Episode 26 - The ISO 13485 Standard

In this episode of the Quality Hub podcast, host Xavier Francis engages ISO experts Murphy Shaw and Matthew Pilley, consultants at Core Business Solutions, in a discussion centered around ISO 13485, a critical standard for medical devices. Murphy and Matthew emphasize the rigorous controls and risk management inherent in ISO 13485. They clarify that the standard applies not only to manufacturers of implantable devices but also to various healthcare industry players, from software providers to equipment suppliers. The implementation of ISO 13485 is underscored as pivotal for traceability, reliability, and consistency in medical device production. It also can significantly impact a company's reputation, compliance, and operational efficiency. Success stories of clients achieving ISO 13485 certification highlight the transformative power of the standard. Helpful Resources: ISO 13485:  https://www.thecoresolution.com/iso-13485 For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015 Contact us at 866.354.0300 or email us at info@thecoresolution.com ISO 9001 Standards: https://www.thecoresolution.com/iso-90012015-standard-1 Articles: https://www.thecoresolution.com/free-learning-resources ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting    

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The Quality Hub podcast is where we chat with ISO experts about “all things Quality.” Many businesses find themselves required to or find it valuable to implement a Quality Management System. Our goal is to share the knowledge we’ve gained by working with Quality Management Systems (QMS’s), ISO standards, and other business best practices with our podcast listeners. We want you to be encouraged by our education and experiences. We know that QMS and ISO standard concepts can be confusing, and we want to act as “translators” to simplify these principles, so you can apply them to YOUR business. Our organization has a vast amount of combined experience, having worked with 1000’s of customers over the past 23 years. We want to share these stories and lessons learned with YOU, our listeners! Tune in weekly as we share our experiences to help you get the most from your Quality Management System.