Certifications

ISO 13485:2016

Medical Devices Quality Management System

ISO 13485:2016 is the Medical Device Industry’s most widely used International Standard for Quality Management. ISO 13485:2016 specifies requirements for a Quality Management System where an organization needs to demonstrate its ability to provide Medical Devices and Related Services that consistently meet Customer and applicable Regulatory Requirements. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services. ISO 13485:2016 responds to the latest QMS practices, reflecting the evolution in medical device technology and changes in regulatory requirements and expectations. This ensures that the standard remains compatible with other management system standards, including the new edition of ISO 9001:2015. With a thorough understanding of ISO 13485:2016 Standard and its application in a wide variety of industries, countries and businesses of different sizes, Quantum Systems can assist you to develop and implement an ISO 13485:2016 based Quality Management System specific to the needs of your organization. Quantum Systems provides Consulting, Training, Internal Audit, Pre-Assessment Audit and Facilitation during ISO 13485:2016 Certification Audit.