''6.3 Infrastructure''

The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable

a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport or communication).

The organization shall establish documented requirements for maintenance activities, including their frequency, when such activities or lack thereof can affect product quality.

Records of such maintenance shall be maintained (see [[4.2.4 Control of records|ISO13485 - 4.2.4 Control of records]]).
bag
quality_public
created
Thu, 19 Mar 2015 22:58:08 GMT
creator
dirkjan
modified
Thu, 19 Mar 2015 23:00:27 GMT
modifier
dirkjan
tags
ISO13485