Why are they necessary?

Standardization is defined as an activity that gives rise to solutions for repetitive application to problems in various disciplines including science and it is aimed at achieving the optimum degree of order in each context. Generally, the activity consists of the process of establishing (determining, formulating, and issuing) and implementing standards. Therefore, standards are the ultimate result of a standardization activity and within the context of quality systems consist of quality documents or documents related to the quality systems.

The quality documents consist of Company policies, quality management plan, SOPs, working instructions, conventions, guidelines, forms, templates, logs, tags and labels. They are established by consensus and approved by a nominated body, and they provide for common and repeated use, rules, guidelines or characteristics for activities or their results with a view to promote transparency, consistency, reproducibility, interchangeability and to facilitate communication. The hierarchy and types of quality documents relevant to quality systems will depend upon Company business objectives employee competency and business model. SOPs are Level 2 quality documents and, along with other relevant quality documents, ensure the effectiveness and efficiency of quality systems.

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