News about the ISO 15189 standard version 2022 medical laboratory

"Medical laboratories – Requirements for quality and competence"

 

 

The 2022 version of ISO 15189 replaces the third edition (2012 version) and also replaces ISO 22870 (2016). The requirements for point-of-care testing (POCT), which were previously in ISO 22870, are now integrated into ISO 15189 (2022). Obtaining ISO 15189 accreditation for your laboratory enables you to improve:

ISO 15189 (2022 version) requirements

 

ISO 15189 (2022 version) requirements quiz

 

PQB T 65v22 training: ISO 15189 readiness (2022 version) and free, demo without registration

 

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PQB T 90v22 training package: ISO 15189 (2022 version)

 

 

The technical revision of the ISO 15189 standard primarily addresses the following:

ARTICLES and clauses aligned with ISO 17025 (2017 version)

• Foreword
• Introduction
• 1 Scope
• 2 Normative references
• 3 Terms and definitions
• 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
• 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
  • 5.3 Laboratory activities
    • 5.3.1 General
    • 5.3.2 Conformance
    • 5.3.3 Advisory services
  • 5.4 Structure and authority
    • 5.4.1 General
    • 5.4.2 Quality management
  • 5.5 Objectives and policies
  • 5.6 Risk management
• 6 Resource requirements
  • 6.1 General
  • 6.2 Personnel
    • 6.2.1 General
    • 6.2.2 Competence requirements
    • 6.2.3 Authorization
    • 6.2.4 Continuing education and professional development
    • 6.2.5 Personnel records
  • 6.3 Facilities and environmental conditions
    • 6.3.1 General
    • 6.3.2 Facility controls
    • 6.3.3 Storage facilities
    • 6.3.4 Personnel facilities
    • 6.3.5 Sample collection facilities
  • 6.4 Equipment
    • 6.4.1 General
    • 6.4.2 Equipment requirements
    • 6.4.3 Equipment acceptance procedure
    • 6.4.4 Equipment instructions for use
    • 6.4.5 Equipment maintenance and repair
    • 6.4.6 Reporting adverse incident reporting
    • 6.4.7 Equipment records
  • 6.5 Equipment calibration and metrological traceability
    • 6.5.1 General
    • 6.5.2 Equipment calibration
    • 6.5.3 Metrological traceability of measurement results
  • 6.6 Reagents and consumables
    • 6.6.1 General
    • 6.6.2 Reagents and consumables — Receipt and storage
    • 6.6.3 Reagents and consumables — Acceptance testing
    • 6.6.4 Reagents and consumables — Inventory management
    • 6.6.5 Reagents and consumables — Instructions for use
    • 6.6.6 Reagents and consumables — Adverse incident reporting
    • 6.6.7 Reagents and consumables — Records
  • 6.7 Service agreements
    • 6.7.1 Agreements with laboratory users
    • 6.7.2 Agreements with POCT operators
  • 6.8 Externally provided products and services
    • 6.8.1 General
    • 6.8.2 Referral laboratories and consultants
    • 6.8.3 Review and approval of externally provided products and services
• 7 Process requirements
  • 7.1 General
  • 7.2 Pre-examination processes
    • 7.2.1 General
    • 7.2.2 Laboratory information for patients and users
    • 7.2.3 Requests for providing laboratory examinations
    • 7.2.4 Primary sample collection and handling
    • 7.2.5 Sample transportation
    • 7.2.6 Sample receipt
    • 7.2.7 Pre-examination handling, preparation, and storage
  • 7.3 Examination processes
    • 7.3.1 General
    • 7.3.2 Verification of examination methods
    • 7.3.3 Validation of examination methods
    • 7.3.4 Evaluation of measurement uncertainty (MU)
    • 7.3.5 Biological reference intervals and clinical decision limits
    • 7.3.6 Documentation of examination procedures
    • 7.3.7 Ensuring the validity of examination results
  • 7.4 Post-examination processes
    • 7.4.1 Reporting of results
    • 7.4.2 Post-examination handling of samples
  • 7.5 Nonconforming work
  • 7.6 Data control and information management
    • 7.6.1 General
    • 7.6.2 Authorities and responsibilities for information management
    • 7.6.3 Information system management
    • 7.6.4 Downtime plans
    • 7.6.5 Off-site management
  • 7.7 Complaints
    • 7.7.1 Process
    • 7.7.2 Receipt of complaint
    • 7.7.3 Handling of complaint
  • 7.8 Continuity and emergency preparedness planning
• 8 Management system requirements
  • 8.1 General requirements
    • 8.1.1 General
    • 8.1.2 Fukfiment of management system requirements
    • 8.1.3 Management system awareness
  • 8.2 Management system documentation
    • 8.2.1 General
    • 8.2.2 Competence and quality
    • 8.2.3 Evidence of commitment
    • 8.2.4 Documentation
    • 8.2.5 Personnel access
  • 8.3 Control of management system documents
    • 8.3.1 General
    • 8.3.2 Control of documents
  • 8.4 Control of records
    • 8.4.1 Creation of records
    • 8.4.2 Amendment of records
    • 8.4.3 Retention of records
  • 8.5 Actions to address risks and opportunities for improvement
    • 8.5.1 Identification of risks and opportunities for improvement
    • 8.5.2 Actions on risks and opportunities for improvement
  • 8.6 Improvement
    • 8.6.1 Continual improvement
    • 8.6.2 Laboratory patients, users, and personnel feedback
  • 8.7 Nonconformities and corrective actions
    • 8.7.1 Actions when nonconformity occurs
    • 8.7.2 Corrective action effectiveness
    • 8.7.3 Records of nonconformities and corrective actions
  • 8.8 Evaluations
    • 8.8.1 General
    • 8.8.2 Quality indicators
    • 8.8.3 Internal audits
  • 8.9 Management reviews
    • 8.9.1 General
    • 8.9.2 Review input
    • 8.9.3 Review output
• Annex A (normative) Additional requirements for Point-Of-Care Testing (POCT)
• Annex B (informative) Comparison between ISO 9001:2015 and ISO 15189:2022 (this document)
• Annex C (informative) Comparison between ISO 15189:2012 and ISO 15189:2022 (this document)
• Bibliography

DEtails AND commentS

• Clause 4
  • 4.1 b) Section dedicated to impartiality (document, § 8.2)
  • 4.1 d) Identify threats that could compromise impartiality
  • 4.1 e) Demonstrate how the effects of threats are mitigated
  • 4.2 Section dedicated to confidentiality
  • 4.2.2 The patient shallbe informed of their results
  • 4.3 d) Reporting of incidents and recording of actions taken
  • 4.3 g) Availability of patient samples and records (risk analysis)
  • 4.3 i) Non-discrimination regarding patient rights (documented management commitment, such as a charter)
• Clause 5
  • 5.1 COFRAC verifies the recognition of the legal entity (for France)
  • 5.2.1 The director of the medical biology laboratory (MBL) is the biologist in charge or co-biologist in charge. The director of the anatomic pathology and cytology (APC) unit is the pathologist in charge or the co-responsible pathologist
  • 5.2.2 The laboratory director is responsible for risk management (job description available)
  • 5.3.1 The laboratory's scope of activity shall include affiliated sites (excluding outsourced services)
  • 5.3.3 Advisory services and responses made available to patients and users
  • 5.4.2 The role of quality manager for the management system may be assigned to several individuals
  • 5.5 The term "quality policy" is no longer used, but objectives and policies remain in effect
  • 5.5 a) Regulatory provisions regarding good practices for performing examinations shall be followed
  • 5.6 b) The laboratory director shall ensure the effectiveness of processes and modify them when processes are ineffective (effectiveness criteria, specific risks)
• Clause 6
  • 6.2.1 Personnel shall act in an ethical manner
  • 6.2.4 Continuing education and professional development
  • 6.3.2 d) Provision of safety facilities and equipment
  • 6.3.3 c) Storage and disposal facilities for hazardous materials and biological waste shall be appropriate
  • 6.3.4 Space for staff activities, such as study and rest rooms, is no longer a requirement
  • 6.4.5 b) Equipment shall be maintained to ensure electrical safety and shall be equipped with an emergency stop device
  • 6.4.6 Incidents (adverse events) and accidents involving equipment shall be handled according to established procedures (responsibility, reporting, and corrective actions). Reporting to the ANSM (for France)
  • 6.5.2 f) Procedures for handling out-of-specification calibration results (analysis of metrological and patient-related risks)
  • 6.5.3 b) Metrological traceability guaranteed by calibration or by the manufacturer
  • 6.5.3 c) Metrological traceability guaranteed by other means (reference measurement method, consensus standards, measurement of the standard using a different procedure)
  • 6.5.3 d) Traceability to reference genetic sequences shall be established (for genetic tests)
  • 6.5.3 e) Traceability via examination of a known material or previously analyzed samples (when no known material is available)
  • 6.6.6 Procedure for incidents (adverse events) and accidents involving reagents and consumables (responsibility, reporting, and actions to be implemented). Reporting to the ANSM (for France)
  • 6.8.2 c) Communication of requirements to subcontracting laboratories and consultants regarding personnel competence (required qualifications)
• Clause 7
  • 7.1 Identify and assess risks. Monitor the effectiveness of risk management (control and reduction). Identify and manage opportunities for improvement
  • 7.2.3.2 Documented procedure for managing verbal requests (written confirmation)
  • 7.2.4.3.a) Obtain patient informed consent for procedures performed
  • 7.2.4.4 b) Instructions for patient verification and recording of pre-examination requirements
  • 7.2.5 c) Demonstrate the suitability and verification of sample transport systems
  • 7.3.2 f) Verification records maintained include target performance, results obtained, and a final evaluation (including actions taken, if necessary)
  • 7.3.3 e) 2) Maintain records of specific requirements regarding intended use
  • 7.3.4 c) Justification for not estimating measurement uncertainty (MU) shall be documented
  • 7.3.4 e) When users request clarification on MU, the laboratory's response shall consider other sources of uncertainty (e.g., biological variation)
  • 7.3.4 f) The MU of the measurand shall be estimated using representative samples
  • 7.3.4 g) Consider the MU of intermediate measurement steps for high-risk stages of the process
  • 7.3.7.2 c) Internal quality control (IQC) procedure, including for situations where suitable IQC material is unavailable (justification of the alternative approach)
  • 7.3.7.3 External evaluation. External Quality Assessment (EQA) is mandatory for every analysis. In the absence of an EQA program, an alternative method shall be justified and its effectiveness demonstrated
  • 7.4.1.4 a) Results may be communicated in a simplified format
  • 7.4.1.4 d) Management shall ensure that results of concern to the patient are communicated with appropriate support
  • 7.4.1.6 a) Unique patient identification, date of sample collection, and date of report issuance are required, unless otherwise documented and justified
  • 7.4.1.8 a) The reason for any modification shall be recorded and included in the revised report
  • 7.5 Take risk analysis into account regarding nonconforming work
  • 7.8 Emergency plans shall be tested regularly, and exercises to assess response capability shall be planned (examples of root causes)
• Clause 8
  • 8.2.1 A quality manual is no longer a requirement
  • 8.2.3 Provide evidence of management commitment to the development, implementation, and continual improvement of the management system's effectiveness (active participation in management review)
  • 8.5.1 New paragraph. Identification of risks and opportunities for improvement
  • 8.5.2 New paragraph. Actions addressing risks and opportunities for improvement
  • 8.7.1 f) Risk management is a continual activity
  • 8.8.3.2 a) The internal audit program shall prioritize risks to patients associated with laboratory activities

Documents REQUIRED

• recommended procedures 
  • Personnel management (§ 6.2)
  • Facility management (§ 6.3)
  • Equipment management (§ 6.4)
  • Calibration and metrological traceability (§ 6.5)
  • Reagent and consumable management (§ 6.6)
  • Contract management (§ 6.7)
  • External service providers (§ 6.8)
  • Patient and user information management (§ 7.2.2)
  • Examination request management (§ 7.2.3)
  • Sample collection (§ 7.2.4.1)
  • Sample identification and labeling (§ 7.2.4.2)
  • Sample transport (§ 7.2.5)
  • Sample receipt (§ 7.2.6.1)
  • Pre-examination handling (§ 7.2.7)
  • Verification of examination methods (§ 7.3.2)
  • Validation of examination methods (§ 7.3.3)
  • Biological reference intervals (§ 7.3.5)
  • Examination procedures (§ 7.3.6)
  • Validity of examination results (§ 7.3.7.1)
  • Internal quality control (§ 7.3.7.2)
  • External quality assessment (§ 7.3.7.3)
  • Internal and external communication (§ 7.4)
  • Nonconforming work (§ 7.5)
  • Data control (§ 7.6)
  • Complaint management (§ 7.7)
  • Document control (§§ 8.2; 8.3)
  • Record control (§ 8.4)
  • Risk and opportunity management (§ 8.5)
  • Continual improvement (§ 8.6.1)
  • Nonconformity management (§ 8.7.1)
  • Corrective actions (§ 8.7.2)
  • Internal audits (§ 8.8.3)
  • Management review (§ 8.9.1)
  • Point-of-care testing (Annex A)
• explicit and implicit records 
  • declaration of no conflict of interest (§ 4.1)
  • confidentiality agreement (§ 4.2.3)
  • patient needs and expectations (§§ 4.3; 8.6.2)
  • legal status (§ 5.1)
  • laboratory director role (§§ 5.2.2; 8.2.3)
  • scope (§ 5.3.1)
  • compliance register (§ 5.3.2)
  • consulting services (§ 5.3.3)
  • organizational chart (§ 5.4.1)
  • duty schedule (§ 5.4.1)
  • quality policy (§ 5.5)
  • welcome handbook (§ 6.2.1)
  • job description (§ 6.2.1)
  • competency matrix (§ 6.2.2)
  • personnel authorization register (§ 6.2.3)
  • training register (§ 6.2.4)
  • personnel file (§ 6.2.5)
  • authorization record (§ 6.2.5)
  • facilities register (§ 6.3.2)
  • cleaning and disinfection (§ 6.3.3)
  • waste register (§ 6.3.3)
  • pest prevention and control (§ 6.3.3)
  • temperature log (§§ 6.3.5; 6.6.4)
  • equipment register (§ 6.4.1)
  • equipment maintenance program (§ 6.4.5)
  • calibration certificate register (§ 6.5.2)
  • reagents and consumables register (§ 6.6.7)
  • supplier contracts (§§ 6.7.1; 6.8.1)
  • supplier evaluations (§ 6.8.2)
  • register of products and services from external providers (§ 6.8.3)
  • patient communication (§ 7.2.2)
  • examination requests register (§ 7.2.3)
  • sample collection log (§ 7.2.4)
  • sample labeling records (§ 7.2.4.2)
  • sample transport log (§ 7.2.5)
  • sample receipt log (§ 7.2.6)
  • pre-examination handling log (§ 7.2.7)
  • method verification reports (§ 7.3.2)
  • method validation reports (§ 7.3.3)
  • measurement uncertainty evaluations (§ 7.3.4)
  • reference interval log (§ 7.3.5)
  • list of examination procedures (§ 7.3.6)
  • examination result validity log (§ 7.3.7)
  • internal quality control log (§ 7.3.7.2)
  • external quality assessment log (7.3.7.3)
  • comparability results (§ 7.3.7.4)
  • result reports (§ 7.4.1)
  • verbally communicated results (§ 7.4.1.4)
  • sample result archiving log (§ 7.4.2)
  • nonconforming results (§ 7.5)
  • root causes of nonconformities (§ 7.5)
  • data access log (§ 7.6.2)
  • data backup log (§ 7.6.3)
  • business continuity plan (§ 7.6.4; 7.8)
  • BCP testing log (§ 7.6.4; 7.8)
  • complaints log (§ 7.7.2)
  • quality meeting minutes (§ 8.1.1)
  • list of documents (§§ 8.2; 8.3; 8.4)
  • risk register (§ 8.5)
  • opportunities for improvement (§ 8.6.1)
  • nonconformities and corrective actions (§ 8.7.3)
  • quality indicators (§ 8.8.2)
  • audit program and reports (§ 8.8.3)
  • list of auditors (§ 8.8.3)
  • management review record (§ 8.9.3)
  • contracts with POCT sites (Annex A.2)
  • POCT sites register (Annex A.2)
  • POCT equipment register (Annex A.2)
  • POCT samples register (Annex A.2)
  • POCT site audit report (Annex A.3)
  • POCT training register (Annex A.4)
• often used processes 
  • manage patient rights (§ 4.3)
  • manage personnel (§ 6.2)
  • manage facilities (§ 6.3)
  • manage equipment (§ 6.4)
  • manage reagents and consumables (§ 6.6)
  • manage suppliers (§§ 6.7 and 6.8)
  • collect samples (§ 7.2.4)
  • transport samples (§ 7.2.5)
  • receive samples (§ 7.2.6)
  • secure samples (§ 7.2.7)
  • validate examination methods (§ 7.3.3)
  • perform internal quality control (§ 7.3.7.2)
  • compare performance (§ 7.3.7.3)
  • validate result reports (§ 7.4.1)
  • store samples (§ 7.4.2)
  • control data (§ 7.6)
  • manage business continuity (§ 7.6.4)
  • manage complaints (§ 7.7)
  • manage documentation (§§ 8.2, 8.3 and 8.4)
  • address risks (§ 8.5)
  • improve (§ 8.6.1)
  • control nonconformities (§ 8.7.1)
  • implement corrective actions (§ 8.7.2)
  • conduct audits (§ 8.8.3)
  • conduct management review (§ 8.9)
  • govern POCTs (Annex A.2)
• policies ("Recommended Good Practices") 
  • quality policy (§ 5.2.2)
    • "Our laboratory is committed to providing reliable and accurate results in compliance with ISO 15189:2022, and to continually improving our processes to meet the expectations of patients and referring healthcare professionals."
  • personnel management (§ 6.2)
    • "The laboratory is committed to recruiting competent staff, providing regular training, and assessing skills to ensure the quality of analyses."
  • continuous training (§ 6.2.4)
    • "All staff shall undergo annual training on updates to procedures, equipment, and applicable standards."
  • safety and environmental conditions (§ 6.3)
    • "Facilities shall be maintained in a clean and safe condition, with regular monitoring of environmental conditions (temperature, humidity)."
  • equipment management (§ 6.4)
    • "All equipment shall be regularly calibrated by accredited bodies, and maintenance shall be documented."
  • management of reagents and consumables (§ 6.6)
    • "Reagents shall be stored according to manufacturer instructions and validated before use; their traceability shall be ensured."
  • sample collection (§ 7.2.4)
    • "All sample collections shall be performed according to standardized protocols, using certified equipment and by trained personnel."
  • sample transport (§ 7.2.5)
    • "Samples shall be transported under controlled conditions (temperature, timeframe < 24h), and their traceability shall be ensured."
  • result validation (§ 7.3.7)
    • "All results shall be validated by an authorized biologist or technician, following verification of internal and external quality controls."
  • communication (§ 7.4)
    • "All communication regarding results or processes shall be clear, accurate, and traceable, while respecting patient data confidentiality."
  • reporting of results (§ 7.4.1)
    • "Results shall be transmitted to requesting clinicians within a maximum of 24 hours for urgent analyses, using electronic signatures and secure archiving"
  • archiving of sample results (§ 7.4.2)
    • "Results are archived for 10 years and samples are stored in accordance with legal requirements, with traceable destruction"
  • risk management (§ 8.5)
    • "We identify and control risks associated with our activities to ensure patient safety, result reliability, and regulatory compliance"
  • continual improvement (§ 8.6.1)
    • "We implement continual improvement actions based on stakeholder feedback, audits, and quality indicators"
  • management of nonconformities (§ 8.7.1)
    • "Any nonconformity is reported, investigated, and addressed through corrective actions to prevent recurrence"
  • management review (§ 8.9)
    • "Management reviews the MS at least once a year to ensure its alignment with strategic objectives and regulatory requirements"