ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

Laboratory provides oversight for point-of-care testing including governance, training and quality assurance.

• POCT committee minutes
• Operator training records
• QC results

• POCT users not in competence programme
• Connectivity to LIS missing

Requires laboratories to operate free of bias and conflicts of interest, with identification and management of risks to impartiality.

• Impartiality policy and risk register
• Declarations of interest from laboratory staff
• Top management commitment statement
• Impartiality review minutes

• No periodic review of impartiality risks
• Commercial pressures on referring clinicians not assessed
• Director conflicts not declared
• Mitigations not documented for identified risks

Requires secure management of patient data with controlled disclosure, including legally enforceable commitments to confidentiality.

• Confidentiality agreements for staff and contractors
• Patient data handling procedure
• Disclosure log with legal basis
• Information security policy referencing patient records

• Verbal disclosures to clinicians not logged
• No process for legally compelled disclosures
• Third party service providers without confidentiality clauses
• Patient consent for secondary use not captured

Requires consideration of patient input in methods, cost transparency, and obtaining informed consent for examinations.

• Patient information leaflets
• Informed consent records
• Test catalogue with turnaround times and cost
• Patient feedback channel

• Consent missing for genetic or sensitive tests
• Pricing information not accessible to patients
• Vulnerable patient pathways not defined
• No mechanism to capture patient input on methods

Requires the laboratory to be a legal entity or a defined part of a legal entity that is legally accountable for its laboratory activities.

• Certificate of incorporation or equivalent
• Organizational structure referencing legal parent
• Liability insurance certificate
• Scope statement linking entity to laboratory

• Laboratory operating under undefined organizational unit
• Insurance limits not reviewed annually
• Legal accountability split unclear between sites
• Subsidiary status not reflected in management system

Specifies competence requirements, responsibilities, and authority of the laboratory director including duty delegation.

• Director appointment letter and CV
• Documented duties of the laboratory director
• Delegation register with named deputies
• Director performance review records

• Director qualifications not aligned with national requirements
• Delegations verbal and not recorded
• No deputy named for absence cover
• Director responsibilities overlap with quality manager without clear split

Requires documentation of the scope of laboratory activities spanning pre-examination, examination, and post-examination phases.

• Defined scope of laboratory activities
• Test menu mapped to pre, examination, post phases
• Point of care testing inventory
• Outsourced examination list

• Point of care testing excluded from documented scope
• Send out tests not part of management system
• Scope statement not updated when new assays go live
• Pre and post examination activities not explicitly covered

Requires a defined organizational hierarchy with clear roles, responsibilities, and reporting relationships.

• Organization chart
• Role descriptions with authorities
• Quality manager appointment letter
• Reporting matrix for clinical and operational decisions

• Quality manager reports to operations creating conflict
• Authorities not defined for after hours decisions
• Locum staff not placed in the org chart
• No documented escalation path for critical issues

Requires measurable objectives and policies aligned with ISO 15189 and commitment to good professional practice at all levels.

• Quality policy statement
• Measurable quality objectives
• Annual quality plan
• Communication evidence to staff

• Objectives not measurable or time bound
• Objectives not cascaded to teams
• Policy not reviewed annually
• Progress on objectives not reported to management review

Requires proactive identification, assessment, and mitigation of risks to patient safety and laboratory operations.

• Laboratory risk register
• Risk assessment methodology
• Patient safety incident reviews
• Risk treatment plans with owners

• Risks captured but not scored or owned
• Patient impact not assessed for new assays
• Risk reviews not linked to incidents and complaints
• No prospective risk analysis before method changes

Competence requirements for personnel involved in the certification process

• Competence matrix for laboratory personnel
• Training and qualification records
• Authorization records for examination activities
• Continuing professional development log

• Competence reassessment intervals not defined
• Authorization tied to job title rather than verified competence
• No evidence of practical assessment for new methods
• Training records missing for locum or agency staff

Maintain up to date records of qualifications, training, experience and performance for ISMS personnel.

• Personnel files
• Performance evaluations
• CPD records

• Out of date records
• No performance evidence

Requires the laboratory to have the resources needed to carry out its activities in accordance with the requirements of this document.

• Resource plan covering staff, space, equipment, consumables
• Budget approval for laboratory operations
• Capacity and workload analysis
• Business case records for resource changes

• Workload not measured against capacity
• Resource gaps surfaced only after incidents
• Budget cycles not aligned with method changes
• Surge capacity not planned for outbreak scenarios

Specifies competency requirements, authorization processes, continuing education obligations, and maintenance of qualification records.

• Job descriptions and competence requirements
• Training plans and records
• Authorization records for sign out
• Annual competence reassessment records

• Reassessment overdue for long serving staff
• New starter checklist incomplete
• Competence on rare assays not maintained
• Locum induction not recorded

Requires controls for contamination prevention, adequate ventilation, proper storage, and appropriate amenities.

• Facility layout with zoning and containment
• Temperature and humidity monitoring logs
• Biosafety risk assessment and SOPs
• Access control records for restricted areas

• Containment level not validated for new agents
• Environmental excursions not investigated
• Storage of patient samples not segregated from reagents
• Cleaning and decontamination logs incomplete

Requires proper selection, acceptance testing, regular maintenance, and adverse event reporting for all laboratory equipment.

• Equipment inventory with unique identifiers
• Preventive maintenance schedule and records
• Installation and operational qualification records
• Equipment use log per analyser

• Backup analysers not maintained to same standard
• Out of service status not flagged in LIS
• Maintenance carried out by users without training
• No verification after software upgrades

Requires SI unit alignment, documented measurement uncertainty, and metrological traceability of measurement results.

• Calibration programme with intervals
• Traceability statements for reference materials
• Certificates from accredited calibration providers
• Calibration verification records

• Traceability chain broken to manufacturer working calibrators
• Calibration intervals not justified by data
• Reference material lot changes not bridged
• No measurement uncertainty estimate per assay

Requires procedures for receipt, storage, acceptance testing, inventory control, and adverse event reporting for reagents and consumables.

• Reagent inventory with lot and expiry
• Acceptance criteria for new lots
• Lot to lot verification records
• Storage condition monitoring for reagents

• Lot to lot verification skipped under pressure
• Expired reagents found in active stock
• Storage temperature deviations not actioned
• Critical reagents single sourced without contingency

Requires formal contracts with users and POCT operators defining responsibilities, service levels, and expectations.

• Service agreements with referring clinicians and trusts
• Contract review records
• Change communication to customers
• Service level reports

• Agreements not updated when scope changes
• Turnaround time commitments not monitored
• Sample acceptance criteria not in writing
• No periodic review of agreements

Requires supplier qualification processes and ongoing monitoring of performance for externally sourced products and services.

• Approved supplier list
• Referral laboratory accreditation evidence
• Supplier evaluation records
• Contract terms for referral testing

• Referral labs used without accreditation evidence
• Supplier performance not monitored
• Critical suppliers not risk assessed
• No process for handling unaccredited referral results

Requires documented procedures for all laboratory processes from pre-examination through post-examination.

• Process map covering pre, examination, post phases
• Linked SOPs for each phase
• Roles and responsibilities per phase
• Process performance indicators

• Handoffs between phases not documented
• Indicators tracked for examination only
• Process map out of date after LIS upgrade
• No single owner for end to end test journey

Covers patient information management, request handling, sample collection, transportation, receipt, and storage procedures.

• Sample collection manual
• Patient identification procedure
• Transport conditions and chain of custody
• Sample rejection criteria and log

• Phlebotomy staff outside laboratory governance
• Transport temperature not monitored end to end
• Rejection criteria applied inconsistently between shifts
• Mislabelled sample rate not trended

Requires method verification/validation, measurement uncertainty evaluation, reference interval establishment, and result validity assurance.

• Validated methods with verification records
• IQC plan with rules and ranges
• IQC review evidence with sign off
• Examination SOPs with revision history

• IQC rules not chosen based on error budget
• Verification limited to vendor claims
• IQC failures closed without root cause
• Method changes not revalidated

Covers result reporting, clinical advice, sample retention, and disposal in accordance with regulations.

• Reporting SOP with reference intervals and units
• Critical results notification log
• Result amendment and recall procedure
• Reporting template for each test

• Critical results notified but not acknowledged
• Reference intervals not validated for local population
• Amended results not flagged in downstream systems
• Interpretive comments inconsistent between reporters

Requires detection, evaluation, documentation, and correction of nonconforming laboratory work.

• Nonconformity register
• Containment and recall procedure
• Patient impact assessment template
• Communication records to clinicians

• Patient impact assessed only for severe events
• Recall actions not closed within target
• Nonconformities not linked to risks
• Trend analysis missing across nonconformity types

Requires validation of information systems, documented downtime procedures, and oversight of off-site data providers.

• LIS validation records
• Access control matrix for laboratory systems
• Backup and restore test evidence
• Interface validation for instrument and EHR connections

• LIS changes not revalidated
• Generic accounts in use for analyser interfaces
• Backups untested or restores not exercised
• Audit trails disabled or unreviewed

Requires structured receipt, investigation, and objective resolution of complaints from patients and other stakeholders.

• Complaints procedure
• Complaints register with categories
• Investigation and response records
• Complaint trend analysis

• Verbal complaints not captured
• No target for complaint closure
• Trends not reviewed in management review
• Complainants not informed of outcome

Requires business continuity planning with regular testing to ensure service during disruptions and emergencies.

• Laboratory continuity plan
• Emergency response procedures
• Backup analyser arrangements
• Exercise reports and lessons learned

• Plan not tested in last 12 months
• Critical assays without backup arrangements
• LIS failure scenarios not exercised
• Mutual aid with peer laboratories undocumented

Requires a structured quality management system ensuring consistent compliance with ISO 15189.

• Statement of chosen management system option
• Mapping between laboratory and parent organization systems
• Quality manual or equivalent overview
• Management system scope statement

• Option chosen but integration not documented
• Conflicts between parent and laboratory procedures
• Quality manual out of date
• Scope of management system unclear

Requires documented quality policies, objectives, leadership commitment, and personnel access to documentation.

• Documented information register
• Quality manual or system overview
• Procedure and SOP library
• Document templates with controls

• Documents stored in multiple locations
• Procedure scope unclear for multi site labs
• No master index of controlled documents
• Inconsistent format across SOPs

Requires document approval, periodic review, version control, and access safeguards for management system documents.

• Document control procedure
• Document approval and review records
• Version history per controlled document
• Distribution list and acknowledgement

• Superseded documents still accessible at the bench
• Review intervals exceeded
• External documents not controlled
• Acknowledgement of new versions not captured

Requires real-time creation, traceable amendments, and retention based on legal and clinical requirements.

• Records retention schedule
• Storage and access controls for records
• Disposal records
• Backup evidence for electronic records

• Retention not aligned with national requirements
• Paper records stored without environmental controls
• Disposal not authorized or recorded
• Electronic records not protected against alteration

Requires identification, evaluation, and prioritization of risks and opportunities for improvement of the management system.

• Risk and opportunity register
• Planned actions with owners and dates
• Effectiveness review evidence
• Linkage to objectives and management review

• Opportunities not captured alongside risks
• Actions closed without effectiveness check
• Risks not refreshed after major changes
• No traceability between risks, objectives, and audits

Requires continual enhancement of the management system using audit data, feedback, and performance metrics.

• Improvement project register
• Performance trend analyses
• Lessons learned summaries
• Improvement objectives linked to KPIs

• Improvement reactive rather than planned
• Lessons not shared across sites
• Improvement actions without measurable benefit
• No staff led improvement channel

Requires immediate correction of nonconformities, root cause analysis, and verification of corrective action effectiveness.

• Corrective action procedure
• CAPA tracker with root cause and effectiveness
• Root cause analysis templates
• Trend analysis of nonconformities

• Corrective actions limited to fixing the symptom
• Root cause analysis superficial
• Effectiveness not reverified after closure
• No common cause analysis across similar events

Requires quality indicators, internal audit planning, and compliance verification through systematic evaluation.

• Internal audit programme and schedule
• Audit reports with findings and actions
• EQA participation records and reviews
• IQC trend analysis and indicator reports

• Audits do not sample all examination disciplines annually
• EQA failures not investigated as nonconformities
• Indicators tracked but not acted on
• Auditor independence not assured

Requires periodic management system assessment with documented decisions, actions, and resource allocation.

• Management review schedule and inputs list
• Management review minutes
• Action register from management review
• Resource decisions tied to review outputs

• Reviews held but inputs incomplete
• Patient and clinician feedback missing
• Actions not tracked between reviews
• EQA and IQC performance not summarized

Top management reviews QMS at planned intervals to ensure continuing suitability, adequacy and effectiveness.

• Management review minutes
• Input pack
• Action register

• Inputs missing patient safety data
• Actions without owners

Externally provided products and services that affect laboratory activities are evaluated and approved.

• Supplier evaluation forms
• Approved supplier register
• Periodic performance reviews

• Critical suppliers not re-evaluated
• Single-source risk untreated