9000

21])

• ISO 9001 Quality management systems – Requirements (last published 2008 [22])

• ISO 9004 Quality management systems – Guidelines for performance improvements (last published 2000 [23], due for republication 2009 [24] with a new focus on ‘sustained success’).

The standards themselves are subject to a review programme to ensure that they remain relevant. There were major changes when ISO 9001:2000 was introduced, whereas the publication of ISO 9001:2008 included only minor amendments.

The scope of a department’s QMS defines the activities included within the QMS and is determined by the organization. There are variations between oncology departments: some include just radiotherapy whereas others include planning and dosimetry, medical physics, chemotherapy, clinical trials and clerical areas. ISO 9001 is the standard against which an organization is assessed. It specifies the requirements a QMS must meet but not how the organization should meet them.

The ISO 9001:2008 [22] standard comprises nine clauses, listed in Box 14.1.