This presentation explains the requirements for control of inspection, measuring, and test equipment. This includes a calibration program that satisfies FDA's Quality System Regulation (QSR), ISO 13485:2003, and ISO 13485:2016. The presentation defines accuracy, precision, and traceability. After explaining the concepts, it moves to an analysis of the requirements from each of the quality management standards. Implementing these requirements requires attention to detail, accurate records, and effective systems. Manufacturers must understand the requirements so they can develop and implement effective processes and procedures. In addition to the specific requirements, the presentation includes examples from FDA Warning Letters, information from FDA's Quality System Inspection Technique (QSIT), and the Medical Device Single Audit Program (MDSAP) Audit Model.
Why should you Attend:
Implementing a program for monitoring and measuring requires adequate control over the measuring equipment including calibration, traceability, and records. Managing this program is a key element in delivering good products and services.
Regulators will check your system, so you need a solid understanding of the requirements as well as the two programs regulators use - QSIT and MDSAP.
Areas Covered in the Session:
Learn to role of monitoring and measuring in a medical device Quality Management System (QMS)
Learn how measuring supports measuring and monitoring
Understand the requirements for calibration in FDA's QSR for calibration
Understand the requirements of ISO 13485:2003 and ISO 13485:2016
Distinguish between accuracy and precision
Understand the role of traceability in a calibration program
Learn what QSIT and MDSAP look for
Who Will Benefit:
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.