The international quality standard ISO 9001 essentially requires the determination of processes (documented as standard operating procedures) used in any manufacturing process that could affect the quality of the product. New employees use a SOP to answer questions without having to interrupt supervisors to ask how an operation is performed. SOPs can also provide employees with a reference to common business practices, activities, or tasks. The Quality Assurance Unit are individuals who are responsible for monitoring whether the study report and tests are meeting the SOP.
Study director is mainly responsible for SOPs. Further application is with triage, when limited resources get used according to an assessment on ranking, urgence and staffing possibilities.
There the focus is always set on repeated application of unchanged processes and procedures and its documentation, hence supporting the segregation of origins, causes and effects. SOPs usually get applied in pharmaceutical processing and for related clinical studies. In clinical research, the International Council for Harmonisation (ICH) defines SOPs as 'detailed, written instructions to achieve uniformity of the performance of a specific function'.
