Dirkjan: Created page with "'''4.2.2 Quality manual''' The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of an..."

2020-08-25T09:45:48Z

Created page with "'''4.2.2 Quality manual''' The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of an..."

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'''4.2.2 Quality manual'''

The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusion and/or non-application (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.

The [[Quality Manual|Quality Manual]] shall outline the structure of the documentation used in the quality management system
[[Category:quality]]

[[Category:ISO13485]]

ISO13485 - 4.2.2 Quality manual - Revision history

Dirkjan: Created page with "'''4.2.2 Quality manual''' The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of an..."