Last Updated on
January 20, 2023
Unscalable and unreliable medical devices can heavily impact work in medical areas, which can affect public health. To mitigate the inherent risks in some medical tools and equipment, there needs to be some sort of quality management system (QMS) in place that’s enforced. This is where the implementation of customizable and configurable QMS like ISO 13485 comes into play.
Please note that the information provided in this blog is for informational purposes only. We do not offer certification or accreditation services. If you are interested in obtaining certification or accreditation, we recommend contacting the relevant program directly.
Quality management system ISO 13485 is an international and very commonly used QMS regulatory standard for medical devices. It’s one of the most comprehensive standards for medical device manufacturers to use in order to meet customer and applicable QMS regulatory requirements.
In this case, a medical device is defined as a product (ranging from larger machines to in vitro reagents to individual tools) that is intended for use in the prevention, diagnosis, and treatment of diseases or other medical conditions.
ISO 13485 applies to medical device industries and manufacturers (those involved in the design, production, installation, and servicing of medical devices and any related services). It’s also used by internal and external parties, such as certification bodies, to assist with their auditing processes.
The ISO 13485 standard goes hand-in-hand with ISO 9001, with the main difference being ISO 13485’s added layer of customer satisfaction and continuous improvements.
All standards are revised every few years to keep them updated according to the changes and demands of the marketplace. So far, two revised editions of the ISO 13485 standard have been introduced after 1996: ISO 13485:2003 and ISO 13485:2016.
ISO 13485:2016 is the current standard. It focuses more on risk management, risk-based decision making, and changes related to the increased regulatory requirements for organizations in the supply chain industry.
The implementation of ISO 13485 provides a practical foundation for medical device manufacturers; it allows manufacturers to meet the Medical Device Directives (in EU and UK), regulations, and responsibilities for the safety and quality of medical devices.
Some of the other benefits of ISO 13485 standards are mentioned below:
Accreditation bodies assess the implementation of the ISO 13485 standard in organizations and provide a certificate of conformity. This provides CE marking and permission to sell medical devices in the European Union.
The implementation of the ISO 13485 standard, while recommended, is not mandatory. (You can also create your own QMS, as long as it meets the legal and regulatory requirements for manufactured and sellable medical devices.)
The ISO 13485 certification process is a multistep approach. A medical device manufacturing lab is accredited only after satisfying the applicable regulatory requirements of ISO standards and demonstrating a commitment to medical device quality and safety.
While it’s not mandatory, a third-party certification demonstrates your commitment to the safety and quality of medical devices. (If your lab does seek accreditation, it must pass a third-party Medical Device Single Audit Program or “MDSAP” audit.)
Below is an overview of the ISO 13485 requirements:
ISO 13485 is an international standard to assist medical device manufacturers focus on their management system, mitigate risk, and meet regulatory requirements. It assesses the quality of the medical devices throughout their lifecycle, starting from their design, development, storage, servicing to final distributions.
One way you can support and increase the standards of your business is to use high-quality lab and medical device equipment. If you’re working with a limited budget and want to reduce the upfront costs of purchasing expensive new or refurbished items, you can lease the equipment instead.