<P> 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". SOPs usually get applied in pharmaceutical processing and for related clinical studies . 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 . Further application is with triage, when limited resources get used according to an assessment on ranking, urgence and staffing possibilities . Study director is mainly responsible for SOPs . The Quality Assurance Unit are individuals who are responsible for monitoring whether the study report and tests are meeting the SOP . SOPs can also provide employees with a reference to common business practices, activities, or tasks . New employees use a SOP to answer questions without having to interrupt supervisors to ask how an operation is performed . 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 . </P> <P> Procedures are extensively employed to assist with working safely . They are sometimes called safe work methods statements (SWMS). They are usually preceded by various methods of analyzing tasks or jobs to be performed in a workplace, including an approach called job safety analysis, in which hazards are identified and their control methods described . Procedures must be suited to the literacy levels of the user, and as part of this, the readability of procedures is important . </P>

Standard operating procedures can be linked to which of the 5s