One of the most time consuming aspects of developing and maintaining a quality system is creating procedures. I think it’s no secret that teams tend to look for procedure templates to get a baseline of what the procedure should look like and what it should contain. With proof-reading, formatting and routing for signatures, developing procedures always take longer than expected. There are a lot of templates out there and most of them are either too rudimentary or too expensive. This is outrageous. Companies should have easy access to the resources needed to sufficiently comply with FDA and ISO standards. So, in an attempt to push the industry in the right direction, here is the first (of what I hope to be many) procedure template that I am releasing. It is a Design Control Procedure template that is geared for medical device companies under the FDA CFR 820 regulations and ISO 13485 standards. You will need to add company-specific information to it, but it should help smaller companies jump start their Quality System. It is saved as a Microsoft 2010 Word Document.
Download it here:
Design Control SOP
If you need a different Microsoft Word version or would like to request a different procedure template, let me know in the comments. Thanks and good luck!
Also, If you like these templates, consider donating to help me pay for server costs and keep me motivated to continue putting these free templates out. Have a good day!