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A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. [1] SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations. [citation needed]
As with GMP, operating within this flexibility, it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective, and to establish methods and procedures to design, produce, and distribute devices that meet the quality system requirements.
ISO 3103 is a standard published by the International Organization for Standardization (commonly referred to as ISO), specifying a standardized method for brewing tea, possibly sampled by the standardized methods described in ISO 1839. [1]
A standard practice or procedure gives a set of instructions for performing operations or functions. For example, there are detailed standard operating procedures for operation of a nuclear power plant. [3] A standard guide is general information or options that do not require a specific course of action.
It documents the approved standard procedures for performing operations safely to produce goods and provide services. [2] Compliance with the operations manual will generally be considered as activity approved by the persons legally responsible for the organisation. [3] The operations manual is intended to remind employees of how to do their job.
Organizations typically document procedures in their published policy and procedures guide, or their standard operating procedure (S.O.P.) guide. A procedures manual or procedural manual typically gathers together a number of procedures used within an organisation, [3] or for a specific set of functions. [4]
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