4 Key Steps for Effective Internal Audit of ISO 13485:2016 QMS
QMS helps ensure medical devices being manufactured are consistently meeting strict quality standards, thereby ensuring their safety and efficacy. A robust QMS helps medical device manufacturers reduce errors, minimize risks, and ensure product quality. The ISO...
Effective Risk-Based CAPA in Quality Management System
Corrective Action Preventive Action (CAPA) focuses on eliminating the root cause of non-conformities It is a systematic approach aimed at mitigating the risks of undesirable events and non-conformities. CAPA forms the core of quality management system (QMS) in...
ISO 13485 Certification for Class A and B Medical Devices
In the medical device industry, safety and quality are non-negotiable. Hence, various regulatory guidelines govern the medical device industry to ensure high-quality, safe, and effective devices are being manufactured. One such guideline is ISO 13485 standards. ISO...