Standard Operating Procedure Template

Description

This template contains all the information you need to get started writing high-quality and complaint standard operating procedures. We designed it for companies that need to comply with:

• ISO 13485,
• the EU Medical Device Regulations 2017/745, and
• the FDA 21 CFR 820.

This template includes detailed information about how to fill out each section as well as providing clear examples. It also identifies which aspects of the template are required by the ISO standard and which others are best practices.