The standard requires the management system doc-
umentation to include documented procedures required
by ISO 9001.
ISO 9000 defines a procedure as a specified way to
carry out an activity or a process. This definition is
ambiguous because an activity is on a different scale
than a process. Process outputs are dependent upon
many factors of which activities are but one. An
activity is the smallest unit of work. Several activities accomplish a task and
several tasks reflect the stages in a process but there is more to a process than
a series of tasks. This definition also results in a
belief that procedures are documented processes but this too is inaccurate.
Procedures tell us how to proceed – they are a sequence of steps to execute a
routine activity and result in an activity or a task being performed regardless
of the result.
There are very few procedures actually required by the standard but this
does not imply you don’t need to produce any others. The specific procedures
required are:
(a) A documented procedure for document control
(b) A documented procedure for the control of records
(c) A documented procedure for conducting audits
(d) A documented procedure for nonconformity control
(e) A documented procedure for corrective action
(f) A documented procedure for preventive action
These areas all have something in common. They are what the authors of the
early drafts of ISO 9000 :2000 referred to as system procedures – they apply to
the whole system and are not product, process or customer specific although it
is not uncommon for customers to specify requirements that would impact
these areas. Why procedures for these aspects are required and not for other
aspects of the management system is unclear but it seems that the authors of
ISO 9000 felt these were not processes – a conclusion I find difficult to justify.
They are certainly not business processes but could be work processes.
However, there is another message that this requirement conveys. It is that
procedures are not required for each clause of the standard. Previously,
countless organizations produced a manual of 20 procedures to match the 20
elements of ISO 9001. Some limited their procedures to the 26 procedures cited
by the standard and others produced as many as were necessary to respond to
the requirements.
