Everything You Need to Know About ISO 13485 Certification

Medical devices undergo a rigorous design and testing phase before being manufactured and distributed to health facilities. Therefore, new ones need patenting, and old models need design revision to meet current technological demands.

But along the line, there are also intricate yet critical processes that ensure it meets high levels of improvement to meet user and customer satisfaction. And this is where the ISO 13485 steps in. The standardisation process is required for the medical industry to ensure that every medical device meets regulatory compliance laws.

Such certification has become a valuable credential for clinics, hospitals, and other healthcare facilities in ensuring quality services. Meanwhile, the ISO 13485:2016 is based on the model approach of the ISO 9001 standardisation process.

A Reiteration of the ISO 9001 Model Approach

International Standards has become a pivotal framework for most industries revolving around customer products and services. And the ISO 9001 contains all the essential guidelines for organisations regardless of the industry they are catering to.

For example, the aerodynamics industry has its own set of critical guidelines for designing and manufacturing components and equipment. Similarly, the medical field also has different regulatory compliance and manufacturing needs.

ISO 13485 acts as a comprehensive management system entirely dedicated to standardising the development and manufacture of medical devices. While the ISO 9001 entirely gravitates towards customer satisfaction in most industries, the regulatory compliance of medical devices falls under the latter.

The Importance of ISO Certification for Your Medical Devices

The ISO benchmark is highly relevant in the medical device design and manufacturing process because it ensures that patient safety protocols are followed. Nonetheless, distributors, suppliers, and vendors also need to have regulatory certification. This is to make sure that they offer medical products that are of high quality and consistently performing. And since medicine is one of the most precise sciences, regulation means saving the lives of patients and those who are at stake.

An ISO certification also means reliability when it comes to the services your facility offers. The value of the ISO benchmark is not only in matters of implementation, but there is also relevant audit testing that ensures the entire system’s effectiveness.

The ISO accreditation gives manufacturers the confidence to have persistence in their deliverable, minimising risks and failures that potentially put patient safety in peril. In addition, the ISO mark embodies a manufacturer or dealer’s reputation in providing quality medical equipment.

Understanding When You Need Both Certifications

Although most businesses do not require both accreditations, there are instances when they can be useful to an organisation. For example, if your company provides health-related services, including dealing as a contract manufacturer or supplier of medical equipment, you might be required to have both compliance certificates.

The medical ISO standard is a good way to address the comprehensive demands in meeting the QMS framework. Adopting the accreditation feature means having the practical foundation to set regulatory standards and the commitment to provide a safe and quality medical device.

The certification mark is a comprehensive platform in itself and acts as a stand-alone QMS guideline. However, it is an offshoot of the ISO 9001 standard series, adopting the process-based model of the ISO benchmark.

And though formed from the same guiding principles, some manufacturers opt for the precise measures of ISO 13485. It is particularly helpful if you aim to distribute or supply your medical devices in the international market.


I’m a Digital Marketing Consultant, Professional Blogger, Affiliate Marketer, and an Online Entrepreneur. Here, I blog about Technology and digital product reviews, SEO, and help people to choose right digital and tech gadgets.

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