Impact assessment of the quality system regulations for medical devices - ISO 13485:2003 and 21 CFR 820 and the CAPA system
Whittaker, Michelle Alanna
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In the medical device industry product quality, safety, identity and effectiveness are of utmost concern. Processes, equipment and personnel drive product quality, and together ensure safe and effective product is produced meeting quality characteristics defined by the company and industry. In an ideal medical device environment there would be no errors, but it is not ideal and errors can occur. Medical device companies follow regulatory documents and policies which provide guidance to correct, prevent and resolve errors. A Corrective and Preventive Action (CAPA) System can be established to monitor and track errors. Two regulatory documents provide guidance for a CAPA system: FDA regulation 21 CFR 820 – Quality System Regulation and ISO Standard 13485:2003 – Medical Devices: Quality Management Systems—Requirements for Regulatory Purposes. These documents provide the framework for handling errors, enforcing and documenting corrective/ preventive actions and tracking. CAPA systems track and ensure actions are taken to remediate errors.