Assisting organizations in the food sector to implement best practices. We provide certification in food safety, health, environmental and quality management standards. We work with many large and small organizations to ensure that information is managed through a risk based approach management system. Information Resilience and Risk Management We are one of the world's leading certification bodies for the aviation and aerospace industry - serving Lockheed, Boeing, Raytheon, NASA, European Space Agency and many more.
This 1-day ISO 13485:2016 training workshop from QSG provides a comprehensive review/explanation of this standard. QSG’s Overview of the Essentials of ISO 13485:2016
For the time being, separate guidance remains in effect. quality system requirements with ISO 13485, and plans to issue a notice of proposed rulemaking in 2021. The FDA is in the process of harmonizing U.S.
Therefore, conformity to ISO 13485 does not sufficiently demonstrate to the FDA that a manufacturer is in full compliance with the QSR. For instance, the QSR has more detailed requirements in the areas of complaint handling and reporting requirements. And because the QSR is a regulation, it is often more specific than ISO 13485. The FDA’s QSR is structured differently than ISO 13485 but they have no conflicting requirements. This in turn provides economic benefits in the form of reduced scrap and general process efficiencies. In addition to being a regulatory requirement, an ISO 13485-compliant QMS makes good business sense because it helps device manufacturers minimize variation. The guidelines for maintaining effective quality management processes outlined in ISO 13485 are all geared toward the safe design, manufacture and distribution of effective medical devices. Since different countries often have different standards, ISO 13485 is intended to provide a globally harmonized model of QMS requirements for international markets. It is focused on maintaining QMS effectiveness and meeting regulatory and customer requirements. ISO 13485 is the most common medical device QMS regulatory standard in the world.