ISO 15189:2022 is the international standard defining quality management system and technical competence requirements for medical laboratories. For respiratory and sleep laboratories specifically, meeting every clause is not just a compliance exercise — it is a framework for safer patient outcomes, reproducible testing, and defensible clinical decisions. This guide breaks down the most critical clauses and translates them into practical actions your team can take today.

TL;DR

• ISO 15189:2022 introduced significant updates to risk management, POCT integration, and leadership accountability that directly affect respiratory and sleep labs.

• Document control, training records, and quality control are the three areas where labs most commonly fall short during audits.

• Pulmonary function lab accreditation requires clause-specific evidence, not just good intentions.

• A purpose-built laboratory quality management system removes most of the administrative burden of compliance.

• Transitioning your existing system to one built for accreditation is simpler than most labs expect.

About the Author: This guide was developed by the Rezibase team — respiratory scientists and healthcare technology specialists with over 37 years of combined experience building and supporting accredited respiratory and sleep laboratories across Australia, New Zealand, the UK, and Ireland.

What Is ISO 15189:2022 and What Changed from the Previous Version?

ISO 15189 is the international standard that outlines quality management system and competence requirements for medical laboratories. The 2022 edition (the fourth edition) replaced the 2012 version with a substantially restructured framework.

According to Qualio's complete overview of ISO 15189, the standard applies to all medical laboratories seeking to demonstrate competence and improve patient safety.

Key ISO 15189 2022 changes include:

As Roche Diagnostics notes, a key update is the stronger focus on risk-based thinking, which now runs through every clause rather than sitting in isolation. For respiratory and sleep labs, this means your quality framework must demonstrate that risk has been considered at every point in the patient testing pathway.

Which Clauses Are Most Relevant to Respiratory and Sleep Laboratories?

Not every clause carries equal weight for a specialist respiratory or sleep lab. The clauses below represent the highest-risk areas for non-compliance in this setting.

Clause 4: General Requirements (Impartiality and Confidentiality)

• Labs must demonstrate structural independence in their reporting processes.

• Patient data handling must be formally documented.

Clause 5: Structural Requirements (Leadership and Governance)

• Laboratory directors must have defined, documented responsibilities.

• Governance structures must be visible and auditable.

Clause 6: Resource Requirements (Competence, Equipment, Environment)

• All staff performing pulmonary function testing must have documented competency assessments.

• Equipment calibration and maintenance records must be traceable and current.

• Environmental conditions (temperature, humidity) must be monitored and recorded.

Clause 7: Process Requirements (Pre-, Intra-, and Post-Examination)

• Referral intake, patient preparation instructions, and result reporting must all follow documented procedures.

• Turnaround times and critical value notifications must be defined.

Clause 8: Management System Requirements (ISO 15189 Quality Management)

• This is where iso 15189 document control lives.

• Includes internal audits, non-conformance management, corrective actions, and management review.

How Should a Respiratory Lab Approach ISO 15189 Document Control?

ISO 15189 document control means maintaining a controlled, version-managed library of all policies, procedures, and forms that govern laboratory operations.

According to the ISO 15189:2022 Documentation Guide, the laboratory must establish and implement processes to ensure that publicly available information about examinations is accessible and current.

Practical steps for document control in a respiratory lab:

1. Catalogue all documents — SOPs, referral forms, consent forms, report templates, equipment manuals, and training records.

2. Assign version numbers and review dates — Every document must have a clear version history.

3. Control access and distribution — Staff must only access the current approved version.

4. Link documents to processes — Each procedure should map to a specific clause or workflow step.

5. Schedule periodic reviews — At minimum annually, or when a process changes.

The most common audit failure in this area is not the absence of documents, but the presence of outdated versions still in circulation. A cloud-based laboratory quality management system with built-in document control eliminates this risk automatically.

What Does ISO 15189:2022 Require for Quality Control in Pulmonary Function Testing?

Quality control in the context of pulmonary function lab accreditation means demonstrating that your measurement processes are stable, reproducible, and within defined limits of acceptable performance.

Key QC requirements under ISO 15189:2022:

• Internal QC: Regular use of control materials with defined acceptance criteria (Westgard rules are widely used).

• External QC / EQA: Participation in an approved external quality assurance scheme.

• Equipment verification: Calibration checks must be performed and recorded at defined intervals.

• Biological QC: Some labs use trained staff as biological controls for spirometry, which must be formally documented.

For sleep laboratories, QC extends to signal quality verification, scoring reliability, and inter-scorer agreement documentation.

How Does the 2022 Edition Handle Point-of-Care Testing?

As Poctify's guide to ISO 15189:2022 explains, the 2022 edition incorporates ISO 22870 for point-of-care testing directly into the standard, rather than treating it as a separate document. This is relevant to respiratory labs that perform bedside spirometry, capillary blood gas testing, or satellite sleep studies outside the main laboratory.

Requirements for POCT under ISO 15189:2022:

• POCT must be governed by the same quality management framework as the main lab.

• Staff performing POCT must hold documented competency assessments.

• Results must be traceable and integrated into the patient record.

What Is the UKAS Transition Timeline and Why Does It Matter?

According to UKAS, the transition to ISO 15189:2022 has been underway since 2024, with accreditation bodies progressively requiring compliance with the new edition. Labs that have not yet transitioned should treat this as an active priority, not a future consideration.

The transition involves a gap analysis against the new clauses, followed by systematic updates to your quality management system, documentation, and staff training records.

How Can Rezibase Help Respiratory and Sleep Labs Meet ISO 15189:2022?

Rezibase includes a dedicated accreditation module built specifically for respiratory and sleep departments seeking to meet TSANZ/NATA Standards and ISO 15189 requirements. The module covers:

• Document management with version control

• Training records and competency tracking

• Non-conformance logging and corrective action plans

• Internal audit management

• Quality control using Westgard methods

Because Rezibase was founded by respiratory scientists, every feature reflects the real workflows of a clinical physiology lab, not a generic laboratory template. Labs currently using Respiro or other legacy systems can migrate to Rezibase with straightforward data transfer support, making the switch far less disruptive than most teams expect.

Frequently Asked Questions

What is the main purpose of ISO 15189:2022?
It defines quality and competence requirements for medical laboratories to ensure consistent, safe, and reliable patient testing.

Do respiratory and sleep labs need ISO 15189 accreditation?
In Australia, NATA accreditation against ISO 15189 is required for many funded respiratory and sleep services. In the UK, UKAS accreditation is the equivalent requirement.

What are the biggest changes in ISO 15189 2022?
Risk-based thinking, stronger leadership accountability, POCT integration, and a more explicit focus on patient-centred processes.

How long does ISO 15189 implementation take?
Typically six to eighteen months depending on the lab's starting point and the resources available.

Can a cloud-based system satisfy ISO 15189 document control requirements?
Yes, provided it maintains version control, access logs, and audit trails — all of which Rezibase supports natively.

What is Westgard and why does it matter for QC?
Westgard rules are a set of statistical criteria used to evaluate whether a QC run is in control. They are widely accepted as the standard approach for laboratory QC and are referenced in ISO 15189 guidance.

Is POCT covered under ISO 15189:2022?
Yes. The 2022 edition incorporates ISO 22870 directly, meaning POCT services must comply with the same quality framework as the main laboratory.

About Rezibase

Rezibase is Australia's most advanced cloud-based respiratory and sleep reporting and management platform, trusted by over 35 sites including NHS hospitals in the UK and NSW Health in Australia. Built by respiratory scientists Peter Rochford and the late Jeff Pretto, and now part of the Cardiobase group, Rezibase delivers a vendor-neutral, fully integrated solution covering everything from patient referrals and bookings through to accreditation management and AI-assisted reporting. With over 37 years of combined experience and a transparent, no lock-in pricing model, Rezibase exists to make life easier for respiratory scientists and safer for their patients.

Ready to see how Rezibase can simplify your ISO 15189:2022 compliance journey? Visit rezibase.com to book a demo or start your 30-day free trial.

References

• ISO. ISO 15189:2022(en), Medical laboratories. https://www.iso.org/obp/ui/#iso:std:iso:15189:ed-4:v1:en

• Scribd. ISO 15189:2022 Documentation Guide. https://www.scribd.com/document/754888491/DocumentationrequirementsinISO15189-2022

• Qualio. What is ISO 15189? A complete overview. https://www.qualio.com/blog/iso-15189

• Roche Diagnostics. Insights on updated accreditation guidelines ISO 15189:2022. https://diagnostics.roche.com/global/en/lab-leaders/article/iso-15189-updated-accreditation-guidelines.html

• Poctify. ISO 15189:2022 - Poctify Guide to POCT Accreditation. https://poctify.com/iso151892022/

• UKAS. Embracing change - the transition to ISO 15189:2022. https://www.ukas.com/resources/resources/15189-transition-update/