iso15189-2022.pptxDear Honorable Dan Amos, I hope this message finds you in great health and high spirits. My name is

Medical laboratories — Requirements for quality and
competence
INTERNATIONAL STANDARD ISO 15189 : 2022
Fourth Edition
2003; 2007; 2012
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Optimal Laboratory System
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Training
Q
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C
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Facilities
People
Equipment
Methods

Test selection
Test ordering
Sample collection
Transportation
Sample Accessioning
Analysis
Reporting
Interpretation
ACTION
1. Has the right test been ordered ? 2. Errors between result receipt & action
Post post analytical
Pre Preanalytical
Pre Preanalytical
Preanalytical
Preanalytical
Preanalytical
Post post analytical
Post analytical
Post analytical
analytical
Diagnostic Cycle
TAT (from vein to brain)

Donot start testing clinical samples without putting system essentials in place
ISO 15189:2022 gives you information on setting up an excellent diagnostic lab

What is ISO 15189 2022
 ISO 15189:2022, Medical Laboratories – Requirements for
Quality and Competence, outlines the standards for establishing
and maintaining a quality management system (QMS) specific to
medical laboratories.
 It ensures accurate, reliable, and timely diagnostic results. Below
is a detailed explanation of all clauses in ISO 15189:2022, along
with guidance on implementing each requirement:

This fourth edition cancels and replaces the third edition (ISO
15189:2012), which has been technically revised. It also
replaces ISO 22870:2016. (POCT)
• The main changes are as follows:
• — Alignment with ISO/IEC 17025:2017 resulted in the management
requirements now appearing at the end of the document;
• — Requirements for point-of-care testing (POCT), previously in ISO
22870, have been incorporated;
• — Increased emphasis on risk management

• The objective of this document is to promote the welfare of patients and
satisfaction of laboratory users through confidence in the quality and
competence of medical laboratories
• This document contains requirements for the medical laboratory to plan and
implement actions to address risks and opportunities for improvement
• Benefits of this approach include:
• increasing the effectiveness of the management system,
• decreasing probability of invalid results, and
• reducing potential harm to
• patients,
• laboratory personnel,
• the public and
• the environment.

• The format of this document is based on ISO/IEC 17025:2017
• The requirements for risk management are aligned with the principles
of ISO 22367.
• The requirements for laboratory safety are aligned with the principles
of ISO 15190
• The requirements for sample collection and transport are aligned with
ISO 20658
• This document contains the requirements for point-of-care testing
(POCT) and supersedes ISO 22870, which will be withdrawn
upon publication of this document

• intended for use throughout the currently recognized medical
laboratory disciplines
• can effectively be applied to other healthcare services
• diagnostic imaging
• respiratory therapy
• physiological sciences
• blood banks
• transfusion services
• use of this document facilitates cooperation between medical
laboratories and other healthcare services, assists in the exchange of
information, and in the harmonization of methods and procedures.

Medical laboratory is essential to patient care
• activities are provided within an ethical and governance framework,
• that recognizes the obligations of healthcare providers to the patient.
• These activities are undertaken in a timely manner to meet the needs of all patients and the
personnel responsible for the care of those patients.
• Activities include arrangements for
• examination requests,
• patient preparation,
• patient identification,
• collection of samples,
• transportation,
• processing of patient samples,
• selection of examinations that are fit for intended use,
• examination of samples,
• sample storage,
• as well as subsequent interpretation,
• result reporting and advice to laboratory users.
• This may also include the provision of results to the patient, arrangements for urgent testing
and the notification of critical results

ISO 15189: 2022
International Standard
competence
Medical laboratories — Requirements for quality and
• 1. Scope
• 2. Normative References
• 3. Terms & Definitions
• 4. General Requirements
• 5. Structural & Governance requirements
• 6. Resources Requirements
• 7. Process Requirements
• 8. Management Systems requirements
• Annexure
• A. POCT
• B. Comparison with ISO 9001: 2915; ISO 17025: 2017
• C. ISO 15189:2012 changes

4 General requirements
• 4.1 Impartiality
• 4.2 Confidentiality
• 4.2.1 Management of information
• 4.2.2 Release of information
• 4.2.3 Personnel responsibility
• 4.3 Requirements regarding patients
• Laboratory management shall ensure that patients’ well-being, safety and
rights are the primary considerations

The laboratory shall establish and implement the following
processes:
• a) opportunities for patients and laboratory users to provide helpful information to aid the
laboratory in the selection of the examination methods, and the interpretation of the examination
results;
• b) provision of patients and users with publicly available information about the examination process,
including costs when applicable, and when to expect results;
• c) periodic review of the examinations offered by the laboratory to ensure they are clinically
appropriate and necessary;
• d) where appropriate, disclosure to patients, users and any other relevant persons, of incidents that
resulted or could have resulted in patient harm, and records of actions taken to mitigate those
harms;
• e) treatment of patients, samples, or remains, with due care and respect;
• f) obtaining informed consent when required;
• g) ensuring the ongoing availability and integrity of retained patient samples and records in the
event of the closure, acquisition or merger of the laboratory;
• h) making relevant information available to a patient and any other health service provider at the
request of the patient or the request of a healthcare provider acting on their behalf;
• i) upholding the rights of patients to care that is free from discrimination.

Summary of clause 4
•4.1 Impartiality
 Requirement: Laboratories must operate impartially, ensuring no conflicts of interest influence testing results.
 Implementation:
o Establish and communicate an impartiality policy.
o Identify potential risks to impartiality and document mitigation measures.
o Example: Prevent financial incentives from affecting the reporting of test results.
•4.2 Confidentiality
 Requirement: Safeguard all patient information and ensure compliance with data protection laws.
 Implementation:
o Train staff on data privacy regulations like GDPR or local equivalents.
o Use secure systems for storing, processing, and transmitting patient data.
o Example: Encrypt patient records and restrict access based on roles.
•

Summary of clause 4
4.3 Complaints Management
 Requirement: Implement a system to manage and resolve complaints effectively.
 Implementation:
o Develop a documented complaints-handling process.
o Assign responsibility for investigation and resolution.
o Example: Maintain a complaints log and document corrective
actions.

5 Structural and governance requirements
• 5.1 Legal entity
• 5.2 Laboratory director
• 5.2.1 Laboratory director competence
• 5.2.2 Laboratory director responsibilities
• 5.2.3 Delegation of duties
• laboratory director shall maintain the ultimate responsibility for the overall
operation of the laboratory.

5.3 Laboratory activities
• 5.3.1 General:
• The laboratory shall specify and document the range of laboratory activities, including
laboratory activities performed at sites other than the main location (e.g. POCT,
sample collection) for which it conforms with this document
• 5.3.2 Conformance with requirements
• applies to the complete range of specified and documented laboratory activities, regardless
of where the service is provided
• 5.3.3 Advisory activities
• a) advising on choice and use of examinations, including required type of sample, clinical
indications and limitations of examination methods, and the frequency of
requesting the examination;
• b) providing professional judgments on the interpretation of the results of examinations;
• c) promoting the effective utilization of laboratory examinations;
• d) advising on scientific and logistical matters such as instances of failure of sample(s) to
meet acceptability criteria.

5.4 Structure and authority
• 5.4.1 General
• define its organization and management structure
• specify the responsibility, authority, lines of communication and interrelationship of all
personnel
• specify its procedures to ensure the consistent application & the validity of the results
• 5.4.2 Quality management
• personnel who, have the authority and resources needed to carry out,
• a) implementation, maintenance and improvement of the management system;
• b) identification of deviations from the management system or from the procedures for performing
laboratory activities;
• c) initiation of actions to prevent or minimize such deviations;
• d) reporting to laboratory management on the performance of the management system and any
need for
improvement;
• e) ensuring the effectiveness of laboratory activities.

5.5 Objectives and policies
• A.
• 1) meet the needs and requirements of its patients and users;
• 2) commit to good professional practice;
• 3) provide examinations that fulfil their intended use;
• 4) conform to this document.
• B. Objectives shall be measurable, and consistent with policies
• C. integrity of the management system
• D. establish quality indicators to evaluate performance throughout key
aspects of pre-examination, examination, and post-examination
processes and monitor performance in relation to objectives
• NOTE Types of quality indicators include the number of unacceptable samples relative to the number received, the number of
errors at either registration or sample receipt, or both, the number of corrected reports, the rate of achievement of specified
turnaround times.

5.6 Risk management
• a) Laboratory management shall establish, implement, and maintain
processes for identifying risks of harm to patients and opportunities
for improved patient care associated with its examinations and
activities, and develop actions to address both risks and opportunities
for improvement (see 8.5).
• b) The laboratory director shall ensure that these processes are
evaluated for effectiveness and modified, when identified as
being ineffective
• NOTE 1 ISO 22367 provides details for managing risk in medical laboratories.
• NOTE 2 ISO 35001 provides details for laboratory biorisk management.

Summary of clause 5
•5.1 Legal Entity
 Requirement: The laboratory must operate under a legally recognized entity.
 Implementation:
o Register with relevant regulatory bodies.
o Display compliance certificates publicly.
•5.2 Laboratory Leadership and Responsibilities
 Requirement: Define roles, responsibilities, and authorities within the laboratory.
 Implementation:
o Create an organizational chart.
o Appoint a qualified laboratory director with oversight responsibilities.
o Example: Clearly document responsibilities for quality control and patient safety.

Summary of clause 5
•5.3 Quality Management System (QMS)
 Requirement: Establish, document, implement, and maintain a QMS.
 Implementation:
o Use ISO 15189 as the basis for the QMS.
o Regularly review and update procedures, policies, and work instructions.
o Example: Develop a quality manual covering all laboratory processes.

6 Resource requirements
• 6.1 General
• The laboratory shall have available the personnel, facilities, equipment, reagents,
consumables and support services necessary to manage and perform its activities
• 6.2 Personnel
• 6.2.1 General
• a) The laboratory shall have access to a sufficient number of competent persons
• b) be competent and work in accordance with the laboratory’s management
system
• c) importance of meeting the needs and requirements of users & this document
• d) have a programme to introduce personnel to the organization, the department or
area in which the person will work, the terms and conditions of employment,
staff facilities, health and safety requirements, and occupational health services.

6.2.2 Competence requirements
• a) The laboratory shall specify the competence requirements for each
function, including requirements for education, qualification, training,
re- training, technical knowledge, skills and experience
• b) The laboratory shall ensure all personnel have the competence
• c) The laboratory shall have a process for managing competence of its
personnel
• d) The laboratory shall have documented information demonstrating
competence of its personnel.
• NOTE Examples of competence assessment methods that can be used in any combination include:
• — direct observation of an activity, — monitoring the recording and reporting of examination results, — review of work records, —
assessment of problem-solving skills, — examination of specially provided samples, e.g. previously examined samples, interlaboratory
comparison materials, or split samples.

6.2.3 Authorization
• shall authorize personnel to perform specific laboratory activities
• a) selection, development, modification, validation and verification of methods;
• b) review, release, and reporting of results;
• c) use of laboratory information systems, in particular: accessing patient data and information,
entering patient data and examination results, changing patient data or examination results.
• 6.2.4 Continuing education and professional development
• personnel shall participate in continuing education & regular professional development
• 6.2.5 Personnel records
• a) determining the competence requirements specified in 6.2.2 a);
• b) position descriptions;
• c) training and re-training;
• d) authorization of personnel;
• e) monitoring competence of personnel.

6.3 Facilities and environmental conditions
• suitable for the laboratory activities and shall not adversely affect the
validity of results, or the safety of patients, visitors, laboratory
users, and personnel.
• The requirements for facilities and environmental conditions
necessary for the performance of the laboratory activities shall be
specified, monitored, and recorded.
• NOTE 1 ISO 15190 provides details for facility and environmental conditions.
• NOTE 2 Environmental conditions that can adversely affect the validity of results include, but are not limited to:
adventitious amplified nucleic acid, microbial contamination, dust, electromagnetic disturbances, radiation, lighting
conditions (illumination), humidity, electrical supply, temperature, sound and vibration

6.3.2 Facility controls
• Facility controls shall be implemented, recorded, monitored,
periodically reviewed, and shall include:
• a) control of access
• b) prevention of contamination, interference, or adverse
influences
• c) prevention of cross-contamination
• d) provision of safety facilities and devices, where applicable and
regularly verifying their functioning;
• EXAMPLES The operation of emergency release, intercom and alarm systems for cold rooms and walk-in
freezers, accessibility of emergency showers, eyewash and resuscitation equipment.
• e) maintenance of laboratory facilities in a functional and reliable

6.3.3 Storage facilities
• a) Storage space for samples, equipment, reagents, consumables,
documents and records, shall be provided.
• b) Patient samples and materials used in examination processes shall be
stored in a manner that prevents cross contamination and
deterioration
• c) Storage and disposal facilities for hazardous materials and biological
waste shall be appropriate to the classification of the materials in the
context of any statutory or regulatory requirements

6.3.4 Personnel facilities
• There shall be adequate access to toilet facilities and a supply of drinking
water, as well as facilities for storage of personal protective equipment and
clothing.
• Space for personnel activities, such as meetings, quiet study and a rest
area, should be provided

6.3.5 Sample collection facilities
• Sample collection facilities shall:
• a) enable collection to be undertaken in a manner that does not invalidate
results or adversely affect the quality of examinations;
• b) consider privacy, comfort and needs (e.g. disabled access, toilet facility) of
patients and accommodation of accompanying persons (e.g. guardian
or interpreter) during collection;
• c) provide separate patient reception and collection areas;
• d) maintain first aid materials for both patients and personnel.
• NOTE ISO 20658 provides details for sample collection facilities.

6.4 Equipment
• 6.4.1 General:
• shall have processes for the selection, procurement, installation, acceptance
testing (including acceptability criteria), handling, transport, storage,
use, maintenance, and decommissioning of equipment, in order to ensure
proper functioning and to prevent contamination or deterioration
• NOTE Laboratory equipment includes hardware and software of instruments, measuring systems, and laboratory
information systems, or any equipment that influences the results of laboratory activities, including sample
transportation systems.

6.4.2 Equipment requirements
• equipment required for the correct performance of laboratory
• requirements of this document are met.
• Each item of equipment that can influence laboratory activities shall
be uniquely labelled, marked or otherwise identified and a register
maintained
• The laboratory shall maintain and replace equipment as needed to
ensure the quality of examination results.

6.4.3 Equipment acceptance procedure
• verify that the equipment conforms to specified acceptability criteria
• Equipment used for measurement shall be capable of achieving either
the measurement accuracy or measurement uncertainty, or both,
required to provide a valid result
• NOTE 1 This includes equipment used in the laboratory, equipment on loan, or equipment used in point of care settings, or
in associated or mobile facilities, authorized by the laboratory.
• NOTE 2 The verification of equipment acceptance testing can be, where relevant, based on the calibration certificate of
the returned equipment.

6.4.4 Equipment instructions for use
• prevent unintended adjustments of equipment
• operated by trained, authorized, and competent personnel
• Instructions for the use of equipment, shall be readily available.
• equipment shall be used as specified by the manufacturer, unless
validated by the laboratory

6.4.5 Equipment maintenance and repair
• shall have preventive maintenance programmes, based on manufacturer’s
instructions. Deviations from the manufacturer's schedules or instructions
shall be recorded
• Equipment shall be maintained in a safe working condition and working
order
• Equipment that is defective or outside specified requirements, shall be taken
out of service & clearly labelled
• laboratory shall decontaminate equipment before service, repair or
decommissioning, provide suitable space for repairs and provide appropriate
personal protective equipment.

6.4.6 Equipment adverse incident reporting
• Adverse incidents and accidents that can be attributed directly to
specific equipment shall be investigated and reported to either
the manufacturer or supplier, or both, and appropriate
authorities, as required.
• The laboratory shall have procedures for responding to any
manufacturer's recall or other notice, and taking actions
recommended by the manufacturer.

6.4.7 Equipment records
• Records shall be maintained for each item of equipment that influences the results
of laboratory activities
• a) manufacturer and supplier details, and sufficient information to uniquely identify each item of
equipment, including software and firmware;
• b) dates of receipt, acceptance testing and entering into service;
• c) evidence that equipment conforms with specified acceptability criteria;
• d) the current location;
• e) condition when received (e.g. new, used or reconditioned);
• f) manufacturer's instructions;
• g) the programme for preventive maintenance;
• h) any maintenance activities performed by the laboratory or approved external service provider;
• i) damage to, malfunction, modification, or repair of the equipment;
• j) equipment performance records such as reports or certificates of calibrations or verifications, or
both, including dates, times and results;
• k) status of the equipment such as active or in-service, out-of-service, quarantined, retired or
obsolete
• These records shall be maintained and shall be readily available for the lifespan of the equipment or longer, as specified in 8.4.3.

6.5 Equipment calibration and metrological
traceability
• 6.5.1 General
• The laboratory shall specify calibration and traceability requirements that are
sufficient to maintain consistent reporting of examination results
• For quantitative methods of a measured analyte, specifications shall include
calibration and metrological traceability requirements.
• Qualitative methods and quantitative methods that measure characteristics rather
than discrete analytes shall specify the characteristic being assessed and
such requirements necessary for reproducibility over time
• NOTE Examples of qualitative methods and quantitative methods that may not allow metrological traceability include
red cell antibody detection, antibiotic sensitivity assessment, genetic testing, erythrocyte sedimentation rate, flow cytometry
marker staining, and tumour HER2 immunohistochemical staining.

6.5.2 Equipment calibration
• a) conditions of use and manufacturer's instructions for calibration;
• b) recording of the metrological traceability;
• c) verification of the required measurement accuracy and the functioning
of the measuring system at specified intervals;
• d) recording the calibration status and date of re-calibration;
• e) ensuring that, where correction factors are used, these are updated
and recorded when recalibration occurs;
• f) handling of situations when calibration was out of control, to minimize
risk to service operation and to patients.

6.5.3 Metrological traceability of
measurement results
• a) The laboratory shall establish and maintain metrological traceability of its
measurement results by means of a documented unbroken chain of calibrations,
each contributing to the measurement uncertainty, linking them to an
appropriate reference.
• b) The laboratory shall ensure that measurement results are traceable to the
highest possible level of traceability and to the International System of Units
(SI) through:
• — calibration provided by a competent laboratory; or
• — certified values of certified reference materials provided by a competent producer with
stated metrological traceability to the SI;

• c) Where it is not possible to provide traceability according to 6.5.3 a), other
means for providing confidence in the results shall be applied, including
but not limited to the following:
• — results of reference measurement procedures, specified methods or
consensus standards, that are clearly described and accepted as providing
measurement results fit for their intended use and ensured by suitable comparison;
• — measurement of calibrator by another procedure.
• NOTE ISO 17511 provides further information on how to manage the compromises in the metrological traceability of
measurands.
• d) For genetic examinations, traceability to genetic reference sequences shall
be established.
• e) For qualitative methods, traceability may be demonstrated by testing of
known material or previous samples sufficient to show consistent
identification and, when applicable, intensity of reaction.

6.6 Reagents and consumables
• The laboratory shall have processes for the selection, procurement,
reception, storage, acceptance testing and inventory management
of reagents and consumables.
• NOTE Reagents include substances which are commercially supplied or prepared in-house, reference materials (calibrators
and QC materials), culture media; consumables include pipette tips, glass slides, POCT supplies etc.

6.6.2 Reagents and consumables —
Receipt and storage
• The laboratory shall store reagents and consumables according to
manufacturers' specifications and monitor the environmental
conditions where relevant.
• When the laboratory is not the receiving facility, it shall verify that the
receiving facility has adequate storage and handling capabilities to
maintain supplies in a manner that prevents damage and
deterioration.

Acceptance testing
• Each reagent or new formulation of examination kits with changes in
reagents or procedure, or a new lot or shipment, shall be verified
for performance before placing into use, or before release of
results, as appropriate.
• Consumables that can affect the quality of examinations shall be
verified for performance before placing into use.
• NOTE 1 Comparative IQC performance of new reagent lots and that of previous lots can be used as evidence for
acceptance (see 7.3.7.2). Patient samples are preferred when comparing different reagent lots to avoid issues with
commutability of IQC materials.
• NOTE 2 Verification can sometimes be based on the certificate of analysis of the reagent.

Inventory management
• The laboratory shall establish an inventory management system for
reagents and consumables.
• The system for inventory management shall segregate reagents and
consumables that have been accepted for use from those that
have been neither inspected nor accepted for use.

6.6.5 Reagents and consumables — Instructions for
use
• Instructions for the use of reagents and consumables, including those
provided by manufacturers, shall be readily available.
• Reagents and consumables shall be used according to the
manufacturer's specifications. If they are intended to be used for
other purposes see 7.3.3.

6.6.6 Reagents and consumables — Adverse
incident reporting
• Adverse incidents and accidents that can be attributed directly to specific
reagents or consumables shall be investigated and reported to either
the manufacturer or supplier, or both, and appropriate authorities, as
required.
• The laboratory shall have procedures for responding to any
manufacturer's recall or other notice and taking actions
recommended by the manufacturer.

6.6.7 Reagents and consumables — Records
• Records shall be maintained for each reagent and consumable that
contributes to the performance of examinations. These records
shall include, but not be limited, to the following:
• a) identity of the reagent or consumable;
• b) manufacturer's information, including instructions, name and batch code or lot
number;
• c) date of receipt and condition when received, the expiry date, date of first use and,
where applicable, the date the reagent or consumable was taken out of
service;
• d) records that confirm the reagent's or consumable's initial and ongoing acceptance
for use.
• Where the laboratory uses reagents prepared, resuspended or combined
in-house, the records shall include, in addition to the relevant
information above, reference to the person or persons undertaking the
preparation, as well as the dates of preparation and expiry.

6.7 Service agreements
• 6.7.1 Agreements with laboratory users
• The laboratory shall have a procedure to establish and periodically review
agreements for providing laboratory activities. The procedure shall
ensure:
• a) the requirements are adequately specified;
• b) the laboratory has the capability and resources to meet the requirements;
• c) when applicable, the laboratory advises the user of the specific activities to be
performed by referral laboratories and consultants.
• Laboratory users shall be informed of any changes to an agreement that can
affect examination results.
• Records of reviews, including any significant changes, shall be retained.

6.7.2 Agreements with POCT operators
• Service agreements between the laboratory and other parts of the
organization using laboratory supported POCT, shall ensure that
respective responsibilities and authorities are specified and
communicated.
• NOTE Established multidisciplinary POCT committees can be used to manage such service agreements as described in
Annex A.

6.8 Externally provided products and services
• 6.8.1 General
• The laboratory shall ensure that externally provided products and services
that affect laboratory activities are suitable when such products and services
are:
• a) intended for incorporation into the laboratory's own activities;
• b) provided, in part or in full, directly to the user by the laboratory, as received from the
external provider;
• c) used to support the operation of the laboratory.
• It can be necessary to collaborate with other organizational departments or
functions to fulfil this requirement.
• NOTE Services include, e.g. sample collection services, pipette and other calibration services, facility and equipment maintenance
services, EQA programmes, referral laboratories and consultants.

6.8.2 Referral laboratories and consultants
• The laboratory shall communicate its requirements to referral laboratories
and consultants who provide interpretations and advice, for:
• a) the procedures, examinations, reports and consulting activities to be provided;
• b) management of critical results;
• c) any required personnel qualifications and demonstration of competence.
• Unless otherwise specified in the agreement, the referring laboratory (and
not the referral laboratory) shall be responsible for ensuring that
examination results of the referral laboratory are provided to the person
making the request.
• A list of all referral laboratories and consultants shall be maintained.

6.8.3 Review and approval of externally provided
products and services
• The laboratory shall have procedures and retain records for:
• a) defining, reviewing, and approving the laboratory's requirements for all externally
provided products and services;
• b) defining the criteria for qualification, selection, evaluation of performance and re-
evaluation of external providers;
• c) referral of samples;
• d) ensuring that externally provided products and services conform to the
laboratory's established requirements, or where applicable to the relevant
requirements of this document, before they are used or directly provided to the user;
• e) taking any actions arising from evaluations of the performance of external
providers.

Medical error is a failure of process
• The concept that errors result largely from the failure of systems, not
from individual carelessness or inadequacy, is fundamental to the
new efforts to address safety and runs counter to the traditional focus
of medical training on individual performance
Process
Input

Summary of Clause 6 of ISO 15189 2022
•Detailed Explanation of Clause 6 of ISO 15189:2022 – Resource Requirements
Clause 6 of ISO 15189:2022 outlines the essential resources that laboratories must
provide and manage to ensure the quality and reliability of their services. These
resources include personnel, facilities, equipment, and externally provided products and
services.
•By addressing Clause 6 comprehensively, laboratories can build a strong foundation to
support their testing activities, maintain compliance with ISO 15189:2022, and enhance
their overall quality management system
•Below is an in-depth explanation of each sub-clause and how to implement its
requirements.

•6.1 General
 Requirement:
Laboratories must determine and provide the necessary resources to implement, maintain, and
continually improve their quality management system (QMS) and ensure reliable and accurate
results.
 Implementation:
o Conduct resource needs assessments annually or whenever significant changes occur (e.g., new
equipment or methods).
o Allocate financial, material, and human resources based on identified needs.
o Regularly review resource adequacy during management reviews.
 Example: A laboratory expanding its molecular testing services may invest in additional PCR
machines, reagents, and trained personnel.

•6.2 Personnel
 Requirement:
Laboratories must ensure that personnel are competent, qualified, and adequately trained for their
roles. This includes defining roles, managing workloads, and providing supervision where necessary.
 Implementation:
1. Develop Job Descriptions: Outline qualifications, skills, and responsibilities for each role.
2. Training and Competency Assessment: Create training programs tailored to specific roles and
assess competency periodically.
3. Monitor Workload: Use tools like workload indicators to ensure staff are neither overburdened
nor underutilized.
4. Documentation: Maintain records of qualifications, training, and competency assessments.
 Example: Use a competency matrix to track which tests each technician is qualified to perform.
•

•6.3 Facilities and Environmental Conditions
 Requirement:
Laboratories must provide and maintain facilities and environmental conditions that support the
quality of testing and minimize risks of contamination or errors.
 Implementation:
1.Facility Design: Separate areas for different activities, such as sample collection, analysis, and
storage, to prevent contamination.
2.Environmental Monitoring: Monitor temperature, humidity, and air quality where applicable.
3.Maintenance: Schedule regular cleaning, inspections, and maintenance of facilities and
equipment.
 Example: Install HEPA filters in microbiology labs to ensure air quality meets testing requirements.

•
•6.4 Equipment
 Requirement:
Equipment used for testing must be fit for its purpose, calibrated, maintained, and verified.
Laboratories must also keep records of equipment management activities.
 Implementation:
1. Equipment Inventory: Maintain a database with details such as make, model, serial number, and
location.
2. Calibration Schedule: Create and follow a schedule for regular calibration and verification.
3. Maintenance Records: Document all maintenance, repair, and performance checks.
4. Decommissioning: Establish procedures for retiring and replacing outdated equipment.
 Example: Use software to manage and track calibration dates and generate alerts for upcoming tasks.

•6.5 Metrological Traceability
 Requirement:
Measurement results must be traceable to national or international standards to ensure reliability
and comparability.
 Implementation:
1. Use Accredited Calibration Services: Ensure calibration providers are accredited to ISO/IEC
17025.
2. Maintain Calibration Certificates: Keep certificates that demonstrate traceability to recognized
standards.
3. Reference Materials: Use certified reference materials where applicable.
 Example: Use weights traceable to national standards for calibrating balances.

•6.6 Externally Provided Products and Services
 Requirement:
Laboratories must ensure that externally provided products and services (e.g., reagents,
calibration services, or IT support) meet specified requirements.
 Implementation:
1.Supplier Qualification: Evaluate and approve suppliers based on their ability to meet
laboratory requirements.
2.Performance Monitoring: Periodically review supplier performance and maintain records.
3.Inspection on Receipt: Verify the quality of products upon delivery.
4.Supplier Records: Keep records of contracts, evaluations, and re-evaluations.
 Example: Maintain an approved supplier list and conduct annual reviews of supplier
performance.

•Key Steps to Implement Clause 6
1. Resource Planning:
o Develop a resource management plan that aligns with laboratory objectives and
projected workload.
o Regularly assess whether resources remain adequate and adjust as needed.
2. Competency Management:
o Establish clear training and competency requirements for each role.
o Implement a system to track and periodically reassess personnel competency.
3. Facility Maintenance:
o Use checklists and schedules to manage facility conditions and address issues proactively.

4. Equipment Management:
• o Implement an equipment lifecycle management system covering
acquisition, maintenance, and decommissioning.
5. Supplier Management:
• o Develop a documented process for selecting, evaluating, and
monitoring external providers.
6. Records and Documentation:
• o Ensure all resource-related activities, from training to equipment
calibration, are fully documented and retrievable for audits.

•Practical Examples of Implementation
 Personnel Training: A lab may use e-learning platforms for
training new staff and updating current staff on emerging
technologies.
 Environmental Monitoring: Laboratories handling molecular
biology samples may install data loggers to monitor and
document freezer temperatures.
 Supplier Audits: Annually review supplier certifications to
ensure continued compliance with ISO standards.

7 Process requirements
• 7.1 General
• The laboratory shall identify potential risks to patient care in the pre-
examination, examination and post-examination processes.
• These risks shall be assessed and mitigated to the extent possible. The
residual risk shall be communicated to users as appropriate.
• The identified risks and effectiveness of the mitigation processes shall be
monitored and evaluated according to the potential harm to the
patient.
• The laboratory shall also identify opportunities to improve patient care and
develop a framework to manage these opportunities (see 8.5).

7.2 Pre-examination processes
• 7.2.1 General
• The laboratory shall have procedures for all pre-examination activities
and make them accessible to relevant personnel.
• NOTE 1 The pre-examination processes can influence the outcome of the intended examination.
• NOTE 2 ISO 20658 provides detailed information for sample collection and transport.
• NOTE 3 ISO 20186-1, ISO 20186-2, ISO 20186-3, ISO 20166 (all parts), ISO 20184 (all parts), ISO 23118 and ISO 4307
provide detailed information for samples from particular sources and for specific analytes.

7.2.2 Laboratory information for patients and users
• The laboratory shall have appropriate information available for its users and
patients. The information shall be sufficiently detailed to provide laboratory
users with a comprehensive understanding of the laboratory's scope of activities
and requirements. The information shall include as appropriate:
• a) the location(s) of the laboratory, operating hours and contact information;
• b) the procedures for requesting and the collection of samples;
• c) the scope of laboratory activities and time for expected availability of results;
• d) the availability of advisory services;
• e) requirements for patient consent;
• f) factors known to significantly impact the performance of the examination or the
interpretation of the results;
• g) the laboratory complaint process

7.2.3 Requests for providing laboratory examinations
• 7.2.3.1 General
• a) Each request accepted by the laboratory for examination(s) shall be
considered an agreement.
• b) The examination request shall provide sufficient information to ensure: —
unequivocal traceability of the patient to the request and sample;
• — identity and contact information of requester;
• — identification of the examination(s) requested;
• — informed clinical and technical advice, and clinical interpretation can be provided.
• c) The examination request information may be provided in a format or medium
as deemed appropriate by the laboratory and acceptable to the user.
• d) Where necessary for patient care, the laboratory shall communicate with
users or their representatives, to clarify the user's request.

7.2.3.2 Oral requests
• The laboratory shall have a procedure for managing oral requests for
examinations, if applicable, that includes the provision of
documented confirmation of the examination request to the
laboratory, within a given time.

7.2.4 Primary sample collection and handling
• 7.2.4.1 General
• The laboratory shall have procedures for the collection and handling of
primary samples. Information shall be available to those responsible for
sample collection.
• Any deviation from the established collection procedures shall be clearly
recorded. The potential risk and impact on the patient outcome of
acceptance or rejection of the sample shall be assessed, recorded and shall
be communicated to the appropriate personnel.
• The laboratory shall periodically review requirements for sample volume,
collection device and preservatives for all sample types, as applicable, to
ensure that neither insufficient nor excessive amounts of sample are
collected, and samples are properly collected to preserve the analyte.

7.2.4.2 Information for pre-collection activities
• The laboratory shall provide information and instructions for pre-collection activities
with sufficient detail to ensure that the integrity of the sample is not compromised.
This shall include:
• a) preparation of the patient (e.g. instructions to caregivers, sample collectors and patients);
• b) type and amount of the primary sample to be collected with descriptions of the containers and
any necessary additives, and when relevant the order of collecting samples;
• c) special timing of collection, where relevant;
• d) provision of clinical information relevant to, or affecting sample collection, examination
performance or result interpretation (e.g. history of administration of drugs);
• e) sample labelling for unequivocal identification of the patient, as well as source and site of
sample, and labelling, when several samples from the same patient are to be collected, including
multiple pieces of tissue or slides;
• f) the laboratory’s criteria for acceptance and rejection of samples specific to the examinations
requested.

7.2.4.3 Patient consent
• a) The laboratory shall obtain the informed consent of the patient for
all procedures carried out on the patient.
• NOTE For most routine laboratory procedures, consent can be inferred when the patient willingly submits to the sample
collecting procedure, for example, venipuncture.
• b) Special procedures, including more invasive procedures, or those
with an increased risk of complications to the procedure, may need
a more detailed explanation and, in some cases, recorded
consent.
• c) If obtaining consent is not possible in emergency situations, the
laboratory may carry out necessary procedures, provided they are
in the patient’s best interest.

7.2.4.4 Instructions for collection activities
• To ensure safe, accurate and clinically appropriate sample collection and pre-
examination storage, the laboratory shall provide instructions for:
• a) verification of the identity of the patient from whom a primary sample is collected;
• b) verification and when relevant, recording that the patient meets pre-examination
requirements [e.g. fasting status, medication status (time of last dose,
cessation), sample collection at predetermined time or time intervals];
• c) collection of primary samples, with descriptions of the primary sample containers
and any necessary additives, as well as the order of sample collection, where
relevant;
• d) labelling of primary samples in a manner that provides an unequivocal link with the
patients from whom they are collected;
• e) recording of the identity of the person collecting the primary sample and the
collection date, and, when relevant, recording of the collection time;
• f) requirements for separating or dividing the primary sample when necessary;
• g) stabilization and proper storage conditions before collected samples are
delivered to
the laboratory;
• h) safe disposal of materials used in the collection process.

7.2.5 Sample transportation
• a) To ensure the timely and safe transportation of samples, the laboratory shall
provide instructions for:
• 1) packaging of samples for transportation;
• 2) ensuring the time between collection and receipt in the laboratory is appropriate for the
requested examinations;
• 3) maintaining the temperature interval specified for sample collection and handling;
• 4) any specific requirements to ensure integrity of samples, e.g. use of designated
preservatives.
• b) If the integrity of a sample has been compromised and there is a health
risk, the organization responsible for the transport of the sample shall be
notified immediately and action taken to reduce the risk and to prevent
recurrence.
• c) The laboratory shall establish and periodically evaluate adequacy of sample
transportation systems

7.2.6 Sample receipt
• 7.2.6.1 Sample receipt procedure
• The laboratory shall have a procedure for sample receipt that includes:
• a) the unequivocal traceability of samples by request and labelling, to a uniquely
identified patient and when applicable, the anatomical site;
• b) criteria for acceptance and rejection of samples;
• c) recording the date and time of receipt of the sample, when relevant;
• d) recording the identity of the person receiving the sample, when relevant;
• e) evaluation of received samples, by authorized personnel, to ensure compliance with
acceptability criteria relevant for the requested examination(s);
• f) instructions for samples specifically marked as urgent, which include details of
special labelling, transport, any rapid processing method, turnaround
times, and special reporting criteria to be followed;
• g) ensuring that all portions of the sample shall be unequivocally traceable to the
original sample

7.2.6.2 Sample acceptance exceptions
• a) The laboratory shall have a process that considers the best interests of the
patient in receiving care, when a sample has been compromised due to
• 1) incorrect patient or sample identification,
• 2) sample instability due to, for example, delay in transport,
• 3) incorrect storage or handling temperature,
• 4) inappropriate container(s), and
• 5) insufficient sample volume.
• b) When a compromised clinically critical or irreplaceable sample is accepted,
after consideration of the risk to patient safety, the final report shall indicate
the nature of the problem and where applicable, advising caution when
interpreting results that can be affected.

7.2.7 Pre-examination handling, preparation, and storage
• 7.2.7.1 Sample protection
• The laboratory shall have procedures and appropriate facilities for securing
patient samples, ensuring sample integrity and preventing loss or
damage during, handling, preparation and storage.
• 7.2.7.2 Criteria for additional examination requests
• Laboratory procedures shall include time limits for requesting additional
examinations on the same sample.
• 7.2.7.3 Sample stability
• Considering the stability of the analyte in a primary sample, the time
between sample collection and performing the examination shall be specified
and monitored where relevant.

7.3 Examination processes
• 7.3.1 General
• a) The laboratory shall select and use examination methods which have been
validated for their intended use to assure the clinical accuracy of the
examination for patient testing.
• NOTE Preferred methods are those specified in the instructions for use of in vitro diagnostic medical devices or those that have been
published in established/authoritative textbooks, peer-reviewed texts, or journals, or in international and national consensus
standards or guidelines, or national or regional regulations.
• b) The performance specifications for each examination method shall relate to the intended
use of that examination and its impact on patient care.
• c) All procedures and supporting documentation, such as instructions, standards, manuals
and reference data relevant to the laboratory activities, shall be kept up to date and be
readily available to personnel (see 8.3).
• d) Personnel shall follow established procedures and the identity of persons performing
significant activities in examination processes be recorded, including POCT operators.
• e) Authorized personnel shall periodically evaluate the examination methods provided by the
laboratory to ensure they are clinically appropriate for the requests received.

7.3.2 Verification of examination methods
• a) The laboratory shall have a procedure to verify that it can properly perform examination
methods before introducing into use, by ensuring that the required performance, as
specified by the manufacturer or method, can be achieved.
• b) The performance specifications for the examination method confirmed during the
verification process shall be those relevant to the intended use of the examination results.
• c) The laboratory shall ensure the extent of the verification of examination methods is
sufficient to ensure the validity of results pertinent to clinical decision making.
• d) Personnel with the appropriate authorization and competence shall review the
verification results and record whether the results meet the specified
requirements.
• e) If a method is revised by the issuing body, the laboratory shall repeat verification
to the
extent necessary.
• f) The following records of verification shall be retained:
• 1) performance specifications to be achieved,
• 2) results obtained, and
• 3) a statement of whether the performance specifications were achieved and if not, action

7.3.3 Validation of examination methods
• a) The laboratory shall validate examination methods derived from the
following sources:
• 1) laboratory designed or developed methods;
• 2) methods used outside their originally intended scope (i.e. outside of the
manufacturer's instructions for use, or original validated measurement range; third
party reagents used on instruments other than intended instruments and
where no validation data are available);
• 3) validated methods subsequently modified.
• b) The validation shall be as extensive as is necessary and confirm, through
the provision of objective evidence in the form of performance
specifications, that the specific requirements for the intended use of the
examination have been fulfilled. The laboratory shall ensure that the
extent of validation of an examination method is sufficient to ensure
the validity of results pertinent to clinical decision making.

• c) Personnel with the appropriate authorization and competence shall
review the validation results and record whether the results meet
the specified requirements.
• d) When changes are proposed to a validated examination method, the
clinical impact shall be reviewed, and a decision made as to whether
to implement the modified method.
• e) The following records of validation shall be retained:
• 1) the validation procedure used;
• 2) specific requirements for the intended use;
• 3) determination of the performance specifications of the method;
• 4) results obtained;
• 5) a statement on the validity of the method, detailing its fitness for the intended
use.

7.3.4 Evaluation of measurement uncertainty (MU)
• a) The MU of measured quantity values shall be evaluated and maintained for its intended use,
where relevant. The MU shall be compared against performance specifications and
documented.
• NOTE ISO/TS 20914 provides details on these activities together with examples.
• b) MU evaluations shall be regularly reviewed.
• c) For examination procedures where evaluation of MU is not possible or relevant, the
rationale for exclusion from MU estimation shall be documented.
• d) MU information shall be made available to laboratory users on request.
• e) When users have inquiries on MU, the laboratory’s response shall take into account other
sources of uncertainty, such as, but not limited to biological variation.
• f) If the qualitative result of an examination relies on a test which produces quantitative
output
data and is specified as positive or negative, based on a threshold, MU in the output quantity
shall be estimated using representative positive and negative samples.
• g) For examinations with qualitative results, MU in intermediate measurement steps or IQC
results which produce quantitative data should also be considered for key (high risk) parts of
the process.
• h) MU should be taken into consideration when performing verification or validation of a
method, when relevant.

7.3.5 Biological reference intervals and clinical decision limits
• Biological reference intervals and clinical decision limits, when needed for
interpretation of examination results, shall be defined and communicated to
users.
• a) Biological reference intervals and clinical decision limits shall be defined, and their basis
recorded, to reflect the patient population served by the laboratory, while
considering the risk to patients.
• NOTE Biological reference values, provided by the manufacturer can be used by the laboratory, if the population base of these values is
verified and deemed acceptable by the laboratory.
• b) Biological reference intervals and clinical decision limits shall be periodically reviewed,
and any changes communicated to users.
• c) When changes are made to an examination or pre-examination method, the laboratory
shall review the impact on associated biological reference intervals and clinical
decision limits and communicate to the users when applicable.
• d) For examinations that identify presence or absence of a characteristic, the biological
reference interval is the characteristic to be identified, e.g. genetic examinations.

7.3.6 Documentation of examination procedures
• a) The laboratory shall document its examination procedures to the extent necessary
to ensure the consistent application of its activities and the validity of its results.
• b) Procedures shall be written in a language understood by laboratory personnel and
be available in appropriate locations.
• c) Any abbreviated document content shall correspond to the procedure.
• NOTE Working instructions, flow process diagrams or similar systems that summarize key information are acceptable for use as a quick
reference at the workbench, provided that a full procedure is available for reference and that the summarized information is updated as
needed, concurrently with the full procedure update.
• d) Information from product instructions for use, that contain sufficient information,
can be incorporated into procedures by reference.
• e) When the laboratory makes a validated change to an examination procedure which
could affect interpretation of results, the implications of this shall be explained to
users.
• f) All documents associated with the examination process shall be subject to
document control (see 8.3).

QMS is a system designed to manage the continual improvement of all
processes in an organisation in order to meet customer expectations

7.3.7 Ensuring the validity of examination results
• 7.3.7.1 General
• The laboratory shall have a procedure for monitoring the validity of
results. The resulting data shall be recorded in such a way that
trends and shifts are detectable and, where practicable,
statistical techniques shall be applied to review the results. This
monitoring shall be planned and reviewed.

7.3.7.2 Internal quality control (IQC)
• a) The laboratory shall have an IQC procedure for monitoring the ongoing
validity of examination results, according to specified criteria, that verifies the
attainment of the intended quality and ensures validity pertinent to clinical
decision making.
• 1) The intended clinical application of the examination should be considered, as the
performance specifications for the same measurand can differ in different clinical settings.
• 2) The procedure should also allow for the detection of either lot-to-lot reagent or
calibrator variation, or both, of the examination method. To enable this, the laboratory
procedure should avoid lot change in IQC material on the same day/run as either lot-to-lot
reagent or calibrator change, or both.
• 3) The use of third-party IQC material should be considered, either as an alternative to, or
in addition to, control material supplied by the reagent or instrument manufacturer.
• NOTE Monitoring of interpretations and opinions can be achieved through regular peer review of examination results.

• b) The laboratory shall select IQC material that is fit for its intended purpose. When
selecting IQC material, factors to be considered shall include:
• 1) stability with regard to the properties of interest;
• 2) the matrix is as close as possible to that of patient samples;
• 3) the IQC material reacts to the examination method in a manner as close as possible to patient
samples;
• 4) the IQC material provides a clinically relevant challenge to the examination method, has concentration
levels at or near clinical decision limits and when possible, covers the measurement range of the
examination method.
• c) If appropriate IQC material is not available, the laboratory shall consider the use of other
methods for IQC. Examples of such other methods may include:
• 1) trend analysis of patient results, e.g. with moving average of patient results, or percentage of samples
with results below or above certain values or associated with a diagnosis;
• 2) comparison of results for patient samples on a specified schedule to results for patient samples
examined by an alternative procedure validated to have its calibration metrologically traceable to the same
or higher order references as specified in ISO 17511;
• 3) retesting of retained patient samples.
• d) IQC shall be performed at a frequency that is based on the stability and robustness of the
examination method and the risk of harm to the patient from an erroneous re7 3
sult.

• e) The resulting data shall be recorded in such a way that trends and shifts are
detectable and, where applicable, statistical techniques shall be applied to
review the results.
• f) IQC data shall be reviewed with defined acceptability criteria at regular
intervals, and in a timeframe that allows a meaningful indication of
current performance.
• g) The laboratory shall prevent the release of patient results in the event that
IQC fails the defined acceptability criteria.
• 1) When IQC defined acceptability criteria are not fulfilled and indicate results are likely to
contain clinically significant errors, the results shall be rejected and relevant patient
samples re-examined after the error has been corrected (see 7.5).
• 2) The results from patient samples that were examined after the last successful IQC event
shall be evaluated.

7.3.7.3 External quality assessment (EQA)
• a) The laboratory shall monitor its performance of examination methods, by
comparison with results of other laboratories. This includes participation in EQA
programmes appropriate to the examinations and interpretation of examination
results, including POCT examination methods.
• b) The laboratory shall establish a procedure for EQA enrollment, participation and
performance for examination methods used, where such programmes are available.
• c) EQA samples shall be processed by personnel who routinely perform pre-
examination, examination, and post-examination procedures.
• d) The EQA programme(s) selected by the laboratory shall, to the extent
possible:
• 1) have the effect of checking pre-examination, examination, and post-examination
processes;
• 2) provide samples that mimic patient samples for clinically relevant challenges
• 3) fulfill ISO/IEC 17043 requirements.

• e) When selecting EQA programme(s), the laboratory should consider the type of target value
offered. Target values are:
• 1) independently set by a reference method, or
• 2) set by overall consensus data, and/or
• 3) set by method peer group consensus data, or
• 4) set by a panel of experts.
• NOTE 1 When method-independent target values are not available, consensus values can be used to determine whether
deviations are laboratory- or method-specific.
• NOTE 2 Where lack of commutability of EQA materials can hamper comparison between some methods, it can still be useful for
comparisons to be made between methods for which it is commutable, rather than relying only on within-method comparisons.
• f) When an EQA programme is either not available, or not considered suitable, the laboratory
shall use alternative methodologies to monitor examination method performance. The
laboratory shall justify the rationale for the chosen alternative and provide evidence of its
effectiveness.
• NOTE Acceptable alternatives include:
• — participation in sample exchanges with other laboratories;
• — interlaboratory comparisons of the results of the examination of identical IQC materials, which evaluates individual laboratory IQC
results against pooled results from participants using the same IQC material;
• — analysis of a different lot number of the manufacturer's end-user calibrator or the manufacturer's trueness control material;
• — analysis of microbiological organisms using split/ blind testing of the same sample by at least two persons, or on at least two
analyzers, or by at least two methods;
• — analysis of reference materials considered to be commutable with patient samples;
• — analysis of patient samples from clinical correlation studies;
• — analysis of materials from cell and tissue repositories

• g) EQA data shall be reviewed at regular intervals with specified acceptability
criteria, in a time frame which allows for a meaningful indication of current
performance.
• h) Where EQA results fall outside specified acceptability criteria, appropriate
action shall be taken (see 8.7), including an assessment of whether the
nonconformance is clinically significant as it relates to patient samples.
• i) Where it is determined that the impact is clinically significant, a review of
patient results that could have been affected and the need for amendment shall
be considered and users advised as appropriate.

7.3.7.4 Comparability of examination results
• a) When either different methods or equipment, or both, are used for an
examination, and/or the examination is performed at different sites, a procedure
for establishing the comparability of results for patient samples throughout the
clinically significant intervals shall be specified.
• NOTE The use of patient samples when comparing different examination methods can avoid the difficulties linked to the limited
commutability of IQC materials. When patient samples are either not available or impractical, see all options described for IQC and EQA.
• b) The laboratory shall record the results of comparability performed and its
acceptability.
• c) The laboratory shall periodically review the comparability of results.
• d) Where differences are identified, the impact of those differences on biological
reference intervals and clinical decision limits shall be evaluated and acted
upon.
• e) The laboratory shall inform users of any clinically significant differences in
comparability of results.

7.4 Post-examination processes
• 7.4.1 Reporting of results
• 7.4.1.1 General
• a) Examination results shall be reported accurately, clearly, unambiguously and in
accordance with any specific instructions in the examination procedure. The report
shall include all available information necessary for the interpretation of the results.
• b) The laboratory shall have a procedure to notify users when examination results
are delayed, based on the impact of the delay on the patient.
• c) All information associated with issued reports shall be retained in accordance with
management system requirements (see 8.4).
• NOTE For the purposes of this document, reports can be issued as hard copies or by electronic means, provided that the requirements of
this document are met.

7.4.1.2 Result review and release
• Results shall be reviewed and authorized prior to release.
• The laboratory shall ensure that authorized personnel review the
results of examinations and evaluate them against IQC and, as
appropriate, available clinical information and previous
examination results.
• Responsibilities and procedures for how examination results are
released for reporting, including by whom and to whom, shall
be specified.

7.4.1.3 Critical result reports
• When examination results fall within established critical decision limits:
• a) the user or other authorized person is notified as soon as relevant, based on
clinical information available;
• b) actions taken are documented, including date, time, responsible person, person
notified, results conveyed, verification of accuracy of communication, and
any difficulties encountered in notification;
• c) the laboratory shall have an escalation procedure for laboratory personnel
when
a responsible person cannot be contacted.

7.4.1.4 Special considerations for results
• a) When agreed with the user, the results may be reported in a simplified way. Any
information listed in 7.4.1.6 and 7.4.1.7 that is not reported to the user shall be readily
available.
• b) When results are transmitted as a preliminary report, the final report shall always be
forwarded to the user.
• c) Records shall be kept of all results which are provided orally, including details of
verification of accuracy of communication, as in 7.4.1.3 b). Such results shall always be
followed by a report.
• d) Special counselling may be needed for examination results with serious implications
for the patient (e.g. for genetic or certain infectious diseases). Laboratory
management
should ensure that these results are not communicated to the patient without the
opportunity for adequate counselling.
• e) Results of laboratory examinations that have been anonymized may be used for
such
purposes as epidemiology, demography, or other statistical analyses, provided
that all

7.4.1.5 Automated selection, review, release
and reporting of results
• When the laboratory implements a system for automated selection, review,
release and reporting of results, it shall establish a procedure to ensure that:
• a) the criteria for automated selection, review and release are specified, approved, readily
available and understood by personnel responsible for authorizing the release of
results;
• b) the criteria are validated and approved before use, regularly reviewed and verified after
changes to the reporting system that can affect their proper functioning and place
patient care at risk;
• c) results selected by an automated reporting system for manual review are identifiable;
and as appropriate, date and time of selection and review, as well as identity of
the reviewer are retrievable;
• d) when necessary, rapid suspension of automated selection, review, release and reporting
is applied

7.4.1.6 Requirements for reports
• Each report shall include the following information, unless the laboratory has
documented reasons for omitting any items:
• a) unique patient identification, the date of primary sample collection and the date of
the
issue of the report, on each page of the report;
• b) identification of the laboratory issuing the report;
• c) name or other unique identifier of the user;
• d) type of primary sample and any specific information necessary to describe the
sample
(e.g. source, site of specimen, macroscopic description);
• e) clear, unambiguous identification of the examinations performed;
• f) identification of the examination method used, where relevant, including, where possible
and necessary, harmonized (electronic) identification of the measurand and
measurement principle;
• NOTE Logical Observation Identifiers Names and Codes (LOINC) and Nomenclature for Properties and Units (NPU, NGC) and SNOMED CT

• g) examination results with, where appropriate, the units of measurement,
reported in SI units, units traceable to SI units, or other applicable units;
• h) biological reference intervals, clinical decision limits, likelihood ratios or
diagrams/nomograms supporting clinical decision limits as necessary;
• NOTE Lists or tables of biological reference intervals can be distributed to users of the laboratory.
• i) identification of examinations undertaken as part of a research or development programme
and for which no specific claims on measurement performance are available
• j) identification of the person(s) reviewing the results and authorizing the release of the report
(if not contained in the report, readily available when needed);
• k) identification of any results that need to be considered as preliminary;
• l) indications of any critical results;
• m) unique identification that all its components are recognized as a portion of a complete
report and a clear identification of the end (e.g. page number to total number of pages).
85

7.4.1.7 Additional information for reports
• a) When necessary for patient care, the time of primary sample collection shall be
included.
• b) Time of report release, if not contained in the report, shall be readily available when
needed.
• c) Identification of all examinations or parts of examinations performed by a referral
laboratory, including information provided by consultants, without alteration, as well as
the name of the laboratory performing the examinations.
• d) When applicable, a report shall include interpretation of results and comments on:
• 1) sample quality and suitability that can compromise the clinical value of examination results;
• 2) discrepancies when examinations are performed by different procedures (e.g. POCT) or in
different locations;
• 3) possible risk of misinterpretation when different units of measurement are in use regionally or
nationally;
• 4) result trends or significant changes over time.

7.4.1.8 Amendments to reported results
• Procedures for the issue of amended or revised results shall ensure that:
• a) The reason for the change is recorded and included in the revised report, when
relevant.
• b) Revised results shall be delivered only in the form of an additional document or data
transfer, and clearly identified as having been revised, and the date and patient's identity
in the original report shall be indicated.
• c) The user is made aware of the revision.
• d) When it is necessary to issue a completely new report, this shall be uniquely identified
and shall contain a reference and traceability to the original report that it replaces.
• e) When the reporting system cannot capture revisions, a record of such shall be kept.

7.4.2 Post-examination handling of samples
• The laboratory shall specify the length of time samples are to be retained
following examination and the conditions under which samples are to
be stored. The laboratory shall ensure that after the examination, the
• a) patient and source identification of the sample are maintained,
• b) suitability of the sample for additional examination is known,
• c) sample is stored in a manner that optimally preserves suitability for additional
examination,
• d) sample can be located and retrieved, and
• e) sample is discarded appropriately.

7.5 Nonconforming work
• The laboratory shall have a process for when any aspect of its laboratory activities
or examination results do not conform to its own procedures, quality
specifications, or the user requirements (e.g. equipment or environmental
conditions are out of specified limits, results of monitoring fail to meet specified
criteria). The process shall ensure that:
• a) the responsibilities and authorities for the management of nonconforming work are
specified;
• b) immediate and long-term actions are specified and based upon the risk analysis
process
established by the laboratory;
• c) examinations are halted, and reports withheld when there is a risk of harm to
patients;
• d) an evaluation is made of the clinical significance of the nonconforming work, including
an impact analysis on examination results which were or could have been released
prior to identification of the nonconformance;

• e) a decision is made on the acceptability of the nonconforming work;
• f) when necessary, examination results are revised, and the user is notified;
• g) the responsibility for authorizing the resumption of work is specified.
• The laboratory shall implement corrective action commensurate with the
risk of recurrence of the nonconforming work (see 8.7).
• The laboratory shall retain records of nonconforming work and actions as
specified in 7.5 a) to g).

7.6 Control of data and information management
• 7.6.1 General
• The laboratory shall have access to the data and information needed to
perform laboratory activities.
• NOTE 1 In this document, "laboratory information systems" includes the management of data and information contained in
both computer and non-computerized systems. Some of the requirements can be more applicable to computer systems than to
non-computerized systems.
• NOTE 2 Risks associated with computerized laboratory information systems are discussed in ISO 22367:2020, A.13.
• NOTE 3 The information security controls, strategies and best practices to ensure the preservation of confidentiality, integrity
and availability of information, are listed in ISO/IEC 27001:2022, Annex A Information security controls reference

7.6.2 Authorities and responsibilities for information
management
• The laboratory shall ensure that the authorities and responsibilities
for the management of the information systems are specified,
including the maintenance and modification to the information
systems that can affect patient care.
• The laboratory is ultimately responsible for the laboratory
information systems.

7.6.3 Information systems management
• The system(s) used for the collection, processing, recording, reporting, storage or
retrieval of examination data and information shall be:
• a) validated by the supplier and verified for functionality by the laboratory before
introduction. Any changes to the system, including laboratory software
configuration or modifications to commercial off-the-shelf software, shall be
authorized, documented and validated before implementation;
• NOTE 1 Validation and verification include, where applicable, the proper functioning of interfaces between the laboratory information system
and other systems such as laboratory equipment, hospital patient administration systems and systems in primary care.
• NOTE 2 Commercial off-the-shelf software used within its designed application range can be considered sufficiently validated (e.g. word
processing and spreadsheet software, and quality management software programs).

• b) documented, and the documentation readily available to authorized users ,
including that for day to day functioning of the system;
• c) implemented taking cybersecurity into account, to protect the system from
unauthorized access and safeguard data against tampering or loss;
• d) operated in an environment that complies with supplier specifications or, in
the case of noncomputerized systems, provides conditions which safeguard
the accuracy of manual recording and transcription;
• e) maintained in a manner that ensures the integrity of the data and information
and includes the recording of system failures and the appropriate immediate
and corrective actions.
• Calculations and data transfers shall be checked in an appropriate and
systematic manner

7.6.4 Downtime plans
• The laboratory shall have planned processes to maintain operations in
the event of failure or during downtime in information systems that
affects the laboratory's activities. This includes automated selection
and reporting of results.

7.6.5 Off site management
• When the laboratory information system(s) are managed and
maintained off-site or through an external provider, the laboratory
shall ensure that the provider or operator of the system complies
with all applicable requirements of this document

7.7 Complaints
• 7.7.1 Process
• The laboratory shall have a process for handling complaints that shall include at
least the following:
• a) a description of the process for receiving, substantiating and investigating
the complaint, and deciding what actions shall be taken in response;
• NOTE The resolution of complaints can lead to implementation of corrective actions (see 8.7) or be used as input into the
improvement process (see 8.6).
• b) tracking and recording the complaint, including the actions undertaken to
resolve it;
• c) ensuring appropriate action is taken. A description of the process for
handling complaints shall be publicly available.

7.7.2 Receipt of complaint
• a) Upon receipt of a complaint, the laboratory shall confirm whether the
complaint relates to laboratory activities that the laboratory is
responsible for and, if so, shall resolve the complaint. (see 8.7.1).
• b) The laboratory receiving the complaint shall be responsible for
gathering all necessary information to determine whether the complaint is
substantiated.
• c) Whenever possible the laboratory shall acknowledge receipt of the
complaint, and provide the complainant with the outcome and, if
applicable, progress reports.

7.7.3 Resolution of complaint
• Investigation and resolution of complaints shall not result in any
discriminatory actions.
• The resolution of complaints shall be made by, or reviewed and
approved by, persons not involved in the subject of the complaint in
question. Where resources do not permit this, any alternative approach
shall not compromise impartiality.

7.8 Continuity and emergency preparedness planning
• The laboratory shall ensure that risks associated with emergency situations or
other conditions when laboratory activities are limited, or unavailable, have
been identified, and a coordinated strategy exists that involves plans,
procedures, and technical measures to enable continued operations after a
disruption.
• Plans shall be periodically tested and the planned response capability exercised,
where practicable. The laboratory shall:
• a) establish a planned response to emergency situations, taking into account the needs
and
capabilities of all relevant laboratory personnel;
• b) provide information and training as appropriate to relevant laboratory personnel;
• c) respond to actual emergency situations;
• d) take action to prevent or mitigate the consequences of emergency situations,
appropriate to the magnitude of the emergency and the potential impact.

Summary of Clause 7 of ISO 15189 2022
•ISO 15189:2022 Clause 7: Process Requirements focuses on the entire workflow in a
medical laboratory, from pre-examination to post-examination processes, including
quality control and reporting.
•By adhering to the process requirements of Clause 7 in ISO 15189:2022, a medical
laboratory ensures that its workflow is robust, reliable, and capable of consistently
delivering high-quality diagnostic services
•Here’s a detailed breakdown of Clause 7 and its subclauses, along with how to
implement each requirement effectively.

•Clause 7: Process Requirements
•7.1 Review of Requests, Tenders, and Contracts
 Requirement:
o Laboratories must review requests for medical examinations to ensure they meet
client requirements, applicable laws, and standards.
o Ensure clarity on sample types, methods, and results.
 Implementation:
o Develop a standard operating procedure (SOP) for request review.
o Use a checklist to confirm compliance with client and legal requirements.
o Example: Before accepting a test request, verify that the requested test can be
performed and meets the laboratory’s accreditation scope.

•7.2 Pre-Examination Processes
 Requirement:
o Manage sample collection, handling, and transportation to maintain
integrity.
o Address environmental factors affecting sample quality.
 Implementation:
o Train personnel on sample collection techniques.
o Use appropriate packaging and labeling to avoid contamination.
o Example: Implement chain-of-custody documentation for forensic
samples.

•7.3 Examination Processes
 Requirement:
o Use validated methods for examination processes to ensure reliable
results.
o Maintain records of validation activities.
 Implementation:
o Validate and document all new methods before use.
o Include verification records for standardized procedures.
o Example: Perform precision, accuracy, and reproducibility tests for new
assays.

•7.4 Post-Examination Processes
 Requirement:
o Ensure accurate and timely reporting of examination results.
o Implement mechanisms for verification and approval before release.
 Implementation:
o Use standardized templates for result reports.
o Assign designated personnel to review and authorize reports.
o Example: Use automated systems to reduce transcription errors in lab
results.

•7.5 Reporting of Results
 Requirement:
o Reports must be clear, unambiguous, and comply with relevant standards.
o Include essential details like patient identifiers, test method, and reference ranges.
 Implementation:
o Establish templates for reports, ensuring compliance with regulatory
requirements.
o Use peer reviews to validate the accuracy of reports.
o Example: Implement double-checks for critical results, such as abnormal cancer
markers.

•7.6 Ensuring Quality of Examination Results
 Requirement:
o Use quality control measures to monitor and maintain examination
accuracy.
o Participate in inter-laboratory comparisons or proficiency testing.
 Implementation:
o Integrate quality control samples into routine testing.
o Investigate and address deviations in QC results promptly.
o Example: Use positive and negative controls for molecular diagnostic
tests.

•7.7 Laboratory Information Management
 Requirement:
o Ensure the security and confidentiality of laboratory information
systems.
o Implement measures to safeguard data integrity.
 Implementation:
o Use secure software systems for data management.
o Regularly back up and test data recovery procedures.
o Example: Implement role-based access controls for laboratory staff.

•How to Implement Clause 7 Requirements
1. Document Procedures:
o Develop detailed SOPs for every stage, from sample collection to reporting.
o Clearly outline responsibilities and required records.
2. Train Personnel:
o Train all staff on the processes and the rationale behind them.
o Conduct refreshers regularly to reinforce compliance.
3. Monitor and Audit:
o Conduct internal audits to verify adherence to process requirements.
• Use audit results to identify gaps and opportunities for improvement

4. Implement Technology:
• Use laboratory information systems (LIS) to streamline
processes and reduce human errors.
• Automate routine QC checks where possible.
5. Feedback Mechanism:
• Collect feedback from patients, clinicians, and other
stakeholders.
• Use this input to refine processes.

8 Management system requirements
• 8.1 General requirements
• 8.1.1 General
• The laboratory shall establish, document, implement and maintain a management
system to support and demonstrate the consistent fulfilment of the requirements of
this document.
• As a minimum, the management system of the laboratory shall include the
following:
• — responsibilities (8.1)
• — objectives and policies (8.2)
• — documented information (8.2, 8.3 and 8.4)
• — actions to address risks and opportunities for improvement (8.5)
• — continual improvement (8.6)
• — corrective actions (8.7)
• — evaluations and internal audits (8.8)
• — management reviews (8.9)

8.1.2 Fulfilment of management system requirements
• The laboratory may meet 8.1.1 by establishing, implementing, and maintaining a
quality management system (e.g. in accordance with the requirements of ISO
9001) (see Table B.1).
• This quality management system shall support and demonstrate the consistent
fulfilment of the requirements of Clauses 4 to 7 and the requirements
specified in 8.2 to 8.9.

8.1.3 Management system awareness
• The laboratory shall ensure that persons doing work under the
laboratory’s control are aware of:
• a) relevant objectives and policies;
• b) their contribution to the effectiveness of the management system, including the
benefits of improved performance;
• c) the consequences of not conforming with the management system
requirements.

8.2 Management system documentation
• 8.2.1 General
• Laboratory management shall establish, document, and maintain objectives
and policies for the fulfilment of the purposes of this document and shall
ensure that the objectives and policies are acknowledged and
implemented at all levels of the laboratory organization.
• NOTE The management system documents can, but are not required to, be contained in a quality manual.
• 8.2.2 Competence and quality
• The objectives and policies shall address the competence, quality and
consistent operation of the laboratory.

• 8.2.3 Evidence of commitment
• Laboratory management shall provide evidence of commitment to the development and
implementation of the management system and to continually improving its effectiveness.
• 8.2.4 Documentation
• All documentation, processes, systems, and records, related to the fulfilment of the
requirements of this document shall be included in, referenced from, or linked to
the management system.
• 8.2.5 Personnel access
• All personnel involved in laboratory activities shall have access to the parts of the
management system documentation and related information that are
applicable to their responsibilities

Documents
• Policies:
• Statements that describe what is done & why
• They define goals & state intent & direction
• Strategic planning, Personnel, Inventory
• Processes:
• Interrelated steps in an activity that uses resources
• transforms input  output
• Flow charts
• Procedures:
• Detailed step by step instructions
• Detail not only technical but also activities such as respond to complaint from customer,
instructions on how to use IT system, how to validate equipment before use.
• Provides staff with clarification & transparency, should be readily accessible
• Records:
• History of what was done & cannot be changed
• TRF, examination results & reports, instrument printouts

8.3 Control of management system documents
• 8.3.1 General
• The laboratory shall control the documents (internal and external)
that relate to the fulfilment of this document.
• NOTE In this context, "document" can be policy statements, procedures and related job aids, flow charts,
instructions for use, specifications, manufacturer's instructions, calibration tables, biological reference intervals and
their origins, charts, posters, notices, memoranda, software documentation, drawings, plans, agreements, and
documents of external origin such as laws, regulations, standards and textbooks from which examination methods
are taken, documents describing personnel qualifications (such as job descriptions), etc. These can be in any form
or type of medium, such as hard copy or digital.

8.3.2 Control of documents
• The laboratory shall ensure that:
• a) documents are uniquely identified;
• b) documents are approved for adequacy before issue by authorized personnel who have
the expertise and competence to determine adequacy;
• c) documents are periodically reviewed and updated as necessary;
• d) relevant versions of applicable documents are available at points of use and, where
necessary, their distribution is controlled;
• e) changes and the current revision status of documents are identified;
• f) documents are protected from unauthorized changes and any deletion or removal;
• g) documents are protected from unauthorized access;
• h) the unintended use of obsolete documents is prevented, and suitable identification is
applied to them if they are retained for any purpose;
• i) at least one paper or electronic copy of each obsolete controlled document is retained for
a specified time period or in accordance with applicable specified requirements

8.4 Control of records
• 8.4.1 Creation of records
• The laboratory shall establish and retain legible records to demonstrate
fulfilment of the requirements of this document. Records shall be created at the
time each activity that affects the quality of an examination is performed.
• NOTE Records can be in any form or type of medium.
• 8.4.2 Amendment of records
• The laboratory shall ensure that amendments to records can be traced to
previous versions or to original observations. Both the original and amended
data and files shall be kept, including the date and where relevant, the time,
of alteration, an indication of the altered aspects and the personnel
making the alterations.

8.4.3 Retention of records
• a) The laboratory shall implement the procedures needed for the identification,
storage, protection from unauthorized access and changes, back-up, archive,
retrieval, retention time, and disposal of its records.
• b) The retention times for records shall be specified.
• NOTE 1 In addition to requirements, retention times can be chosen based on identified risks.
• c) Reported examination results shall be retrievable for as long as necessary or as
required.
• d) All records shall be accessible throughout the entire retention period, legible in
whichever medium the laboratory keeps records, and available for laboratory
management review (see 8.9).
• NOTE 2 Legal liability concerns regarding certain types of procedures (e.g. histology examinations, genetic examinations, pediatric
examinations) can require the retention of certain records for much longer times than for other records.

8.5 Actions to address risks and
opportunities for
improvement
• 8.5.1 Identification of risks and opportunities for improvement
• The laboratory shall identify risks and opportunities for improvement
associated with the laboratory activities to:
• a) prevent or reduce undesired impacts and potential failures in the laboratory
activities;
• b) achieve improvement, by acting on opportunities;
• c) assure that the management system achieves its intended results;
• d) mitigate risks to patient care;
• e) help achieve the purpose and objectives of the laboratory

8.5.2 Acting on risks and opportunities for
improvement
• The laboratory shall prioritize and act on identified risks.
• Actions taken to address risks shall be proportional to the potential impact on
laboratory examination results, as well as patient and personnel safety.
• The laboratory shall record decisions made and actions taken on risks and
opportunities.
• The laboratory shall integrate and implement actions on identified risks and
improvement opportunities into its management system and evaluate
their effectiveness.
• NOTE 1 Options to address risks can include identifying and avoiding threats, eliminating a risk source, reducing the likelihood or
consequences
of a risk, transferring a risk, taking a risk in order to pursue an opportunity for improvement, or accepting risk by informed decision.
• NOTE 2 Although this document requires that the laboratory identifies and addresses risks, there is no requirement for any particular risk
management method. Laboratories can use ISO 22367 and ISO 35001 for guidance.
• NOTE 3 Opportunities for improvement can lead to expanding the scope of the laboratory activities, applying new technology, or creating
other possibilities to fulfil patient and user needs.

8.6 Improvement
• 8.6.1 Continual improvement
• a) The laboratory shall continually improve the effectiveness of the management
system, including the pre-examination, examination and post-examination processes as
stated in the objectives and policies.
• b) The laboratory shall identify and select opportunities for improvement and develop,
document, and implement any necessary actions. Improvement activities shall be
directed at areas of highest priority based on risk assessments and the opportunities
identified (see 8.5).
• NOTE Opportunities for improvement can be identified through risk assessment, use of the policies, review of the
operational
procedures, overall objectives, external evaluation reports, internal audit findings, complaints, corrective actions,
management reviews, suggestions from personnel, suggestions or feedback from patients and users, analysis of data and EQA
results.
• c) The laboratory shall evaluate the effectiveness of the actions taken.
• d) Laboratory management shall ensure that the laboratory participates in continual
improvement activities that encompass relevant areas and outcomes of patient care.
• e) Laboratory management shall communicate to personnel its improvement plans and
related goals.

8.6.2 Laboratory patients, user, and personnel feedback
• The laboratory shall seek feedback from its patients, users, and
personnel.
• The feedback shall be analyzed and used to improve the management
system, laboratory activities and services to users.
• Records of feedback shall be maintained including the actions taken.
• Communication shall be provided to personnel on actions taken arising
from their feedback.

Swiss Cheese model of error prevention

8.7 Nonconformities and corrective actions
• 8.7.1 Actions when nonconformity occurs
• When a nonconformity occurs, the laboratory shall:
• a) Respond to the nonconformity and, as applicable:
• 1) take immediate action to control and correct the nonconformity;
• 2) address the consequences, with a particular focus on patient safety including
escalation to the appropriate person.
• b) Determine the cause(s) of the nonconformity.
• c) Evaluate the need for corrective action to eliminate the cause(s) of the
nonconformity, in order to reduce the likelihood of recurrence or occurrence
elsewhere, by:
• 1) reviewing and analyzing the nonconformity;
• 2) determining whether similar nonconformities exist, or could potentially occur;
• 3) assessing the potential risk(s) and effect(s) if the nonconformity recurs.

• d) Implement any action needed.
• e) Review and evaluate the effectiveness of any corrective action
taken.
• f) Update risks and opportunities for improvement, as needed
• g) Make changes to the management system, if necessary.

• 8.7.2 Corrective action effectiveness
• Corrective actions shall be appropriate to the effects of the nonconformities
encountered and shall mitigate the identified cause(s).
• 8.7.3 Records of nonconformities and corrective actions
• The laboratory shall retain records as evidence of the
• a) nature of the nonconformities, cause(s) and any subsequent actions taken, and
• b) evaluation of the effectiveness of any corrective action.

8.8 Evaluations
• 8.8.1 General
• The laboratory shall conduct evaluations at planned intervals to demonstrate
that the management, support, and pre-examination, examination, and
post- examination processes meet the needs and requirements of patients
and laboratory users, and to ensure conformity to the requirements of this
document.

8.8.2 Quality indicators
• The process of monitoring quality indicators [see 5.5 d)] shall be
planned, which includes establishing the objectives,
methodology, interpretation, limits, action plan and duration
of monitoring. The indicators shall be periodically reviewed,
to ensure continued appropriateness.

8.8.3 Internal audits
• 8.8.3.1 The laboratory shall conduct internal audits at planned intervals to
provide information on whether the management system
• a) conforms to the laboratory’s own requirements for its management system, including
the laboratory activities,
• b) conforms to the requirements of this document, and
• c) is effectively implemented and maintained.
• 8.8.3.2 The laboratory shall plan, establish, implement and maintain an internal
audit programme that includes:
• a) priority given to risk to patients from laboratory activities;
• b) a schedule which takes into consideration identified risks; the outcomes of both external
evaluations and previous internal audits; the occurrence of nonconformities,
incidents, and complaints; and changes affecting the laboratory activities;

• c) specified audit objectives, criteria and scope for each audit;
• d) selection of auditors who are trained, qualified and authorized to assess
the performance of the laboratory's management system, and, whenever
resources permit, are independent of the activity to be audited;
• e) ensuring objectivity and impartiality of the audit process
• f) ensuring that the results of the audits are reported to relevant
personnel;
• g) implementation of appropriate correction and corrective actions without
undue delay;
• h) retention of records as evidence of the implementation of the audit
programme and audit results.
• NOTE ISO 19011 provides guidance for auditing management systems.

8.9 Management reviews
• 8.9.1 General
• Laboratory management shall review its management system at
planned intervals to ensure its continuing suitability, adequacy
and effectiveness, including the stated policies and objectives
related to the fulfilment of this document.

8.9.2 Review input
• The inputs to management review shall be recorded and shall include
evaluations of at least the following:
• a) status of actions from previous management reviews, internal and
external changes to the management system, changes in the
volume and type of laboratory activities and adequacy of
resources;
• b) fulfilment of objectives and suitability of policies and procedures;
• c) outcomes of recent evaluations, process monitoring using quality
indicators, internal audits, analysis of non-conformities, corrective
actions, assessments by external bodies;
• d) patient, user and personnel feedback and complaints

• e) quality assurance of result validity;
• f) effectiveness of any implemented improvements and actions taken to address
risks and opportunities for improvement;
• g) performance of external providers;
• h) results of participation in interlaboratory comparison programmes;
• i) evaluation of POCT activities;
• j) other relevant factors, such as monitoring activities and training.

8.9.3 Review output
• The output from the management review shall be a record of decisions and
actions related to at least:
• a) the effectiveness of the management system and its processes;
• b) improvement of the laboratory activities related to the fulfilment of the
requirements
of this document;
• c) provision of required resources;
• d) improvement of services to patients and users;
• e) any need for change
• Laboratory management shall ensure that actions arising from management
review are completed within a specified time frame.
• Conclusions and actions arising from management reviews shall be
communicated to laboratory personnel.

Comparison between ISO 15189:2012 and
ISO 15189:2022

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