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Standard Operating Procedures : ウィキペディア英語版
Standard operating procedure

The term standard operating procedure, or SOP, is used in a variety of different contexts, including healthcare, aviation, engineering, education, industry, military and civil servants.
The U.S. military sometimes uses the term Standing — rather than Standard — Operating Procedure, because a military SOP refers to a unit's unique procedures, which are not necessarily standard to another unit. "Standard" could imply that there is one (standard) procedure to be used across all units.
Such procedures are a set of step-by-step instructions to achieve a predictable, standardized, desired result often within the context of a longer overall process. For food and drug safety, the related Sanitation Standard Operating Procedures are used.
==Clinical research and practice==
In clinical research, the ''International Conference on Harmonisation'' (ICH) defines SOPs as "detailed, written instructions to achieve uniformity of the performance of a specific function". SOPs get usually 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 an 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.〔(Guidance on the Documentation Requirements of ISO 9001:2008 )〕

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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