Laboratory Quality Management System (LQMS)

A Laboratory Quality Management System is a structured framework that applies quality principles specifically to laboratory settings, focusing on laboratory services’ reliability, accuracy, and integrity. Laboratory QMS governs the entire testing lifecycle, from sample collection and analysis to result reporting and corrective action.

Laboratories differ in function, and each type, whether medical, clinical, calibration, environmental, food and beverage, pharmaceutical, biotechnology, forensic, or research, requires a quality management framework tailored to its sample nature and applicable requirements.

Several laboratory QMS requirements include ISO 15189:2022, ISO/IEC 17025:2017, WHO’s LQMS Handbook, Good Laboratory Practice (GLP), and CLIA (Clinical Laboratory Improvement Amendments). Other requirements include FDA 42 CFR 493, Clinical and Laboratory Standards Institute (CLSI) QMS Standards, College of American Pathologists (CAP), Good Clinical Laboratory Practice (GCLP), ISO 17043:2023, and ISO 9001:2015.

The documentation structure of a laboratory QMS follows a hierarchical format, including a quality manual, policies and objectives, standard operating procedures (SOPs), work instructions (WIs), and records such as logs and reports.

Core processes of a laboratory QMS include document control, change management, training management, deviation management, complaint handling, and corrective and preventive action (CAPA). Additionally, laboratory QMS processes involve audit management, supplier management, equipment and facility management, examination management, and management reviews.

Compliance with laboratory QMS frameworks requires defining a clear quality policy, implementing rigorous documentation control, training laboratory staff regularly, conducting internal audits and reviews, executing CAPA workflows, and tracking quality indicators. Additionally, environmental control and supplier oversight are vital to maintaining a compliant laboratory QMS.

Laboratory companies can utilize an electronic Quality Management System (eQMS) to streamline QMS processes, enhance traceability, and ensure compliance with applicable requirements.

SimplerQMS is a fully validated electronic QMS solution built specifically for life science companies. SimplerQMS streamlines essential quality processes and helps ensure compliance with relevant requirements.

Laboratories aiming to enhance the QMS’s operational efficiency and regulatory adherence can explore SimplerQMS through a tailored demo by booking a demo of SimplerQMS!

What Is a Laboratory Quality Management System (LQMS)?

A Laboratory Quality Management System (LQMS) is a structured framework that integrates policies, processes, and procedures to manage and improve the quality and reliability of laboratory services.

The laboratory QMS primarily concentrates on overseeing and ensuring quality within the laboratory’s operations. Laboratory QMS encompasses the full testing lifecycle, including sample collection, handling, analysis, result reporting, and corrective actions to ensure valid testing results.

LQMS manages documentation, audits, equipment calibration, personnel competence, and issues to minimize errors and increase reliability.

Laboratories with an established quality management system reduce errors, improve efficiency, and gain client and regulator trust, as well as demonstrate commitment to improvement, risk-based thinking, and CAPA to maintain accreditation and protect public health.

A laboratory QMS may adopt different structural formats depending on organizational size, type of testing, and available resources. Some laboratories implement paper-based systems or hybrid systems, while others use digital platforms, such as quality management software.

Quality management software for laboratories, like SimplerQMS, offers document control, training management, audits, CAPA, and more to help laboratories increase operational efficiency and maintain compliance with relevant requirements.

What Are the 12 Elements of a Laboratory Quality Management System?

The 12 elements of laboratory QMS according to WHO’s Laboratory Quality Management System Handbook (2011) are listed below.

• Organization: Establishes the management structure, roles, and responsibilities necessary to implement and maintain the QMS effectively.
• Personnel: Focuses on the recruitment, training, and competency evaluation of staff to ensure that employees are equipped with the necessary knowledge and skills to perform their jobs effectively.
• Equipment: Ensures the proper selection, installation, maintenance, and calibration of laboratory instruments for reliable results of laboratory tests.
• Purchasing and Inventory: Manages procurement and storage of supplies such as reagents, standards, and equipment.
• Process Control: Covers all stages of laboratory testing, including sample collection, handling, method validation, and quality control procedures to maintain result accuracy.
• Information Management: Handles data confidentiality, integrity, and accessibility for storing and sharing laboratory information.
• Documents and Records: Defines how procedures, policies, and SOPs are created, controlled, and maintained.
• Occurrence Management: Involves detection, reporting, and analysis of errors or issues, emphasizing root cause analysis and CAPA management.
• Assessment: Includes internal and external quality assessments or audits to evaluate laboratory performance against established requirements.
• Process Improvement: Aims to enhance efficiency and quality through corrective actions, preventive measures, and quality indicators.
• Customer Service: Involves assessing satisfaction, gathering feedback, and addressing concerns to ensure laboratory outputs meet customer expectations.
• Facilities and Safety: Covers physical infrastructure, hazard containment, and ergonomics to protect personnel and samples, to maintain a safe and secure environment.  ​

The 12 elements of a laboratory QMS are shown in the image below.

What Are the Different Types of Laboratories?

The different types of laboratories, categorized by the types of samples they analyze, are listed below.

• Medical and Clinical Laboratories: Focus on analyzing patient samples for diagnosis, treatment monitoring, and disease prevention
• Calibration Laboratories: Calibrate instruments and measurement standards to ensure accuracy in measurement systems.
• Research and Academic Laboratories: Conduct scientific investigations in universities or research institutions, focusing on method development, hypothesis testing, and innovation across different sample types.
• Pharmaceutical and Biotechnology Laboratories: Support drug development, clinical trials, and quality control of biopharmaceuticals.
• Environmental Laboratories: Analyze air, water, and soil samples to assess pollution and ensure compliance with environmental regulations and relevant requirements.
• Food and Beverage Testing Laboratories: Evaluate food products for safety, contaminants, nutritional content, and labeling accuracy.
• Forensic Laboratories: Examine evidence related to criminal investigations.
• Industrial and Manufacturing Quality Control Laboratories: Ensure that raw materials and finished products meet design and safety requirements.

Each laboratory type requires a tailored QMS that reflects its operations, area of specialty, regulatory environment, and risk levels.

What Are the Different Laboratory QMS Requirements?

The different laboratory QMS requirements are listed below.

• ISO 15189:2022: Defines requirements for medical laboratory quality and competence, focusing on patient safety, accurate reporting, and staff qualifications
• ISO 17025:2022: Applies to testing and calibration laboratories, ensuring technical competence through method validation, equipment calibration logs, and traceability of measurement results.
• WHO LQMS Handbook (Laboratory Quality Management System): Provides a comprehensive framework for laboratory quality systems, emphasizing quality planning, documented procedures, risk-based control, and performance monitoring.
• CLIA (Clinical Laboratory Improvement Amendments): Establishing minimum quality requirements and a U.S. federal law for clinical laboratory testing on human specimens.
• FDA 42 CFR Part 493: Governs CLIA regulations for clinical laboratories, establishing quality standards for all testing performed on human specimens.
• GLP (Good Laboratory Practice): Governs non-clinical safety studies, ensuring data integrity, reproducibility, and chain of custody documentation.
• CLSI QMS Standards: Outlines the 12 Quality System Essentials (QSEs) for structured QMS implementation in clinical laboratories provided by the Clinical and Laboratory Standards Institute.
• College of American Pathologists (CAP): Builds on CLIA and ISO principles to certify clinical laboratory quality, issued by the CAP
• GCLP (Good Clinical Laboratory Practice): Integrates GLP and Good Clinical Practice (GCP) for laboratories involved in clinical trial support.
• ISO 17043:2023: Sets competence criteria for proficiency testing providers, ensuring the credibility of external quality assurance programs used by laboratories to benchmark performance.
• ISO 9001:2015: Demonstrates a practical QMS framework, though it is not laboratory-specific, ISO 9001 is commonly integrated with ISO 15189 or 17025 for holistic QMS coverage.

Some requirements result in certifications such as ISO 15189 and ISO/IEC 17025. Other requirements such as WHO LQMS Handbook, CLSI QMS Standards, and GCLP serve as guidelines or operational frameworks that support laboratory compliance and quality assurance.

ISO 15189:2022

ISO 15189:2022 (Medical laboratories – Requirements for Quality and Competence) is an international standard that specifies requirements for quality and competence in medical laboratories and for implementing a Laboratory QMS.

The 2022 revision of ISO 15189 adds a stronger focus on risk-based decisions, information systems, and structural alignment with ISO/IEC 17025 and ISO 9001. The standard is developed and published by the International Organization for Standardization (ISO), with technical input from ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems).

The purpose of ISO 15189 is to ensure the provision of reliable, timely, and patient-centered diagnostic services. ISO 15189 integrates risk-based thinking, continuous improvement, and competence-based evaluations.

Key requirements include personnel training, equipment calibration, nonconformances, complaints, data retrieval and storage, and environmental conditions.

ISO 17025:2017

ISO/IEC 17025:2017 (General Requirements for the Competence of Testing and Calibration Laboratories) is an international standard that outlines general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories.

The purpose of ISO 17025:2017 is to ensure that laboratories generate valid and traceable results.  The validity and traceability of results are ensured through standardized procedures, proper equipment management, and staff competence.

Key requirements include impartiality and confidentiality, resource management (personnel, equipment, and facilities), method validation, measurement traceability, sampling and testing procedures, handling of test items, and reporting of results.

The standard is issued by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), through the ISO/CASCO committee.

WHO LQMS Handbook (Laboratory Quality Management System)

The WHO LQMS Handbook is a comprehensive guideline developed by the World Health Organization to support laboratories in implementing a QMS for laboratories. WHO LQMS Handbook provides a practical framework tailored for clinical and public health laboratories.

The purpose of the WHO LQMS Handbook is to improve the quality, reliability, and efficiency of laboratory services. It promotes a systematic approach to quality by guiding laboratories in aligning processes with international requirements and strengthening health systems.

Key principles outlined include the 12 Quality System Essentials: organization, personnel, equipment, purchasing and inventory, process control, information management, documents and records, occurrence management, assessment, process improvement, customer service, and facilities and safety. These elements support quality across the entire testing cycle, from sample collection to result reporting.

The WHO LQMS Handbook supports broader laboratory QMS frameworks by bridging ISO standards such as ISO 15189 and ISO/IEC 17025 with real-world implementation strategies.

CLIA (Clinical Laboratory Improvement Amendments)

CLIA (Clinical Laboratory Improvement Amendments) is a US federal regulatory framework that sets quality requirements for laboratory testing on human specimens.

The purpose of CLIA is to ensure the accuracy and reliability of test results in clinical laboratories involved in the diagnosis, prevention, or treatment of disease.

Essential CLIA requirements include personnel competency, proficiency testing, quality control procedures, patient test management, equipment calibration, and recordkeeping.

CLIA supports broader laboratory QMS frameworks by establishing requirements that align with quality system principles in FDA 42 CFR Part 493, ISO 15189, and ISO/IEC 17025.

CLIA is administered by the Centers for Medicare & Medicaid Services (CMS), with technical support from the Centers for Disease Control and Prevention (CDC) and the US FDA. These agencies oversee certification, enforcement, and policy updates to ensure the maintenance of public health requirements in laboratory testing.

FDA 42 CFR 493

FDA 42 CFR 493 is a section of the US Code of Federal Regulations that implements CLIA. FDA 42 CFR 493 is enforced by the CMS, in collaboration with the US FDA and the CDC. FDA 42 CFR 493 defines the conditions laboratories must meet to be certified for conducting tests on human specimens for health assessment or disease diagnosis.

The purpose of FDA 42 CFR 493 is to ensure the quality and integrity of clinical laboratory testing across all US states and territories.

Key requirements include laboratory certification categories based on test complexity, personnel qualification, quality assessment systems, equipment maintenance, and record retention. FDA 42 CFR 493 outlines inspection procedures, enforcement mechanisms, and requirements for laboratory director responsibilities.

FDA 42 CFR 493 aligns with broader laboratory QMS frameworks by integrating quality assurance, risk-based systems, and documented evidence of competence. FDA 42 CFR 493 supports similar principles to ISO 15189 and reinforces quality across all phases of laboratory testing.

GLP (Good Laboratory Practice)

GLP is a framework that governs the planning, execution, monitoring, recording, and reporting of non-clinical laboratory studies. GLP primarily applies to safety testing in pharmaceuticals, chemicals, cosmetics, and environmental studies, complementing standards such as ISO/IEC 17025.

The purpose of GLP is to ensure the integrity, reliability, and traceability of study data through enforcing standardized procedures and clear documentation throughout the study lifecycle.

Key GLP requirements include defined organizational roles, study plans, standard operating procedures (SOPs), equipment maintenance, data recording, and quality assurance procedures. GLP mandates audit trails, proper training, and strict separation of functions to prevent bias and ensure study validity.

GLP is established by national authorities such as the US FDA, the European Medicines Agency (EMA), and other Organization for Economic Co-operation and Development (OECD) member countries.

CLSI QMS Standards

CLSI QMS standards are guidelines developed by the Clinical and Laboratory Standards Institute (CLSI) for clinical and medical laboratories.

CLSI QMS standards provide structured guidance for implementing and enhancing laboratory QMS to bridge regulatory requirements and daily laboratory operations.

CLSI QMS standards support consistent, accurate, and reliable test results through standardized practices. CLSI standards outline the best practices across various operational areas to meet regulatory and accreditation requirements. These standards include 12 Quality System Essentials that form the foundation of their quality approach, which mirror the structure of the WHO LQMS model.

CAP Accreditation (College of American Pathologists)

CAP accreditation is a laboratory accreditation program designed to ensure compliance with industry-leading standards for quality, accuracy, and laboratory competence. CAP accreditation is recognized in the United States and internationally.

CAP accreditation helps ensure the safety and reliability of laboratory testing by verifying regulatory compliance and adherence to best practices.

CAP requirements include CLIA compliance, personnel qualifications, quality control, proficiency testing, equipment calibration, document control, and internal audits. CAP inspections are peer-based and assess all phases of testing, including pre-analytical, analytical, and post-analytical. CAP accreditation supports QMS frameworks aligned with ISO 15189, CLIA, and CLSI.

CAP administers CAP accreditation as the regulatory body responsible.

GCLP (Good Clinical Laboratory Practice)

GCLP is a framework that helps ensure the reliability, integrity, and regulatory compliance of laboratory data generated during clinical trials. GCLP combines principles from GLP and Good Clinical Practice (GCP) to support accurate and reproducible analysis of clinical trial samples.

The purpose of GCLP is to standardize laboratory operations that support clinical research across all phases of sample testing in compliance with regulatory expectations.

Key GCLP requirements include defined roles and responsibilities, validated analytical methods, equipment calibration, personnel training, quality assurance oversight, documented SOPs, and proper data recording and archiving. Additionally, GCLP requires adherence to chain-of-custody procedures for trial samples and secure data management.

GCLP supports broader laboratory QMS frameworks by incorporating elements of ISO/IEC 17025, GLP, and GCP, and adapting them to clinical research settings.

Organizations such as the WHO, the US National Institutes of Health (NIH), and the Medicines and Healthcare products Regulatory Agency (MHRA) recognize and adopt GCLP principles. Various contract research organizations (CROs) and sponsor laboratories follow GCLP to meet international clinical trial requirements.

ISO 17043:2023

ISO/IEC 17043:2023 (Conformity assessment — General requirements for the competence of proficiency testing providers) specifies requirements for the competence of proficiency testing providers. ISO and IEC developed ISO 17043. International Laboratory Accreditation Cooperation (ILAC)-recognized accreditation bodies assess compliance with ISO 17043.

ISO/IEC 17043:2023 applies to organizations conducting interlaboratory comparisons to evaluate laboratory performance. ISO 17043:2023 ensures that proficiency testing (PT) schemes are impartial, accurate, and consistent. ISO 17043:2023 enables laboratories to verify their technical performance against external benchmarks hence enabling laboratories to detect performance issues and implement necessary improvements.

Key requirements include impartiality, confidentiality, documented PT design, statistical analysis, participant feedback, corrective actions, and result reporting. ISO 17043:2023 aligns with ISO/IEC 17025 and ISO 15189 by supporting ongoing competence evaluation and external quality assurance.

ISO 9001:2015

ISO 9001:2015 is an international standard that defines the criteria for a QMS, applicable across all industries, including laboratories. ISO, the International Organization for Standardization, published and maintains ISO 9001:2015.

In the laboratory QMS, ISO 9001:2015 promotes quality through standardized procedures, continuous improvement, risk-based thinking, and data-driven decision-making.

ISO 9001:2015 aligns with requirements, such as ISO 15189:2022 and ISO 17025:2022, through its emphasis on documented processes, quality objectives, and proactive risk management.

ISO 9001:2015 outlines key QMS components, as listed below.

• Context of the Organization: Understand the internal and external factors that affect objectives.
• Leadership: Define clear roles and responsibilities and ensure top management commitment.
• Planning: Identify risks, and opportunities, and set quality objectives.
• Support: Secure resources, competence, and control over documentation.
• Operation: Execute and manage processes to meet quality standards and requirements.
• Performance Evaluation: Monitor, measure, and audit system performance.
• Improvement: Use performance data to drive continual improvement.

Some laboratory companies adopt ISO 9001:2015 along with other requirements in an Integrated Quality Management System (IQMS) to enhance operational performance and ensure their QMS aligns with quality requirements.

What Are the Different Laboratory Certifications or Accreditations?

The several certifications or accreditations a laboratory can obtain are listed below.

• ISO/IEC 17025: Covers testing and calibration laboratories that are commonly used by food, industrial, environmental, and research laboratories for technical reliability.
• CLIA: Governs clinical laboratories in the US handling human specimens for diagnosis. Different types of CLIA certificates include Certificate of Waiver, Certificate for Provider-Performed Microscopy Procedures (PPMP), Certificate of Registration, Certificate of Compliance, and Certificate of Accreditation.
• CAP: Voluntary program for clinical and pathology laboratories primarily in the US (but also recognized internationally) that complements CLIA requirements.
• ISO 15189: Applies to medical laboratories performing clinical testing and focuses on quality and competence in pre-analytical, analytical, and post-analytical phases.
• Good Laboratory Practice (GLP): Ensures the integrity and traceability of non-clinical laboratory studies, which are often required in pharmaceutical, pesticide, and chemical safety testing.
• ISO 9001: Certifies quality management systems across industries, including the laboratory.

Laboratory certifications or accreditations vary by area, scope, operational focus, and industry requirements. Each certification or accreditation ensures that a laboratory meets specific requirements for quality, technical competence, and regulatory compliance.

What Is the Documentation Structure of a Laboratory QMS?

A laboratory QMS follows a structured documentation hierarchy consisting of several tiers that organize information from high-level policies to operational records. The purpose of a structured quality system is to document, standardize, and review processes to maintain uniform practices across operations.

The typical structure of documentation in a laboratory QMS is outlined below.

• Quality Manual: A top-tier document outlining the laboratory’s QMS scope, applicable requirements, references, and key processes.
• Policies: The QMS policies (e.g., quality policies and company policies) and objectives reflect the organization’s commitment to quality, risk management, and regulatory compliance.
• Procedures or Standard Operating Procedures (SOPs): Procedures define the steps for quality-related tasks such as document control, equipment management, training management, and more.
• Work Instructions (WIs): WIs provide detailed, task-specific, and step-by-step instructions to ensure consistent execution.
• Records (Forms, Logs, Reports): Records capture objective evidence of laboratory activities, including temperature logs, calibration records, and test result reports.

The standard structure of documentation in a laboratory QMS is shown in the image below.

What Are the Core Processes of a Laboratory QMS?

The several core processes of a laboratory QMS are listed below.

• Document Control: Manages the creation, approval, distribution, revision, and retirement of laboratory QMS documents, ensuring version control and proper archiving (e.g., SOPs, WIs, protocols).
• Change Management: Provides a systematic approach to evaluating and implementing updates to methods, equipment, or processes.
• Training Management: Identifies training needs, delivers programs, and evaluates effectiveness to ensure personnel are competent for their roles.
• Deviation or Nonconformity Management: Handles unplanned events or variances from approved protocols or processes.
• Complaint Management: Captures and manages client feedback or dissatisfaction related to issues such as service, turnaround time, or data.
• CAPA Management: Identifies root causes of recorded issues and implements CAPA to resolve them and prevent future occurrences.
• Audit Management: Schedules, conducts, and records audits (internal, external, supplier), tracks findings, and ensures timely closure of audit findings.
• Supplier Management: Incorporates the approval, review, and monitoring of vendors providing supplies such as reagents, kits, equipment, and services.
• Equipment Management: Includes calibration, preventive maintenance, and qualification (IQ/OQ/PQ) of laboratory equipment.
• Examination Management: Ensures that all laboratory testing processes, from method selection to result reporting, are scientifically valid, controlled, and documented to produce accurate, reliable, and traceable results.
• Facility Management: Maintains environmental conditions to ensure reliable test results.
• Management Review: Conducts scheduled, structured evaluations of QMS metrics (quality KPIs, audits, deviations, CAPAs, risks) at the executive level to drive continual improvement.

Document Control

Document control manages documents from creation, review, approval, distribution, revision, and retirement.

Document control ensures the use of current, approved SOPs, protocols, policies, and specifications. Compliant documents and records through laboratory document management support audits, training, inspections, investigations, change control, and other QMS processes.

A typical laboratory document control workflow begins with the creation or update of a document. Authorized personnel review and approve the document, which is assigned a unique identifier, and then release and make it accessible to relevant personnel. Users follow the issued procedures, and training is provided if changes are significant. Documents are reviewed periodically to confirm relevance, while outdated versions are either revised or archived.

ISO 15189:2022 mandates control of documents including reviews, approvals, issue control, periodic reviews, and identification of obsolete documents under Clause 8.3 Control of Management System Documents.

ISO/IEC 17025:2017 Clause 8.3 Control of Management System Documents requires laboratories to maintain document control procedures for internal and external documents, including technical records and method validation files.

Change Management

Change management is a systematic QMS approach to implementing process modifications, product updates, and workflow improvements.

Change management helps ensure that any alterations made to the laboratory processes or services are carefully evaluated to minimize risks and maximize benefits.

The change management process begins with the initiation and documentation of the required modification. The assessment phase includes stakeholder analysis to evaluate risks and impact on quality, safety, and compliance. The review and approval step involves quality, regulatory, and other authorized representatives to assess feasibility.

The implementation plan defines timelines, responsibilities, and communication methods. The implementation phase executes the change, while training and documentation updates are provided to relevant teams. Verification checks that the change meets successful criteria and introduces no new issues, with outcomes recorded for final review. Archive and store documents, including all actions and lessons learned, for archiving and audit readiness. Ongoing monitoring tracks post-implementation stability and identifies unforeseen implications.

ISO 15189:2022 Clause 8.9 (Control of Changes) requires laboratories to identify and control changes that affect laboratory activities. ISO 15189:2022 mandates review, approval, and risk assessment before implementing any change. ISO 15189:2022 requires documented information on review outcomes and actions taken.

ISO/IEC 17025:2017 does not label “change management” as a standalone clause, but it embeds the concept. For example, Clause 8.5 (Actions to Address Risks and Opportunities) states that whenever a change arises, it should be evaluated in terms of its impact on quality objectives, technical validity, and compliance.

Training Management

Training management is the process that equips personnel to possess the necessary skills, knowledge, and expertise to perform their job effectively. Training management ensures that training needs are met, and the required competencies are available to comply with relevant requirements.

Training management helps ensure personnel understand process modifications and regulatory updates. Communication informs employees who are affected by new procedures, process changes, or regulatory requirements. Role-based training sessions, tailored to responsibilities and interactions with the change, are another component of effective training management.

Competency assessments verify understanding through quizzes, tests, or practical demonstrations. Training records are maintained, such as logs, certificates, and compliance reports. Documented training supports audit readiness for internal and external audits.

ISO 15189:2022 Clause 6.2.2 (Competence Requirements) requires documented competence criteria, including training and re-training. ISO 15189:2022 Clause 6.2.4 (Continuing education and professional development) mandates continuing education and professional development. ISO 15189:2022 Clause 6.2.5 (Personnel records), requires the retention of personnel training and competency records.

ISO/IEC 17025:2017 Clauses 6.2.2 to 6.2.5 require documented competence, training, supervision, monitoring, and recordkeeping.

Deviation or Nonconformity Management

Deviation or nonconformity management controls the identification, documentation, investigation, and resolution of events that fail to follow approved procedures, specifications, or expectations.

Common workflows include issue detection, such as deviations, nonconformities, complaints, or audit findings. Deviations are investigated and documented with the time, location, personnel involved, and incident details. Secondly, deviation impact is typically classified as minor, major, or critical and evaluated for risk to product quality, safety, and compliance. Investigations employ structured methods, such as the 5 Whys or Ishikawa, and CAPAs are implemented to address both the root cause and the specific incident. Typically, the quality unit reviews all data, verifies the resolution, and formally closes the deviation. Lastly, data is analyzed to detect recurring or systemic issues.

Deviation management ensures the early detection of quality issues, prevents the release of unverified products, supports process improvement, ensures audit readiness, and documents compliance decisions. Deviation management integrates with CAPA for remedial actions, change management for process updates, training management for error-related retraining, document control for procedural revisions and records, and audit management for effectiveness checks.

The specific clauses and regulatory expectations for deviation management, for instance, are mentioned in ISO 15189:2022 and ISO/IEC 17025:2017.

ISO 15189:2022 Clause 7.5 (Nonconforming Work) mentions that laboratories must have a documented procedure to manage nonconforming work. Clause 7.5 includes identifying the nonconformity, assessing its significance, taking appropriate action, retaining records, notifying customers (if needed), and implementing corrective actions to prevent recurrence.​

ISO/IEC 17025:2017 Clause 7.10 (Nonconforming Work) specifies that laboratories are required to implement a procedure when results or activities do not conform to requirements. The procedure must define responsibilities, actions based on risk, significance evaluation, record retention, customer communication, and authority for resuming work.

Complaint Management

Complaint management is a formal QMS process for receiving, documenting, investigating, and resolving customer complaints to improve product quality and compliance.

Complaint management enables companies to respond effectively to customer feedback, address quality issues, and drive continuous improvement. By prioritizing customer satisfaction and actively engaging with customer complaints, companies can build trust, loyalty, and long-term relationships with their customers while maintaining compliance with regulatory requirements.

The typical workflow of complaint management begins with logging and acknowledging the complaint. The validation step determines whether the issue relates to laboratory operations. The investigation phase collects and verifies facts to identify root causes. The resolution phase determines whether corrective or preventive actions are necessary. The communication step provides updates and outcomes to the complainant. The closure step formally completes the complaint with documented results. Review and analyze complaint trends to drive quality improvement and risk mitigation.

Complaint records must be linked with document control, training, CAPA, and audit management systems.

ISO 15189:2022, Clause 7.7 (Complaints), requires a documented process for receiving, investigating, and resolving complaints, including tracking actions and publicly describing the process.

ISO/IEC 17025:2017, Clause 7.9 (Complaints), mandates complaint handling through validation, investigation, communication, and corrective action. ISO/IEC 17025:2017 requires that complaint outcomes be made, reviewed by, and approved by personnel not involved in the original work.

CAPA Management

CAPA management addresses systematic identification, investigation, correction, and prevention of recorded issues (e.g. deviation, nonconformance, complaint, audit finding).

CAPA management ensures that errors do not recur and that potential risks are proactively controlled. CAPA management drives continual improvement, reduces recurring errors, and aligns laboratory activities with customer and regulatory expectations.

CAPA management is triggered by recorded issues or risks. The investigation phase uses root cause analysis with tools such as 5 Whys or Fishbone Diagram. Action planning involves identifying and implementing corrective and preventive actions to eliminate root causes and mitigate recurrence risk. Implementation executes the approved actions with assigned responsibilities and deadlines. Verification of effectiveness assesses whether the issue is resolved and recurrence is prevented. Closure documents outcomes and archives actions for traceability and audit readiness.

CAPA integrates with document control to ensure procedure updates. CAPA integrates with training management to restore staff competency. CAPA integrates with audit management as a corrective response. CAPA integrates with deviation and occurrence management to address root causes and prevent recurrence.

ISO 15189:2022 Clause 8.7 (Nonconformities and corrective actions) requires a CAPA process involving root cause analysis, action implementation, and effectiveness review with documented evidence.

ISO/IEC 17025:2017 Clause 8.7 (Corrective Actions) outlines nonconformance management steps including reaction, evaluation, action, verification, and record retention, emphasizing risk-based responses and necessary system updates.

Audit Management

Audit management is a QMS process that ensures internal and external audits are effectively planned, executed, and reviewed.

Audit management helps ensure that laboratory management processes are effectively implemented and followed throughout the company. Audit management assesses compliance with internal policies, procedures, quality requirements, industry guidelines, and regulatory requirements.

Typically, audit management begins with audit planning, which defines the scope, frequency, roles, and responsibilities. Audits are scheduled and notified and are conducted using checklists, interviews, and observations, with findings recorded and classified. Audit results are reported to stakeholders and assigned to CAPA, if applicable. CAPAs are tracked and re-audited as needed. Audit trends are monitored to identify recurring issues and support improvement.

Audit management is often integrated with CAPA, deviation, document control, supplier management, and other related quality elements.

Clause 8.8.3 (Internal Audit) of ISO 15189:2022 requires laboratories to plan and conduct internal audits at planned intervals to verify conformity with their own requirements and with ISO 15189.

ISO/IEC 17025:2017 Clause 8.8 (Internal Audits) mandates laboratories are required to plan, establish, implement, and maintain an audit program.

Supplier Management

Supplier management is a QMS process that ensures suppliers meet quality and compliance requirements. Supplier management involves evaluating, selecting, and monitoring suppliers to ensure that they consistently deliver uniform and high-quality products or services.

Effective supplier management helps companies identify reliable and capable suppliers, optimize supply chain performance, and mitigate risks associated with poor supplier performance.

The typical workflow involves evaluating supplier qualifications to assess potential suppliers based on capability, certification, or historical performance. Approval and contracting formally approve suppliers and establish supply terms. Monitoring and evaluation track supplier performance and quality of delivered products or services. Deviation or nonconformance handling documents and resolving issues arising from supplied materials or services. Re-evaluation periodically assesses suppliers for continued suitability.

Supplier records integrate with document control for contracts and specifications, equipment management for calibration tracking, audit management for supplier audits, and CAPA for resolving nonconformities.

ISO 15189:2022 Clause 6.8 (Externally provided products and services) requires laboratories to ensure the suitability of externally provided products and services used in operations.

ISO/IEC 17025:2017 Clause 6.6 (Externally provided products and services) requires the control and verification of external products and services to meet laboratory requirements.

Equipment Management

Equipment management is a systematic approach to ensuring the ongoing functionality, accuracy, and reliability of all equipment used within the laboratory processes. Equipment management encompasses the registration, qualification, calibration, maintenance, and disposal of equipment used in laboratory processes.

Properly managed equipment ensures that manufacturing processes are conducted accurately and consistently, minimizing the risk of defects or deviations from quality specifications.

The usual workflow begins with equipment selection and qualification, ensuring suitability based on the intended use and performance specifications. Secondly, installation and commissioning verify that the equipment is correctly installed and functioning. Calibration ensures measurement accuracy through a documented program. Routine maintenance prevents unexpected equipment failure. Performance monitoring detects equipment drift or malfunction using internal checks and alarms. Decommissioning removes equipment when it becomes unreliable or obsolete.

Additionally, document and archive records on all calibration, maintenance, repair, and performance data.

Equipment management is linked to document control for SOPs and records, training management for competency requirements, audit and CAPA for the traceability of failures, and supplier management for supplier service oversight.

ISO 15189:2022 Clauses 6.4 (Equipment) and 6.5 (Equipment calibration and metrological traceability) require laboratories to maintain performance records and traceability to reference criteria.

ISO/IEC 17025:2017 Clause 6.4 (Equipment) and 6.5 (metrological traceability) mandate procedures for equipment handling, calibration, labeling, verification, and maintenance, with complete records.

Examination Management

Examination management ensures that all laboratory testing processes, from method selection to result reporting, are scientifically valid, controlled, and documented.

Examination management is crucial for producing accurate, reliable, and traceable results.

Method selection involves choosing methods that are aligned with the intended use. Method verification or validation confirms the reliability of results in a specific laboratory setting. Method verification is a narrower process that ensures a laboratory can replicate an already validated method in its own setting. Method validation is a comprehensive, in-depth study that demonstrates the suitability and reliability of a new or modified method for a specific analytical purpose.

Once the method has been selected, sample testing is conducted using qualified personnel and calibrated equipment to examine the samples. Internal Quality Control (QC) monitors routine accuracy and detects performance shifts. Result reporting records, reviews, authorizes, and releases test outcomes. Result amendments procedure control updates and corrections with full traceability.

Examination management links to training management for qualified personnel, equipment management for calibrated instruments, document control for SOP accessibility, and deviation and CAPA for addressing examination-related issues.

ISO 15189:2022 Clause 7.3 (Examination processes) requires method verification and validation, uncertainty evaluation, documentation of examination methods, and continuous quality control.

ISO/IEC 17025:2017 Clauses 7.2 to 7.8 under process requirements cover method selection, sampling, test item handling, technical records, uncertainty evaluation, result validity, and result reporting.

Facility Management

Facility management covers infrastructure, access control, contamination prevention, utilities, and workspace organization.

Facility management ensures that laboratory environments support the integrity of testing activities, personnel safety, and compliance with applicable quality and regulatory requirements.

In a laboratory set-up, environmental and infrastructure controls begin with the planning and designing of laboratory layout and zoning to minimize cross-contamination risks. Environmental monitoring tracks critical conditions, including temperature, humidity, air quality, lighting, and noise, to prevent interference with test accuracy. Access control and safety measures restrict unauthorized entry and ensure the presence of emergency and protection systems. Routine housekeeping and maintenance preserve workspace cleanliness and the operational functionality of laboratory systems. Waste management procedures govern the handling of biological, chemical, and general waste to mitigate health and environmental risks. All environmental parameters, inspections, and maintenance activities are documented to support compliance and operational integrity.

Facility management is linked to examination management through environmental control, document control for procedure access, training management for safety and laboratory awareness, and audit management for inspection readiness.

ISO 15189:2022 Clause 6.3 (Facilities and environmental conditions) requires suitable facilities, contamination prevention, access control, and safety measures.

ISO/IEC 17025:2017 Clause 6.3 (Facilities and environmental conditions) mandates the monitoring of environmental conditions, the control of contamination risks, and the maintenance of records demonstrating compliance.

Management Review

Management review evaluates performance, compliance, and effectiveness with senior leadership at defined intervals or risk-driven scope.

The management review’s purpose is to ensure top-level accountability, align quality goals with business needs, identify compliance risks early, support system improvement, and maintain audit readiness.

Before the management review, the data needed is prepared. Data includes quality metrics, audit outcomes, CAPAs, complaints, training records, supplier performance, and customer or regulatory updates. During the review, senior management reviews the data, identifies improvements, and plans actions and resource allocations. Actions are documented, responsibilities are assigned, and completion must be tracked.

Management review integrates with processes such as CAPA and deviation systems for trend analysis, audit management for issue tracking, training for capability review, and change management for decision-making.

Management review is required under several requirements. For example, ISO 15189:2022 Clause 8.9 (Management reviews) requires management reviews at planned intervals. Management review inputs must include feedback, nonconformities, audit results, risks, and improvement opportunities. Management review outputs must include action decisions and changes to the QMS.

ISO/IEC 17025:2017 Clause 8.9 (Management reviews) specifies reviews of system effectiveness, changes, objectives, and performance trends. Management review outputs must include improvement actions and resource needs. Clause 8.9.2 requires the retention of records from management reviews.

How to Ensure Quality Management Compliance in a Laboratory?

To ensure compliance with quality management in a laboratory, consider the steps outlined below.

1. Define the Quality Framework: Establish a comprehensive laboratory quality policy, measurable objectives, and a documented QMS aligned with requirements such as ISO 15189 or ISO/IEC 17025. This quality framework creates a consistent structure for managing laboratory quality across all functions.
2. Maintain Controlled Documentation: Implement laboratory document control procedures that govern the creation, approval, distribution, review, and retirement of SOPs, policies, and forms. Ensure staff access only current, approved versions via a controlled document repository to avoid outdated or non-compliant practices.
3. Conduct Regular Training and Competency Checks: Train laboratory personnel on QMS procedures and technical protocols. Use training matrix and competency assessment logs to verify that staff possess the necessary skills and knowledge before performing laboratory tasks.
4. Perform Internal Audits and Management Reviews: Schedule routine internal audits to assess compliance with QMS. Conduct laboratory management reviews using audit findings, customer feedback, and quality indicators to evaluate performance and plan strategic improvements.
5. Implement CAPA Processes: Document root cause analyses, implement resolution strategies, and perform effectiveness verification to ensure the issues are properly addressed.
6. Control Laboratory Equipment and Environment: Maintain compliance by regularly calibrating, qualifying, and servicing laboratory instruments under documented schedules. Monitor environmental factors, including temperature, humidity, and airflow, to ensure consistency in analytical results.
7. Manage Supplier and Inventory Quality: Qualify suppliers and track reagents and consumables through inventory systems. Storage conditions should be continuously monitored to prevent material degradation.
8. Handle Deviations and Complaints Effectively: Use standardized nonconformance reporting to document deviations promptly when issues arise. Investigate customer complaints through root cause analysis and implement CAPAs to prevent recurrence.
9. Use Quality Indicators and Risk Assessments: Define measurable quality indicators (e.g., turnaround time, defect rate) to monitor laboratory performance. Integrate risk-based quality management approaches to prioritize improvements.
10. Continuously Improve Processes: Analyze trends from audits, CAPA outcomes, and quality metrics to update SOPs, training content, and documentation.

What Is the Role of Quality Control and Quality Assurance in a Laboratory QMS?

Quality Assurance (QA) and Quality Control (QC) are fundamental components of a laboratory’s QMS. QA is a proactive, system-wide approach that establishes policies, processes, and requirements to prevent laboratory errors. QC is a reactive, result-focused process that verifies testing outcomes against predefined specifications.

QA establishes the quality framework through strategic planning, implementation, and verification, ensuring process compliance throughout the testing process, from pre-testing to post-testing. Laboratory quality assurance involves managing SOPs, document control, audits, regulatory oversight, and training, and maintaining a system-wide approach that develops and sustains quality processes.

QC, on the other hand, operates as a task-specific and detective function that verifies output quality by performing sampling, analytical testing, data verification, and material inspection. QC involves analyzing known samples, performing calibration checks, and monitoring performance data to confirm the correct functioning of methods and instruments, ensuring that final outputs meet established quality criteria.

By combining QA’s system-level processes oversight with QC’s direct inspection of results, a laboratory can continuously detect and resolve inconsistencies, uphold regulatory obligations, and sustain a culture of quality in day-to-day work.

How Does a Laboratory QMS Differ from a Pharmaceutical QMS?

The main difference between a laboratory QMS and a pharmaceutical QMS lies in their specific focus and scope. A laboratory QMS is a structured framework ensuring accurate, reliable, and traceable test results by overseeing analytical workflows, data management, and personnel competence. A pharmaceutical QMS oversees quality systems for chemically synthesized drugs and finished dosage forms. While both systems share the fundamental goal of helping to ensure product or service quality, they differ in operational focus. Laboratory QMS is rooted in analytical reliability.  Pharmaceutical QMS’s scope is end-to-end product quality and regulatory compliance.

Laboratory QMS governs the result validity, sample traceability, and analytical workflows. Additionally, laboratory QMS emphasizes other processes such as method validation, equipment calibration, and staff training while complying with relevant regulatory requirements. It aligns with requirements like ISO 15189, ISO/IEC 17025, ISO 9001, CLIA, GLP and more.

Pharmaceutical QMS, in contrast, manages quality throughout drug development, manufacturing, and distribution of pharmaceutical products. Pharmaceutical QMS focuses on processes such as product quality, risk management, and batch release. Pharmaceutical QMS is guided by requirements like FDA 21 CFR Parts 210/211, ICH Q10, and EU GMP.

While differences exist in laboratory and pharmaceutical QMS, it’s worth noting that various QMS can be unified into a single framework, commonly referred to as an Integrated QMS.

How Does a Laboratory QMS Differ from a Biotechnology QMS?

The main difference between a laboratory QMS and a biotechnology QMS lies in their application and quality oversight areas. A laboratory QMS ensures quality in analytical testing and data accuracy, while a Biotechnology QMS manages quality across research, development, and manufacturing of biologics and biotech products. A laboratory QMS focuses on sample handling, method validation, personnel competence, and reliable test results. Laboratory QMS supports compliance with requirements like ISO 15189, ISO/IEC 17025, ISO 9001, CLIA, GLP, and more.

In contrast, biotechnology QMS covers end-to-end quality across genetically engineered therapies, cell-based products, and biosimilars. Biotechnology QMS processes can involve bioreactors and specialized assays, such as bioassays and immunological testing, to manage variability and ensure product consistency. Depending on the product’s function, biotechnology QMS adheres to requirements such as 21 CFR Parts 210/211, 21 CFR Part 600, or 21 CFR Part 820, as well as the EU MDR and EU IVDR.

What Is the Role of QMS Software in Laboratory Operations?

QMS software plays a critical role in laboratory operations by streamlining and automating quality management processes to help ensure compliance with requirements such as ISO 15189, ISO 17025, CLIA, and CAP.

Laboratory QMS software enables automated document control, training management, CAPA tracking, audit management, risk assessment, and more. Additionally, laboratory eQMS platforms include features such as electronic signatures, version control, audit trails, user access control, automated alerts, and data retention. These features support data integrity, reduce manual errors, and streamline compliant document and record keeping.

Laboratories using electronic systems must comply with FDA 21 CFR Part 11, and EU Annex 11 depending on the applicability or relevant requirements.

SimplerQMS offers laboratory QMS software that is compliant with FDA 21 CFR Part 11 and EU Annex 11 and is fully validated under GAMP5.

SimplerQMS helps laboratory companies ensure compliance with applicable laboratory QMS requirements, including ISO 15189, ISO/IEC 17025, GLP, CLIA, and CAP. SimplerQMS offers comprehensive QMS process support, including document control, change control, design control, training, CAPA, audits, supplier management, and more.

Book a demo today to find out how SimplerQMS can streamline compliance, improve efficiency, and support your laboratory’s QMS processes.