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Quality System Record's Role

Updated: Feb 17


The Quality System Record serves as the backbone of compliance with the FDA's Quality System Regulation (QSR), delineated within Part 820. This well-structured repository captures a wealth of essential information, including procedures, processes, documentation, and other critical records pertaining to the entire lifecycle of a medical device. The QSR plays a pivotal role in ensuring that manufacturers operate under rigorous quality control measures, maintain consistent production standards, and adhere to good manufacturing practices (GMP) throughout the design, development, manufacturing, and post-market surveillance phases.  This comprehensive article aims to shed light on the paramount significance of the Quality System Record (QSR) in the medical device industry. We will delve into the core elements and requirements that constitute the QSR, explore its multifaceted role in enhancing patient safety and product efficacy, and outline the invaluable benefits it brings to manufacturers. By providing a comprehensive understanding of the Quality System Record, this article empowers medical device manufacturers to navigate the regulatory landscape with confidence, elevating their commitment to compliance, quality, and continuous improvement in the pursuit of delivering innovative and life-changing medical devices.

The Quality System Record serves as the backbone of compliance with the FDA's Quality System Regulation (QSR), delineated within Part 820. This well-structured repository captures a wealth of essential information, including procedures, processes, documentation, and other critical records pertaining to the entire lifecycle of a medical device. The QSR plays a pivotal role in ensuring that manufacturers operate under rigorous quality control measures, maintain consistent production standards, and adhere to good manufacturing practices (GMP) throughout the design, development, manufacturing, and post-market surveillance phases.


This comprehensive article aims to shed light on the paramount significance of the Quality System Record (QSR) in the medical device industry. We will delve into the core elements and requirements that constitute the QSR, explore its multifaceted role in enhancing patient safety and product efficacy, and outline the invaluable benefits it brings to manufacturers. By providing a comprehensive understanding of the Quality System Record, this article empowers medical device manufacturers to navigate the regulatory landscape with confidence, elevating their commitment to compliance, quality, and continuous improvement in the pursuit of delivering innovative and life-changing medical devices.


Key Takeaways from the Medical Device Quality System Regulation:

  1. Scope and Applicability: The Quality System Regulation (QSR) is applicable to all medical device manufacturers, regardless of their size or type of devices produced. Compliance with the QSR is essential for gaining FDA approval to market medical devices in the United States.

  2. Comprehensive Documentation: The QSR mandates that medical device manufacturers maintain a Quality System Record (QSR). This record serves as a centralized repository that encompasses various aspects of device manufacturing processes, procedures, and documentation.

  3. Subpart M - Records: Subpart M of the Quality System Regulation specifically deals with "Records." It outlines the requirements for maintaining records related to the manufacturing and quality control activities of medical devices.

  4. Quality System Record (QSR): The Quality System Record (QSR) is a collection of records that are not specific to a particular type of device. It includes or refers to the location of procedures and documentation of activities required by the regulations outlined in Part 820.

  5. Inclusion of Procedures and Documentation: Medical device manufacturers must include essential procedures and documentation in the Quality System Record (QSR). These records should cover activities required by Part 820, ensuring compliance with regulatory requirements.

  6. Preparation and Approval: The QSR must be carefully prepared and approved in accordance with the guidelines specified in Section 820.40. This ensures that the record is complete, accurate, and aligns with the quality management practices and standards set forth by the FDA.

  7. Record Accessibility: The Quality System Record (QSR) must be readily accessible for review and examination by FDA inspectors during inspections. Easy access to these records allows the FDA to evaluate a manufacturer's compliance with the QSR.

  8. Maintaining Records for Inspection: Medical device manufacturers should maintain the Quality System Record (QSR) for a designated period to accommodate FDA inspections. Timely access to records during inspections facilitates a smoother evaluation process.

The Importance of Quality System Records: The Quality System Record (QSR) is a critical component of the Medical Device Quality System Regulation, and its significance cannot be overstated. Here are some key reasons why maintaining a comprehensive QSR is crucial:

  1. Compliance Verification: The QSR provides a roadmap for manufacturers to demonstrate compliance with FDA regulations. It enables FDA inspectors to evaluate whether the manufacturer's processes adhere to quality management practices, enhancing the safety and efficacy of medical devices.

  2. Traceability and Accountability: With the inclusion of documentation of activities and procedures, the QSR offers traceability and accountability throughout the manufacturing process. In case of any issues or concerns, the QSR aids in identifying the source and implementing corrective actions promptly.

  3. Enhanced Quality Control: The QSR acts as a tool for medical device manufacturers to monitor and improve their quality control measures continuously. Regular review of the records helps identify potential areas of improvement and ensures consistent adherence to quality standards.

  4. Facilitating FDA Inspections: During FDA inspections, the Quality System Record (QSR) provides inspectors with a comprehensive view of the manufacturer's operations. Easy accessibility to these records streamlines the inspection process and minimizes disruptions to manufacturing operations.

Ensuring Compliance with the Quality System Regulation (QSR): To comply with the FDA's Medical Device Quality System Regulation, medical device manufacturers must take several crucial steps:

  1. Robust Documentation: Manufacturers should establish comprehensive procedures and document all relevant activities throughout the manufacturing process. This includes design, development, production, and post-market surveillance.

  2. Training and Awareness: Employees involved in the manufacturing process must be adequately trained and informed about the importance of adhering to established procedures. Awareness of compliance requirements promotes a culture of quality and safety within the organization.

  3. Document Control: Proper document control practices must be in place to ensure the accuracy, completeness, and accessibility of records. This includes version control, approval processes, and secure storage of documents.

  4. Record Maintenance: Manufacturers must maintain the Quality System Record (QSR) for the required period, typically for at least two years after the last device shipment. Some records, such as device specifications and production and process control records, may need to be retained for even longer periods.

  5. Continual Improvement: Regular internal audits and management reviews should be conducted to identify areas for improvement and ensure ongoing compliance with the QSR. Corrective and preventive actions should be implemented promptly when issues arise.

The FDA's Medical Device Quality System Regulation is a comprehensive framework designed to ensure the safety and effectiveness of medical devices. Key takeaways from this regulation include the requirement to maintain a Quality System Record (QSR) and the importance of comprehensive documentation and adherence to procedures. The QSR plays a vital role in facilitating compliance verification, enhancing quality control measures, and facilitating smooth FDA inspections.


Contact BioBoston Consulting today or visit our website to learn more about how we can support your organization.

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