ISO 13485 is a quality management standard for the manufacturers of medical devices. Medical device producers must be able to provide evidence that their devices consistently meet safety and quality standards and perform as intended for patients or consumers. ISO 13485 provides an international approach to meeting the wide-ranging requirements of medical device production and related services for the world market.

Building a QMS for Manufacturing Medical Devices

While it’s considered a stand-alone set of requirements, ISO 13485 is also designed to be used in conjunction with the ISO 9001 Quality Management System. ISO 13485 enhances the general foundation for a Quality Management System defined by ISO 9001 through fleshing out details and specifics that apply to the medical device industry.

Producing medical devices can be a regulatory labyrinth. ISO 13485 can be employed as a Quality Management System to handle the numerous requirements from various regulations and standards, thereby reducing complexity and effort.

Like the ISO 9001 document, the first few sections of ISO 13485 cover basic introductions and definitions. The real requirements are in Section 4 through Section 8 and cover the following elements:

  • Quality System Requirements
  • Management Responsibility
  • Resource Requirements
  • Product Realization
  • Remedial Requirements

ISO 13485 Is More Stringent Than ISO 9001

Those familiar with ISO 9001 will recognize that the sections listed above align directly with those in ISO 13485. While ISO 13485 does share some similarities with ISO 9001 (such as using a process approach to meet requirements), it is not a duplicate effort. There are a number of important differences between ISO 9001 and ISO 13485:

A Focus on Meeting Regulations: Meeting regulatory requirements may be an implied part of ISO 9001, but with ISO 13485, it is a focus of the Quality Management System and a top management responsibility.

Risk Management: ISO 13485 requires more risk management efforts (understanding, preventing, mitigating) during product design and manufacturing than ISO 9001.

Documentation and Traceability: While ISO 9001 has minimal documentation and traceability requirements (i.e., seven required procedures), ISO 13485 has more extensive documentation requirements, including maintaining product specific files.

Inspection and TestingISO 13485 spells out more detailed requirements for product inspection and testing versus the brief, general clause in ISO 9001.

Work Environment: ISO 9001 has a general requirement for facilities, but ISO 13485 lays out stringent requirements for the environment in which medical devices are produced.

Nonconforming Product: This area is briefly addressed in ISO 9001, but ISO 13485 has more rigorous standards, as it is a much larger concern for medical device producers.

Measurement and Quality System Improvement: Improvement of all processes, including the quality management system, is inherent in ISO 9001. This area is much more critical for medical devices and has additional requirements in ISO 13485.

Instead of adding an extra layer of bureaucracy for medical device producers, companies that embrace ISO 13485 can use it as a way to coordinate and manage a diverse set of regulations and requirements. Plus, being ISO 13485-certified demonstrates that an organization has its processes in control, in compliance to an internationally recognized standard. This can help companies gain credibility with customers around the globe, no matter where they are in the supply chain.

For more information, visit the International Organization for Standardization’s catalogue on ISO 13485.