ISO 13485

ISO 13485 is a quality standard for organizations that design, develop, produce or service medical devices. It is intended to promote harmonization in the medical device industry and set a basis for quality system regulations worldwide. It includes specific requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate to the medical device industry. All requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size of the organization.

The standard contains specific requirements for manufacture, installation and servicing and calls for:

• Implementation of a Quality Management System with several enhancements
• Risk Management approach to product development and product realization
• Validation of processes
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems

Benefits

The benefits of an ISO 13485:2003 compliant quality management system to the thousands of companies worldwide includes:

• Recognition by regulators around the world of ISO 13485:2003 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

Who is ISO 13485 applicable to?

ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.

How can ISO - Kuwait help you to get ISO 13485 Certification?

ISO - Kuwait will assist your organization in ISO awareness training, documentation, implementation, internal auditing and overall process optimization as per ISO/TS 16949 standard. ISO - Kuwait is a result oriented professional training and certification service providers, offering systematic approaches to improve quality and effectiveness of the system and enhance the productivity by offering systematic approaches. Our main objective is to help you and your organization improve profitability, through better utilization of all of your resources