6.3 Infrastructure The organisation 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 manufacturer 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. 6.4 Work environment: The organisation shall determine and manage the work environment needed to achieve conformity to product requirements. Following requirements shall apply, namely:—