Quality Management Systems (QMS) typically include provisions for the control of inspection, measuring, and test equipment. The QSR requirements are in 21 CFR §820.72, while the ISO 13485 requirements are in Clause 7.6.

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. These procedures must include simple calibration stickers to aid in understanding accuracy and precision.

This audio conference explains the concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. The audio conference describes the concepts of accuracy and precision that define the measuring equipment’s requirements, and explains the meaning of traceability. With these concepts, the presentation moves to an analysis of FDA requirements and ISO 13485 requirements.

This audio conference covers:

• Metrology requirements of FDA QSR
• Metrology requirements of ISO 13485 and ISO 9001
• Understanding metrology terms
• Chapter 7 of the FDA’s Quality Systems Manual
• ISO 10012:2003 requirements

About the speaker:

Dan O'Leary is 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 of 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.

Who should attend?

• Quality Managers
• Quality Engineers
• Production Managers & Supervisors
• Production & Process Engineers
• Manufacturing Engineers
• Design Engineers
• Production Engineers
• Process Owners