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Many medical laboratories run good science but fragile quality systems. Procedures describe what should happen rather than what does happen, internal quality control is plotted but rarely acted on, method verification is incomplete, and nonconformities are closed without addressing the cause. Pre-examination errors at collection and transport often go unmeasured because they sit outside the laboratory walls. Under ISO 15189:2022 these weaknesses matter more, because the standard now puts patient risk, impartiality and point-of-care testing inside the scope of the laboratory's responsibility.

This programme follows the path of a sample and the structure of the standard together. It moves through five stages: understanding the requirements and the risk-based logic of the 2022 edition, controlling the pre-examination process, assuring the validity of examination results, managing post-examination reporting and information, and running the management system that sustains improvement and prepares the laboratory for assessment.

Built on recognised practice. The programme references ISO 15189:2022 and its relationship with ISO/IEC 17025, ISO 22367 on risk management for medical laboratories, ISO 15190 on laboratory safety, ISO 35001 on biorisk management, CLSI guidance on method verification, and widely used statistical quality control approaches such as Westgard multirule procedures and sigma metrics. Participants learn how to apply them to real laboratory decisions, not only what they say.

Decisions this programme improves. Whether a method is fit for clinical use; which control rules and frequencies to apply to each assay; when to stop releasing results and what to do with patient results already reported; how to classify and respond to a nonconformity; which risks to prioritise; and what evidence management and assessors need to see that the system works.

How it is delivered. Twenty hours across five sessions, built around one running case: a hospital laboratory with a satellite point-of-care service preparing for assessment against ISO 15189:2022. Participants map its gaps, verify a method using sample data, interpret control charts, investigate a reporting error and write the management review summary.

In-house option. For organisations, the programme can be tailored to your own procedures, analysers, laboratory information system and assessment findings, and delivered for laboratory, quality and clinical staff together so that responsibilities across the testing pathway are clear.

Who Should Attend

Laboratory leadership: laboratory directors, managers and section heads in hospital, private and public health laboratories

Quality professionals: quality managers, quality officers and document controllers in medical laboratories

Senior technical staff: senior medical technologists, specialists and supervisors responsible for methods and quality control

Point-of-care coordinators: staff responsible for testing performed outside the central laboratory

Health sector quality and regulatory staff who oversee or assess laboratory services

Objectives

Explain the structure of ISO 15189:2022 and the main changes from the previous edition, including the integration of point-of-care testing

Carry out a gap analysis of a laboratory quality management system against the standard's requirements

Apply a risk management process to the testing pathway and record risks, controls and residual risk

Define controls for sample collection, identification, transport and acceptance, and set quality indicators to monitor them

Plan and document method verification and, where needed, validation, including precision, trueness and measurement uncertainty

Select statistical quality control rules and interpret control charts to accept or reject analytical runs

Use external quality assessment results to identify and correct analytical bias

Establish controls for result reporting, critical results, report amendments and laboratory information systems

Investigate nonconformities using root cause analysis and verify the effectiveness of corrective actions

Plan internal audits and a management review that give leadership a reliable view of system performance

Course Outline

What ISO 15189:2022 Expects: Structure, Principles and Risk-Based Thinking

Purpose and scope of ISO 15189 and how it differs from ISO/IEC 17025 and ISO 9001
Structure of the 2022 edition: general, structural, resource, process and management system requirements
Key changes: patient focus, risk management and the inclusion of point-of-care testing
Impartiality, confidentiality and the laboratory's responsibilities to patients and users
Risk management for medical laboratories using ISO 22367 principles
Gap analysis and planning the path to assessment

Getting the Sample Right: Pre-Examination Control

Request information, patient identification and sample labelling
Collection instructions for wards, clinics and external sites
Transport, stability, acceptance and rejection criteria
Managing referral laboratories and outsourced examinations
Quality indicators for pre-examination errors and how to act on them
Working with clinical teams to reduce avoidable recollections

Assuring Valid Results: Methods, Equipment and Quality Control

Method verification and validation: precision, trueness, linearity and reference intervals
Measurement uncertainty and metrological traceability in practical terms
Equipment, reagents and consumables: acceptance, calibration and maintenance records
Internal quality control design: control materials, rules, frequency and sigma metrics
Responding to control failures and assessing the impact on patient results
External quality assessment and interlaboratory comparisons
Point-of-care testing governance: devices, operators, training and oversight

Reporting and Information: Post-Examination Control

Review and release of results, including autoverification rules
Critical and significant results: communication and records
Report content, interpretive comments and amended reports
Laboratory information systems: validation, access control and data integrity
Retention and disposal of samples and records
Complaints and feedback from clinicians and patients

Sustaining the System: Nonconformities, Audit and Improvement

Document control that staff actually use, including electronic systems
Personnel competence: training, assessment and authorisation records
Nonconformity management and root cause analysis tools
Planning and conducting internal audits, including vertical audits along the testing pathway
Management review inputs and outputs that drive decisions
Laboratory safety and biorisk management under ISO 15190 and ISO 35001
Action plan: priorities for your laboratory's quality system

Competencies

ISO 15189:2022 requirements and gap analysis

Risk management across the laboratory testing pathway

Pre-examination control and quality indicators

Method verification and measurement uncertainty

Statistical quality control and external quality assessment

Point-of-care testing governance

Result reporting, critical results and information system control

Nonconformity management and root cause analysis

Internal audit and management review for medical laboratories

Dubai

Elite Academy can deliver its complete portfolio of professional training programs in Dubai. With a global business, aviation and services hub with excellent international accessibility, the destination suits both scheduled learning and tailored arrangements for organizations or individual professionals. As an Elite Academy training destination, Dubai provides access to our full portfolio rather than a city-specific set of specializations. The city is a global business, aviation and services hub with excellent international accessibility, creating a suitable environment for organizations developing their teams and for professionals attending independently. Upcoming scheduled courses are listed on this page, while any other Elite Academy program can also be requested for delivery in Dubai, subject to scheduling and delivery requirements. Explore the schedule or browse our training areas to find the right option.

Quality Management in Medical Laboratories to ISO 15189