ISO 13485 has been revised in 2016 to expand its scope to external suppliers and service providers in addition to medical device manufacturers. Key changes include requiring a risk-based approach to device safety and performance, controlling all changes to processes, and validating computer software used in quality management systems. The standard also places more emphasis on handling customer complaints, controlling nonconforming products, and maintaining design and development files. Organizations must comply with the new ISO 13485 requirements starting in March 2016.

1. ISO 13485:2016
HIGHLIGHTS
Mary Roopsy
www.i3cglobal.com
mrj@i3cglobal.com

2. ISO 13485 has been revised in 2016 and following are
the important highlights in the new ISO standard.
This standard is applicable not only to the manufacturers
of the medical devices but also the external suppliers or
service providers such as QMS related services to such
organizations
Importance given to the risk based approach for the
medical devices with regard to their safety and
performance.
Any changes to be made on the standard insisted
processes should be evaluated for their impact and
controlled.

3. Requirement for the validation of the computer software
applied in the QMS, processes like production and service
provision, monitoring and measurement etc.
Medical Device file requirements with the details of
medical device including the intended use, labelling,
instructions for use, processes from its manufacturing to
its servicing etc.
The requirement for the procedure for the design transfer
to manufacturing and maintenance of a design and
development file is added.

4. Sterile Barrier system validation requirement
Handling Customer complaints and reporting to the
regulatory authorities is given more aspects and
importance by compulsory documented procedure
Nonconforming products detected before and after
delivery are controlled with suitable actions explained in
the standard.

5. • The ISO 13485:2016 standard is insisted to follow from
March 2016. So it’s time to start !!!!