New ISO 13485:2016 - Medical Devices Quality Management System

GENEVA - March 31, 2016 - PRLog -- The new edition of the ISO 13485 standard was published on March 1 2016, concluding almost five years of intense discussion and development by experts around the world to improve and update the standard with new European requirements and other international regulatory changes, implemented since its previous revision in 2003.

ISO 13485 defines the requirements for a quality management system designed to demonstrate an organization's ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Organizations complying with this standard, such as medical devices manufacturers, as well as suppliers and external parties that provide products or services to manufacturers, will be able to demonstrate compliance with regulatory requirements, manage risk, ensure best practice for quality and safety, improve processes and provide confidence to patients and users.

The new ISO 13485:2016 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system.

Organizations have until March 1, 2019 to transition from ISO 13485:2003 to ISO 13485:2016. SGS will soon provide materials, services and courses to help make the transition in the best possible conditions.

SGS is currently making arrangements with the appropriate accreditation authorities to confirm the plan to start the certification service for ISO 13485:2016 and will soon communicate accordingly.

For more information, please contact:

Vivien Chan
International Marketing Manager
SGS S.A.
t: +603 2095 9200

Read more: http://www.sgs.com/en/life-sciences/medical-devices/audit-certification-and-verification/certification/transition-to-iso-13485-2016