ISO 13485 2016 QMS for Medical Devices

ISO 13485:2016 Structure and Requirements

Similar to other quality management systems, the backbone of ISO 13485:2016 is documentation.  This documentation should apply to processes required for the quality management system.  It should then control these processes with a risk based approach and determine how these processes should interact and be sequenced.  This information should include a quality manual that includes policies and objectives of the QMS.

Emphasis is placed on ensuring that all these processes are effective.  This requires that adequate controls, resources, and information are allocated to the execution processes.  It also requires that appropriate monitoring and analysis are conducted and that these findings are recorded.  This information should include systematic processes for collection and analysis of medical devices in the field.

Documented processes include product specifications; procedures for manufacturing, packaging, storage, handling, and shipping; procedures for monitoring and measurement, installation, and servicing.  This includes certification of equipment and personnel.  These procedures and processes must be documented and validated.  Furthermore precise and extensive records must be maintained of the validation and validation criteria.

Specific Requirements for Manufacturers and Service Providers

Because ISO 13485:2016 applies to a variety of designers, manufacturers, and service providers, the standard contains specific requirements to each of these activities.  These requirements include:

• Product Specification, Design, and Development requirements.
• Production and Service provisions to ensure product conformity to specifications.
• Product Cleanliness with regard to processes to be used prior to sterilization or use.
• Provisions for the control of contamination with microorganisms and particulate matter.
• Product Installation procedures complete with acceptance criteria.
• Validation procedures for the application of software used in production and service environments.

Additional Jurisdictional Requirements for Medical Devices

Medical Devices Regulation and the Food and Drug Administration (FDA)

In  the United States, it is a requirement for manufacturers of medical devices to establish and comply with quality systems to ensure consistency in product quality.  Under the jurisdiction of the Food and Drug Administration (FDA), the Current Good Manufacturing Practices (CMGP) are defined under Part 820 of the Code of Federal Regulations Title 21.  Because this places additional requirements on those organizations involved with medical devices in multiple countries, the FDA has signaled its intent to harmonize the U.S. Quality System Regulation with the international standard.

The FDA Medical Device Regulations are under revision by the FDA in an effort to harmonize with ISO 13485:2016 and promote more current quality management standards.  This make it easier for medical device manufacturers to produce and sell their devices internationally.  It will also reduce costs and ease record keeping requirements.