Corrective Actions - Current Expectation of ISO 13485 and FDA Auditors
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This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity.
There will be a review of the corrective and preventive action requirements. We will cover how corrective actions should be used throughout your Quality Management System. Definitions of Correction and corrective actions, their differences and importance will be covered. Examples of each will be provided. Information will be provided to make sure your Corrective Action system including your procedures meets current FDA Quality System Regulation and ISO 13485 expectations. This includes how this leads to a robust Corrective Action system for meeting FDA Corrective Actions expectations.
Why should you Attend: For many year, early in the life of ISO 9001 and ISO 13485, it to a lot of education on the part of ISO auditors to teach companies the difference between Corrections (fixing the problem) and Corrective Actions, fixing the root cause of the problem. And companies learned that well, and generally meeting expectations of their ISO auditors.
However, now, although corrections are usually being done, they are usually done under other portions of ISO 13485, such as control of nonconforming product and customer feedback and complaints. These often have little visibility in the Corrective Action system, and generally do not address at all containing or correcting quality system issues that are often a major part of a Corrective Actions system. So now ISO auditors, or at least ISO 13485 Notified Body auditors, are expecting that companies now document and provide evidence that they are doing containment or correction, and quickly as well!
Areas Covered in the Session:
Who Will Benefit:
- Overview of CAPA system for Current ISO 13485 compliance
- Why Containment and Correction have been overlooked
- Why this is a hot item with ISO auditors
- What is really the difference between correction and corrective action
- What kinds of containment can be done for Quality System nonconformities
- Defining and documenting Containment actions - Quickly
- Where does Preventive Action fit in
- Examples of Containment actions
- Quality Managers
- QA Specialists
- CAPA coordinators
- Quality Engineers
- Engineers doing Corrective Actions
- Operations managers
- Manufacturing Engineers
- Quality auditors
- Medical device Consultants
Betty Lane has over 30 years' experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well for quality system requirements for other geographic area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate quality system processes for design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.
Betty's training experience includes over 25 years of training on all aspects of ISO 13485, the ISO standard for Medical Device - Quality Management Systems - System Requirements for regulatory purposes, and FDA Quality System Regulation - Medical Devices; Good Manufacturing Practice (cGMP), in companies where she worked as manager or director, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs as an Adjunct at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.