Academic Reference • Open Access (CC BY)

Laboratory Quality Management
System Fundamentals

Segaran P. Pillai & Elizabeth Fox • U.S. Food and Drug Administration
Frontiers in Bioengineering and Biotechnology, Vol. 13, Article 1578654 • Published 21 May 2025

12 Quality System Essentials DOI: 10.3389/fbioe.2025.1578654 PMCID: PMC12133829
Chapter 1

Abstract

A laboratory quality management system (LQMS) enables the effective operation of laboratories of all types and sizes — this article reviews 12 widely-recognized quality system essentials (QSEs) and provides actionable implementation examples for each.

A laboratory quality management system (LQMS) enables the effective operation of laboratories of all types and sizes. With rapid advances in technology (e.g., artificial intelligence and machine learning, advanced manufacturing) comes the need for laboratories worldwide to conduct proper change management and process improvement to meet the continued demand amidst major changes. In order to do so while ensuring that results and data are accurate, timely, and reproducible, it is crucial for laboratories to sustain a foundational LQMS that accommodates laboratory processes, document and records management, and a path for continual improvement in the laboratory itself and within its contextual organization. A foundational LQMS provides a framework to address gaps in process or product performance and risks present throughout the laboratory’s workflow, any of which could lead to a critical error that compromises the organization’s credibility. There are many LQMS frameworks–benchmarks such as consensus standards or regulations (e.g., Good Laboratory Practices for Nonclinical Laboratory Studies) – that the laboratory can select from to govern its LQMS. While these frameworks vary in applicability, there are several common elements across these frameworks that can serve as the basic components of any LQMS. The aim of this study is to review and assess 12 widely-recognized, fundamental aspects of an LQMS to identify actionable examples and templates that can enable effective implementation of a robust LQMS. A robust LQMS is one that fosters long term success of the laboratory, and which ultimately ensures reliable results, efficient operations, and the protection of public health.

Keywords

quality assurance · quality management · LQMS · laboratory · implementation · total quality · continual improvement · workflow

Citation

Pillai SP and Fox E (2025). Laboratory quality management system fundamentals. Front. Bioeng. Biotechnol. 13:1578654. doi: 10.3389/fbioe.2025.1578654

Chapter 2

Introduction: What Is a Laboratory Quality Management System?

Workflow starts with the customer, ends with reporting, and results in interpretation, leading to appropriate actions and decisions.

An LQMS is a formal system that documents the personnel, processes, and procedures by which laboratory management ensures the consistent quality of the processes conducted, outputs generated, and results reported. The entire set of operations that impacts a laboratory is considered the path of workflow. Workflow starts with the customer, ends with reporting, and results in interpretation, leading to appropriate actions and decisions. The path of workflow includes all steps before and after testing that affect laboratory outputs. There are three phases of the laboratory path of workflow: pre-analytic, analytic, and post-analytic (WHO, 2011), which Figure 1 graphically presents.

Figure 1: Phases of the laboratory path of workflow — pre-analytic, analytic, and post-analytic stages.
Figure 1. Phases of the laboratory path of workflow. Source: Pillai & Fox (2025), PMC12133829, Figure 1 (CC BY).

A Nature survey of 1,576 researchers found that 52% of responders agreed that there is a crisis of reproducibility; and over 70% have failed to reproduce another scientist’s data (Baker, 2016). To mitigate this crisis and protect public health through the generation of reliable and reproducible data, all aspects of laboratory operations, including organizational structure, processes, and procedures, must be addressed; an optimal solution for such is the implementation of a robust and efficient LQMS. To do so, consider establishing a quality policy and quality objectives; establishing processes, procedures, and systems to ensure that objectives and requirements are consistently fulfilled; and monitoring LQMS performance for continual improvement. To structure and guide effective LQMS implementation, activities can be grouped into components. Herein we describe one such framework, overviewed in the next section.

Chapter 3

The 12 Quality System Essentials

An LQMS can be framed around 12 quality system essentials (QSEs), modified from the World Health Organization’s Laboratory Quality Management System Handbook, and aligned with the laboratory path of workflow.

The purpose of this article is to detail the fundamental elements of an LQMS and provide examples in support of implementation and improvement of organization-specific LQMS processes, procedures, and manuals that meet a laboratory’s unique needs. Fundamentally, an LQMS can be framed around 12 quality system essentials (QSEs), which are graphically represented in Figure 2 and aligned with the appropriate laboratory path of workflow. The 12 QSEs, modified from the World Health Organization’s (WHO’s) Laboratory Quality Management System Handbook (WHO, 2011), include Organization, Facilities and Safety, Personnel, Equipment, Purchasing and Inventory, Process Management, Documents and Records, Information Management, Assessments, Occurrence Management, Customer Satisfaction, and Continual Improvement. While very beneficial for understanding LQMS implementation, one limitation of the WHO Handbook is that it does not include templates for on-the-job use in the laboratory. The templates and examples provided herein (see Table 1 in Chapter 5, and the Supplementary Material) provide added benefit to laboratory personnel at all levels by enabling consistent documentation and a starting point for effective LQMS implementation.

Figure 2: The 12 quality system essentials (QSEs) arranged in a wheel, grouped by pre-analytic, analytic, and post-analytic workflow phase.
Figure 2. The 12 QSEs and their associated workflow phase. Source: Pillai & Fox (2025), PMC12133829, Figure 2 (CC BY).

Implementing the 12 QSEs is beneficial for many laboratory types with the goal of assuring the continued generation of accurate, reliable, reproducible, and timely data. Pillai et al. reviewed five widely recognized quality management (QM) regulations and standards commonly applied in laboratories and found that at least 10 out of 12 QSEs (83%) are addressed in all five frameworks (Pillai et al., 2022). This finding highlights the significance of QSEs in laboratory QM. The subsequent sections provide descriptions and recommendations pertaining to each QSE, beginning with QSE 1: Organization.

QSE 1: Organization

The first QSE, Organization, focuses on the laboratory staffing structure and how it sits within its organization. Leadership’s commitment plays a critical role in the successful implementation of an LQMS. If leadership does not clearly demonstrate interest in adherence to the LQMS, it will likely become difficult to instill a strong culture of quality in the laboratory. Designing a laboratory’s organizational structure in a manner that ensures quality objectives are met and aligned with organizational strategy can serve to fulfill its mission. For example, the role of a “Quality Liaison” can be established to uphold a culture of quality and promote best practices and policies. Implementation of the Organization QSE would also ensure that roles and responsibilities for monitoring and assessment are established to mitigate risks. With the appropriate resources and leadership’s dedication to the success of an LQMS, a laboratory is further equipped to protect public health.

QSE 2: Facilities and Safety

Facilities and Safety involves the laboratory environment and the processes, procedures, and plans that support its safe and secure operation. With this QSE, laboratories follow approved facility procedures, instructions, rules, national and state regulations, guidelines, and standards. A suitable environment for effective and conformant laboratory operations should be provided and maintained, including social, psychological, and physical factors that ensure staff safety and health. Consider the purpose and type of laboratory work when determining what is needed; for example, if environmental monitoring is conducted, ensure that proper facility systems are in place (e.g., air filtration, humidity monitoring, alarms for out-of-range measurements). Some may wonder, what does safety have to do with quality? While quality and safety practices have slightly different goals, they are complementary. Quality is defined as the “degree to which a set of inherent characteristics of an object fulfills requirements” (ISO, 2015a), and safety is an important laboratory requirement. It is recommended that safety and quality staff have separate, clearly delineated responsibilities, but also collaborate to achieve objectives. Leadership is responsible for establishing policies and resources to ensure safety and health of employees, the organization’s most critical asset. It is everyone’s duty to embrace safety and responsible behavior in their work. Regardless of the type of laboratory, a higher safety risk must inform enhanced safety protocol. Implementing this QSE is a proactive measure to sustain safety and quality in the laboratory.

QSE 3: Personnel

The Personnel QSE focuses on defining job descriptions, qualifications, and training requirements for laboratory staff. This begins before they are hired–establishing competence requirements and position descriptions ensures that qualified staff conduct laboratory operations–and continues with enabling staff to grow professionally. Laboratory staff should receive appropriate training upon hiring and throughout employment, including safety training aligned with applicable regulatory requirements; hands-on training on laboratory procedures and equipment; and quality training needed for LQMS activities. Personnel must be fully trained and deemed competent to execute their responsibilities safely and accurately prior to beginning work. According to a 2019 review, a survey of 2,400 academic researchers found that while 70% received safety training, only 26% were trained within 30 days of onboarding; among other harrowing statistics presented, one study found that 25% of researchers had not been trained in the specific hazard with which they worked (Ménard and Trant, 2020). Hazard identification and risk mitigation strategies are foundational components of LQMS. To ensure training effectiveness, laboratory management should conduct competency assessments and/or proficiency testing at established intervals. This may reveal the need for additional or specific training, and incorporating safety requirements into assessments will help ensure that nothing is missed when it comes to the laboratory’s most important resource: its people.

QSE 4: Equipment

Well-maintained equipment is crucial to safe laboratory operation and the quality of data generated. The Equipment QSE focuses on ensuring that policies and procedures are in place and available to appropriately receive, identify (label), qualify, inventory, calibrate, and maintain critical equipment throughout its lifecycle, including a decommissioning/retirement policy. Critical equipment refers to laboratory equipment or instrumentation used for scientific operations (e.g., sample analysis, processing, handling, and/or manipulation and data collection). It is important for leadership to prioritize equipment management and allocate resources to ensure it is done effectively. Routine preventive maintenance and calibration of critical equipment will help to ensure the validity of results. A preventive approach will not only minimize downtime from malfunction, but it can also reduce the likelihood of variability in test results, which can occur over time as equipment gradually degrades. Testing positive, negative, and calibration controls on analytical equipment, where applicable, ensures proper function. For equipment used to store valuable materials and conduct analysis—the loss of which can be detrimental—it is essential to implement redundant systems to manage equipment failure risks. Equipment must also be fit for purpose; fitness for purpose can be determined in many ways (e.g., calibration), but evidence should be documented (e.g., calibration records, temperature records). When traceability is required or essential, it becomes critical to identify (e.g., label), calibrate using measurement standards (e.g., National Institute of Standards and Technology), and safeguard equipment from anything that would invalidate it for use. If measurement equipment is found to be unfit (e.g., control results out-of-specification), the laboratory should determine if previous results that the equipment generated are valid or invalid, and take appropriate action as necessary (e.g., repeating analysis using newly calibrated equipment, recalling data). The above activities should be documented as evidence that they were performed–for example, an equipment receipt form may be completed when new equipment arrives, and a preventive maintenance log could be updated when routine service is performed (with certificates and receipts of service saved).

QSE 5: Purchasing and Inventory

Maintaining inventory and monitoring the quality of suppliers’ products and services helps ensure consistent quality of results. This QSE focuses on processes and procedures to appropriately receive, identify, use, store, and discard materials. Routine inventory should be conducted to ensure that chemicals, reagents, and other materials are within expiry and properly stored. Inventory management can prevent occurrence of testing interruptions (see Chapter 3, QSE 10: Occurrence Management). It can also assist with measurement of stock levels over time to optimize stock quantities of fast- and slow-moving materials. Another key aspect of this QSE is ensuring purchased material fitness-for-use. Establishing procedures and criteria for supplier qualification and continued capability, and coordinating with purchasing staff to implement guardrails (e.g., approved vendor lists), ensure that the laboratory receives suitable materials that support the validity and reproducibility of results. Additionally, handling requirements should be incorporated into procedures, including signing for receipt, confirming if the material is hazardous, inspecting for damage, and storing properly. For testing and research materials—the integrity of which is critical to scientific conduct—it is essential to manage risks associated with inventory such as incorrect storage, misidentification, and retention past expiry.

QSE 6: Process Management

Process management involves organizing and controlling laboratory processes and procedures to ensure accurate and reliable testing, which ultimately ensures the quality of data produced and the accurate interpretation of results. This QSE describes the planning, managing, and documenting of connected processes. Well-planned and managed processes help a laboratory to be more effective and efficient. This QSE involves establishing quality control (QC) activities. The purpose of QC is to monitor processes related to the analytic phase of testing and to allow for detecting errors in testing so that corrective action can be taken before flawed results are released from the laboratory. Variability in manufacturing processes is the result of many disruptions that occur during their implementation and by their nature cannot be 100% eliminated (Misztal and Ratajszczak, 2025). This natural variability further increases the need for QC. Whether the laboratory science is quantitative or qualitative, automated or manual, employing adequate QC procedures ensures the reliability of results generated. For a laboratory associated with product or method development, it is advisable to incorporate appropriate verification and validation procedures when implementing a new product or method or a significant change to an existing product or method.

QSE 7: Documents and Records

The Documents & Records QSE focuses on the development, control, and maintenance of written laboratory policies, processes, procedures, protocols, work instructions, forms, and records associated with laboratory operations. Records are documented information that serves as evidence of laboratory activities (e.g., laboratory notebooks, reports). Key aspects of analysis or research such as instrument used, maintenance/calibration data, and reagents used (including manufacturer, date of receipt, date of expiration, lot number, etc.), should be documented to support the reproducibility of results. Employees should be able to find documents and records when needed and easily understand the information conveyed. Document control procedures should ensure that applicable documents are identifiable; access-controlled; reviewed and approved before distribution and at periodic intervals; archived or destroyed as applicable; and that audit trails are in place to ensure accountability for edits or corrections (i.e., capturing who, when, and why, without obscuring the original entry). Procedures should also address correct format and media; storage and preservation; change control; and retention and disposition. It is recommended to maintain records electronically to the greatest extent possible. Records of evidence of conformity (i.e., records that prove requirements have been met), as well as non-conformity, should be protected from unauthorized alterations.

QSE 8: Information Management

The Information Management (IM) QSE focuses on management of data and its flow through the laboratory, from incoming to outgoing. IM systems may be paper-based, electronic, or a combination of both; whatever technology is employed, the IM QSE is essential and is closely related to the Documents and Records QSE (WHO, 2011). The main difference is that the IM QSE encompasses a broader system for management of information (e.g., security, data governance, how information moves through the path of workflow), while the Documents and Records QSE focuses on controlling written information about policies, processes, and procedures, and the completed information that serves as records (e.g., a batch record, a form that was filled out). The IM QSE involves reviewing and meeting information requirements (e.g., intellectual property, material transfer agreements) and disseminating information (e.g., test results) in approved system(s) to end users in a secure, timely, and accurate manner. Properly addressing this QSE ensures that data is accurate and confidential, and accessible to authorized users. Laboratories should establish procedures to ensure that information received, generated, disseminated, and published is effectively governed to safeguard its quality, integrity, reproducibility, security, and confidentiality based on sensitivity and/or privacy. Leadership (or designee) should assign access levels for laboratory personnel per job descriptions and work requirements, and for external users. Stored data, reports, and other information should be traceable and readily retrievable.

QSE 9: Assessments

The Assessments QSE is a way to analyze an LQMS’s efficacy through internal and external assessments (e.g., audits), as well as through performance evaluation in an external quality assessment (EQA) program (Dhara et al., 2024) to verify conformance to regulatory, accreditation/certification, and customer requirements. The QSE involves evaluating laboratory performance compared to a standard, benchmark, or performance of other laboratories, as appropriate. Assessments and audits may be internal (e.g., self-assessments conducted within the organization by personnel trained for assessment, belonging to a department separate from the one being assessed) or external (e.g., conducted by a third-party entity). An internal assessment, for example, could be a process audit conducted by QA staff for the manufacturing department; and an external assessment could be an ISO/IEC 17025:2017 accreditation audit (International Organization for Standardization, 2017) for a calibration laboratory conducted by an ISO registrar. Standardized assessments conducted at established intervals help to evaluate the effectiveness of the LQMS. Properly addressing this QSE ensures comprehensive implementation of the LQMS, supports identification of opportunities for improvement, and improves the ability to achieve quality objectives. To implement this QSE, laboratories should establish procedures for internal assessments. Quality assurance (QA) staff (or appropriate designee) should also develop and implement procedures for supporting external assessments. Further, QA staff/designee(s) should define quality indicators for LQMS assessment.

QSE 10: Occurrence Management

In the complex world of laboratories, occurrences can and will naturally occur in any phase of the path of workflow. An occurrence is defined as any event that has a negative impact on an organization, including its personnel, the product of the organization, equipment, or the environment in which it operates (WHO, 2011). Unintended errors and other events in the laboratory can have serious consequences that affect the quality of its results and could negatively impact public health or trust. But when occurrences are properly managed through identification, reporting using appropriate channels, and application of corrective actions (CAs), the output of occurrence management is a continually improving organization. This QSE involves establishing procedures to investigate unintended consequences (e.g., non-conformances) from laboratory activities, identify root causes, and implement CAs to eliminate recurrence. Laboratories cannot prevent every error or incident, and events should be tracked to identify process gaps. But properly addressing this QSE can reduce risk of future occurrences, personnel injury, facilities damage, equipment or material loss, and events adverse to organizational decisions. Laboratory management should establish procedures for: identifying, reporting, documenting, and investigating occurrences; conducting risk assessments associated with occurrences; developing and implementing risk mitigation strategies; and implementing CAs properly with effectiveness checks.

QSE 11: Customer Satisfaction

The Customer Satisfaction QSE emphasizes laboratory customers, their expectations, and the importance of designing process(es) to meet those expectations. To uphold a laboratory’s organizational and public health missions, it is essential to consider the needs and expectations of its customers (i.e., interested parties). Customers can be both internal (e.g., leadership, another department that the laboratory interacts with such as manufacturing) and external (e.g., clients, regulators, proficiency testing providers). Anyone impacted by laboratory outputs could be considered a customer. Ultimately, the laboratory generates a product—data and results—for its customers. If the customer is not well served, the laboratory is not achieving its primary function. This QSE involves procedures to monitor customer needs through feedback mechanisms (e.g., surveys, emails, online chat), quality indicators, and assessments (see QSE 9: Assessments). Leadership is responsible for ensuring that customer expectations are understood and met. Properly implementing this QSE can reduce customer dissatisfaction, ensure that the “voice” of the customer is heard, and improve internal processes through addressing feedback; it also demonstrates commitment to the customer. To do so, laboratory management should establish procedures to identify internal and external customers; document their needs, expectations, and requirements; manage satisfaction through feedback review and analysis; and address complaints in a timely manner.

QSE 12: Continual Improvement

The Continual Improvement QSE focuses on increasing LQMS effectiveness and efficiency to provide added benefit to the organization and its customers. Improvement strategies such as the Plan-Do-Check-Act approach, defined below, could be used to continually evaluate and improve laboratory processes:

In support of organizational missions and the protection of public health, it is essential to take steps to implement and improve upon the LQMS to facilitate increased accuracy, reliability, reproducibility, and timeliness of data. Ensuring the quality of laboratory outputs is the main objective of an LQMS and ultimately relies on continual improvement. This QSE involves procedures to monitor and evaluate the effectiveness of the LQMS. Review of internal assessment reports, occurrences, customer satisfaction surveys, and data trends, are all ways to continually improve the laboratory. Leadership, QA staff, and laboratory management are responsible for monitoring LQMS compliance and evaluating the system overall for effectiveness. Implementing this QSE can help to identify and reduce risks in the laboratory, as well as increase productivity by fixing process inefficiencies; additionally, it enhances commitment to a culture of quality and responsible conduct of science.

Chapter 4

Table 1: Implementation Examples

Illustrative examples of how staff responsible for LQMS oversight could apply each QSE within an organization to demonstrate conformance.
QSEImplementation Examples
1. Organization
  • Develop and maintain organizational chart(s) showing where the laboratory sits within the overarching organization and conveying roles, responsibilities, and reporting structure.
  • Establish detailed position descriptions for all laboratory roles, with defined responsibilities and selection qualifications.
  • Ensure adequate resources are allocated for the laboratory to execute, monitor, and control processes within the LQMS scope.
  • Establish clear communication channels and lines of authority so staff are aware of quality activities and empowered to suggest improvements.
  • Develop a quality manual to organize documented contextual elements of the LQMS (scope statement, quality policy/objectives) and aid new staff and auditors.
  • Use a responsibility assignment matrix (“RASCI”: responsible, accountable, supporting, consulted, informed) to outline responsibilities for a given process.
  • Conduct management review of the LQMS at established intervals (at minimum, annually).
  • Foster a culture of quality and responsible conduct of science, for example through quality “champions,” lunch-and-learn sessions, visible dashboards, celebrating successes, professional development opportunities, valuing staff input, and wellness programs.
2. Facilities & Safety
  • Establish clear lines of communication related to safety and facilities (e.g., with a facilities manager and safety officer).
  • Optimize laboratory workspace design for workflow, coordinating with facilities staff.
  • Coordinate with facilities staff on move/renovation guides and occupant emergency plans.
  • Coordinate with safety staff on job hazard analysis and staff training on relevant hazards.
  • Ensure the laboratory is secure and designed for safe, efficient operations, including control of unauthorized access, proper storage/environmental conditions, environmental monitoring, and pest control.
  • Track select agents and toxins used in the laboratory and the personnel permitted to handle them.
  • Make safety data sheets readily available for materials such as biological agents, toxins, chemicals, and reagents.
  • Establish housekeeping procedures and coordinate with safety staff on compliance with facility safety and health rules (fire plans, safety/spill kits, evacuation and fire training, extinguishers).
  • Establish laboratory safety manuals, plans, guides, and templates, and ensure periodic safety inspections per applicable OSHA requirements.
3. Personnel
  • Provide employee onboarding/orientation training that includes LQMS and safety training.
  • Provide on-the-job training for laboratory staff.
  • Retain and periodically update records of staff competence (resumes, diplomas/transcripts, proficiency testing results).
  • Evaluate actions taken to acquire additional competence, such as mentor observation and annual performance reviews.
  • Ensure all required training is completed in a timely manner, including training on data security/integrity for staff with access to personally identifiable information.
  • Establish training requirements for each role, and retain/review training records.
  • Conduct competency assessments and/or proficiency testing.
  • Provide continuing education and professional development opportunities.
4. Equipment
  • Develop/update a preventive maintenance procedure with documented maintenance logs.
  • Develop/update an equipment management procedure covering identification, inventory, operation, status, disposal/decommissioning; labeling; qualification/validation (IQ/OQ/PQ); and calibration.
  • Implement temperature logs for equipment requiring a specified temperature range (incubators, refrigerators, water baths).
  • Maintain a preventive maintenance log as part of the controlled document system, including equipment ID, description of maintenance, date conducted, and next due date; a monthly checklist can help prioritize by risk level.
  • Calibrate, maintain, and certify engineering controls to ensure staff safety and health.
5. Purchasing & Inventory
  • Conduct high-level resource budgeting/planning sessions at established intervals.
  • Establish requirements and procedures for ordering critical laboratory materials.
  • Identify and qualify suppliers, establishing requirements (e.g., certification/accreditation) and periodically re-evaluating them.
  • Develop an inventory procedure covering receipt and labeling (including expiration dates), inspection/acceptance criteria, safe storage and handling (e.g., first-in-first-out), traceability to purchase orders, custodial sign-off, inventory-check intervals, and proper disposal.
  • Implement a robust inventory management system to track items and reduce excess ordering or untraceable materials.
6. Process Management
  • Plan and document all laboratory management, support, and operational processes; a turtle diagram or process map can help capture inputs, outputs, responsible parties, performance indicators, and risks.
  • Identify process owners when planning processes/services.
  • Define good documentation practices for the laboratory.
  • Ensure all staff understand the laboratory path of workflow.
  • Establish/update quality indicators (key performance indicators/quality objectives).
  • Establish a lot/batch numbering system for inputs and outputs, as applicable.
  • Develop procedures to protect the integrity of regulatory samples (e.g., cold-storage requirements).
  • Establish written specifications for laboratory outputs so in-specification and out-of-specification (OOS) results can be easily identified.
  • Apply appropriate QC materials (certified reference materials, controls, blanks, matrix spikes) to each analytical batch to ensure accuracy and detect contamination.
  • Use visual workplace aids (posters, system alerts) to reinforce required controls.
7. Documents & Records
  • Develop written procedures for all laboratory processes, standardizing critical processes.
  • Identify external documented information used within LQMS scope (e.g., reagent certificates of analysis, equipment manuals).
  • Establish a records management program, including retention periods and disposition.
  • Establish a document control procedure covering identification, development, review and approval, distribution, access/retrieval/use, storage and preservation, version control, retention, and disposition.
  • Review controlled documents (procedures, templates, forms, reports, notebooks) for adequate controls.
  • Transition paper records to secure electronic systems where feasible.
  • Maintain and routinely update a master list of forms used by the laboratory.
  • Keep documents and records in a secure, access-controlled location.
  • Maintain instrumentation, calibration, maintenance, certification, training, and proficiency testing records.
  • Ensure updated documents/procedures/policies are readily available, with previous versions archived.
8. Information Management
  • Train all staff on the applicable information management (IM) systems, including confidentiality requirements.
  • Ensure correct access permissions are applied for all personnel.
  • Track file inventory during any major shift to a new IM system to ensure proper migration.
  • Ensure data is stored on servers with appropriate capacity, IT support, security patching, backups, and recovery; establish a data management procedure describing these aspects and update/backup intervals.
  • Ensure stored data, reports, and information are traceable and readily retrievable.
  • Apply appropriate governance to data subject to intellectual property agreements (e.g., Material Transfer Agreements).
  • Maintain data integrity over its entire lifecycle.
9. Assessments
  • Establish procedures for planning, follow-up, and appropriate conduct during external assessments (e.g., proficiency testing, certification audits).
  • Establish procedures for auditing suppliers.
  • Establish procedures for internal LQMS self-assessments at set intervals, including audit reports shared with leadership; ensure auditor impartiality (auditors should not assess their own work areas).
  • Support QA staff professional development (e.g., QM certifications) to strengthen internal audit capability.
  • Define quality indicators for monitoring/assessing LQMS activities.
  • Implement an assessment findings tracker to help manage corrective actions related to findings.
10. Occurrence Management
  • Establish a Risk Management procedure covering how risks are identified, categorized, and tracked; the interval for risk assessments; how corrective actions and their effectiveness are reviewed; and the risk treatment strategy used (Avoid, Mitigate, Accept, or Transfer).
  • Address how risks to impartiality and confidentiality are treated.
  • Establish a nonconformance (NCM) and corrective action (CA) procedure covering responsibilities, how NCM is identified/documented/segregated, severity classification, required risk/impact assessment, decision-making guidance and timeframes, record retention, possible actions (halting work, recalls, formal CA), root cause analysis methods, CA implementation, and CA effectiveness review/closure.
  • Conduct root cause analysis (e.g., Failure Modes & Effects Analysis, Ishikawa diagram) to identify weaknesses in existing controls.
  • Develop a corrective action plan whenever an occurrence (e.g., NCM) is identified.
11. Customer Satisfaction
  • Identify all internal and external customers (interested parties) and document their needs, expectations, and product/service requirements.
  • Develop/update a customer feedback process, ideally as a written procedure.
  • Gather feedback at established intervals via intake forms, portals, or surveys (e.g., online form tools distributed via client lists), and evaluate satisfaction using built-in analytics.
  • Track and manage all customer complaints and feedback, including corrections and corrective actions taken.
  • Incorporate customer satisfaction as a performance indicator and part of periodic LQMS effectiveness review.
12. Continual Improvement
  • Establish quality indicators for overall LQMS effectiveness.
  • Document, plan, and implement opportunities for improvement (OFIs); maintain a lessons learned log across all phases of a project or initiative.
  • Ensure any LQMS changes are conducted in a planned, formalized manner (revising processes/procedures, training materials, communication plans, monitoring/measurement, etc.).
  • Include continual improvement as an item for review during management review.
  • Increase staff participation through empowerment, rewards, and recognition — for example, a “quality badge” awarded to any employee who identifies an NCM, OFI, or other quality-affecting issue.
Chapter 5

Discussion

Application of the 12 QSEs organizes and improves LQMS implementation, ensures risks are mitigated, and prepares the laboratory for third-party certification or accreditation.

The foundational information described in this article and implementation examples provided in Chapter 4 support effective laboratory QM related to the 12 QSEs in the framework outlined. It is important that organizational leadership, laboratory management, QA staff, and laboratory staff have a foundational understanding of the measures available to ensure quality of laboratory operations, including the LQMS QSEs. Application of the QSEs can not only organize and improve the LQMS implementation process, but it can also ensure that all aspects of an LQMS are addressed to mitigate risks, allow for structured assessments, and prepare for third-party certification or accreditation. This study, including provision of examples and templates pertaining to each key area described, demonstrates that implementing a well-structured, robust framework that the 12 QSEs offer can support the continued success of the laboratory using consistent, standardized documentation and a clear understanding of what implementation could entail–this is critical for planning the LQMS. Implementation using the supplementary templates provided can also contribute to time and cost savings.

As laboratories conduct different types of work and have distinct needs and goals, further examination of the QSEs beyond this article may be beneficial, including identifying how to modify and apply their respective concepts to reflect a laboratory’s chosen LQMS framework (e.g., Good Laboratory Practices for Nonclinical Studies [GLP]; ISO standards) in order to improve applicability.

Table 1 (Chapter 4) provides illustrative examples of how staff responsible for oversight of the LQMS, and leadership where appropriate, could apply each QSE within the organization to demonstrate conformance, should the organization decide to conform to the 12 QSE framework.

Acknowledgments

The findings and conclusions in this paper are those of the author(s) and do not represent the official position of the United States Department of Health and Human Services or Food and Drug Administration.

Funding Statement

The author(s) declare that no financial support was received for the research and/or publication of this article.

Author Contributions

SP: Conceptualization, Formal Analysis, Methodology, Resources, Supervision, Visualization, Writing – original draft, Writing – review and editing. EF: Conceptualization, Formal Analysis, Methodology, Resources, Visualization, Writing – original draft, Writing – review and editing.

Conflict of Interest

The author(s) declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Generative AI Statement

The author(s) declare that no Generative AI was used in the creation of this manuscript.

Publisher’s Note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

Chapter 6

Reference Material

Supplementary templates, abbreviations, and the full reference list cited throughout this article.

Supplementary Material

The Supplementary Material for this article can be found online at: frontiersin.org/articles/10.3389/fbioe.2025.1578654/full#supplementary-material

DataSheet1.zip (653.9 KB) contains the referenced templates and examples: Laboratory Organizational Chart, Position Description, Environmental Sampling Plan, SOP template, On-the-Job Training Log, Performance Indicator Development Form, Data Migration & Inventory Map, Assessment Findings Tracker, Occurrence Management Workflow, Customer Feedback Process Workflow, and Lessons Learned Log.

Abbreviations

CA, Corrective Action; CFR, Code of Federal Regulations; EQA, External Quality Assessment; GLP, Good Laboratory Practices; IEC, International Electrotechnical Commission; IM, Information Management; ISO, International Organization for Standardization; LQMS, Laboratory Quality Management System; NCM, Nonconformance; OFI, Opportunity for Improvement; PI, Principal Investigator; QA, Quality Assurance; QC, Quality Control; QM, Quality Management; QSE, Quality System Essential; WHO, World Health Organization.

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Articles from Frontiers in Bioengineering and Biotechnology are provided courtesy of Frontiers Media SA. Original article: Pillai SP and Fox E (2025). Laboratory quality management system fundamentals. Front. Bioeng. Biotechnol. 13:1578654. doi: 10.3389/fbioe.2025.1578654. © 2025 Pillai and Fox. Distributed under the Creative Commons Attribution License (CC BY) — reproduction permitted with attribution to the original authors and citation of the original publication.