iso 13485 version 2016 pdf free download

This will give more detail than our current flow charts, and internal and external auditors can use the turtle diagrams to understand process interactions.

To systematically improve our procedures, we will be systematically replacing those flow charts with turtle diagrams for each process. Create a process “turtle diagram” for each quality procedureĪll of the procedures that Medical Device Academy created have a flow chart at the beginning of the procedure showing the procedures and forms associated with processes that are inputs to that procedure and outputs from that procedure. Referring to your template as “suggested formatting” will avoid unnecessary nonconformities. The ISO 13485:2016 standard does require a “mandatory” format.

Just make sure that your document control procedure allows flexibility to deviate from the template. In addition, using templates ensures a consistent format that makes it easier for everyone to find the information they are looking for. You don’t have to mimic our template, but using a template will accelerate the speed of your writing when you create procedures, and it makes sure you don’t forget any of the essential elements. In 2013 we published a blog about using a procedure template where we described our 12-part procedure template (i.e., TMP-001).

Use a standardized template for your procedures The article was updated and posted as a new blog on Tuesday, March 28, 2023. During my ride home, however, I thought of a few other ideas that might help anyone writing or re-writing a procedure. Several books related to Lean Manufacturing explain how to use visual communication to replace text (i.e., “a picture says a thousand words”). Would you like to learn nine ways to improve your quality system procedures? One method is precisely the opposite of our advice from 2011.ĭuring a CAPA course I taught on Friday, January 28, 2011, one of the attendees asked if we teach a course on “How to write better quality system procedures.” Unfortunately, we could only offer material from a course about “Training the trainer.” That “Training the trainer” course focused on visual communication. Nine easy ways to organize and improve quality system procedures

Iso 13485 version 2016 pdf free download