ISO 15189:2022 – Medical Laboratories: Requirements, Clauses, NABL Accreditation & Practical Laboratory Guide
ISO 15189:2022 is the international standard that specifies requirements for quality and competence in medical laboratories. It provides a framework for laboratories to demonstrate that their processes are controlled, technically competent, clinically relevant, and capable of producing reliable laboratory results.
This practical LabDecoded guide explains the major requirements of ISO 15189:2022, including clauses 4 to 8, personnel competence, equipment, examination processes, method verification and validation, quality control, EQA/PT, risk management, document control, internal audits, management review, laboratory information systems, POCT, nonconformities and continual improvement.
In This Article
- What is ISO 15189:2022?
- What changed from ISO 15189:2012?
- ISO 15189:2022 clause structure
- Clause 4 – General requirements
- Clause 5 – Structural and governance requirements
- Clause 6 – Resource requirements
- Clause 7 – Process requirements
- Clause 8 – Management system requirements
- Risk management in the medical laboratory
- Internal quality control and Westgard rules
- EQA / proficiency testing
- Verification and validation
- Metrological traceability and measurement uncertainty
- LIS, information management and data integrity
- Internal audit and management review
- ISO 15189:2022 and NABL accreditation in India
- Practical laboratory readiness checklist
- Common implementation mistakes
- Frequently asked questions
What Is ISO 15189:2022?
ISO 15189:2022 is the international standard for medical laboratories – requirements for quality and competence. It applies to medical laboratories and is designed to address both the quality-management and technical-competence aspects of laboratory medicine.
The standard goes beyond simply asking whether a laboratory has written procedures. A competent laboratory must be able to demonstrate that its processes are implemented, monitored, evaluated and improved.
In practical terms, accreditation under ISO 15189 requires the laboratory to control the complete laboratory pathway:
Pre-examination
- Test requesting
- Patient identification
- Sample collection
- Sample labelling
- Transport
- Sample acceptance and rejection
- Sample preparation and storage
Examination
- Method selection
- Verification / validation
- Calibration
- Internal quality control
- Equipment maintenance
- Environmental control
- Result evaluation
Post-examination
- Result review
- Result authorization
- Critical-result communication
- Report correction
- Report retention
- Sample retention and disposal
Management system
- Risk management
- Internal audit
- Nonconformity management
- CAPA
- Quality indicators
- Management review
- Continual improvement
ISO 15189:2022 vs ISO 15189:2012
ISO 15189:2022 is the fourth edition of ISO 15189 and was published in December 2022. The 2012 edition was subsequently withdrawn.
The 2022 edition introduced a number of structural and conceptual changes intended to make the standard more aligned with modern medical laboratory practice.
| Area | Practical emphasis in ISO 15189:2022 |
|---|---|
| Risk management | Greater emphasis on identifying and controlling risks associated with laboratory processes. |
| Patient focus | Greater emphasis on patient impact, clinical relevance and laboratory-user needs. |
| Structure | Requirements are reorganized into general, structural/governance, resource, process and management-system requirements. |
| POCT | Point-of-care testing is addressed within the laboratory quality framework. |
| Information management | Greater recognition of electronic systems, LIS, data integrity and information security. |
| Management system | Greater integration of risk, quality indicators, improvement, audits and management review. |
ISO 15189:2022 Clause Structure
| Clause | Subject | Laboratory focus |
|---|---|---|
| 1 | Scope | Application of the standard |
| 2 | Normative references | Referenced documents |
| 3 | Terms and definitions | Terminology used in the standard |
| 4 | General requirements | Impartiality, confidentiality and patient-related requirements |
| 5 | Structural and governance requirements | Legal identity, laboratory director, activities and responsibilities |
| 6 | Resource requirements | Personnel, facilities, equipment, reagents and external services |
| 7 | Process requirements | Pre-examination, examination and post-examination activities |
| 8 | Management system requirements | Documents, records, risks, improvement, audits and management review |
Clause 4 – General Requirements
4.1 Impartiality
The laboratory should identify and manage activities or relationships that could compromise impartiality. Laboratory decisions should be based on objective professional and technical considerations rather than inappropriate commercial or personal influence.
4.2 Confidentiality
Patient information, laboratory reports and other confidential information must be appropriately protected. This includes information handled through paper records, LIS, electronic communication, reporting portals and other systems.
4.3 Requirements Regarding Patients
The laboratory should ensure that patient interests are considered throughout the laboratory process. This includes appropriate communication, protection of patient information and processes that support accurate and clinically useful laboratory results.
Clause 5 – Structural and Governance Requirements
5.1 Legal Entity and Laboratory Responsibility
The laboratory should have a clearly defined legal and organizational identity. Responsibilities and authority for laboratory activities should be established.
5.2 Laboratory Director
The laboratory director has an important role in ensuring the overall quality and competence of laboratory operations. Responsibilities should be clearly documented and supported by appropriate authority and resources.
5.3 Laboratory Activities
The laboratory should define the examinations and activities within its scope and ensure that it has the appropriate personnel, equipment, facilities, methods and quality systems to perform those activities.
5.4 Organizational Structure
Roles, responsibilities and reporting relationships should be clear. This becomes particularly important in large laboratories with multiple sections, shifts, satellite laboratories, collection centres and referral arrangements.
5.5 Objectives and Policies
Laboratory objectives should be consistent with quality, competence and patient needs. Policies should be implemented rather than existing only as controlled documents.
Clause 6 – Resource Requirements
Resources are central to laboratory competence. A laboratory cannot maintain reliable performance without appropriately qualified personnel, suitable facilities, validated equipment, controlled reagents and dependable external services.
6.1 Personnel
The laboratory should have sufficient competent personnel to perform its activities. Competence should be demonstrated through appropriate education, training, experience and assessment.
Important personnel records may include:
- Educational qualifications
- Job descriptions
- Training records
- Competency assessment
- Authorization records
- Continuing education
- Performance monitoring
6.2 Facilities and Environmental Conditions
Laboratory facilities should support the validity of examination results and protect patients, personnel and samples.
Depending on the activity, environmental controls may include:
- Temperature
- Humidity
- Refrigerator/freezer temperature
- Electrical supply
- Water quality
- Ventilation
- Cleanliness
- Biological safety
- Waste management
- Access control
6.3 Equipment
Equipment must be suitable for its intended purpose and appropriately maintained.
Examples include:
- Analyzers
- Centrifuges
- Microscopes
- Refrigerators and freezers
- Incubators
- Pipettes
- Balances
- Temperature-monitoring devices
- Water purification systems
Equipment records should provide appropriate evidence of installation, acceptance, maintenance, calibration or verification, repair and performance monitoring.
6.4 Reagents and Consumables
Reagents and consumables should be appropriately purchased, received, stored, identified and controlled.
Laboratories should pay particular attention to:
- Lot numbers
- Expiry dates
- Storage temperature
- Opening dates where applicable
- Reagent preparation
- Acceptance criteria
- Traceability to patient testing
6.5 External Products and Services
External providers can directly affect laboratory quality. This may include calibration services, equipment maintenance, EQA/PT providers, referral laboratories, reagents, consumables and other outsourced services.
Clause 7 – Process Requirements
Clause 7 is particularly important because it follows the actual laboratory testing pathway.
7.1 General Process Requirements
The laboratory should establish processes that ensure examination results are technically valid and clinically useful.
7.2 Pre-examination Processes
Pre-examination errors are an important source of laboratory problems. The laboratory should control activities from test requesting through sample preparation.
| Stage | Examples of controls |
|---|---|
| Test request | Appropriate patient and test information |
| Patient identification | Defined identification procedure |
| Sample collection | Correct container, volume, timing and collection technique |
| Labelling | Unique and traceable patient/sample identification |
| Transport | Defined temperature, time and transport conditions where applicable |
| Acceptance/rejection | Documented criteria for unsuitable samples |
| Processing | Controlled centrifugation, aliquoting and storage |
7.3 Examination Processes
The laboratory must use examination procedures that are appropriate for their intended purpose.
This includes:
- Selection of examination methods
- Verification or validation
- Calibration and calibration verification where applicable
- Internal quality control
- Environmental control
- Equipment monitoring
- Result review
- Defined acceptance criteria
Method Verification and Validation
One of the most important practical distinctions in laboratory accreditation is between verification and validation.
| Verification | Validation |
|---|---|
| Demonstrates that an established examination procedure performs adequately in the laboratory's own setting. | Establishes performance characteristics when the laboratory develops, modifies or uses a method under circumstances requiring validation. |
| Common with established commercial methods used according to intended instructions. | More extensive evaluation may be required for laboratory-developed, modified or non-standard methods. |
| May include precision, bias/comparison, reportable range and other relevant characteristics. | May include a broader assessment of relevant analytical and clinical performance characteristics. |
The exact studies required depend on the examination procedure, intended use, manufacturer claims, regulatory/accreditation requirements and laboratory circumstances.
Metrological Traceability and Measurement Uncertainty
Metrological Traceability
Where applicable, the laboratory should understand the traceability of measurement results through an appropriate calibration chain.
This becomes particularly important for quantitative measurements such as:
- Glucose
- Creatinine
- HbA1c
- Electrolytes
- Hormones
- Therapeutic drug measurements
- Other quantitative measurands
Measurement Uncertainty
Measurement uncertainty represents the dispersion associated with the measurement result and should be evaluated where relevant to the examination procedure and intended clinical use.
A laboratory should be able to explain:
- Which measurands require consideration of uncertainty
- How major sources of uncertainty are identified
- How uncertainty is estimated
- How the information is used appropriately
Internal Quality Control – IQC
Internal quality control is one of the most visible components of a laboratory quality system, but effective IQC is much more than running two control levels every morning.
A mature IQC system should address:
- Appropriate control materials
- Control frequency
- Control levels
- Target values
- Assigned ranges
- Levey-Jennings charts
- Westgard or other appropriate decision rules
- Lot-to-lot evaluation
- Calibration-related changes
- Trend and shift detection
- Corrective action following unacceptable QC
Westgard Rules
Westgard rules can be used as part of a laboratory statistical quality-control strategy. Depending on the laboratory's chosen QC design, rules such as 1₂s, 1₃s, 2₂s, R₄s, 4₁s and 10x may be considered.
The laboratory should not simply apply rules mechanically. QC design should consider analytical performance, clinical requirements, control frequency, risk and the consequences of erroneous patient results.
External Quality Assessment – EQA / Proficiency Testing
EQA or proficiency testing provides an external assessment of laboratory performance.
A laboratory should maintain evidence of:
- Participation in appropriate EQA/PT programs
- Receipt and testing of EQA material
- Submission of results within the required time
- Review of EQA performance
- Investigation of unacceptable or questionable results
- Corrective and preventive actions where required
- Effectiveness review of corrective action
EQA should be treated as a quality-improvement tool rather than merely an accreditation formality.
Post-examination Processes
Post-examination control includes activities performed after analysis.
Important areas include:
- Result review
- Result authorization
- Reference intervals
- Critical-result communication
- Interpretive comments where applicable
- Report amendment
- Sample storage and retention
- Result archival
- Confidentiality
Critical Results
The laboratory should have clearly defined procedures for critical or alert results, including appropriate communication to authorized healthcare professionals and documentation of the communication.
- Which results are considered critical?
- Who is authorized to receive them?
- How are they communicated?
- How quickly should communication occur?
- Who made the communication?
- Who received the information?
- When was it communicated?
- What happens if the first contact attempt fails?
Risk Management in ISO 15189:2022
Risk management is a major practical component of the 2022 edition.
Laboratories should consider risks throughout the total testing process rather than limiting risk assessment to laboratory safety.
| Process | Potential risk | Possible control |
|---|---|---|
| Patient identification | Wrong-patient result | Two-identifier verification |
| Sample collection | Wrong tube or insufficient sample | Collection SOP and rejection criteria |
| Transport | Temperature/time-related deterioration | Defined transport conditions |
| Analyzer | Instrument failure | Preventive maintenance and backup arrangements |
| QC | Undetected analytical error | Appropriate IQC strategy |
| LIS | Incorrect result transmission | Interface verification and access controls |
| Reporting | Incorrect report release | Defined authorization and review procedures |
A useful approach is to ask:
What can go wrong? → What would be the consequence? → How is the risk controlled? → How do we know the control works?
Laboratory Information System, Data Integrity & Information Management
Modern laboratories are highly dependent on laboratory information systems. ISO 15189:2022 therefore requires laboratories to appropriately control information-management processes.
Important areas include:
- User access control
- Unique user identification
- Password and authentication controls
- Result entry and transmission
- Analyzer-LIS interfaces
- Reference intervals
- Autoverification rules
- Delta checks where applicable
- Critical-result alerts
- Result correction/amendment
- Audit trails
- Data backup
- Downtime procedures
- Business continuity
Point-of-Care Testing – POCT
POCT performed outside the central laboratory can still have significant clinical consequences. Therefore, POCT should be incorporated into an appropriate quality framework.
Key controls may include:
- Defined responsibility
- Operator training
- Competency assessment
- Device maintenance
- Reagent control
- Internal QC
- EQA/PT where available and appropriate
- Connectivity and result traceability
- Documentation of corrective actions
Document and Record Control
A laboratory should distinguish between documents and records.
| Documents | Records |
|---|---|
| SOPs | Completed QC records |
| Policies | Temperature logs |
| Work instructions | Maintenance records |
| Forms/templates | Training records |
| Quality manuals | Audit records |
Controlled documents should have appropriate identification, approval, revision control, availability and withdrawal of obsolete versions.
Nonconformities, Root Cause Analysis & CAPA
Nonconformities can originate from many parts of the laboratory process.
Examples include:
- Sample identification errors
- Incorrect sample handling
- QC failures
- Equipment breakdown
- Temperature excursions
- Delayed reports
- Incorrect reports
- Missed EQA submissions
- Expired reagents
- Unauthorized document use
A good CAPA system should not stop at correcting the immediate problem.
CAPA Thinking
Correction: What was done to address the immediate problem?
Containment: Were potentially affected patient results identified and assessed?
Root cause: Why did the problem occur?
Corrective action: What will prevent recurrence?
Effectiveness: How will the laboratory demonstrate that the action worked?
Internal Audit
Internal audits should assess whether the laboratory's processes conform to applicable requirements and whether the implemented quality system is effective.
An effective audit program should cover:
- Pre-examination processes
- Examination processes
- Post-examination processes
- Equipment
- Personnel competence
- IQC
- EQA
- Documents and records
- Risk management
- Information management
- Nonconformity and CAPA
Management Review
Management review provides an opportunity for laboratory leadership to evaluate whether the quality management system remains suitable and effective.
Useful management-review inputs can include:
- Quality objectives
- Quality indicators
- Internal audit findings
- EQA performance
- Nonconformities
- Complaints and feedback
- Risk-management results
- Equipment performance
- Personnel requirements
- Resource requirements
- Supplier performance
- Improvement opportunities
Quality Indicators for Medical Laboratories
Quality indicators translate laboratory performance into measurable parameters.
| Area | Example quality indicator |
|---|---|
| Pre-analytical | Sample rejection rate |
| Identification | Patient/sample identification errors |
| Analytical | IQC failure frequency |
| Equipment | Analyzer downtime |
| EQA | Unsatisfactory EQA events |
| Post-analytical | Report correction rate |
| Turnaround time | Percentage of reports within defined TAT |
| Customer service | Complaint rate and resolution time |
ISO 15189:2022 and NABL Accreditation in India
In India, medical laboratories seeking accreditation commonly work with the National Accreditation Board for Testing and Calibration Laboratories (NABL). NABL accreditation requirements should be considered together with the applicable ISO 15189 requirements, NABL policies, criteria and other applicable documents.
It is therefore important for an Indian laboratory not to treat the ISO standard as the only document relevant to accreditation.
Typical NABL Accreditation Journey
- Define laboratory scope.
- Perform a gap assessment.
- Establish governance and responsibilities.
- Develop and control the quality-management system.
- Establish technical procedures.
- Complete method verification/validation as applicable.
- Establish IQC and EQA/PT systems.
- Train and assess personnel.
- Implement risk management.
- Conduct internal audits.
- Conduct management review.
- Address identified gaps and demonstrate effectiveness.
- Proceed through the applicable accreditation assessment process.
ISO 15189:2022 Practical Laboratory Readiness Checklist
The following checklist can be used as an internal preparation tool. It is not an official ISO or NABL assessment checklist.
| Area | Questions the laboratory should be able to answer |
|---|---|
| Governance | Are responsibilities, authority and reporting structures clearly defined? |
| Personnel | Are qualifications, training and competency documented? |
| Facilities | Are environmental conditions controlled and monitored where required? |
| Equipment | Are equipment acceptance, maintenance, calibration and performance records available? |
| Reagents | Are reagent lots, expiry, storage and acceptance adequately controlled? |
| Methods | Has every applicable examination method been appropriately verified or validated? |
| Traceability | Is measurement traceability addressed where applicable? |
| IQC | Is there an effective QC strategy with documented investigation of failures? |
| EQA | Does the laboratory participate in appropriate external assessment programs? |
| Pre-analytical | Are sample collection, transport, acceptance and rejection controlled? |
| Reporting | Are result review, authorization and critical-result communication controlled? |
| LIS | Are access, interfaces, changes, backups and data integrity controlled? |
| Risk | Are significant laboratory risks identified, controlled and reviewed? |
| CAPA | Are root causes identified and corrective actions evaluated for effectiveness? |
| Internal audit | Does the audit program cover the laboratory's complete quality system? |
| Management review | Does laboratory leadership review performance and improvement needs? |
Common ISO 15189:2022 Implementation Mistakes
1. Documentation without implementation
SOPs are available, but staff practice does not match the documented process.
2. Weak competency assessment
Training attendance is documented but actual competence is not adequately demonstrated.
3. QC treated as a formality
Control charts are maintained, but failures, trends and shifts are not properly investigated.
4. Poor CAPA
The immediate problem is corrected but the underlying system failure remains.
5. Incomplete method verification
Commercial analyzer installation is assumed to be sufficient without laboratory-specific verification.
6. Ignoring pre-analytical quality
Laboratory quality is assessed mainly through analytical QC while collection and transport errors are overlooked.
7. Weak LIS change control
Software, interfaces or reference intervals are changed without adequate verification and documentation.
8. Audit focused only on documents
The auditor checks whether an SOP exists rather than checking whether the process actually works.
How to Build an Effective ISO 15189:2022 Quality System
A practical implementation strategy can be divided into several stages.
Stage 1 – Define the Scope
Clearly define the examinations, locations, departments, technologies and activities that form the laboratory's intended scope.
Stage 2 – Perform a Gap Assessment
Map current laboratory practices against the applicable requirements. Identify gaps in governance, personnel, equipment, methods, QC, EQA, documentation and management systems.
Stage 3 – Prioritize Risk
Not every gap carries the same patient risk. Prioritize activities according to their potential impact on patient care and laboratory result reliability.
Stage 4 – Implement
Develop or revise procedures, train personnel, establish records and implement the processes in routine laboratory operations.
Stage 5 – Verify Effectiveness
Use QC, EQA, quality indicators, audits, complaints, incident reviews and other evidence to determine whether the system is working.
Stage 6 – Continually Improve
Use data and identified risks to improve laboratory processes rather than treating accreditation as a one-time project.
Frequently Asked Questions
Is ISO 15189:2022 only about laboratory documentation?
No. Documentation is only one component. The standard addresses both quality management and technical competence.
Is ISO 15189:2022 applicable to diagnostic laboratories?
Yes. It is specifically designed for medical laboratories and their quality and competence requirements.
What are the main ISO 15189:2022 clauses?
The major requirement sections are clauses 4, 5, 6, 7 and 8, covering general requirements, structural and governance requirements, resources, laboratory processes and management-system requirements.
What is the difference between ISO 15189 and ISO 17025?
ISO 15189 is specifically focused on medical laboratories, including the clinical laboratory pathway and patient-related requirements. ISO/IEC 17025 is a standard for the competence of testing and calibration laboratories more broadly.
Does every laboratory method require validation?
Not necessarily. The appropriate evaluation depends on whether the method is established, modified, laboratory-developed or otherwise used under circumstances requiring validation. Established methods may require verification before routine use.
Is IQC mandatory for laboratory quality?
Appropriate internal quality-control processes are an important part of demonstrating examination-process performance. The exact QC design should be appropriate for the method, risk and intended use.
Is EQA mandatory for every test?
Participation in appropriate EQA/proficiency-testing programs is an important component of laboratory quality assurance where suitable programs are available. Where no appropriate EQA exists, the laboratory should have an appropriate alternative approach consistent with applicable requirements.
Does ISO 15189:2022 cover POCT?
Yes. POCT activities associated with the medical laboratory quality framework need appropriate control, including responsibility, personnel competence, equipment, QC and result traceability.
What is the role of risk management?
Risk management helps the laboratory identify where failures could occur, assess their potential consequences and establish appropriate controls. It should cover the total testing process, not just occupational safety.
How is ISO 15189:2022 related to NABL?
In India, NABL accreditation of medical laboratories is based on applicable accreditation requirements that include ISO 15189 and relevant NABL policies, criteria and associated documents. Laboratories should always use the current applicable NABL documents when preparing for accreditation.
Key Takeaways
- ISO 15189:2022 is the international standard for quality and competence in medical laboratories.
- The major requirement sections are clauses 4–8.
- The standard addresses the complete laboratory pathway from pre-examination to post-examination.
- Personnel competence must be demonstrated, not simply documented.
- Equipment, reagents, methods and external services require appropriate control.
- Method verification and validation are critical components of analytical quality.
- IQC and EQA/PT provide complementary evidence of laboratory performance.
- Risk management should cover the complete testing pathway.
- LIS, electronic records and data integrity are increasingly important components of laboratory quality.
- Internal audit, CAPA, quality indicators and management review provide evidence that the quality system is functioning.
- For laboratories in India, ISO 15189:2022 should be implemented together with the current applicable NABL requirements and policies.
ISO 15189:2022 – The LabDecoded Perspective
For a modern diagnostic laboratory, accreditation should not be viewed simply as a certificate on the wall. The real objective is to create a laboratory system in which every patient sample is traceable, every analytical process is controlled, every significant risk is understood and every reported result can be supported by objective evidence.
A strong ISO 15189:2022 system connects technical competence with clinical service, quality management, patient safety and continual improvement.
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