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

Self-Assess
International (ISO)
v2022 (4th edition)
10 domains
49 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 10 domains and 49 controls that map to 347 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 (10)

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

3 controls
Controls in the Management System domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 3 controls
CodeTitle
8.5Control effectiveness review
8.8Management of technical vulnerabilities
8.9Management Reviews

Process Requirements

3 controls
Controls in the Process Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 3 controls
CodeTitle
7.5Threat assessment
7.7Likelihood estimation
7.8Consequence estimation

Resource Requirements

5 controls
Controls in the Resource Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 5 controls
CodeTitle
6.4Logging and Monitoring
6.5Preparing and Distributing Audit Report
6.6Confidentiality or non-disclosure agreements
6.7Conducting Audit Follow-up
6.8Externally Provided Products and Services

Structural and Governance

1 controls
Controls in the Structural and Governance domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 1 controls
CodeTitle
5.4Establishing Audit Programme

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

39%

19 controls mapped

Compare →

NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements

31%

15 controls mapped

Compare →

PIC/S Guide to Good Manufacturing Practice for Medicinal Products

29%

14 controls mapped

Compare →

+ 344 more: South Korea ISMS-P (27%), Singapore Government Instruction Manual on ICT&SS Management (IM8) (22%)

See all 347 mapped frameworks ↓

Maps to 347 other frameworks

49 total controls
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration
19 source controls mapped|15 target controls covered
39%
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
15 source controls mapped|14 target controls covered
31%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
14 source controls mapped|6 target controls covered
29%
South Korea ISMS-P
13 source controls mapped|8 target controls covered
27%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
11 source controls mapped|6 target controls covered
22%
ICH Q10 - Pharmaceutical Quality System
11 source controls mapped|5 target controls covered
22%
BRCGS Global Standard for Food Safety Issue 9
11 source controls mapped|8 target controls covered
22%
ISO/IEC 27003:2017
11 source controls mapped|8 target controls covered
22%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
11 source controls mapped|4 target controls covered
22%
IEC 62304:2015 Medical Device Software Lifecycle Processes
10 source controls mapped|7 target controls covered
20%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
10 source controls mapped|8 target controls covered
20%
NIST Cybersecurity Framework 2.0
10 source controls mapped|9 target controls covered
20%
ISO 27018
9 source controls mapped|5 target controls covered
18%
ISO 19011
9 source controls mapped|6 target controls covered
18%
Annex 11 to EU GMP - Computerised Systems
9 source controls mapped|5 target controls covered
18%
ISO 28001:2007 Supply Chain Security Management
9 source controls mapped|4 target controls covered
18%
Florida Digital Bill of Rights (FDBR)
9 source controls mapped|4 target controls covered
18%
TISAX - Trusted Information Security Assessment Exchange
9 source controls mapped|7 target controls covered
18%
ISO 20400:2017 - Sustainable Procurement
9 source controls mapped|7 target controls covered
18%
UK Telecommunications (Security) Act 2021
9 source controls mapped|3 target controls covered
18%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
9 source controls mapped|7 target controls covered
18%
MTCS (Singapore)
9 source controls mapped|4 target controls covered
18%
ISO/IEC 25012:2008 - Data Quality Model
9 source controls mapped|5 target controls covered
18%
ISO 31000:2018
8 source controls mapped|4 target controls covered
16%
PSD2 SCA
8 source controls mapped|3 target controls covered
16%
OSFI B-13
8 source controls mapped|3 target controls covered
16%
Open Banking Security
8 source controls mapped|4 target controls covered
16%
Monetary Authority of Singapore Technology Risk Management Guidelines
8 source controls mapped|4 target controls covered
16%
FFIEC IT Examination Handbook
8 source controls mapped|7 target controls covered
16%
PCI PIN Security
8 source controls mapped|7 target controls covered
16%
PCI SSF
8 source controls mapped|7 target controls covered
16%
PCI P2PE
8 source controls mapped|7 target controls covered
16%
NAIC Insurance Data Security Model Law (MDL-668)
8 source controls mapped|3 target controls covered
16%
MDS2 (Medical Device)
8 source controls mapped|3 target controls covered
16%
IEC 60601-1 - Medical Electrical Equipment Safety
8 source controls mapped|5 target controls covered
16%
WHO Global Strategy on Digital Health 2020-2025
8 source controls mapped|2 target controls covered
16%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
8 source controls mapped|4 target controls covered
16%
ISO 41001:2018 - Facility Management Systems
8 source controls mapped|4 target controls covered
16%
NIST Privacy Framework
8 source controls mapped|5 target controls covered
16%
NIST SP 800-53 Rev 5
8 source controls mapped|12 target controls covered
16%
ISO/IEC 23894:2023
8 source controls mapped|7 target controls covered
16%
SLSA
8 source controls mapped|2 target controls covered
16%
SIG (Shared Assessments)
8 source controls mapped|3 target controls covered
16%
PTES
8 source controls mapped|3 target controls covered
16%
OWASP SAMM
8 source controls mapped|2 target controls covered
16%
OWASP MASVS
8 source controls mapped|4 target controls covered
16%
OpenSSF Scorecard
8 source controls mapped|3 target controls covered
16%
O-RAN WG11 Security Specification
8 source controls mapped|4 target controls covered
16%
NIST SP 800-92
8 source controls mapped|3 target controls covered
16%
NIST SP 800-88
8 source controls mapped|2 target controls covered
16%
NIST SP 800-63-4
8 source controls mapped|3 target controls covered
16%
NIST SP 800-61
8 source controls mapped|3 target controls covered
16%
NIST SP 800-146
8 source controls mapped|2 target controls covered
16%
NIST SP 800-145
8 source controls mapped|2 target controls covered
16%
NIST SP 800-144
8 source controls mapped|2 target controls covered
16%
NIST SP 800-137
8 source controls mapped|3 target controls covered
16%
NIST SP 800-123
8 source controls mapped|3 target controls covered
16%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
8 source controls mapped|2 target controls covered
16%
MITRE ATT&CK
8 source controls mapped|3 target controls covered
16%
PCI DSS 4.0
8 source controls mapped|3 target controls covered
16%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
8 source controls mapped|6 target controls covered
16%
ISO 27017
8 source controls mapped|4 target controls covered
16%
NIST SP 800-190
8 source controls mapped|4 target controls covered
16%
ISO 27043
8 source controls mapped|7 target controls covered
16%
SSAE 18 - Attestation Standards (SOC Reporting)
8 source controls mapped|5 target controls covered
16%
ISO/SAE 21434
8 source controls mapped|7 target controls covered
16%
FDA Quality Management System Regulation (QMSR)
7 source controls mapped|4 target controls covered
14%
Security of Critical Infrastructure Act 2018 (SOCI)
7 source controls mapped|6 target controls covered
14%
ITAR - International Traffic in Arms Regulations
7 source controls mapped|4 target controls covered
14%
UK Gambling Commission - Cyber Resilience Requirements
7 source controls mapped|2 target controls covered
14%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
7 source controls mapped|3 target controls covered
14%
French Sapin II Law (Law No. 2016-1691)
7 source controls mapped|2 target controls covered
14%
Automotive SPICE (ASPICE) v4.0 - Process Assessment Model
7 source controls mapped|3 target controls covered
14%
Sigstore - Software Artifact Signing and Verification
7 source controls mapped|4 target controls covered
14%
FTC GLBA Safeguards Rule (16 CFR Part 314)
7 source controls mapped|2 target controls covered
14%
IEC 62351 - Power Systems Communication Security
7 source controls mapped|3 target controls covered
14%
UK Open Banking Standard
7 source controls mapped|5 target controls covered
14%
ISO 13485
7 source controls mapped|6 target controls covered
14%
Oman National Cybersecurity Framework
6 source controls mapped|3 target controls covered
12%
NIS2 Directive Implementing Acts
6 source controls mapped|4 target controls covered
12%
ISO/IEC 27031:2011
6 source controls mapped|4 target controls covered
12%
ASIS SPC.1-2009 - Organizational Resilience Standard
6 source controls mapped|2 target controls covered
12%
ASD Strategies to Mitigate Cyber Security Incidents
6 source controls mapped|5 target controls covered
12%
AS9100D - Aerospace Quality Management System
6 source controls mapped|4 target controls covered
12%
SQF Code Edition 9 - Safe Quality Food
6 source controls mapped|3 target controls covered
12%
ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)
6 source controls mapped|2 target controls covered
12%
ISO 56002
6 source controls mapped|3 target controls covered
12%
AICPA Privacy Management Framework (PMF)
6 source controls mapped|2 target controls covered
12%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
6 source controls mapped|2 target controls covered
12%
WCAG 2.2
6 source controls mapped|1 target controls covered
12%
Regional Comprehensive Economic Partnership (RCEP) - E-Commerce Chapter
6 source controls mapped|1 target controls covered
12%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
6 source controls mapped|5 target controls covered
12%
Nigeria Data Protection Act 2023 (NDPA)
6 source controls mapped|4 target controls covered
12%
Nebraska Data Privacy Act
6 source controls mapped|4 target controls covered
12%
ISO/IEC 38500:2024 - Governance of IT
6 source controls mapped|4 target controls covered
12%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
6 source controls mapped|2 target controls covered
12%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
6 source controls mapped|4 target controls covered
12%
Illinois Biometric Information Privacy Act (BIPA)
6 source controls mapped|2 target controls covered
12%
ISO/IEC 27007:2020
6 source controls mapped|2 target controls covered
12%
IAIS Insurance Core Principles (ICPs)
6 source controls mapped|3 target controls covered
12%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
6 source controls mapped|4 target controls covered
12%
ISO 22739:2024 - Blockchain and Distributed Ledger Technologies Vocabulary
6 source controls mapped|6 target controls covered
12%
ISO 37000:2021 - Governance of Organizations
6 source controls mapped|4 target controls covered
12%
SOC 2
6 source controls mapped|4 target controls covered
12%
ISO 22320:2018
6 source controls mapped|4 target controls covered
12%
Kuwait National Cybersecurity Framework
6 source controls mapped|2 target controls covered
12%
ISO 27005
5 source controls mapped|6 target controls covered
10%
21 CFR Part 211 - Current Good Manufacturing Practice
5 source controls mapped|4 target controls covered
10%
OWASP Top 10 for LLM Applications 2025
5 source controls mapped|5 target controls covered
10%
ICAO Annex 17 - Aviation Security (AVSEC)
5 source controls mapped|3 target controls covered
10%
FBI CJIS Security Policy
5 source controls mapped|3 target controls covered
10%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
5 source controls mapped|3 target controls covered
10%
ISO/IEC 27011:2024
5 source controls mapped|5 target controls covered
10%
UK GDPR (UK General Data Protection Regulation)
5 source controls mapped|1 target controls covered
10%
UK Bribery Act 2010
5 source controls mapped|3 target controls covered
10%
Trinidad and Tobago Data Protection Act 2011
5 source controls mapped|3 target controls covered
10%
Tanzania Personal Data Protection Act (Draft)
5 source controls mapped|2 target controls covered
10%
Philippines Cybercrime Prevention Act (RA 10175)
5 source controls mapped|1 target controls covered
10%
Notifiable Data Breaches Scheme (Australia)
5 source controls mapped|1 target controls covered
10%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
5 source controls mapped|2 target controls covered
10%
South Korea PIPA
5 source controls mapped|1 target controls covered
10%
ITU Radio Regulations and Space Security Standards
5 source controls mapped|1 target controls covered
10%
Israel Protection of Privacy Law (5741-1981)
5 source controls mapped|2 target controls covered
10%
IATA Operational Safety Audit (IOSA) Standards Manual
5 source controls mapped|1 target controls covered
10%
ISO/IEC 27004:2016
5 source controls mapped|2 target controls covered
10%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
5 source controls mapped|2 target controls covered
10%
FedRAMP High
5 source controls mapped|1 target controls covered
10%
NIST SP 800-53 Revision 5.1 HIGH
5 source controls mapped|1 target controls covered
10%
FedRAMP Moderate
5 source controls mapped|1 target controls covered
10%
NIST SP 800-53 Rev 5 MODERATE
5 source controls mapped|1 target controls covered
10%
NIST SP 800-53 Rev 5 LOW
5 source controls mapped|1 target controls covered
10%
Barbados Data Protection Act 2019
5 source controls mapped|1 target controls covered
10%
ISO/IEC 29147:2018
5 source controls mapped|1 target controls covered
10%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
5 source controls mapped|2 target controls covered
10%
COBIT 2019
5 source controls mapped|1 target controls covered
10%
US Foreign Corrupt Practices Act (FCPA)
5 source controls mapped|1 target controls covered
10%
Science Based Targets Initiative (SBTi) - Net-Zero Standard
5 source controls mapped|2 target controls covered
10%
Azerbaijan Law on Personal Data (2010)
5 source controls mapped|1 target controls covered
10%
ISO/IEC 29100:2024
5 source controls mapped|1 target controls covered
10%
ISO/IEC 30111:2019
5 source controls mapped|1 target controls covered
10%
Singapore Cybersecurity Act 2018
5 source controls mapped|1 target controls covered
10%
ISO 26262:2018 - Functional Safety for Road Vehicles
5 source controls mapped|1 target controls covered
10%
SANS Incident Handler's Handbook and PICERL Methodology
5 source controls mapped|2 target controls covered
10%
ISO 8000 - Data Quality
5 source controls mapped|2 target controls covered
10%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
5 source controls mapped|1 target controls covered
10%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
5 source controls mapped|1 target controls covered
10%
US SEC Digital Assets and Crypto Regulatory Framework
5 source controls mapped|2 target controls covered
10%
Secure by Design: A Guide for Manufacturers (CISA)
5 source controls mapped|2 target controls covered
10%
NIST SP 800-66
5 source controls mapped|1 target controls covered
10%
MARS-E
5 source controls mapped|5 target controls covered
10%
BSI IT-Grundschutz
5 source controls mapped|3 target controls covered
10%
ISO/IEC 27400:2022
5 source controls mapped|2 target controls covered
10%
3GPP 5G Security Architecture (TS 33.501)
5 source controls mapped|5 target controls covered
10%
ISO 27799
5 source controls mapped|4 target controls covered
10%
FedRAMP Rev 5
5 source controls mapped|4 target controls covered
10%
ISO 27018:2019
4 source controls mapped|4 target controls covered
8%
APRA CPS 230 Operational Risk Management
4 source controls mapped|6 target controls covered
8%
ISO/IEC 27010:2015
4 source controls mapped|3 target controls covered
8%
SOC for Cybersecurity - Cybersecurity Risk Management Examination
4 source controls mapped|5 target controls covered
8%
ISO 13485:2016
4 source controls mapped|3 target controls covered
8%
Aged Care Quality Standards 2019 (repealed edition)
4 source controls mapped|4 target controls covered
8%
ISO 10006:2003
4 source controls mapped|3 target controls covered
8%
German Supply Chain Due Diligence Act (LkSG)
4 source controls mapped|3 target controls covered
8%
Authorised Economic Operator (AEO) Programmes - Global Standards
4 source controls mapped|5 target controls covered
8%
Protective Security Policy Framework (PSPF) Release 2024
4 source controls mapped|2 target controls covered
8%
Singapore AI Governance Framework
4 source controls mapped|2 target controls covered
8%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
4 source controls mapped|3 target controls covered
8%
OWASP Top 10:2025
4 source controls mapped|5 target controls covered
8%
OWASP DevSecOps Maturity Model (DSOMM)
4 source controls mapped|4 target controls covered
8%
OWASP ASVS
4 source controls mapped|4 target controls covered
8%
MITRE D3FEND
4 source controls mapped|2 target controls covered
8%
ISMAP (Japan)
4 source controls mapped|3 target controls covered
8%
Ghana Cybersecurity Act
4 source controls mapped|2 target controls covered
8%
FISMA
4 source controls mapped|2 target controls covered
8%
FDA 21 CFR Part 11
4 source controls mapped|2 target controls covered
8%
MARS-E - Minimum Acceptable Risk Standards for Exchanges
4 source controls mapped|2 target controls covered
8%
Belgium CyberFundamentals
4 source controls mapped|2 target controls covered
8%
ISO 27002:2022
3 source controls mapped|3 target controls covered
6%
ISO 10005:2005
3 source controls mapped|3 target controls covered
6%
ISO 22317
3 source controls mapped|3 target controls covered
6%
ISO 22318
3 source controls mapped|3 target controls covered
6%
ISO 22316
3 source controls mapped|3 target controls covered
6%
COSO Internal Control - Integrated Framework (2013)
3 source controls mapped|2 target controls covered
6%
UNESCO Recommendation on the Ethics of AI
3 source controls mapped|1 target controls covered
6%
UK FCA/PRA Operational Resilience Framework
3 source controls mapped|1 target controls covered
6%
SA8000:2014 - Social Accountability Standard
3 source controls mapped|1 target controls covered
6%
SASB Standards
3 source controls mapped|6 target controls covered
6%
NERC CIP
3 source controls mapped|2 target controls covered
6%
IEC 62443
3 source controls mapped|3 target controls covered
6%
API 1164
3 source controls mapped|3 target controls covered
6%
ISO 27019
3 source controls mapped|4 target controls covered
6%
Solvency II
3 source controls mapped|4 target controls covered
6%
NIST SP 1800-32
3 source controls mapped|3 target controls covered
6%
21 CFR Part 58 - Good Laboratory Practice (GLP)
3 source controls mapped|1 target controls covered
6%
TSA Pipeline Cybersecurity Directives
3 source controls mapped|1 target controls covered
6%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
3 source controls mapped|2 target controls covered
6%
IATF 16949:2016 - Quality Management System for Automotive Production
3 source controls mapped|3 target controls covered
6%
GAMP 5 - Good Automated Manufacturing Practice
3 source controls mapped|3 target controls covered
6%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
3 source controls mapped|2 target controls covered
6%
ICH E6(R3) - Good Clinical Practice
3 source controls mapped|2 target controls covered
6%
ISO 19011:2018
3 source controls mapped|7 target controls covered
6%
W3C Verifiable Credentials (VC) Data Model 2.0
3 source controls mapped|3 target controls covered
6%
TEFCA - Trusted Exchange Framework and Common Agreement
3 source controls mapped|1 target controls covered
6%
Regulation on the European Health Data Space (EHDS)
3 source controls mapped|2 target controls covered
6%
OWASP API Security Top 10 - 2023
3 source controls mapped|2 target controls covered
6%
NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems
3 source controls mapped|3 target controls covered
6%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
3 source controls mapped|5 target controls covered
6%
New Zealand Information Security Manual (NZISM)
3 source controls mapped|2 target controls covered
6%
HL7 FHIR Security Framework
3 source controls mapped|2 target controls covered
6%
HKMA SPM
3 source controls mapped|2 target controls covered
6%
HKMA Cyber Resilience Assessment Framework (C-RAF)
3 source controls mapped|2 target controls covered
6%
GLI-33 - Gaming Laboratories International Event Wagering Systems
3 source controls mapped|2 target controls covered
6%
GLBA
3 source controls mapped|2 target controls covered
6%
FIDO2 / WebAuthn
3 source controls mapped|2 target controls covered
6%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)
3 source controls mapped|3 target controls covered
6%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
3 source controls mapped|5 target controls covered
6%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
3 source controls mapped|3 target controls covered
6%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
3 source controls mapped|4 target controls covered
6%
IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems
3 source controls mapped|2 target controls covered
6%
AML/CTF Act 2006 (Australia)
3 source controls mapped|2 target controls covered
6%
BS 65000:2014 - Guidance on Organizational Resilience
2 source controls mapped|2 target controls covered
4%
NFPA 1600 - Standard on Continuity, Emergency, and Crisis Management
2 source controls mapped|5 target controls covered
4%
ISO/IEC TR 24028:2020
2 source controls mapped|1 target controls covered
4%
ISO 14004:2016
2 source controls mapped|1 target controls covered
4%
NIST SP 800-39
2 source controls mapped|2 target controls covered
4%
NIST SP 800-37
2 source controls mapped|2 target controls covered
4%
NIST SP 800-30
2 source controls mapped|3 target controls covered
4%
EASA Part-IS - Information Security in Aviation
2 source controls mapped|4 target controls covered
4%
ISO 31000
2 source controls mapped|4 target controls covered
4%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
2 source controls mapped|1 target controls covered
4%
Modern Slavery Act 2018 (Australia)
2 source controls mapped|2 target controls covered
4%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
2 source controls mapped|1 target controls covered
4%
Responsible Minerals Initiative (RMI) - Responsible Minerals Assurance Process
2 source controls mapped|3 target controls covered
4%
BREEAM - Building Research Establishment Environmental Assessment Method
2 source controls mapped|1 target controls covered
4%
ISO 26000:2010
2 source controls mapped|1 target controls covered
4%
UK Security and Emergency Measures Direction (SEMD) - Water Industry
2 source controls mapped|1 target controls covered
4%
ISO 50001:2018 - Energy Management Systems
2 source controls mapped|1 target controls covered
4%
FFIEC Cybersecurity Assessment Tool (CAT)
2 source controls mapped|3 target controls covered
4%
GS1 Global Standards - Supply Chain Traceability and Data Security
2 source controls mapped|3 target controls covered
4%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
2 source controls mapped|2 target controls covered
4%
ACSC Essential Eight
2 source controls mapped|9 target controls covered
4%
Virginia CDPA
2 source controls mapped|1 target controls covered
4%
Vietnam PDPD
2 source controls mapped|1 target controls covered
4%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
2 source controls mapped|1 target controls covered
4%
Uruguay DPL
2 source controls mapped|1 target controls covered
4%
Turkey KVKK
2 source controls mapped|1 target controls covered
4%
Texas Data Privacy Act
2 source controls mapped|1 target controls covered
4%
Taiwan PDPA
2 source controls mapped|1 target controls covered
4%
Qatar DPL
2 source controls mapped|1 target controls covered
4%
Privacy Act 2020
2 source controls mapped|1 target controls covered
4%
Privacy Act 1988 (Australia)
2 source controls mapped|1 target controls covered
4%
POPIA
2 source controls mapped|1 target controls covered
4%
Peru DPL
2 source controls mapped|1 target controls covered
4%
Personal Data Act (personopplysningsloven)
2 source controls mapped|1 target controls covered
4%
PDPA Thailand
2 source controls mapped|1 target controls covered
4%
PDPA Singapore
2 source controls mapped|1 target controls covered
4%
PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)
2 source controls mapped|2 target controls covered
4%
Pakistan Personal Data Protection Bill 2023
2 source controls mapped|2 target controls covered
4%
Oregon Consumer Privacy Act
2 source controls mapped|1 target controls covered
4%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
2 source controls mapped|1 target controls covered
4%
NIST SP 800-122
2 source controls mapped|1 target controls covered
4%
Nigeria Open Banking Regulatory Framework (CBN, 2023)
2 source controls mapped|1 target controls covered
4%
Nigeria Data Protection Regulation (NDPR)
2 source controls mapped|1 target controls covered
4%
New Jersey Data Privacy Act
2 source controls mapped|1 target controls covered
4%
New Hampshire Data Privacy Act
2 source controls mapped|1 target controls covered
4%
Montana Consumer Data Privacy Act
2 source controls mapped|1 target controls covered
4%
Minnesota Consumer Data Privacy Act
2 source controls mapped|1 target controls covered
4%
Mexico LFPDPPP
2 source controls mapped|1 target controls covered
4%
Mauritius DPA
2 source controls mapped|1 target controls covered
4%
Maryland Online Data Privacy Act of 2024
2 source controls mapped|1 target controls covered
4%
Malaysia PDPA 2010
2 source controls mapped|1 target controls covered
4%
Liechtenstein DPA
2 source controls mapped|1 target controls covered
4%
LGPD
2 source controls mapped|1 target controls covered
4%
Ley Orgánica de Protección de Datos Personales (LOPDP)
2 source controls mapped|1 target controls covered
4%
Law No. 172-13 on the Protection of Personal Data
2 source controls mapped|1 target controls covered
4%
Kentucky Consumer Data Protection Act
2 source controls mapped|1 target controls covered
4%
Jamaica Data Protection Act 2020
2 source controls mapped|1 target controls covered
4%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
2 source controls mapped|1 target controls covered
4%
Iowa Consumer Data Protection Act
2 source controls mapped|1 target controls covered
4%
Indonesia PDP Law
2 source controls mapped|1 target controls covered
4%
Indiana Consumer Data Protection Act
2 source controls mapped|1 target controls covered
4%
India DPDP Act
2 source controls mapped|1 target controls covered
4%
India Account Aggregator Framework (RBI)
2 source controls mapped|1 target controls covered
4%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
2 source controls mapped|1 target controls covered
4%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
2 source controls mapped|1 target controls covered
4%
HITECH Act
2 source controls mapped|1 target controls covered
4%
Family Educational Rights and Privacy Act (FERPA)
2 source controls mapped|1 target controls covered
4%
FATF Recommendation 16 - Virtual Asset Travel Rule
2 source controls mapped|1 target controls covered
4%
APPI
2 source controls mapped|1 target controls covered
4%
US ITAR and EAR - Export Control and Data Security
2 source controls mapped|2 target controls covered
4%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
2 source controls mapped|1 target controls covered
4%
Saudi Arabia PDPL
2 source controls mapped|1 target controls covered
4%
Bahrain PDPL
2 source controls mapped|1 target controls covered
4%
US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements
2 source controls mapped|1 target controls covered
4%
ITU-T X.805 - Security Architecture for End-to-End Communications
2 source controls mapped|1 target controls covered
4%
Telecommunications Sector Security Reforms (TSSR)
2 source controls mapped|4 target controls covered
4%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
2 source controls mapped|1 target controls covered
4%
US Consumer Product Safety Commission (CPSC) - Connected Product Safety
2 source controls mapped|1 target controls covered
4%
Armenia Law on Protection of Personal Data (2015)
2 source controls mapped|1 target controls covered
4%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
2 source controls mapped|1 target controls covered
4%
ISO/IEC 27018:2019
1 source controls mapped|1 target controls covered
2%
ISO 27001:2022
1 source controls mapped|1 target controls covered
2%
Nevada Gaming Control Board Cybersecurity Requirements
1 source controls mapped|1 target controls covered
2%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
1 source controls mapped|3 target controls covered
2%
ISO 22301:2019
1 source controls mapped|1 target controls covered
2%
ISO/IEC 27014:2020
1 source controls mapped|1 target controls covered
2%
ISO 55001
1 source controls mapped|1 target controls covered
2%
ISO 37301
1 source controls mapped|1 target controls covered
2%
ISO 22000
1 source controls mapped|1 target controls covered
2%
ISO 9001
1 source controls mapped|3 target controls covered
2%
ISO 39001:2012 - Road Traffic Safety Management
1 source controls mapped|1 target controls covered
2%
ISO 37001
1 source controls mapped|1 target controls covered
2%
ISO 45001
1 source controls mapped|1 target controls covered
2%
ISO 30401
1 source controls mapped|1 target controls covered
2%
US Automated Commercial Environment (ACE) - CBP Trade Data Requirements
1 source controls mapped|1 target controls covered
2%
Samoa Telecommunications Act (2005) - Privacy & Data Protection
1 source controls mapped|2 target controls covered
2%
Uganda Data Protection and Privacy Act (2019)
1 source controls mapped|1 target controls covered
2%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
1 source controls mapped|1 target controls covered
2%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) - IASR Web Standard
1 source controls mapped|1 target controls covered
2%
NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production
1 source controls mapped|3 target controls covered
2%
IRM Enterprise Risk Management Framework (Institute of Risk Management)
1 source controls mapped|1 target controls covered
2%
IEEE 1686
1 source controls mapped|3 target controls covered
2%
NIST SP 800-218
1 source controls mapped|4 target controls covered
2%
FSSC 22000 - Food Safety System Certification
1 source controls mapped|1 target controls covered
2%
UNECE WP.29 R155
1 source controls mapped|1 target controls covered
2%
ISO 20000-1
1 source controls mapped|1 target controls covered
2%
NSA Guidance for Transition to Quantum-Resistant Cryptography
1 source controls mapped|3 target controls covered
2%
Act on the Implementation of the General Data Protection Regulation (OG 42/2018)
1 source controls mapped|1 target controls covered
2%
Cloud Security Alliance Cloud Controls Matrix (CCM) v4.0.1
1 source controls mapped|1 target controls covered
2%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories
1 source controls mapped|1 target controls covered
2%
NY DFS 23 NYCRR 500
1 source controls mapped|1 target controls covered
2%
CCSDS 350.0-G-3 - Space Communications Security (Consultative Committee for Space Data Systems)
1 source controls mapped|1 target controls covered
2%
AICPA SOC 3
1 source controls mapped|1 target controls covered
2%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
1 source controls mapped|1 target controls covered
2%
ISO 27701:2019
1 source controls mapped|1 target controls covered
2%
ISO 27017:2015
1 source controls mapped|1 target controls covered
2%
UK AI Regulation Framework
1 source controls mapped|1 target controls covered
2%
SEC Climate Disclosure Rule
1 source controls mapped|1 target controls covered
2%
Own Risk and Solvency Assessment (ORSA) - NAIC Model Act
1 source controls mapped|1 target controls covered
2%
OECD Recommendation on Artificial Intelligence (2024 Update)
1 source controls mapped|1 target controls covered
2%
OECD AI Principles
1 source controls mapped|2 target controls covered
2%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
1 source controls mapped|2 target controls covered
2%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
1 source controls mapped|1 target controls covered
2%
Japan AI Guidelines
1 source controls mapped|3 target controls covered
2%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|1 target controls covered
2%
APRA CPS 234
1 source controls mapped|2 target controls covered
2%
APRA SPS 220 Risk Management (Superannuation)
1 source controls mapped|1 target controls covered
2%
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 10 domains and 49 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 49 controls organised across 10 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 347 other compliance frameworks. The top mapping partners are ISO/IEC 17025:2017 - General Requirements for Testing and Calibration (39% coverage), NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements (31% coverage), PIC/S Guide to Good Manufacturing Practice for Medicinal Products (29% 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 49 controls and track your progress.

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