The ISO 13485 standard is widely accepted as the benchmark for medical device manufacturers quality management systems.  Many organizations certified under the standard have achieved improved product quality, reliability, regulatory compliance and are aligned with industry best practices. ISO 13485 is an international standard that specifies the quality management system requirements for organizations involved with medical devices at any stage of the product lifecycle. This would include the design, development, production, storage, distribution, installation, service and technical support of the device. Organizations that utilize a process approach to quality management tend to:

• Better understand and consistently meet or exceed product requirements
• Evaluate each process from a value-added perspective
• Achieve a higher level of process performance
• Continually improve processes based upon performance data and not on speculation or opinion

ISO 13485 is an international standard that specifies the quality management system requirements for organizations involved with medical devices at any stage of the product lifecycle. This would include the design, development, production, storage, distribution, installation, service and technical support of the device. 

This standard may be applied to parties that provide material, product or services to the organization and is applicable to organizations of all sizes large and small. In addition, any processes required to obtain or maintain compliance to the ISO 13485:2016 standard that are not performed within the organization, remain the responsibility of the organization and must be included within the quality management system. The organization must monitor, control and ensure proper maintenance of the external processes.

The ISO 13485 standard requires that leadership establish and maintain a Quality Policy and a Quality Manual. The Quality policy is a statement consisting of the company stance regarding product quality along with their basic goals or objectives and the plan to realize them. The objectives are the more definitive goals related to the QMS and quality plans.

Medical technology is expanding at an astounding rate. New medical techniques, medications, equipment and devices are currently being developed that could not have been imagined just a few decades ago. Quality issues in many other types of products may cause inconvenience or put consumers at nominal risk of illness or injury. With medical devices, quality issues could not only cause serious health issues but can also lead to death. Medical device manufacturers must develop and implement a very robust quality management system that must encompass the entire product life cycle. To ensure the quality system is sufficient, most organizations pursue certification of their quality management system to the latest revision of the ISO 13485 standard for Medical Devices Quality Management Systems.