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

Self-Assess
International (ISO)
v2022 (4th edition)
8 domains
39 controls

ISO 15189:2022 (4th edition) specifies requirements for quality and competence in medical (clinical) laboratories. It covers examination processes (pre-examination, examination, post-examination), quality management systems, and resource requirements specific to medical laboratories. Applicable to clinical chemistry, haematology, microbiology, pathology, immunology, and other medical laboratory disciplines. Accreditation to ISO 15189 is increasingly required by healthcare regulators and insurers. The 2022 revision introduces risk-based thinking and aligns with ISO/IEC 17025:2017 structure.

Unverified

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence is a compliance framework from International (ISO) with 8 domains and 39 controls that map to 245 other frameworks. The largest domains are Clause 6: Resource Requirements (10 controls), Clause 8: Management System Requirements (9 controls), Clause 7: Process Requirements (8 controls). Every control below carries what it requires and what an assessor expects to see.

Maintained by Gerard BlokdykControl text last updated

Framework summaries on this platform are AI-assisted interpretations for educational and compliance planning purposes. They do not reproduce or replace the official standards. Refer to the authoritative source for the definitive text. Framework names and trademarks belong to their respective organisations.

Framework Domains (8)

Annex A

1 controls
Controls in the Annex A domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 1 controls
CodeTitle
A.1Point-of-Care Testing Additional Requirements

Clause 4: General Requirements

3 controls
Controls in the Clause 4: General Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 3 controls
CodeTitle
ISO-15189-4.1Impartiality
ISO-15189-4.2Confidentiality
ISO-15189-4.3Requirements regarding patients

Clause 5: Structural and Governance Requirements

6 controls
Controls in the Clause 5: Structural and Governance Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 6 controls
CodeTitle
ISO-15189-5.1Legal entity
ISO-15189-5.2Laboratory director
ISO-15189-5.3Laboratory activities
ISO-15189-5.4Structure and authority
ISO-15189-5.5Objectives and policies
ISO-15189-5.6Risk management

Clause 6: Resource Requirements

10 controls
Controls in the Clause 6: Resource Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 10 controls
CodeTitle
27006-6.1Competence of personnel
27006-6.2Personnel Records
ISO-15189-6.1General
ISO-15189-6.2Personnel
ISO-15189-6.3Facilities and environmental conditions
ISO-15189-6.4Equipment
ISO-15189-6.5Equipment calibration and metrological traceability
ISO-15189-6.6Reagents and consumables
ISO-15189-6.7Service agreements
ISO-15189-6.8Externally provided products and services

Clause 7: Process Requirements

8 controls
Controls in the Clause 7: Process Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 8 controls
CodeTitle
ISO-15189-7.1General
ISO-15189-7.2Pre-examination processes
ISO-15189-7.3Examination processes
ISO-15189-7.4Post-examination processes
ISO-15189-7.5Nonconforming work
ISO-15189-7.6Data and information management
ISO-15189-7.7Complaints
ISO-15189-7.8Continuity and emergency preparedness

Clause 8: Management System Requirements

9 controls
Controls in the Clause 8: Management System Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 9 controls
CodeTitle
ISO-15189-8.1General requirements
ISO-15189-8.2Management system documentation
ISO-15189-8.3Control of documents
ISO-15189-8.4Control of records
ISO-15189-8.5Actions addressing risks and opportunities
ISO-15189-8.6Improvement
ISO-15189-8.7Nonconformities and corrective actions
ISO-15189-8.8Evaluations
ISO-15189-8.9Management reviews

Management System

1 controls
Controls in the Management System domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 1 controls
CodeTitle
8.9Management Reviews

Resource Requirements

1 controls
Controls in the Resource Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 1 controls
CodeTitle
6.8Externally Provided Products and Services

Your Compliance Coverage

If you comply with ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence, you already cover:

ISO/IEC 17025:2017 - General Requirements for Testing and Calibration

38%

15 controls mapped

Compare →

PIC/S Guide to Good Manufacturing Practice for Medicinal Products

28%

11 controls mapped

Compare →

South Korea ISMS-P

23%

9 controls mapped

Compare →

+ 242 more: ICH Q10 - Pharmaceutical Quality System (23%), Singapore Government Instruction Manual on ICT&SS Management (IM8) (21%)

See all 245 mapped frameworks ↓

Maps to 245 other frameworks

39 total controls
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration
15 source controls mapped|13 target controls covered
38%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
11 source controls mapped|6 target controls covered
28%
South Korea ISMS-P
9 source controls mapped|6 target controls covered
23%
ICH Q10 - Pharmaceutical Quality System
9 source controls mapped|5 target controls covered
23%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
8 source controls mapped|5 target controls covered
21%
Annex 11 to EU GMP - Computerised Systems
7 source controls mapped|5 target controls covered
18%
ISO 28001:2007 Supply Chain Security Management
7 source controls mapped|4 target controls covered
18%
IEC 62304:2015 Medical Device Software Lifecycle Processes
7 source controls mapped|7 target controls covered
18%
ISO 20400:2017 - Sustainable Procurement
7 source controls mapped|7 target controls covered
18%
ISO/IEC 27003:2017
7 source controls mapped|7 target controls covered
18%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
7 source controls mapped|4 target controls covered
18%
NIST Cybersecurity Framework 2.0
7 source controls mapped|7 target controls covered
18%
Florida Digital Bill of Rights (FDBR)
6 source controls mapped|3 target controls covered
15%
IEC 60601-1 - Medical Electrical Equipment Safety
6 source controls mapped|5 target controls covered
15%
Security of Critical Infrastructure Act 2018 (SOCI)
6 source controls mapped|5 target controls covered
15%
WHO Global Strategy on Digital Health 2020-2025
6 source controls mapped|2 target controls covered
15%
ISO 41001:2018 - Facility Management Systems
6 source controls mapped|4 target controls covered
15%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
6 source controls mapped|4 target controls covered
15%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
6 source controls mapped|3 target controls covered
15%
UK Telecommunications (Security) Act 2021
6 source controls mapped|3 target controls covered
15%
ISO/IEC 23894:2023
6 source controls mapped|7 target controls covered
15%
ISO 27018
5 source controls mapped|3 target controls covered
13%
PSD2 SCA
5 source controls mapped|3 target controls covered
13%
OSFI B-13
5 source controls mapped|3 target controls covered
13%
Open Banking Security
5 source controls mapped|3 target controls covered
13%
Monetary Authority of Singapore Technology Risk Management Guidelines
5 source controls mapped|3 target controls covered
13%
FFIEC IT Examination Handbook
5 source controls mapped|6 target controls covered
13%
PCI PIN Security
5 source controls mapped|6 target controls covered
13%
PCI SSF
5 source controls mapped|6 target controls covered
13%
PCI P2PE
5 source controls mapped|6 target controls covered
13%
TISAX - Trusted Information Security Assessment Exchange
5 source controls mapped|5 target controls covered
13%
ITAR - International Traffic in Arms Regulations
5 source controls mapped|4 target controls covered
13%
SQF Code Edition 9 - Safe Quality Food
5 source controls mapped|3 target controls covered
13%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
5 source controls mapped|4 target controls covered
13%
UK Gambling Commission - Cyber Resilience Requirements
5 source controls mapped|2 target controls covered
13%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
5 source controls mapped|3 target controls covered
13%
French Sapin II Law (Law No. 2016-1691)
5 source controls mapped|2 target controls covered
13%
Automotive SPICE (ASPICE) v4.0 - Process Assessment Model
5 source controls mapped|3 target controls covered
13%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
5 source controls mapped|4 target controls covered
13%
O-RAN WG11 Security Specification
5 source controls mapped|4 target controls covered
13%
MTCS (Singapore)
5 source controls mapped|3 target controls covered
13%
PCI DSS 4.0
5 source controls mapped|3 target controls covered
13%
SSAE 18 - Attestation Standards (SOC Reporting)
5 source controls mapped|5 target controls covered
13%
ISO/IEC 25012:2008 - Data Quality Model
5 source controls mapped|3 target controls covered
13%
APRA CPS 230 Operational Risk Management
4 source controls mapped|6 target controls covered
10%
ISO/IEC 27031:2011
4 source controls mapped|4 target controls covered
10%
ASIS SPC.1-2009 - Organizational Resilience Standard
4 source controls mapped|2 target controls covered
10%
ISO 13485:2016
4 source controls mapped|3 target controls covered
10%
NAIC Insurance Data Security Model Law (MDL-668)
4 source controls mapped|2 target controls covered
10%
MDS2 (Medical Device)
4 source controls mapped|3 target controls covered
10%
FDA Quality Management System Regulation (QMSR)
4 source controls mapped|2 target controls covered
10%
Aged Care Quality Standards 2019 (repealed edition)
4 source controls mapped|4 target controls covered
10%
ISO 10006:2003
4 source controls mapped|3 target controls covered
10%
German Supply Chain Due Diligence Act (LkSG)
4 source controls mapped|3 target controls covered
10%
AS9100D - Aerospace Quality Management System
4 source controls mapped|3 target controls covered
10%
ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)
4 source controls mapped|2 target controls covered
10%
ISO 56002
4 source controls mapped|3 target controls covered
10%
ISO 19011
4 source controls mapped|3 target controls covered
10%
AICPA Privacy Management Framework (PMF)
4 source controls mapped|2 target controls covered
10%
ISO 27005
4 source controls mapped|5 target controls covered
10%
21 CFR Part 211 - Current Good Manufacturing Practice
4 source controls mapped|4 target controls covered
10%
NIST Privacy Framework
4 source controls mapped|5 target controls covered
10%
Authorised Economic Operator (AEO) Programmes - Global Standards
4 source controls mapped|5 target controls covered
10%
NIST SP 800-53 Rev 5
4 source controls mapped|6 target controls covered
10%
SLSA
4 source controls mapped|2 target controls covered
10%
SIG (Shared Assessments)
4 source controls mapped|2 target controls covered
10%
PTES
4 source controls mapped|2 target controls covered
10%
OWASP SAMM
4 source controls mapped|2 target controls covered
10%
OWASP MASVS
4 source controls mapped|2 target controls covered
10%
OpenSSF Scorecard
4 source controls mapped|2 target controls covered
10%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
4 source controls mapped|5 target controls covered
10%
NIST SP 800-92
4 source controls mapped|2 target controls covered
10%
NIST SP 800-88
4 source controls mapped|1 target controls covered
10%
NIST SP 800-63-4
4 source controls mapped|2 target controls covered
10%
NIST SP 800-61
4 source controls mapped|2 target controls covered
10%
NIST SP 800-146
4 source controls mapped|2 target controls covered
10%
NIST SP 800-145
4 source controls mapped|2 target controls covered
10%
NIST SP 800-144
4 source controls mapped|1 target controls covered
10%
NIST SP 800-137
4 source controls mapped|2 target controls covered
10%
NIST SP 800-123
4 source controls mapped|2 target controls covered
10%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
4 source controls mapped|2 target controls covered
10%
MITRE ATT&CK
4 source controls mapped|2 target controls covered
10%
ISO/IEC 38500:2024 - Governance of IT
4 source controls mapped|4 target controls covered
10%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
4 source controls mapped|4 target controls covered
10%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
4 source controls mapped|3 target controls covered
10%
IEC 62351 - Power Systems Communication Security
4 source controls mapped|2 target controls covered
10%
IAIS Insurance Core Principles (ICPs)
4 source controls mapped|3 target controls covered
10%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
4 source controls mapped|4 target controls covered
10%
ISO 27017
4 source controls mapped|2 target controls covered
10%
ISO 22739:2024 - Blockchain and Distributed Ledger Technologies Vocabulary
4 source controls mapped|5 target controls covered
10%
ISO 37000:2021 - Governance of Organizations
4 source controls mapped|4 target controls covered
10%
SOC 2
4 source controls mapped|4 target controls covered
10%
ISO 22320:2018
4 source controls mapped|4 target controls covered
10%
NIST SP 800-190
4 source controls mapped|2 target controls covered
10%
ISO 27043
4 source controls mapped|2 target controls covered
10%
Kuwait National Cybersecurity Framework
4 source controls mapped|2 target controls covered
10%
ISO/SAE 21434
4 source controls mapped|2 target controls covered
10%
ISO 10005:2005
3 source controls mapped|3 target controls covered
8%
ISO/IEC 27010:2015
3 source controls mapped|2 target controls covered
8%
ISO 22317
3 source controls mapped|3 target controls covered
8%
ISO 22318
3 source controls mapped|3 target controls covered
8%
ISO 22316
3 source controls mapped|3 target controls covered
8%
COSO Internal Control - Integrated Framework (2013)
3 source controls mapped|2 target controls covered
8%
UNESCO Recommendation on the Ethics of AI
3 source controls mapped|1 target controls covered
8%
UK FCA/PRA Operational Resilience Framework
3 source controls mapped|1 target controls covered
8%
SA8000:2014 - Social Accountability Standard
3 source controls mapped|1 target controls covered
8%
SASB Standards
3 source controls mapped|6 target controls covered
8%
OWASP Top 10 for LLM Applications 2025
3 source controls mapped|4 target controls covered
8%
NERC CIP
3 source controls mapped|2 target controls covered
8%
ICAO Annex 17 - Aviation Security (AVSEC)
3 source controls mapped|2 target controls covered
8%
IEC 62443
3 source controls mapped|3 target controls covered
8%
API 1164
3 source controls mapped|3 target controls covered
8%
FBI CJIS Security Policy
3 source controls mapped|1 target controls covered
8%
ISO/IEC 27011:2024
3 source controls mapped|2 target controls covered
8%
ISO 27019
3 source controls mapped|4 target controls covered
8%
Solvency II
3 source controls mapped|4 target controls covered
8%
Sigstore - Software Artifact Signing and Verification
3 source controls mapped|2 target controls covered
8%
NIST SP 1800-32
3 source controls mapped|3 target controls covered
8%
WCAG 2.2
3 source controls mapped|1 target controls covered
8%
UK GDPR (UK General Data Protection Regulation)
3 source controls mapped|1 target controls covered
8%
Regional Comprehensive Economic Partnership (RCEP) - E-Commerce Chapter
3 source controls mapped|1 target controls covered
8%
UK Bribery Act 2010
3 source controls mapped|3 target controls covered
8%
Trinidad and Tobago Data Protection Act 2011
3 source controls mapped|3 target controls covered
8%
Tanzania Personal Data Protection Act (Draft)
3 source controls mapped|2 target controls covered
8%
Philippines Cybercrime Prevention Act (RA 10175)
3 source controls mapped|1 target controls covered
8%
Notifiable Data Breaches Scheme (Australia)
3 source controls mapped|1 target controls covered
8%
Nigeria Data Protection Act 2023 (NDPA)
3 source controls mapped|3 target controls covered
8%
Nebraska Data Privacy Act
3 source controls mapped|3 target controls covered
8%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
3 source controls mapped|2 target controls covered
8%
South Korea PIPA
3 source controls mapped|1 target controls covered
8%
ITU Radio Regulations and Space Security Standards
3 source controls mapped|1 target controls covered
8%
Israel Protection of Privacy Law (5741-1981)
3 source controls mapped|2 target controls covered
8%
IATA Operational Safety Audit (IOSA) Standards Manual
3 source controls mapped|1 target controls covered
8%
FTC GLBA Safeguards Rule (16 CFR Part 314)
3 source controls mapped|1 target controls covered
8%
ISO/IEC 27004:2016
3 source controls mapped|2 target controls covered
8%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
3 source controls mapped|2 target controls covered
8%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
3 source controls mapped|1 target controls covered
8%
FedRAMP High
3 source controls mapped|1 target controls covered
8%
NIST SP 800-53 Revision 5.1 HIGH
3 source controls mapped|1 target controls covered
8%
FedRAMP Moderate
3 source controls mapped|1 target controls covered
8%
NIST SP 800-53 Rev 5 MODERATE
3 source controls mapped|1 target controls covered
8%
NIST SP 800-53 Rev 5 LOW
3 source controls mapped|1 target controls covered
8%
Barbados Data Protection Act 2019
3 source controls mapped|1 target controls covered
8%
Illinois Biometric Information Privacy Act (BIPA)
3 source controls mapped|1 target controls covered
8%
ISO/IEC 29147:2018
3 source controls mapped|1 target controls covered
8%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
3 source controls mapped|2 target controls covered
8%
COBIT 2019
3 source controls mapped|1 target controls covered
8%
US Foreign Corrupt Practices Act (FCPA)
3 source controls mapped|1 target controls covered
8%
Science Based Targets Initiative (SBTi) - Net-Zero Standard
3 source controls mapped|2 target controls covered
8%
ISO/IEC 27007:2020
3 source controls mapped|1 target controls covered
8%
Azerbaijan Law on Personal Data (2010)
3 source controls mapped|1 target controls covered
8%
ISO/IEC 29100:2024
3 source controls mapped|1 target controls covered
8%
ISO/IEC 30111:2019
3 source controls mapped|1 target controls covered
8%
Singapore Cybersecurity Act 2018
3 source controls mapped|1 target controls covered
8%
UK Open Banking Standard
3 source controls mapped|1 target controls covered
8%
ISO 26262:2018 - Functional Safety for Road Vehicles
3 source controls mapped|1 target controls covered
8%
SANS Incident Handler's Handbook and PICERL Methodology
3 source controls mapped|2 target controls covered
8%
ISO 8000 - Data Quality
3 source controls mapped|2 target controls covered
8%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
3 source controls mapped|1 target controls covered
8%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
3 source controls mapped|1 target controls covered
8%
US SEC Digital Assets and Crypto Regulatory Framework
3 source controls mapped|2 target controls covered
8%
Singapore AI Governance Framework
3 source controls mapped|2 target controls covered
8%
ISO 27018:2019
2 source controls mapped|3 target controls covered
5%
ISO 27002:2022
2 source controls mapped|3 target controls covered
5%
Oman National Cybersecurity Framework
2 source controls mapped|2 target controls covered
5%
NIS2 Directive Implementing Acts
2 source controls mapped|2 target controls covered
5%
BS 65000:2014 - Guidance on Organizational Resilience
2 source controls mapped|2 target controls covered
5%
ASD Strategies to Mitigate Cyber Security Incidents
2 source controls mapped|3 target controls covered
5%
NFPA 1600 - Standard on Continuity, Emergency, and Crisis Management
2 source controls mapped|5 target controls covered
5%
SOC for Cybersecurity - Cybersecurity Risk Management Examination
2 source controls mapped|4 target controls covered
5%
ISO/IEC TR 24028:2020
2 source controls mapped|1 target controls covered
5%
ISO 14004:2016
2 source controls mapped|1 target controls covered
5%
NIST SP 800-39
2 source controls mapped|2 target controls covered
5%
NIST SP 800-37
2 source controls mapped|2 target controls covered
5%
NIST SP 800-30
2 source controls mapped|3 target controls covered
5%
EASA Part-IS - Information Security in Aviation
2 source controls mapped|4 target controls covered
5%
ISO 31000
2 source controls mapped|4 target controls covered
5%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
2 source controls mapped|1 target controls covered
5%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
2 source controls mapped|1 target controls covered
5%
Modern Slavery Act 2018 (Australia)
2 source controls mapped|2 target controls covered
5%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
2 source controls mapped|1 target controls covered
5%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
2 source controls mapped|1 target controls covered
5%
Responsible Minerals Initiative (RMI) - Responsible Minerals Assurance Process
2 source controls mapped|3 target controls covered
5%
BREEAM - Building Research Establishment Environmental Assessment Method
2 source controls mapped|1 target controls covered
5%
Protective Security Policy Framework (PSPF) Release 2024
2 source controls mapped|1 target controls covered
5%
ISO 26000:2010
2 source controls mapped|1 target controls covered
5%
UK Security and Emergency Measures Direction (SEMD) - Water Industry
2 source controls mapped|1 target controls covered
5%
ISO 50001:2018 - Energy Management Systems
2 source controls mapped|1 target controls covered
5%
21 CFR Part 58 - Good Laboratory Practice (GLP)
2 source controls mapped|1 target controls covered
5%
FFIEC Cybersecurity Assessment Tool (CAT)
2 source controls mapped|3 target controls covered
5%
ISO/IEC 27018:2019
1 source controls mapped|1 target controls covered
3%
ISO 27001:2022
1 source controls mapped|1 target controls covered
3%
Nevada Gaming Control Board Cybersecurity Requirements
1 source controls mapped|1 target controls covered
3%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
1 source controls mapped|3 target controls covered
3%
ISO 22301:2019
1 source controls mapped|1 target controls covered
3%
ISO/IEC 27014:2020
1 source controls mapped|1 target controls covered
3%
ISO 55001
1 source controls mapped|1 target controls covered
3%
ISO 37301
1 source controls mapped|1 target controls covered
3%
ISO 22000
1 source controls mapped|1 target controls covered
3%
ISO 9001
1 source controls mapped|3 target controls covered
3%
ISO 39001:2012 - Road Traffic Safety Management
1 source controls mapped|1 target controls covered
3%
ISO 37001
1 source controls mapped|1 target controls covered
3%
ISO 45001
1 source controls mapped|1 target controls covered
3%
ISO 30401
1 source controls mapped|1 target controls covered
3%
TSA Pipeline Cybersecurity Directives
1 source controls mapped|1 target controls covered
3%
Secure by Design: A Guide for Manufacturers (CISA)
1 source controls mapped|1 target controls covered
3%
NIST SP 800-66
1 source controls mapped|1 target controls covered
3%
MARS-E
1 source controls mapped|1 target controls covered
3%
BSI IT-Grundschutz
1 source controls mapped|1 target controls covered
3%
US Automated Commercial Environment (ACE) - CBP Trade Data Requirements
1 source controls mapped|1 target controls covered
3%
ISO/IEC 27400:2022
1 source controls mapped|1 target controls covered
3%
3GPP 5G Security Architecture (TS 33.501)
1 source controls mapped|2 target controls covered
3%
ISO 27799
1 source controls mapped|1 target controls covered
3%
ISO 13485
1 source controls mapped|1 target controls covered
3%
Samoa Telecommunications Act (2005) - Privacy & Data Protection
1 source controls mapped|2 target controls covered
3%
Uganda Data Protection and Privacy Act (2019)
1 source controls mapped|1 target controls covered
3%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
1 source controls mapped|1 target controls covered
3%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
1 source controls mapped|1 target controls covered
3%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
1 source controls mapped|1 target controls covered
3%
OWASP Top 10:2025
1 source controls mapped|1 target controls covered
3%
OWASP DevSecOps Maturity Model (DSOMM)
1 source controls mapped|2 target controls covered
3%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) - IASR Web Standard
1 source controls mapped|1 target controls covered
3%
NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production
1 source controls mapped|3 target controls covered
3%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
1 source controls mapped|1 target controls covered
3%
IEEE 1686
1 source controls mapped|3 target controls covered
3%
IATF 16949:2016 - Quality Management System for Automotive Production
1 source controls mapped|1 target controls covered
3%
GS1 Global Standards - Supply Chain Traceability and Data Security
1 source controls mapped|2 target controls covered
3%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
1 source controls mapped|1 target controls covered
3%
GAMP 5 - Good Automated Manufacturing Practice
1 source controls mapped|1 target controls covered
3%
FedRAMP Rev 5
1 source controls mapped|1 target controls covered
3%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
1 source controls mapped|1 target controls covered
3%
UK AI Regulation Framework
1 source controls mapped|1 target controls covered
3%
SEC Climate Disclosure Rule
1 source controls mapped|1 target controls covered
3%
Own Risk and Solvency Assessment (ORSA) - NAIC Model Act
1 source controls mapped|1 target controls covered
3%
OECD Recommendation on Artificial Intelligence (2024 Update)
1 source controls mapped|1 target controls covered
3%
OECD AI Principles
1 source controls mapped|2 target controls covered
3%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
1 source controls mapped|2 target controls covered
3%
New Zealand Information Security Manual (NZISM)
1 source controls mapped|1 target controls covered
3%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
1 source controls mapped|1 target controls covered
3%
Japan AI Guidelines
1 source controls mapped|3 target controls covered
3%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|1 target controls covered
3%
APRA CPS 234
1 source controls mapped|2 target controls covered
3%
AML/CTF Act 2006 (Australia)
1 source controls mapped|1 target controls covered
3%
APRA SPS 220 Risk Management (Superannuation)
1 source controls mapped|1 target controls covered
3%
Telecommunications Sector Security Reforms (TSSR)
1 source controls mapped|1 target controls covered
3%
Compare ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence with ISO/IEC 17025:2017 - General Requirements for Testing and Calibration

What is ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence and who does it apply to?

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence is a compliance framework from International (ISO) with 8 domains and 39 controls. ISO 15189:2022 (4th edition) specifies requirements for quality and competence in medical (clinical) laboratories. It covers examination processes (pre-examination, examination, post-examination), quality management systems, and resource requirements specific to medical laboratories. Applicable to clinical chemistry, haematology, microbiology, pathology, immunology, and other medical laboratory disciplines. Accreditation to ISO 15189 is increasingly required by healthcare regulators and insurers. The 2022 revision introduces risk-based thinking and aligns with ISO/IEC 17025:2017 structure. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.

What does ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence actually require?

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence has 39 controls organised across 8 domains. The largest domains are Clause 6: Resource Requirements (10 controls), Clause 8: Management System Requirements (9 controls), Clause 7: Process Requirements (8 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

If I already comply with another framework, how much of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence do I already cover?

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence maps to 245 other compliance frameworks. The top mapping partners are ISO/IEC 17025:2017 - General Requirements for Testing and Calibration (38% coverage), PIC/S Guide to Good Manufacturing Practice for Medicinal Products (28% coverage), South Korea ISMS-P (23% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I implement ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence?

Start your ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 39 controls and track your progress.

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