This presentation will include discussion of the medical device service industry and major developments from the past three years as well as an explanation as to why ChristianaCare Clinical Engineering committed to this process. Mike Powers will touch on having a formal quality management system, to meet industry best practices and evolving standards and risk management as a component of that followed by a description of the certification, the journey to certification and the pitfalls along the way. He will touch on how continual improvement of Quality & Safety align with ChristianaCare’s core values of Excellence and Love. Mike will also share the four core competencies his team manages and KPIs they use for measurement and improvement. Wrapping up with a discussion regarding the benefits and drawbacks to the ISO 9001 certification in this industry as an in-house program.