ISO 13485: Frequently Asked Questions Answered

ISO 13485Recent news that the US Food and Drug Administration (FDA) will use ISO 13485 as the basis for its quality system legislation for medical devices was well received by those in the industry, perhaps none more than the ISO (International Organization for Standardization) itself. ISO 13485 is the international standard for quality management systems (QMS) that establish requirements for regulatory purposes for the medical device sector. The regulation is designed and intended to function with other management systems around the world, and by doing so, work more efficiently and transparently with each other. The move by the FDA is intended to help streamline regulatory processes for medical devices around the world.


The FDA’s decision to use ISO 13485 will also help the standard gain further recognition. By replacing the current quality system regulation, the FDA is taking an important step in the recognition that ISO 13485 has already gained globally. The convergence of medical device regulatory processes has been a goal of ISO for decades. The standard is already the foundation for the Medical Devices Single Audit Program (MDSAP) that is currently used by Australia, Brazil, Canada, Japan, and the USA.

As the impact of the FDA adopting ISO 13485 to replace its current regulatory system for quality management has begun to sink in, questions concerning QMS by medical device manufacturers, companies, and organizations have been steadily growing. Below is an FAQ primer in anticipation of the changes:

Why should medical device companies have a quality management system (QMS)?

The practice of implementing a QMS is a long-term strategic decision that, once in place, works to guide your company or organization to consistently meet standards, improve overall performance, and to provide a sound basis for sustainable development initiatives. A QMS also gives assurances and confidence to customers that the most stringent requirements for quality have been met.

What is an ISO 13485 Quality Management System?

Implementing a QMS for ISO 13485 follows a set of conformance requirements and interrelated processes, including any guidelines that establish, implement, and maintain the provisions outlined in the requirements of the standard with the aim of meeting customer and applicable regulatory requirements for businesses operating in the medical device sector.

What are the requirements for ISO 13485 compliance?

For medical device companies to be ISO 13485 compliant, they must have a QMS that demonstrates an ability to provide medical devices and related services that meet applicable regulatory requirements and customer approval. This standard applies to any company or organization that is involved with any one or more stages of the life-cycle of a medical device. This can include design and development, production, manufacturing, packaging, storage and distribution, installation, or servicing of a medical device or provision of associated activities such as technical support, supply chains, or product related consulting services.

Are there testing requirements for ISO 13485?

There are no testing requirements, but there are standards that must be met. Because ISO 13485 is considered a stand-alone set of quality management requirements, manufacturers of medical devices and related support and service organizations must provide documented evidence that their devices will meet safety and quality standards and perform as intended for patients or consumers. Testing of a particular product is part of the overall QMS which companies implement to meet the numerous requirements of various regulations and standards.

Does Biomedical Polymers, Inc., adhere to ISO 13485?

BMP is a global manufacturer of plastic medical devices that are used in research and medical diagnostic laboratories. As an Original Equipment Manufacturer (OEM) of medical devices, adherence to ISO 13485 has been critical to its success. BMP implemented a QMS that met the requirements of certification for ISO 13485 in 2016. Today, it provides design and engineering consultation, coordinates tooling fabrication and mold parts to specification and meets production with a state-of-the-art plastic injection molding and injection blow molding equipment all under the auspices of ISO 13485.