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ISO 13485:2016 Certification

ISO 13485: 2016 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488. Though based on ISO 9001, 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes.

ISO 13485: 2016 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488.

Though based on ISO 9001, 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices.

13485 is in part designed to produce a management system that facilitates compliance to the requirements of customer’s and-preeminently-various global regulators. While being certified to 13485 does not fulfill the requirements of either the FDA or foreign regulators, the certification aligns an organization’s management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world. Therefore, 13485 certification serves to create a management system that can be thought of as a framework on which to build compliance to various regulatory and customer requirements.

Benefits of ISO 13485

  • Expanded market access – National regulatory authorities require or strongly prefer that manufacturers marketing medical products in their countries have a third-party audited and certified management system in place. Investing in such a system speeds access into those countries that necessitate it, and expedites market entry into the others.
  • Reduced cost of sales – Your certification establishes your company’s credibility and commitment to quality. Because the task of clarifying the specifics and demonstrating the value of your quality system is more straightforward, it takes less time to earn your prospective customers’ trust and confidence.
  • Improved performance – Based on a uniform and widely-accepted system of procedure control, your company’s certified management system helps you progress your products and procedures. This can foster enhanced relationships with your suppliers, business partners, and customers, and give you a real benefit in the market.

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