important to nurture freedom, creativity and initiative and
therefore feel that documenting procedures is counterproductive. Their view
is that documented procedures hold back improvement, forcing staff to
follow routines without thinking and prevent innovation. While it is true that
blindly enforcing procedures that reflect out-of-date practices coupled with
bureaucratic change mechanisms is counter productive, it is equally short-
sighted to ignore past experience, ignore decisions based on valid evidence
and encourage staff to reinvent what were perfectly acceptable methods.
Question by all means, encourage staff to challenge decisions of the past, but
encourage them to put forward a case for change. That way it will cause
them to study the old methods, select the good bits and modify the parts that
are no longer appropriate. It is often said that there is nothing new under thesun – just new ways of packaging the same message.