TABLE OF CONTENTS A system must have an aim. A system must create something of value, in other words results. Management of the system requires knowledge of the interrelationships between all the components within the systems and of the people that work in it.
W. Edwards Deming
Section 4 of ISO 9001 contains the basic requirements for establishing a management system rather than any particular component of the system. In some instances they are duplicated in other Clauses of the standard but this is no bad thing because it emphasizes the principal actions necessary to develop, implement, maintain and improve such a system. Unlike previous versions, the focus has moved away from documentation towards processes and therefore these general requirements capture some of the key activities that are required to develop an effective system.
Although the Clauses in Section 4 are not intended as a sequence there is a relationship that can be represented as a cycle, but first we have to lift some Clauses from Section 5 to commence the cycle. The words in bold indicate the topics covered by the Clauses within Sections 4 and 5 of the standard. The cycle commences with the Organization's purpose (Clause 5.3 requires the quality policy to be appropriate to the organization's purpose) through which are passed customer requirements (Clause 5.2 requires customer requirements to be determined) from which are developed objectives (Clause 5.4.1 requires objectives to be consistent with the quality policy) . In planning to meet these...
