ISO 9001:2008 - Quality management systems
1.1 General
The adoption of a quality management system should be a strategic decision of an organization.The design
and implementation
of an organization's quality management system is influenced by
a) its organizational environment, changes in that environment, and the risks associated with that
environment,
b) its varying needs,
c) its particular objectives,
d) the products it provides,
e) the processes it employs,
f) its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the structure of quality management
systems or
uniformity of documentation.
The quality management system requirements specified in this International Standard are complementary to
requirements
for products. Information marked “NOTE” is for guidance in understanding or clarifying the
associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to
assess the
organization's ability to meet customer, statutory and regulatory requirements applicable to the
product, and the
organization's own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during
the
development of this International Standard.ts.