Also, abbreviations and acronyms should be included there as well. Sometimes terminology should be included as well in case there is any complicated term.Incorporate Procedure Scope, only if it’s needed – because some processes can stretch onto different departments or teams.It is good to have a table of content because if the document is longer than average, it will be easier to navigate through.Make sure your SOP includes a title page, by giving the specific name of the process, the name of the department that the SOP applies to, etc.In two sentences describe the aim of this document. Whoever would read that SOP, would probably like to know it’s purpose.Try to be consistent with the format of your SOP when you start writing.Let’s skip to the main thing, and number up all the things you should keep in mind about your SOP: Standard Operating Procedures for medical devices are well-written instructions that specifically describe how each department should do a specific task. In essence, it should always be at hand in the workplace.īut in another word, we could put it this way. The aim of the SOP is to carry out the operations correctly and always in the same manner.

So, you are a medical device creator and you reached to the point when you see that SOP (Standard Operating Procedure) is required by the FDA, ISO, and other regulatory bodies.īut what SOP actually means? By definition, it’s a document that describes the regularly recurring operations relevant to the quality of the investigation.

Iso 13485 sop documents