Management System Services

ISO 13485

Medical Devices — Quality Management Systems

About

ISO 13485 is a stand-alone QMS standard derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical devices manufacturing environment.

What it means for your business

Having ISO 13485 certification shows an established and maintained effectiveness of your process, while ensuring the consistent design, development, production, installation and delivery of medical devices that are safe for their intended purposes.

Benefits of certification

Companies that implement the requirements of ISO 13485:2016 and achieve certification commonly find benefits such as meeting legal, regulatory, contractual and marketing requirements for proved product safety.

Although not fully harmonized, an ISO 13485 Quality Management System (QMS) is very close to the Food and Drug Administration’s (FDA) QSR standards.

Email us at info@iapmoscb.org. Let us know a bit about your certification needs and we’ll get back to you ASAP.

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