ISO 13485:2016 – Why Is This Important For Medical Device Manufacturers?
Ready to join the international Medical Device arena? What is ISO 13485:2016 ? Let’s dive in! For medical device manufacturers, the Food and Drug Administration (FDA) is no stranger and compliance with federal regulations will make or break a company! Those seeking to market and export internationally now have another face in the game, the International Organization for Standardization (ISO).
People ask, why is it “ISO” and not “IOS” based on the name? Per the International Organization for Standardization, “Because International Organization for Standardization would have different acronyms in different languages (IOS in English, OIN in French for Organisation internationale de normalisation), the founders opted for the short form - ISO. The story goes that ISO is derived from the Greek word “isos”, meaning equal. Whatever the country, whatever the language, we are always ISO” [1] . If you didn’t know, now you know!
ISO 13485:2016 titled “Medical devices – Quality Management Systems – Requirements for Regulatory Purposes” was based on ISO 9001 “Quality Management Systems – Requirements”, that was a more general standard to help organizations of all sizes to improve their performance and demonstrate their commitment to quality. A principal difference is that ISO 9001 driven companies are more customer focused and perform risk-based decisions to drive and meet customer satisfaction. Continuous improvement (Kaizen) is emphasized to enhance both customer satisfaction and improve the quality management system (QMS). ISO 13485 is primarily focused on ensuring that medical devices meet regulatory requirements and are safe and effective with a focus on improvement activities such as continuing adequacy, suitability, and effectiveness of the QMS.
ISO 13485 is typically a prerequisite for manufacturers to obtain regulatory approvals in many countries if they want to market their devices abroad. ISO 13485 is a standard and not a legal requirement, however, many regulatory bodies recognize it as a valuable framework that ensures quality and safety and also similar to those countries’ legal requirements. This standard helps manufacturers work more efficiently and reduce product failures in their Quality Management System (QMS) similar to (cue FDA entrance...) Quality System Regulation (QSR) a.k.a. Quality Management System Regulation (QMSR).
What are key aspects of this standard?
ISO 13485 provides a framework for manufacturers to establish and maintain their QMS to medical device requirements like FDA’s QSR. By ensuring the medical devices are designed, manufactured, and maintained consistently through its lifecycle, this minimizes risks for patient safety while maximizing the effectiveness of the device.
Lifecycle
What does this entail? This standard covers everything from its initial design, development phase, outputs, and even includes post-market surveillance and product recall. It’s an all-in-one deal!
How challenging is it to get certified?
It depends on the manufacturer’s size and complexity and how new, or seasoned their QMS is! For a well-established company, it could take a few months, for those who are newer, it could take much longer. Performing an internal audit will guide leadership on the strength of their QMS and how prepared it will be for overall certification. (If you need more information on auditing your system, reach out to us on our Contact page and schedule a meeting here!)
Do you know what the FDA’s thoughts are on ISO 13485:2016? Curious as to how the global harmonization efforts are coming along? Here’s a sneak peek for our next blog:
The International Medical Device Regulators Forum (IMDRF) who replaced the Global Harmonization Task Force, is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization and convergence. IMDRF was established in October 2011, when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa to address the establishment and operation of this new Forum 3 .
On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820…This rule amends 21 CFR 820 by incorporating by reference the quality management system requirements of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016. The FDA has determined that the requirements in ISO 13485 are…. To Be Continued…
Check out our upcoming blog that brings in FDA’s QMSR and ISO 13485:2016 global harmonization efforts! See you next time!
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