A Healthcare Quality Management System (QMS) is a formalized system employed by healthcare companies to ensure compliance with customer and regulatory requirements regarding healthcare services and patient outcomes. Healthcare QMS involves policies, processes, and procedures aimed at monitoring, assessing, and improving the quality of healthcare.
The purpose of a QMS for healthcare companies is to ensure uniform high-quality, safe, and effective healthcare services for patients.
Healthcare companies such as hospitals and medical clinics must comply with stringent requirements to ensure the safety, quality, and efficacy of their services.
Several standards and guidelines outline specific requirements for implementing a QMS in healthcare companies, such as ISO 7101:2023, ISO 9001:2015, ISO 15189:2022, EN 15224:2016, and others.
Many healthcare companies also need to comply with Life Science QMS requirements as they operate in industries such as pharmaceuticals, biotechnology, medical devices, and others. These QMS requirements define the criteria for essential QMS processes such as document control, change control, training management, audit management, supplier management, patient management, and more. The QMS requirements help ensure the effective management of quality-related activities.
SimplerQMS provides QMS software designed for the Life Science industry and is a flexible solution for healthcare companies operating in the Life Sciences. Book a demo to discover how SimplerQMS streamlines quality management efficiently.
The article discusses the following topics in greater detail:
- What is a Healthcare Quality Management System (QMS)?
- What are the Relevant QMS Requirements in the Healthcare Industry?
- Which Are the 10 Most Critical Healthcare Quality System Elements?
- What Are the Essential Life Science QMS Processes?
- What Is the Role of QMS Software for Companies With QMS Life Science Requirements?
What is a Healthcare Quality Management System (QMS)?
A healthcare Quality Management System (QMS) is a structured system of policies, procedures, processes, and records implemented by healthcare companies. The Quality Management System for the healthcare industry helps ensure compliance with requirements, the quality and safety of products and services, and the effectiveness of patient care.
QMS in healthcare aims to establish and maintain a culture of quality and safety throughout all aspects of healthcare, encompassing clinical care, administrative processes, and support services.
Healthcare QMS critical processes requiring compliance with customer and regulatory requirements include management of information, risk management, management of change, communication, and education and training, among others.
The traditional paper-based approach to managing QMS relies on physical documents, spreadsheets, and manual filing systems. Paper-based QMS often results in cumbersome workflows, as documents must be physically created, signed, and managed.
In contrast, an Electronic Quality Management System (eQMS) is a digital solution for managing QMS in a more efficient and streamlined manner.
eQMS provides centralized repositories for electronic documents, records, and data, enabling easier access, retrieval, and information sharing across the company. Automated workflows streamline document management, change control, training management, and other QMS processes, reducing manual effort and cycle times.
SimplerQMS offers a comprehensive eQMS solution designed specifically for Life Sciences, including healthcare companies that also operate in the Life Science industry.
Electronic QMS software integrates all QMS modules to improve process efficiency while helping ensure compliance with regulatory and customer requirements. With SimplerQMS, companies can centralize quality processes, automate workflows, and drive continuous improvement across their operations.
What are the Relevant QMS Requirements in the Healthcare Industry?
Healthcare companies must comply with various requirements governing quality management to maintain high and uniform quality across various processes.
Below are some of the main QMS requirements relevant for healthcare companies to ensure consistency and excellence in patient care, safety, products, services, and patient outcomes.
NOTE
This section discusses some requirements applicable to QMS for healthcare companies, but this is not an exhaustive list. Please always refer to applicable regulations, standards, and guidelines for official information.
ISO 7101:2023
ISO 7101:2023 is an internationally recognized standard for quality management systems in healthcare companies. ISO 7101:2023 sets forth comprehensive requirements for establishing and maintaining uniform and high quality within healthcare systems, regardless of their size or structure.
ISO 7101:2023 promotes a patient-centered approach, emphasizing respect, compassion, and equity. The standard outlines requirements for identifying and mitigating risks and ensuring the safety and well-being of patients and healthcare workers.
ISO 7101:2023 specifies the requirements for documented processes and information, ensuring consistent service delivery and mechanisms for monitoring and evaluating both clinical and non-clinical performance. ISO 7101:2023 specifies the requirements for continuous improvement, encouraging healthcare companies to evolve and refine their processes and outcomes over time.
ISO 9001:2015
ISO 9001:2015 is an international standard that outlines the requirements for a quality management system applicable to all industries, including healthcare.
ISO 9001:2015 provides a framework for establishing processes to ensure consistent quality, safety, and efficiency in product and service delivery. Compliance with ISO 9001:2015 helps companies meet patient needs, improve performance, and demonstrate a commitment to continuous improvement and excellence in healthcare services.
ISO 15189:2022
ISO 15189:2022 standard provides medical laboratories with the requirements for quality and competence in medical testing.
Healthcare companies that are compliant with ISO 15189:2022 ensure the accuracy, reliability, and competency of laboratory testing processes and personnel.
Compliance with ISO 15189:2022 helps healthcare companies achieve and maintain high-quality patient care, support accurate diagnosis and treatment decisions, and improve confidence in laboratory services.
ISO/IEC 17025:2017
ISO/IEC 17025:2017 standard specifies the requirements for the competence of testing and calibration laboratories.
Compliance with ISO/IEC 17025:2017 ensures that testing laboratories maintain the highest accuracy, reliability, and technical proficiency. The standard ensures the validity and reliability of laboratory results used in diagnosis, treatment decisions, and patient care.
ISO/IEC 17025:2017 helps improve confidence in laboratory services, healthcare outcomes, and patient safety and also facilitates international recognition and acceptance of test results.
EN 15224:2016
EN 15224:2016 is a European standard that specifies the requirements for quality management systems in healthcare. EN 15224:2016 is based on ISO 9001:2015.
EN 15224:2016 provides additional requirements from ISO 9001:2015 that are tailored to healthcare companies’ unique needs and challenges.
EN 15224:2016 applies when a healthcare company needs to demonstrate its ability to consistently provide healthcare products or services in compliance with customer and regulatory requirements and aims to increase customer satisfaction.
CEN/TR 15592:2007
CEN/TR 15592:2007 is a European technical report that provides guidelines for the effectiveness and efficiency of a quality management system and for the potential to improve a company’s performance. CEN/TR 15592:2007 is based on EN ISO 9004:2018, which guides companies to achieve sustained success.
CEN/TR 15592:2007 supports healthcare companies in achieving performance improvement and continuous improvement in health services.
By following the requirements outlined in CEN/TR 15592:2007, healthcare companies can increase patient care, optimize operational efficiency, and achieve greater consistency and effectiveness in quality management.
Which Are the 10 Most Critical Healthcare Quality System Elements?
The ten most critical healthcare quality system elements are listed below.
- Leadership Commitment, Planning, and Review
- Feedback Loops/Measurement
- Environment of Care
- Management of Finances and Support Resources
- Management of Information
- Communication, Education, and Training
- Risk Management
- Management of Change
- Teamwork
- Compliance With Requirement
The elements mentioned and further described below are derived from the “Implementing The Healthcare Quality Management System” monograph publication. The publication originates from the Healthcare Technical Committee, a collaborative effort between ASQ’s Healthcare and Quality Management Divisions.
The monograph comprises multiple articles featuring case studies from various healthcare facilities. Each article explores a specific critical element of quality management in healthcare.
NOTE
The healthcare QMS elements may differ for healthcare companies involved with pharmaceutical, medical device, or Life Sciences products and services. QMS processes for such healthcare companies are mentioned in the next section.
1. Leadership Commitment, Planning, and Review
Leadership commitment, planning, and review in a healthcare QMS refers to the dedication and strategic guidance top-level management provides to ensure healthcare services comply with relevant efficiency and patient care requirements.
The leadership element is essential because it directly influences organizational culture, priority setting, and the overall dedication to quality improvement across all levels of healthcare organization.
The leadership process typically involves setting clear, achievable goals, maintaining open lines of communication between leaders and staff, and regularly evaluating progress toward these goals.
2. Feedback Loops/Measurement
Feedback loops and measurement focus on collecting and analyzing data to support continuous improvement in healthcare processes and outcomes. Feedback loops and measurements are essential for understanding the effectiveness of interventions and practices within healthcare companies.
Feedback loops are processes where outputs are continuously monitored and re-evaluated to improve future outputs. In healthcare, feedback loops include patient outcomes, treatment efficacy, and staff performance.
Measurement involves the tools and metrics used to assess these areas, such as patient satisfaction surveys, clinical outcome tracking, and performance evaluations.
3. Environment of Care
The environment of care emphasizes creating a safe, efficient, and patient-centered setting in healthcare companies.
The environment of care element ensures that the physical and procedural environment contributes positively to patient outcomes and staff well-being. A well-managed environment reduces the risks of accidents and infections, improving health outcomes and patient satisfaction.
The environment of care involves several aspects, such as maintaining clean and hygienic facilities, effective waste disposal, safe handling and storage of hazardous materials, and the security of the healthcare environment.
4. Management of Finances and Support Resources
Management of finances and support resources ensures that financial resources are efficiently utilized and that adequate support is available for operational and clinical functions. Effective financial management is essential for maintaining healthcare services’ sustainability and supporting quality continuous improvement.
The allocation and management of financial resources directly impact the ability to provide high-quality patient care. By securing financial stability, healthcare companies can invest in advanced medical technologies, recruit skilled professionals, and maintain facilities that comply with customer and regulatory requirements.
5. Management of Information
Management of information in healthcare quality systems encompasses the collection, analysis, and distribution of data to improve clinical outcomes and operational efficiency.
The information management element impacts decision-making processes and the overall effectiveness of healthcare delivery. The management of information allows healthcare companies to track performance metrics, manage patient care more effectively, and identify areas for improvement.
Management of information involves technology solutions like Electronic Health Records (EHRs) and Health Information Systems (HIS). These technologies support the seamless integration of data across various departments, fostering collaboration and enhancing the continuity of care.
Effective information management also mitigates risks by providing accurate and timely data, which is essential for preventing errors and improving health outcomes.
6. Communication, Education, and Training
Communication, education, and training ensure that healthcare professionals receive ongoing training relevant to healthcare practices and administrative operations.
The communication, education, and training element aims to improve patient safety and service quality. Well-informed and trained healthcare professionals are more able to manage patient needs, employ up-to-date practices, and follow safety protocols.
7. Risk Management
Risk management in the context of healthcare QMS involves identifying, analyzing, and mitigating risks associated with healthcare provision. The risk management element directly impacts patient safety and care quality, as it encompasses strategies to prevent adverse events that could lead to patient harm.
Effective risk management requires developing and implementing procedures to address all potential risks systematically. Risk management includes the utilization of tools for risk identification and assessment, such as Failure Modes And Effects Analysis (FMEA) and Root Cause Analysis (RCA).
8. Management of Change
Management of change in healthcare refers to the systematic approach to overseeing and implementing changes within processes, procedures, systems, or structures. Change management allows healthcare companies to remain responsive to advancements in medical knowledge, technology, changes in patient needs, and others.
Change management involves systematically planning, implementing, monitoring, and evaluating change. Effective change management reduces resistance to change, minimizes service disruption, and contributes to continuous improvements.
9. Teamwork
Teamwork involves the coordinated efforts of healthcare professionals to achieve goals focused on patient safety and care quality.
Teamwork within a healthcare company entails collaboration across various departments and specialties, allowing for comprehensive care planning and execution. Effective teamwork ensures that different perspectives are considered in decision-making processes, leading to more accurate diagnoses, effective treatment plans, and fewer medical errors.
Effective teamwork fosters a supportive environment that can improve employee and job satisfaction, contributing positively to the healthcare delivery system.
10. Compliance With Requirement
Compliance with customer and regulatory requirements ensures that healthcare companies maintain safety and deliver uniform and high-quality patient care.
Compliance involves following the requirements outlined in regulations, standards, and guidelines set by regulatory authorities. Compliance includes adhering to mandatory processes and procedures, passing audits and inspections, and maintaining certifications.
What Are the Essential Life Science QMS Processes?
The essential Life Science QMS processes that may apply to companies within the healthcare industry are listed below.
- Document Control: Manages the creation, review, and approval of documents.
- Training Management: Tracks and controls training to ensure employees know how to perform their tasks.
- Change Control: Manages modifications to documents and processes.
- Incident Management: Manages the identification, investigation, and resolution of incidents to prevent recurrence and improve processes.
- CAPA Management: Addresses and prevents quality issues through Corrective and Preventive Actions (CAPA).
- Complaint Management: Controls and resolves customer complaints.
- Supplier Management: Evaluates and monitors suppliers to ensure they comply with requirements.
- Audit Management: Plans, conducts, and tracks audits to verify compliance with customer and regulatory requirements.
- Risk Management: Identifies, assesses, and mitigates risks to ensure safety.
- Equipment Management: Maintains, calibrates, and manages equipment to ensure reliability.
These are some of the QMS processes for healthcare companies with combined products and services in the pharmaceutical, medical device, or Life Science industries. The processes may vary depending on the specific needs of each healthcare company.
Examples of how SimplerQMS software can further streamline the QMS process are also provided.
Document Control
Document control manages the creation, review, approval, updating, storage, and sharing of documents within the quality management system.
Document control is essential to ensure that accurate and up-to-date information is available to all relevant personnel. Efficient documentation management supports compliance with customer and regulatory requirements and informed decision-making.
SimplerQMS document control module provides predefined workflows for document review and approval processes, maintains version control, and tracks document access and changes. The QMS software also offers a centralized repository for easy document access and retrieval.
Training Management
Training management involves planning, delivering, tracking, and documenting employee training activities to ensure competency, compliance, and continuous improvement.
Life Science companies utilize training management to help ensure that employees are adequately trained to perform their roles and comply with requirements. Well-trained employees help improve the quality of products, services, and patient safety.
SimplerQMS facilitates training management to help ensure employees stay up-to-date on current procedures. The software automatically sends reminders and notifications for new or updated procedures and processes, supporting continuous employee training.
Change Control
Change control is the process of managing changes to processes and documents systematically to mitigate risk, maintain compliance, and ensure quality.
Change control in Life Science companies helps prevent unintended consequences of changes, ensure that changes are properly evaluated, approved, and implemented, and maintain the integrity of processes, products, and services.
QMS software, like SimplerQMS, streamlines change management within healthcare companies. With the SimplerQMS change management module, companies can create, review, and electronically sign change request documents, ensuring efficient approval workflows. Additionally, eQMS helps prevent unauthorized changes in documentation by implementing access-level security measures.
Incident Management
Incident management involves capturing, reporting, investigating, and resolving nonconformances or deviations to prevent recurrence and improve processes.
Incident management is essential to identify and address issues that may impact product and service quality, patient safety, and compliance. Efficient incident management helps to minimize risks and improve organizational performance.
SimplerQMS simplifies nonconformance management and deviation management by providing predefined workflows for recording, reviewing, and closing incidents. The system allows the seamless escalation of incidents to the CAPA process, ensuring comprehensive issue resolution.
CAPA Management
CAPA management involves identifying, investigating, addressing, and preventing quality issues, such as nonconformance and deviations.
Efficient CAPA management helps Life Science companies to ensure continuous improvement, address root causes of issues, improve processes, and prevent issue recurrence.
SimplerQMS CAPA management module provides automated CAPA routing for review and approval, tracking CAPA status and effectiveness, and linking CAPAs to related documents or incidents. The system includes tools for the CAPA effectiveness assessment, ensuring CAPA actions adequately address and resolve the issues.
Complaint Management
Complaint management is the process of receiving, recording, investigating, and resolving complaints from customers or patients regarding products or services provided by the healthcare company.
Complaint management is essential to address customer and patient concerns, identify trends or recurring issues, improve products or services, and increase customer satisfaction.
An eQMS solution, such as SimplerQMS, facilitates the efficient recording, monitoring, and resolution of complaints. The complaint management module allows for tracking of complaint status and resolution, provides complaint reports, and helps ensure timely response and resolution with automatic reminders and notifications.
Supplier Management
Supplier management involves selecting, evaluating, qualifying, approving, and monitoring suppliers to ensure they comply with customer and regulatory requirements.
Efficient supplier management helps Life Science companies ensure a reliable supply chain, mitigate risks associated with suppliers, maintain product quality and safety, and comply with regulatory requirements.
SimplerQMS supplier management module provides capabilities to maintain an Approved Suppliers List (ASL), track supplier qualification statuses and performance metrics, manage supplier documents, and manage supplier audits.
Audit Management
Audit management involves planning, conducting, documenting, and tracking audits to verify compliance with customer and regulatory requirements.
Audit management helps assess and improve companies’ quality management systems, identify areas for improvement, and support compliance with requirements. Audit findings can lead to CAPA, mitigating potential risks.
SimplerQMS streamline audit management by automating audit tasks’ reminders and notifications, providing tools for scheduling and managing audits, facilitating remote or on-site audit activities, and tracking audit findings and corrective actions.
Risk Management
Risk management is the process of systematically identifying, assessing, prioritizing, and mitigating risks related to products, services, processes, and others.
Risk management is essential for Life Science companies to proactively manage risks, prevent incidents, comply with customer and regulatory requirements, and optimize decision-making and resource allocation.
SimplerQMS risk management module enables the creation of risk management plans to analyze, evaluate, and monitor risks. The software utilizes automated workflows to guide users in handling risk management documentation, ensuring compliance with relevant requirements.
Equipment Management
Equipment management involves maintaining, calibrating, tracking, and managing equipment. Equipment management ensures equipment reliability, accuracy, and precision, supporting compliance with customer and regulatory requirements.
Life Science companies utilize equipment management to ensure the proper functioning of equipment used in product manufacturing, patient care, and research activities.
SimplerQMS equipment management module provides an overview of equipment status and simplifies setting up maintenance and calibration plans. The system automatically sends out reminders and notifications to ensure equipment-related tasks are performed on time.
What Is the Role of QMS Software for Companies With QMS Life Science Requirements?
The role of QMS software for Life Science companies is to streamline and automate quality management processes. The eQMS supports compliance with customer and regulatory requirements, helps ensure safety, and improves quality management efficiency.
eQMS software streamlines the management of quality management system processes within companies, such as document control, change management, training management, audit management, complaint management, equipment management, and more.
Some healthcare companies offer products and services integrated with the pharmaceutical, medical device, and Life Science industries. These companies may need to comply with relevant Life Science requirements.
The QMS software supports quality management system elements by providing functionalities designed to comply with specific requirements within the Life Science industries. The software facilitates seamless collaboration and efficient quality management across departments. Implementing eQMS helps drive continuous improvement and helps ensure the delivery of safe, uniform, and high-quality products and services.
SimplerQMS offers comprehensive QMS software for the Life Sciences that streamlines and automates quality management processes.
Comprehensive QMS process support helps companies to effectively comply with several Life Science requirements, including ISO 9001:2015, GxP, ISO 13485:2016, ISO 15189:2022, FDA 21 CFR Part 11, 211, and 820, MDR, IVDR, EU Annex 11, and others.
SimplerQMS is fully validated according to the ISPE GAMP5 guideline. The system is continuously validated whenever new versions or updates are introduced to maintain its validated state, ensuring compliance and readiness for audits and inspections.
Learn more about how the SimplerQMS solution can streamline your QMS documentation management. Book a demo and talk with our Quality Solution Consultants experts to better understand how SimplerQMS can support healthcare companies in complying with Life Science requirements.
