ISO 13485:2016 (QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICES)
KEY ELEMENTS:
- Knowledge of all medical devices quality regulations
- Documented manufacturing quality control processes
- A focus on risk management and design control processes
- Documented traceability of materials, components, and all processes
- Analysis and Improvement
INTRODUCTION: ISO 13485 is a quality management standard for medical devices. It defines a set of quality management requirements. The purpose of this standard is to help both the medical devices suppliers and service providers to meet customer expectations and requirements.
BENEFITS: The benefits of adhering to ISO 13485, which outlines the quality management system standards for medical devices, include efficient cycle times, less waste and a reputation for reliability that can permeate throughout the medical industry.
APPLICABLE TO: ISO 13485 applies to medical device suppliers and medical device service providers of all kinds. It applies to the organizations that participate in one or more stages of the product life cycle. Also that design, develop, produce, store, distribute, install, or service medical devices and to the organizations that design, develop, or provide related medical device support service activities.
