Standard Operating Procedures (What Are They Good For ?)

Abstract

Standardization is defined as an activity that gives rise to solutions for repetitive application to problems in various disciplines. Generally, the activity constitudes the process of estab‐ lishing (determining, formulating, and issuing) and implementing standards. Thus, stand‐ ards are the perfect result of a standardization activity and inside the context of quality systems consist of quality documents or documents related to the quality system. High lev‐ els of quality are important to accomplish Company business objectives. Quality, a source of competitive benefit, should stay a symbol of Company products and services. High quality is not an additional value; it is an important elemantary necessity. Each employee in all or‐ ganizational units is responsible for guaranteeing that their work processes are effective and continually getting better. Top management should provide the training and an appropriate motivating environment to support teamwork both inside and across organizational units for employees to advance processes. Ultimately, everyone in an institution is responsible for the quality of its products and services. An institution in the role of a sponsor of clinical tri‐ als can best achieve its business objectives by establishing and managing robust quality sys‐ tems with their integral quality documents including standard operating procedures (SOPs) (Manghani, K. 2011). The Quality Management system must evolve by trial and error, with enlarging experience, by group discussions and with changing understanding. In the begin‐ ning, attention will be focused on basic operational SOPs, afterwards moving to record keeping (as more and more SOPs are issued) and filling gaps as practice admits missing links in the chain of Quality Assurance. Essentially problems will turn up. One way to react to them is to talk with people in other laboratories who have faced similar problems. It

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