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ISO 13485: 2016

ISO 13485: 2016 Quality Management System – Medical Devices

ISO 13485: Brief Synopsis

ISO 13485 is an international standard that represents the requirements for a strict and comprehensive Quality Management System (QMS) for the design, production, installation and servicing of medical devices and related services. Also known as Quality Management System – Medical Devices, this standard requires certified organisations to demonstrate that the quality system is effectively implemented and maintained.

ISO 13485 was revised in 2016 (now it is called ISO 13485:2016) to ensure that the new quality management systems kept up with the changes in technology and regulatory requirements in the supply chain for medical devices and related services. It put greater emphasis on risk management for organizations in the medical industry.

We at Globus can help you in certifying your Medical Devices System.

Advantages of ISO 13485 Certification

Benefits of Getting the ISO 13485 Certification

Like all ISO standards, organisations can reap the benefits of the ISO 13485 standard by implementing it without taking the certificate. However, accredited an ISO 13485 certification offers plenty of benefits such as

Improves Credibility and Brand Image:

ISO 13485:2016 is an internationally recognised standard for quality management in the medical device industry. It gives you a competitive advantage and builds credibility in the market and shows your clients that your organisation takes quality seriously. You can use your QMS as a marketing tool as well to grab more opportunities since many customers prefer to do business with ISO 13485 certified companies.

Assures Customer Satisfaction:

A Medical Devices Quality Management System (QMS) in place for the design, production, installation and servicing of medical devices and related services means that the end product will be of high quality. This directly leads to fewer complaints and issues and assures customer satisfaction. This is also going to be good for the business and help strengthen its image in the marketplace.

Promotes Continual Improvement:

One of the key things to stay ahead of the competition in this fast-paced world is to seek opportunities for continual improvement. With the ISO 13485 Quality Management System, continuous improvement becomes a part of the organisation’s culture and everyone is always on the lookout for ways to improve how things are done. This helps in identifying future risks and mitigates their effects by preparing in advance.

Rules out the Need for Multiple Certifications:

For organisations that operate in multiple locations across the globe, it can be troublesome to keep a track of local regulations and get the necessary certifications for each location. However, with an internationally recognised certification like ISO 13485, they do not need to look for location or country-specific registrations or certifications. It also expedites the process of entering new markets.

Globus is an independent certification body that provides ISO 13485 certification in addition to other certifications such as ISO 9001, ISO 14001, ISO 27001, etc. to organisations across the globe. Get in touch with us for ISO 13485:2016 Medical Devices Quality Management System certification today. Call at 289-426-1382 or email us.


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