QMS (Quality Management System) and ISO 13485

A Quality Management System is defined by ISO 13485 as a set of processes, procedures, and responsibilities for achieving quality policies and objectives in a medical device manufacturing organisation. It is a structured system that ensures that medical devices consistently meet customer and regulatory requirements.

ISO 13485 is an international standard that specifies requirements for a QMS specific to the medical device industry. ISO 13485 is a stand-alone QMS standard based on ISO 9001:2008, superseded by ISO 9001:2015.

It covers the design, development, production, storage, distribution, installation, servicing, and final decommissioning of medical devices.

Implementing a QMS based on ISO 13485 helps organisations demonstrate their ability to provide medical devices and related services that meet customer expectations and regulatory requirements, fostering customer confidence and regulatory compliance.

One of the critical advantages of ISO 13485 is that it ensures a strong starting point if a manufacturer wants to certify their products under the EU Medical Device Regulation and In Vitro Diagnostic Regulation (IVDR).

MDR requirements for QMS

EU MDR states the requirement for a well-established and maintained QMS in Article 10 (9).

Article 10 of the Medical Device Regulation (MDR) outlines a set of criteria governing Quality Management Systems (QMS) for Manufacturers operating in the medical device sector.

This article mandates that manufacturers establish, document, implement, maintain, update, and enhance a QMS that aligns with MDR specifications. Furthermore, it stipulates that the QMS must be aligned with the risk classification, the nature of the device and the business.

Article 10 specifies several fundamental aspects that the QMS must address at a minimum, which are as follows:

  1. A strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system.
  2. Identification of applicable general safety and performance requirements and exploration of options to address those requirements.
  3. Responsibility of the management.
  4. Resource management, including selection and control of suppliers and sub-contractors.
  5. Risk management is set out in Section 3 of Annex I.
  6. clinical evaluation by Article 61 and Annex XIV, including PMCF.
  7. Product realisation, including planning, design, development, production, and service provision.
  8. Verify the UDI assignments made by Article 27(3) to all relevant devices and ensure the consistency and validity of the information provided by Article 29.
  9. Setting up, implementing and maintaining a post-market surveillance system in accordance with Article 83.
  10. Handling communication with competent authorities, notified bodies, other economic operators, customers and other stakeholders.
  11. Processes for reporting serious incidents and field safety corrective actions in the context of vigilance.
  12. Management of corrective and preventive actions and verification of their effectiveness.
  13. Processes for monitoring and measurement of output, data analysis and product improvement.

This list of minimum requirements highlights that the Quality Management System necessitates a documented procedure for all significant activities directly associated with individual medical devices, along with broader processes about the company’s overall operations.

The EU MDR does not impose specific requirements for a QMS. However, manufacturers are responsible for implementing appropriate content tailored to the risk class and organisational nature.

How do you implement a QMS that actually works?

Manufacturers can utilise harmonised standards, such as ISO, to aid in implementing MDR requirements. Compliance with recognised harmonised standards, like ISO 13485:2016 for Quality Management Systems, establishes a presumption of conformity with relevant aspects of the MDR.

ISO 13485 provides detailed provisions for developing QMSs that align with most MDR quality management requirements.

Manufacturers must, therefore, ensure that a system compliant with both ISO standards and the MDR requirements outlined in Article 10 is in place to address the comprehensive demands of quality management in the medical device industry.

A manufacturer’s quality management system will be assessed as part of the conformity assessment procedures outlined in MDR Annex IX to XI. Conformity assessment for Class Ir, Is, a Notified Body will carry out Im, IIa, IIb and III devices.

Formal evaluation and certification by a notified body are not conducted for Class I devices, but the QMS requirements still apply.