ISO 13485 : 2016
ISO 13485 STANDARD: MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEM
ISO 13485 defines the requirements for a quality management system designed to demonstrate an organization’s ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Organizations complying with this standard, such as medical devices manufacturers, as well as suppliers and external parties that provide products or services to manufacturers, will be able to demonstrate compliance with regulatory requirements, manage risk, ensure best practice for quality and safety, improve processes and provide confidence to patients and users.
The new ISO 13485:2016 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system.
ISO 13485 Certification – Benefits
The benefits of an ISO 13485:2016 Certification compliant quality management system to the many of companies worldwide include:
- Recognition by regulators around the world of ISO 13485:2016 as a good basis for addressing medical device design and manufacturing regulatory requirements
- Controlled consistency of manufactured products
- Managed productivity and efficiency, controlling costs
- Competitive advantage and increased marketing and sales opportunities.
- Improved customer perception of the organization’s image, culture and performance.