General requirements of ISO 13485
General requirements of ISO 13485
Clause 4.1
The organization shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard.
The organization shall
a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),
b) determine the sequence and interaction of these processes,
c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
e) monitor, measure and analyze these processes, and
f) implement actions necessary to achieve planned results and maintain the effectiveness of theseprocesses.
These processes shall be managed by the organization in accordance with the requirements of this International Standard.
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system (see 8.5.1).
NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.
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