ISO13485 - 6.3 Infrastructure

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).