ISO 9001:2008 Differences
Whittington Page 2 of 19 August 2008
ISO 9001:2008 - Introduction
In this section of the Introduction, ISO 9001:2008
adds “business environment” to the list of factors that
influence the design and implementation of a quality management system. The other changes to thistext are minor revisions to the other factors, as well as, the use of a bulleted list.
The design and implementation of an organization's quality management system is influenced by - its business environment, changes in that environment, or risks associated with that environment,-
its varying needs,- its particular objectives,- the products it provides provided,- the processes it
its the size and organizational structure of the organization.
Later in section 0.1, ISO 9001:2008 changes "regulatory" to
"statutory and regulatory” and clarifies that
the customer, statutory, and regulatory requirements are those applicable to the product.
This International Standard can be used by internal and external parties, including certification bodies, toassess the organization's ability to meet customer,
statutory, and regulatory requirements applicable to
the product, and the organization's own requirements.
0.2 Process Approach
In the Process Approach section, ISO 9001:2008 switches from having to
“identify” linked activities to“determine” linked activities. Th
e section clarifies that a Process can be an activity or set of activities.
For an organization to function effectively, it has to identify
determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable thetransformation of inputs into outputs, can be considered as a process.
Also in this section, the definition of the Process Approach has been clarified by adding "to produce thedesired outcome" to the text below:
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management
to produce the desired outcome, can be referred to as the "process approach".
0.3 Relationship with ISO 9004
The planned revision to ISO 9004:2000 is expected in 2009 with extensive changes, including a newclause structure that no longer matches that of ISO 9001.