ISO 13485:2016 Medical Device Quality Management System

ISO 13485:2016

What is ISO 13485:2016 Medical devices -- Quality management systems?

ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for:

• Implementation of a Quality Management System with several enhancements
• An emphasis on meeting regulatory as well as customer requirements
• Risk management approaches to product development and product realization
• Validation of processes
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems

Benefits of ISO 13485 Certification

ISO 13485 certification demonstrates that your organization has successfully implemented a quality management system that conforms to the standard. This brings several benefits:

• Demonstrates compliance with regulatory and legal requirements
• Provides a competitive advantage in the marketplace
• Improves risk management and quality processes
• Increases efficiency and reduces costs
• Enhances customer satisfaction and trust
• Facilitates access to global markets

Our ISO 13485 Services

ISO-Iraq.com offers comprehensive ISO 13485 services including:

• Gap analysis and readiness assessment
• Development of quality management system documentation
• Implementation support and guidance
• Staff training and awareness programs
• Internal audits and pre-certification reviews
• Ongoing maintenance and improvement support