ISO 15189:2022
Medical laboratories — Requirements for quality and competence
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
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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 with requirements
5.3.3 Advisory activities
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 Equipment 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 Control of data and information management
7.6.1 General
7.6.2 Authorities and responsibilities for information management
7.6.3 Information systems 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 Resolution of complaint
7.8 Continuity and emergency preparedness planning
8 Management system requirements
8.1 General requirements
8.1.1 General
8.1.2 Fulfilment 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 Acting on risks and opportunities for improvement
8.6 Improvement
8.6.1 Continual improvement
8.6.2 Laboratory patients, user, 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
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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 with requirements
5.3.3 Advisory activities
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 Equipment 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 Control of data and information management
7.6.1 General
7.6.2 Authorities and responsibilities for information management
7.6.3 Information systems 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 Resolution of complaint
7.8 Continuity and emergency preparedness planning
8 Management system requirements
8.1 General requirements
8.1.1 General
8.1.2 Fulfilment 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 Acting on risks and opportunities for improvement
8.6 Improvement
8.6.1 Continual improvement
8.6.2 Laboratory patients, user, 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