What is ISO 13485 Medical Devices – Quality Management System?

What is a medical device?

A medical device is a product, such as an instrument, machine, implant or in vitro reagent, that is intended for use in the diagnosis, prevention and treatment of diseases or other medical conditions.

Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. More and more, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

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

If any requirement(s) in Clause 7 of ISO 13485 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.

The processes required by ISO 13485, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system.

This international standard is based off the ISO 9001 international standard with specific requirements to meet regulatory needs. This standard, applicable on a voluntary base, was designed in particular for medical device manufacturers.

The ISO 13485 standard, officially named EN ISO 13485, can be used by organizations in the design, development and production process for medical devices but also related services. It can also be used by notification bodies to meet regulatory requirements.

Though replicating the format of ISO 9001, ISO 13485 switches the focus from customer satisfaction and continual improvement to standardization of regulatory requirements for medical devices manufacturers. ISO 13485 can be achieved by upgrading from ISO 9001 or as a standalone certification.

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the medical device directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

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