''4.2.1 General''

The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by this International Standard,
d) documents needed by the organization to ensure the effective planning, operation and control of its processes,
e) records required by this International Standard (see 4.2.4), and
f) any other documentation specified by national or regional regulations.

Where this International Standard specifies that a requirement, procedure, activity or special arrangement be “documented”, it shall, in addition, be implemented and maintained.

For each type or model of medical device, the organization shall establish and maintain a file either containing or identifying documents defining product specifications and quality management system requirements (see 4.2.3). These documents shall define the complete manufacturing process and, if applicable, installation and servicing.

NOTE 1 The extent of the quality management system documentation can differ from one organization to another due to
a) the size of the organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.

NOTE 2 The documentation can be in any form or type of medium.
Thu, 19 Mar 2015 19:58:10 GMT
Thu, 19 Mar 2015 20:12:18 GMT