6.3 Infrastructure

ISO 9001:2008, Quality management systems — Requirements
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, communication or information systems).

6.3.1 Plant, facility and equipment planning
The organization shall use a multidisciplinary approach (see 7.3.1.1) for developing plant, facility and equipment plans. Plant layouts shall optimize material travel, handling and value-added use of floor space, and shall facilitate synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations.

NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system.

6.3.2 Contingency plans
The organization shall prepare contingency plans to satisfy customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure and field returns.