ISO 13485

ISO 13485:2003 is a quality system standard designed specifically for medical device companies. The ISO 13485 standard supplements ISO 9001 and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability and more.

ISO 13485 is an international standard that specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of medical devices.

The quality management system requirements specified in the ISO 13485:2003 standard complements technical requirements for products. The primary purpose of the ISO 13485:2003 standard is to facilitate harmonized medical device regulatory requirements for quality systems.

ISO 13485 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.

Improved communications, morale and job satisfaction – staff understand what is expected of them and each other.

Gaining registration to ISO 13485 through various certification bodies will help your organization flourish. Whether you are looking to operate internationally or to expand locally to accommodate new business, ISO 13485 will help you demonstrate to customers that you have a commitment to quality.

The regular assessment process will ensure you continually use, monitor and improve your processes.

Registration can improve overall performance, remove uncertainty and widen market opportunities.

Who is it applicable to?

This standard can be used by international and external parties, including certification bodies, for assessment of the organization's ability to meet customer and regulatory requirements.

All requirements of the ISO 13485:2003 standard are specific to organizations providing medical devices, regardless of the type or size.

How can ISO - Certification help you to get ISO 13485:2003 Certification?

ISO - Certification will assist your organization in ISO awareness training, documentation, implementation, internal auditing and overall process optimization as per ISO 13485:2003 standard. ISO - Certification 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.