What is a quality management system (QMS)? A basic guide to ISO 13485.

What is a QMS?

A quality management system (QMS) is required for most medical devices. A QMS is a set of processes and procedures that ensure that medical devices are consistently designed, developed, manufactured, and distributed in compliance with applicable regulatory requirements and standards, while also meeting the needs of the intended users.

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A QMS for medical devices typically includes the following elements:

• Quality Policy and Objectives: A written statement of the organization's commitment to quality and its overall goals and objectives.
• Organizational Structure: A description of the organization's structure and the roles and responsibilities of its employees.
• Document Control: Procedures for the creation, approval, distribution, and maintenance of documents and records.
• Risk Management: A systematic process for identifying, assessing, and managing risks associated with the use of medical devices.
• Design Controls: A set of procedures for designing and developing medical devices, including requirements gathering, design input, design output, design verification, and design validation.
• Supplier Management: Procedures for evaluating, selecting, and monitoring suppliers of materials, components, and services.
• Production and Process Controls: Procedures for manufacturing, testing, and releasing medical devices.
• Corrective and Preventive Action: Procedures for identifying, investigating, and correcting problems that arise during the design, development, manufacture, or distribution of medical devices.
• Complaint Handling: Procedures for receiving, evaluating, and resolving complaints related to medical devices.
• Post-Market Surveillance: Procedures for monitoring the performance of medical devices once they are on the market, including adverse event reporting and device tracking.

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A well-designed QMS for medical devices can help ensure that products are safe, effective, and meet the needs of patients and healthcare providers, while also minimizing the risks of non-compliance with regulatory requirements.

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What kinds of devices require a QMS?

In the European Union (EU), medical devices are regulated by the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Under these regulations, manufacturers of medical devices are required to establish and maintain a Quality Management System (QMS).

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The MDR classifies medical devices into four classes (I, IIa, IIb, and III), based on the level of risk they pose to patients. The higher the risk, the more stringent the regulatory requirements. All medical devices, regardless of their classification, are subject to the requirements of the MDR and IVDR, which mandate the use of a QMS.

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These devices can be:

• Active or non-active implantable devices
• Non-implantable medical devices
• Software as a medical device
• In vitro diagnostic devices
• Low risk medical devices

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In summary, any medical device intended for commercial distribution in the EU is subject to regulatory oversight and must meet the requirements of the MDR and IVDR, including the establishment and maintenance of a QMS.

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What is ISO 13485?

ISO 13485:2016 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 and applicable regulatory requirements. Essential ISO 13485 is an international standard used to create and maintain a QMS. In the EU, ISO 13485 is considered a law whereas in the USA it is recognized as a harmonized standard but medical device companies must comply with the Code of Federal Regulations (21 CFR, Part 820) to be on the market. Most of the world regards ISO 13485 as the defacto standard for QMS. In fact, the U.S. Food and Drug Administration recently proposed a new regulation update for 21 CFR Part 820 that would align it with ISO 13485, making life for medical device manufacturer’s lives much easier.

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So what is in ISO 13485:2016? The standard provides guidelines on what is required documentation and processes for a company’s quality management system, resource allocation, and product development. Some of those requirements include:

• Quality Management System General Requirements - Quality manual and associated processes that will ensure you take a risk-based approach to your product and that procedures and processes are planned appropriately.
• Management Responsibility - Ensure you have qualified and appropriate personnel in place to manage your product
• Resource Management - Make sure your business and human infrastructure is appropriate for the development and management of your product
• Product Realization - Defined processes for product development through release, including appropriate personnel to develop and sign off on product design control stages
• Measurement, Analysis, Improvement - Establishing a process to constantly stay in compliance of the QMS and regulations while operating including auditing, CAPAs, etc.

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