The SRA Symposium - College of Medicine

Complementing these underlying principles are a series of requirements that need to be met in
order to be certified (or registered as it is often referred to in North America). They are:
1. Management Responsibility – The systems responsibility rests with the ‘top management’ of
the organisation – thus at a strategic level.
2. Resource Management – Sufficient human and physical resources are available to carry out the
process.
3. Product Realisation: There are necessary processes in place to produce the product or provide
the service
4. Measurement. Analysis and improvement – There are measurements in place that allow the
system to be objectively measured, which give rise to the provision of information on how the
system is performing in relation to customer
Unlike many of the ISO standards, ISO9001: 2000 is a “generic” standard. Within the context of
this paper “generic” means that it can be applied to any organisation, regardless of size or type.
The model’s four requirements function in a similar way to the PLAN-DO-CHECK-ACT (PDCA)
improvement process that was popularised by W. Edwards Deming. It is a process approach; therefore
its model (figure1) illustrates how customer requirements drive the input and how customer
satisfaction drives the output. The process approach emphasises the importance of: Understanding
and fulfilling the requirements of the customer; The need to consider processes in terms of added
value; Obtaining results of process performance and effectiveness and Continual improvement of
processes based on objective measurement (Joint Technical Committee QR-008, 2000).
Figure 1
Papers
2005 Symposium Proceedings Book 89