What is a QMS?

A QMS, or Quality Management System, is a system used to structure policies, processes, procedures, and records that companies leverage to maintain their documentation & ensure that their Medical Devices or services remain compliant. The primary objectives of a QMS are to meet regulatory requirements, improve internal processes continually, in the end enhancing customer experiences for the business through better and more compliant products.

There are several key component to a QMS (Quality Management System) that include:

Quality Policy: A document outlining the organization's commitment to quality and its overall quality objectives.

Quality Manual: A document providing an overview of the organization's QMS, including its scope and key processes.

Procedures: Detailed instructions on how specific processes should be carried out to ensure quality.

Process Management: Identification, definition, and management of key processes that contribute to delivering quality products or services.

Documentation: Creation and maintenance of documents such as work instructions, forms, and records to support the QMS.

Monitoring and Measurement: Regular assessment and monitoring of processes and outcomes to ensure that quality standards are being met.

Continuous Improvement: A commitment to ongoing improvement of the QMS and its processes through corrective and preventive actions. You can learn more about our Quality Management System here.

QMS frameworks, such as ISO 13485, provide internationally recognized guidelines for organizations to establish and maintain effective quality management systems. Implementing a Quality Management System helps organizations enhance efficiency, minimize errors, and build a culture of continuous improvement.

What is the purpose of a medical device quality system (QMS)?

The purpose of a Medical Device Quality Management System (QMS) is to ensure that Medical Devices consistently meet regulatory requirements and are safe and effective. The QMS for medical devices is a comprehensive framework from design to post-market activities.

What is the role of a QMS?

The QMS ensures regulatory compliance, pushing adherence to standards such as ISO 13485. Rigorous design controls, risk management, and validation activities guarantee safety and efficacy.

Consistency in quality is maintained through well-defined processes and regular checks.

Traceability and proper documentation are priorities, aiding issue resolution and regulatory compliance. The Quality Management System (QMS) fosters continuous improvement, incorporating feedback for ongoing enhancements.

In essence, it's a strategic approach ensuring medical devices meet the highest standards throughout their lifecycle.

What are the main regulations governing medical device QMS?

Several key regulations govern the Quality Management Systems (QMS) for medical devices, and these regulations are different depending on the region or market. Some of the most common regulations include:

ISO 13485:2016: This international standard outlines the requirements for a quality management system specific to the medical device industry. Compliance with ISO 13485 is often a prerequisite for regulatory approval in many markets.

ISO 14971: is a global standard offering guidance on implementing risk management for medical devices. It outlines systematic approaches to identify, evaluate, and control risks throughout the entire lifecycle of these devices.

FDA Quality System Regulation (QSR): In the United States, the Food and Drug Administration (FDA) enforces the QSR, outlined in 21 CFR Part 820. This regulation establishes the requirements for the design, production, and distribution of medical devices.

European Medical Device Regulation (MDR): The European Union's MDR, which became fully applicable in May 2021, outlines stringent requirements for the quality and safety of medical devices sold in EU member states.

There are many other regions that have strict regulations for Medical Devices including the Canadian Medical Devices Regulations (CMDR), Therapeutic Goods Administration (TGA) in Australia, Japan's Pharmaceutical and Medical Device Act (PMD Act). 

It's very important for Medical Device manufacturers to be familiar with and adhere to the specific regulations relevant to the markets in which they intend to sell their medical devices and how having your Quality Management System will help you achieve compliance faster.

ISO 13485

ISO 13485 is an international standard specifying the requirements for a Quality Management System (QMS) specifically tailored to the medical device industry.

Developed by the International Organization for Standardization (ISO), this standard outlines the criteria for establishing, implementing, and maintaining an effective QMS to ensure the consistent production of safe and effective medical devices.

ISO 13485 places a strong emphasis on regulatory compliance, risk management, and process optimization throughout the entire product lifecycle. Adherence to ISO 13485 is often a prerequisite for regulatory approval in various markets, making it a key tool for medical device manufacturers to demonstrate their commitment to quality, customer satisfaction, and continuous improvement.

Certification to ISO 13485 provides a globally recognized benchmark for organizations seeking to navigate complex regulatory landscapes and enhance their competitiveness in the medical device industry.

ISO 14971

ISO 14971 is an international standard that provides guidelines for the application of risk management to medical devices.

Developed by the International Organization for Standardization (ISO), ISO 14971 outlines a systematic approach to identifying, evaluating, and controlling risks associated with medical devices throughout their entire lifecycle.

The standard emphasizes the importance of a proactive risk management process, including risk analysis, risk evaluation, and the implementation of risk control measures.

ISO 14971 aims to assist medical device manufacturers in systematically addressing potential hazards and ensuring that the benefits of the device outweigh any associated risks. Compliance with ISO 14971 is often a regulatory requirement, contributing to the overall safety and effectiveness of medical devices in the global market.

FDA

The FDA Quality System Regulation (QSR), outlined in 21 CFR Part 820, is a set of regulations established by the U.S. Food and Drug Administration (FDA) to ensure the quality and safety of medical devices distributed in the United States.

This regulatory framework outlines comprehensive requirements for the design, manufacturing, and distribution of medical devices, emphasizing the implementation of a robust Quality Management System (QMS). The QSR covers key aspects such as device design controls, document controls, production processes, and post-market surveillance.

Compliance with the FDA QSR is essential for medical device manufacturers to obtain and maintain FDA approval, ensuring that their products meet the highest standards of safety and efficacy for the benefit of patients and consumers in the U.S. market.

MDR

The European Medical Device Regulation (MDR), fully effective since May 2021, represents a comprehensive framework within the European Union, setting forth strict standards to ensure the quality and safety of medical devices available in EU member states. This regulation establishes rigorous requirements that medical device manufacturers must adhere to, emphasizing compliance with the latest industry standards and enhancing patient safety across the European market.

The MDR is designed to create a harmonized regulatory framework for medical devices across these EU member states, streamlining market access and ensuring consistent standards for product safety and performance. You can watch our recent webinar on how to Master EU MDR.

What quality processes constitute a QMS?

The specific quality processes within a QMS can vary based on the organizational structure, but common elements often include:

1. Document Control within a Quality Management System (QMS) involves the systematic management of documents, including policies, procedures, and work instructions. This process ensures that only the latest, approved versions are used throughout the organization. It encompasses the creation, approval, and distribution of documents, with version control being a key element to track changes.

   Access to documents is carefully controlled to prevent unauthorized use, and security measures are implemented. When changes are necessary, a formal change management process is initiated, involving review, approval, and communication. Obsolete documents are archived or removed, and an audit trail is maintained for transparency. Teams are trained on Document Control procedures to ensure understanding and compliance. The overall aim is to enhance efficiency, reduce errors, and demonstrate adherence to quality standards and regulatory requirements.

2. Implementing processes for reviewing, approving, and documenting changes is a crucial aspect of managing a Quality Management System (QMS) within an organization. This involves establishing a systematic approach to assess and authorize modifications to various elements, including products, processes, or the QMS framework. 

3. Risk management is a fundamental process within a Quality Management System (QMS) that involves systematically identifying, assessing, and mitigating potential risks to safeguard product safety, ensure regulatory compliance, and maintain overall business continuity.

   This comprehensive approach begins with the identification of internal and external risks, followed by a thorough assessment of their likelihood and impact. Prioritizing risks allows organizations to focus on the most critical concerns. Mitigation strategies are then developed and implemented, encompassing preventive measures, contingency plans, and controls.

   Continuous monitoring ensures adaptability to evolving risk landscapes, contributing not only to compliance but also to business resilience by anticipating and preparing for potential disruptions. Effective risk management is integral to maintaining the integrity of products, adherence to regulations, and the seamless continuity of business operations.

   The management of the design and development of medical device products or services is a critical aspect to consider when ensuring alignment with customer requirements and regulatory standards.

4. This process involves a systematic approach to the creation and enhancement of medical devices, from conception to market release.

   Rigorous design controls are implemented to guarantee that products meet specified criteria, encompassing aspects such as performance, safety, and efficacy. Compliance with regulatory standards, such as ISO 13485, is integral, as it establishes a framework for quality assurance throughout the design and development lifecycle.

   By managing these processes within the QMS, organizations can deliver medical devices that not only satisfy customer expectations but also adhere to the highest regulatory and quality standards, fostering trust and confidence in the market.

5. The evaluation, selection, and management of suppliers are integral components of a robust Quality Management System (QMS).

   This process ensures the quality of purchased materials and services by systematically assessing supplier capabilities, making informed selections, and implementing ongoing management protocols to uphold stringent quality standards and regulatory requirements.

6. Ensuring that personnel are adequately trained and competent to perform their tasks, promoting a culture of continuous improvement.

7. Corrective and Preventive Actions (CAPAs) are crucial components of a Quality Management System, involving the implementation of measures to identify and address issues that could impact product quality or compliance. This systematic approach not only addresses existing problems but also proactively prevents their recurrence, fostering continuous improvement and adherence to stringent quality standards.

8. Regular internal audits are a fundamental aspect of a Quality Management System, providing a systematic evaluation of its effectiveness. These audits aim to identify areas for improvement, ensuring that the QMS continually evolves to meet the organization's objectives and adhere to the highest quality standards.

9. Establishing a systematic approach for identifying opportunities for improvement and implementing changes to enhance the productivity of the team and encourage collaboration.

These processes collectively contribute to the development, implementation, maintenance, and improvement of a QMS, ensuring that organizations consistently deliver products or services that meet or exceed customer expectations and comply with relevant regulations and standards.

Implementation of a Quality Management System (QMS)

To implement a Quality Management System (QMS), Medical Device companies should start by securing leadership commitment, defining clear objectives, and engaging key stakeholders.

Document existing processes, design the QMS based on recognized standards, and gradually implement it while focusing on continuous improvement. Monitor performance, obtain optional certification, and foster adaptability to ensure the QMS aligns with legal requirements and enhances overall organizational quality and customer satisfaction.

Matrix Requirements GmbH is a global software leader helping innovative Medical Device companies remain focused on developing safer products faster. The MatrixQMS (QMS) Quality Management System reduces the regulatory burden by bridging the gap between agile & compliance teams to ensure quality across the entire product lifecycle. We are also very proud to be EN ISO 13485 and ISO/IEC 27001 certified.

Our 200+ clients, medtech leaders such as Medtronic, GE Healthcare, Stryker, Roche Diagnostics, and B.Braun, as well as startups and scale-ups such as Proscia, Element Biosciences, Clue, MindMaze and Diabeloop, are saving time in documenting product development and quality processes with our intuitive platform. Matrix Requirements was founded in 2015 by medical device developers, and has a team of 40 distributed between Germany, United States, France, UK, Belgium, and Spain.

Learn more about Matrix Requirements today.