Event Details
4 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually
This course is appropriate for anyone who wishes to learn about changes to the ISO 13485:2016 standard or anyone beginning at the introductory level of ISO 13485:2016.
Not Yet a Member? Request Membership Now
4 hours
Combination lecture and classroom exercises
Available at QSG’s training facilities, on-site at your organization, and virtually
ISO 13485 is the most common medical device QMS regulatory standard in the world. It is focused on maintaining QMS effectiveness and meeting regulatory and customer requirements. Since different countries often have different standards, ISO 13485 is intended to provide a globally harmonized model of QMS requirements for international markets.
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. In addition to being a regulatory requirement, an ISO 13485-compliant QMS makes good business sense because it helps device manufacturers minimize variation. This in turn provides economic benefits in the form of reduced scrap and general process efficiencies.
The FDA’s QSR is structured differently than ISO 13485 but they have no conflicting requirements. And because the QSR is a regulation, it is often more specific than ISO 13485. For instance, the QSR has more detailed requirements in the areas of complaint handling and reporting requirements. Therefore, conformity to ISO 13485 does not sufficiently demonstrate to the FDA that a manufacturer is in full compliance with the QSR.
The FDA is in the process of harmonizing U.S. quality system requirements with ISO 13485, and plans to issue a notice of proposed rulemaking in 2021. For the time being, separate guidance remains in effect. Until the QSR’s shift to ISO 13485 requirements is fully completed, compliance with the QSR is required for manufacturers planning to distribute medical devices in the U.S. Additionally, if a device maker based in the U.S. wishes to market its products internationally, it must comply with both the QSR and ISO 13485 manufacturing standards.
Key requirements of ISO 13485:2016 include:
QSG’s ISO 13485:2016 Requirements Workshop provides a comprehensive review/explanation of this standard. ISO 13485:2016 is explained clause-by-clause with examples from various industries to illustrate individual concepts. This workshop provides a general understanding of the necessary concepts of the standard and its impact on day-to-day operations of organizations in the medical devices industry
This course is appropriate for anyone who wishes to learn about changes to the ISO 13485:2016 standard or anyone beginning at the introductory level of ISO 13485:2016.
This workshop includes a detailed review of ISO 13485:2016, and through training, participants will learn to:
Chris, Angelo and Barbara,
The recent meeting “What we can learn from FDA Warning Letter” was an excellent and exactly what I was looking for. Please keep me on the list for future meetings. Real professional of you folks. I have given your companies information out to an acquaintance from ASQ as a source for training for internal auditing. Looking forward to a long relationship with your team.
Hi Angelo,
Great ISO 13485:2016 Internal Auditing class, honestly the most well run and informative class I’ve taken.
Hi Angelo,
We are satisfied with the process and the report. Gordon does a good job! He is up on the regulations and what we need to focus on. I have found in past years what he points out is what comes up on the radar with the Notified Body. It helps us to be ready for the process.
Thanks for letting us know!
Please fill in the information below so that we can keep you informed.
QSG has secured over $20M in training grants for companies across the USA. We specialize in expert grant writing and comprehensive support, creating tailored training solutions for organizations in states like in Massachusetts, Connecticut, Florida, Ohio, Michigan, and beyond!
Privacy & Cookies: This site uses cookies. By continuing to use this website, you agree to their use.
To find out more, including how to control cookies, please see here: Cookie Policy
If you have any questions, would like more information, or would like to speak with a QSG representative, please contact us at any time!