![]() ![]() Representatives from 25 nations convened in London. But to get the concepts of these ISO standards, let’s take a step back in time to their inception. ISO 9001 extends its relevance to all organizations, while ISO 13485 zeroes in on medical device manufacturers. ![]() Ĭore Concepts of ISO 9001 and ISO 13485 Standards So, before collaborating with a third party or entrusting vital patient safety standards to your team, read this article to learn the differences between ISO 9001 and ISO 13485. It also clarifies the distinctions that set it apart from other standards. On the bright side, ISO 13485 serves as a trust badge, ensuring your partners follow patient safety and quality guidelines. Without ISO 13485, global regulatory licenses could be jeopardized, limiting your ventures in international markets that require this standard. Still, some companies wrongly believe that ISO 9001 can replace ISO 13485, underestimating the need for dual certifications. It focuses on assessing patient risks throughout the lifecycle of device usage. Let’s take ISO 13485, designed specifically for the medical devices industry. In fact, there’s been a surprising number of missteps in applying ISO standards in healthcare. ISO standards create tailored Quality Management Systems for different industries, but understanding these subtleties can be a challenge. But why does it matter? Well, just because a business flaunts an ISO certification doesn’t mean it has all safety and quality bases covered. ISO 13485 is a persistent debate in the medical device industry. ![]()
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