"A Standard Operating Procedure is a document which describes the regularly recurring operations relevant to the quality of the investigation. The purpose of a SOP is to carry out the operations correctly and always in the same manner. A SOP should be available at the place where the work is done".

Writing and implementing standard operating procedures (SOPs) for the manufacture of medical devices is required by ISO 13485, FDA, and other regulatory bodies. An SOP is a set of written instructions that documents a routine or repetitive activity that is followed by employees in an organization.

Standard operating procedures provide the policies, processes and standards needed for the organization to succeed. They can benefit a business by reducing errors, increasing efficiencies and profitability, creating a safe work environment and producing guidelines for how to resolve issues and overcome obstacles.

5 Essentials for Every SOP Keep a Clear User Viewpoint. You should always be thinking about your end user when you write an SOP. ... Format Clearly. As well as being careful with language, process documentation should always use intuitive formatting. ... Keep Scope in Mind. ... Observe Roles and Impacts. ... Seek Authority and Approval.