A quality management system is only effective when the people expected to use it understand how it works, why its controls exist and what is required of them at their particular stage of development.
Standard operating procedures sit at the centre of many regulated operations. They define how activities are performed, establish consistency, support training and provide documented evidence of how controlled processes are expected to operate.
Clear writing is a practical component of effective standard operating procedures. In regulated environments, the purpose of an SOP is not simply to document what an organisation expects people to do.
Standard operating procedures are fundamental to a functioning quality system. In regulated environments, however, having an SOP is not enough.