ISO 13485:2016 Concepts
ISO 13485 is an important quality management standard for medical device companies not only in the US but also in Europe. I read the standard line by line, and below are some summary diagrams as well as TL;DR (“Too long; Didn’t read”) answers to some common questions.
For a more detailed note on the subsections in the standard, click here.
What is ISO 13485? Who is it for?
TL;DR: It’s a standard for setting up and maintaining an effective quality management system (QMS). It’s for companies who work with medical device(s) or service(s).
ISO stands for International Organization for Standardization. ISO 13485:2016 is a standard published by ISO in 2016 to provide best-practices and frameworks for establishing (and improving) an effective quality management system (QMS), so that the product meets the requirements of customers, users, and regulatory authorities.
ISO 13485 can be useful for organizations that:
- Supply resources and services for medical devices
- Design and develop medical devices
- Manufacture/ produce medical devices
- Store, distribute medical devices
- Install, service, and dispose medical devices
What is a process approach? What is a process?
TL;DR: ISO 13485 uses the process approach, which considers the function of an organization as a system of processes (aka a set of activities that produce outputs from some inputs).
The standard defines a process as an activity that receives and converts input to output.
The process approach involves viewing the function of the organization as a system of processes. In quality management, it means the organization will identify these processes as well as their interactions, and manage them to ensure quality of the system and products.
What are the requirements for a QMS under this standard?
What are the stages in establishing and improving a QMS/ process?
Using the Deming cycle, the stages for establishing and improving a QMS or a process can be summarized below.
What records are required under this standard?
What are some processes involved in design and development of medical device/ service?
