Quality Systems and Compliance is a consulting firm dedicated to the implementation of quality systems that meet the requirements for the clinical diagnostic laboratory and various other industries.
At Quality Systems and Compliance our goal is simple — to define and produce a customized quality system by implementing the necessary recommendations and documentation that will assist your organization in meeting and maintaining compliance.
Our personalized approach has been proven successful by consistently keeping our clients in compliance.
Our president, Deborah Sumner, holds a B.S. degree in biology (compounded with a chemistry minor and medical technology concentration). For over 35 years, she’s been advising senior management teams in the implementation and productivity of laboratories, from ground-floor to established facilities.
Deborah has worked as a clinical diagnostic consultant for the past 23 years, and has over 35 years’ experience as a medical technologist in the clinical laboratory field. She has extensive knowledge of FDA/ISO regulations and is certified in ISO 13485:2016, ISO 9001:2015 and auditing ISO 19011:2018. Deborah offers strategic services in the medical and clinical diagnostic markets. Her focus includes regulatory consulting for FDA/ISO, technical support, auditing, management and quality assurance.
As your Laboratory consultant, Deborah wants to help you grow your clinical diagnostic laboratory, utilizing her experience in compliance (state and local/COLA/CLIA/CAP/ISO requirements), workflow analysis, operational improvements and laboratory management.
What makes QSC different…strength is knowledge!
Quality Systems and Compliance is your one-stop shop for all your laboratory needs, including new laboratory installation, laboratory upgrades, documentation, point of care testing, training, auditing, on-call services and compliance needs.
For over 20 years, QSC’s experience has made our client laboratories more efficient and compliant through our customized and thorough approach.