SOP’s are standard operation procedures, this is included on all realms of QA, manufacturing, clinical/non clinical testing etc. SOPs is the document that describes what a trained individual needs to do to run certain tests step-by-step to achieve certain results or outcomes. SOPs are approved by the author, SOPs are needed in Design Controls and is required to have GMP and ISO 9001 certification and approval. Only those trained in SOP development can create one.