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

Self-Assess
International (ISO)
v2022 (4th edition)
11 domains
89 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

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 (11)

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

5 controls
Controls in the Clause 4: General Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 5 controls
CodeTitle
ISO-15189-4.1Impartiality
ISO-15189-4.2Confidentiality
ISO-15189-4.3Requirements regarding patients
ISO-17025-4.1Impartiality
ISO-17025-4.2Confidentiality

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

16 controls
Controls in the Clause 6: Resource Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 16 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
ISO-17025-6.1General
ISO-17025-6.2Personnel
ISO-17025-6.3Facilities and environmental conditions
ISO-17025-6.4Equipment
ISO-17025-6.5Metrological traceability
ISO-17025-6.6Externally provided products and services

Clause 7: Process Requirements

19 controls
Controls in the Clause 7: Process Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 19 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
ISO-17025-7.1Review of requests, tenders and contracts
ISO-17025-7.10Nonconforming work
ISO-17025-7.11Control of data and information management
ISO-17025-7.2Selection, verification and validation of methods
ISO-17025-7.3Sampling
ISO-17025-7.4Handling of test or calibration items
ISO-17025-7.5Technical records
ISO-17025-7.6Evaluation of measurement uncertainty
ISO-17025-7.7Ensuring the validity of results
ISO-17025-7.8Reporting of results
ISO-17025-7.9Complaints

Clause 8: Management System Requirements

18 controls
Controls in the Clause 8: Management System Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 18 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
ISO-17025-8.1Options
ISO-17025-8.2Management system documentation
ISO-17025-8.3Control of management system documents
ISO-17025-8.4Control of records
ISO-17025-8.5Actions to address risks and opportunities
ISO-17025-8.6Improvement
ISO-17025-8.7Corrective actions
ISO-17025-8.8Internal audits
ISO-17025-8.9Management reviews

General Requirements

3 controls
Controls in the General Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 3 controls
CodeTitle
4.1Password Policy
4.2Multi-Factor Authentication
4.3Determining Scope of SMS

Management System

4 controls
Controls in the Management System domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 4 controls
CodeTitle
8.5Control effectiveness review
8.7Protection against malware
8.8Management of technical vulnerabilities
8.9Management Reviews

Process Requirements

7 controls
Controls in the Process Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 7 controls
CodeTitle
7.2Security Training and Awareness
7.3Risk evaluation
7.4Asset valuation
7.5Threat assessment
7.6Vulnerability assessment
7.7Likelihood estimation
7.8Consequence estimation

Resource Requirements

7 controls
Controls in the Resource Requirements domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 7 controls
CodeTitle
6.2Approach selection
6.3Information security awareness, education and training
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

3 controls
Controls in the Structural and Governance domain of ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence — 3 controls
CodeTitle
5.1Logical Access Control
5.2Token Management
5.4Establishing Audit Programme

Your Compliance Coverage

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

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

24%

21 controls mapped

Compare →

PIC/S Guide to Good Manufacturing Practice for Medicinal Products

22%

20 controls mapped

Compare →

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

21%

19 controls mapped

Compare →

+ 414 more: AS9100D - Aerospace Quality Management System (20%), ISO/IEC 27003:2017 (20%)

See all 417 mapped frameworks ↓

Maps to 417 other frameworks

89 total controls
NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements
21 source controls mapped|14 target controls covered
24%
PIC/S Guide to Good Manufacturing Practice for Medicinal Products
20 source controls mapped|9 target controls covered
22%
ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories
19 source controls mapped|12 target controls covered
21%
AS9100D - Aerospace Quality Management System
18 source controls mapped|13 target controls covered
20%
ISO/IEC 27003:2017
18 source controls mapped|13 target controls covered
20%
AS9100D:2016 - Quality Management Systems for Aviation, Space, and Defence
18 source controls mapped|13 target controls covered
20%
SWIFT CSCF
18 source controls mapped|15 target controls covered
20%
SQF Code Edition 9 - Safe Quality Food
17 source controls mapped|6 target controls covered
19%
BRCGS Global Standard for Food Safety Issue 9
17 source controls mapped|12 target controls covered
19%
South Korea ISMS-P
16 source controls mapped|8 target controls covered
18%
IEC 62304:2015 Medical Device Software Lifecycle Processes
16 source controls mapped|7 target controls covered
18%
ISO 19011
16 source controls mapped|6 target controls covered
18%
ISO 45001:2018
15 source controls mapped|6 target controls covered
17%
ISO 20000-1
15 source controls mapped|7 target controls covered
17%
SWIFT CSCF v2024
15 source controls mapped|9 target controls covered
17%
ISO 9001:2015
15 source controls mapped|7 target controls covered
17%
ICH Q10 - Pharmaceutical Quality System
14 source controls mapped|5 target controls covered
16%
21 CFR Part 211 - Current Good Manufacturing Practice
14 source controls mapped|5 target controls covered
16%
ISO 13485
14 source controls mapped|10 target controls covered
16%
ISO/IEC 27006:2024
13 source controls mapped|7 target controls covered
15%
ISO 14001
13 source controls mapped|4 target controls covered
15%
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security
12 source controls mapped|7 target controls covered
13%
ISO 41001:2018 - Facility Management Systems
12 source controls mapped|11 target controls covered
13%
ISO 39001:2012 - Road Traffic Safety Management
12 source controls mapped|11 target controls covered
13%
ISO 50001:2018 - Energy Management Systems
12 source controls mapped|11 target controls covered
13%
ISO 22313:2020 - Guidance on Business Continuity Management Systems
12 source controls mapped|11 target controls covered
13%
ISO 20400:2017 - Sustainable Procurement
12 source controls mapped|7 target controls covered
13%
PAS 1192-5:2015 - Security-Minded Approach to BIM and Digital Built Environments
12 source controls mapped|9 target controls covered
13%
New Zealand Information Security Manual (NZISM)
12 source controls mapped|9 target controls covered
13%
South Korea Cloud Security Assurance Program (CSAP)
12 source controls mapped|9 target controls covered
13%
NRC 10 CFR 73.54 - Nuclear Facility Cybersecurity
12 source controls mapped|11 target controls covered
13%
Singapore Government Instruction Manual on ICT&SS Management (IM8)
12 source controls mapped|7 target controls covered
13%
US OFAC Sanctions Compliance Framework
12 source controls mapped|4 target controls covered
13%
21 CFR Part 58 - Good Laboratory Practice (GLP)
12 source controls mapped|3 target controls covered
13%
ISO/IEC 25012:2008 - Data Quality Model
12 source controls mapped|3 target controls covered
13%
NAIC Insurance Data Security Model Law (MDL-668)
12 source controls mapped|9 target controls covered
13%
TISAX - Trusted Information Security Assessment Exchange
11 source controls mapped|11 target controls covered
12%
CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0
11 source controls mapped|8 target controls covered
12%
Protective Security Policy Framework (PSPF) Release 2024
11 source controls mapped|13 target controls covered
12%
NIST Cybersecurity Framework 2.0
11 source controls mapped|9 target controls covered
12%
UK Gambling Commission - Cyber Resilience Requirements
11 source controls mapped|7 target controls covered
12%
RBI Cybersecurity Framework for Banks
11 source controls mapped|8 target controls covered
12%
APRA CPS 234
11 source controls mapped|10 target controls covered
12%
ASIS SPC.1-2009 - Organizational Resilience Standard
11 source controls mapped|4 target controls covered
12%
ISO 27005
11 source controls mapped|8 target controls covered
12%
ISO 31000:2018
11 source controls mapped|2 target controls covered
12%
Illinois Biometric Information Privacy Act (BIPA)
11 source controls mapped|6 target controls covered
12%
DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition)
11 source controls mapped|4 target controls covered
12%
FDA Quality Management System Regulation (QMSR)
10 source controls mapped|4 target controls covered
11%
OWASP DevSecOps Maturity Model (DSOMM)
10 source controls mapped|8 target controls covered
11%
UK Telecommunications (Security) Act 2021
10 source controls mapped|3 target controls covered
11%
ISO 28001:2007 Supply Chain Security Management
10 source controls mapped|4 target controls covered
11%
Annex 11 to EU GMP - Computerised Systems
10 source controls mapped|5 target controls covered
11%
NIST SP 800-124 Revision 2 - Guidelines for Managing the Security of Mobile Devices
10 source controls mapped|7 target controls covered
11%
OWASP Top 10:2025
10 source controls mapped|7 target controls covered
11%
Papua New Guinea National Cybersecurity Policy & Cybercrime Act (2016)
10 source controls mapped|7 target controls covered
11%
ISO 13485:2016
10 source controls mapped|4 target controls covered
11%
MTCS (Singapore)
10 source controls mapped|4 target controls covered
11%
ITAR - International Traffic in Arms Regulations
10 source controls mapped|4 target controls covered
11%
Florida Digital Bill of Rights (FDBR)
10 source controls mapped|2 target controls covered
11%
ISO 56002
10 source controls mapped|10 target controls covered
11%
ISO 37002:2021 - Whistleblowing Management Systems
10 source controls mapped|9 target controls covered
11%
Regulation on the European Health Data Space (EHDS)
10 source controls mapped|5 target controls covered
11%
Wisconsin Data Privacy Act (SB 670)
10 source controls mapped|7 target controls covered
11%
NIST Special Publication 800-34 Revision 1, Contingency Planning Guide for Federal Information Systems
10 source controls mapped|5 target controls covered
11%
TEFCA - Trusted Exchange Framework and Common Agreement
10 source controls mapped|6 target controls covered
11%
ISO/IEC 27011:2024
9 source controls mapped|9 target controls covered
10%
NIS2 Directive
9 source controls mapped|6 target controls covered
10%
ISO/IEC 23894:2023
9 source controls mapped|7 target controls covered
10%
USMCA Chapter 19 - Digital Trade (United States-Mexico-Canada Agreement)
9 source controls mapped|3 target controls covered
10%
Regulation (EU) 2019/1239 on the Maritime Single Window (MSW)
9 source controls mapped|5 target controls covered
10%
NIST AI Risk Management Framework (AI RMF 1.0)
9 source controls mapped|5 target controls covered
10%
NIST AI 600-1: Generative AI Profile
9 source controls mapped|5 target controls covered
10%
ISO 14001:2015
9 source controls mapped|5 target controls covered
10%
Monetary Authority of Singapore Technology Risk Management Guidelines
9 source controls mapped|4 target controls covered
10%
MITRE ATT&CK
9 source controls mapped|3 target controls covered
10%
ISO/IEC 27014:2020
9 source controls mapped|4 target controls covered
10%
ISO/IEC 27400:2022
9 source controls mapped|6 target controls covered
10%
NIST SP 800-137
9 source controls mapped|7 target controls covered
10%
NIST SP 800-144
9 source controls mapped|4 target controls covered
10%
OpenSSF Scorecard
9 source controls mapped|8 target controls covered
10%
NIST SP 800-92
9 source controls mapped|7 target controls covered
10%
SSDF (NIST)
9 source controls mapped|7 target controls covered
10%
UK PSTI Act
9 source controls mapped|7 target controls covered
10%
SIG (Shared Assessments)
9 source controls mapped|7 target controls covered
10%
AWS Well-Architected Security Pillar
9 source controls mapped|4 target controls covered
10%
WHO Global Strategy on Digital Health 2020-2025
9 source controls mapped|2 target controls covered
10%
SLSA
9 source controls mapped|7 target controls covered
10%
PCI SSF
9 source controls mapped|7 target controls covered
10%
NIST SP 800-88
9 source controls mapped|7 target controls covered
10%
NIST SP 800-61
9 source controls mapped|6 target controls covered
10%
UNECE WP.29 R156
9 source controls mapped|7 target controls covered
10%
SWIFT CSP
9 source controls mapped|7 target controls covered
10%
NIST SP 800-63-4
9 source controls mapped|6 target controls covered
10%
Rhode Island Data Transparency and Privacy Protection Act (RIDTPPA)
9 source controls mapped|4 target controls covered
10%
NIST SP 800-115 (Technical Guide to Information Security Testing and Assessment)
9 source controls mapped|7 target controls covered
10%
ISO/SAE 21434
9 source controls mapped|7 target controls covered
10%
Azure Security Benchmark
9 source controls mapped|4 target controls covered
10%
NIST SP 800-145
9 source controls mapped|4 target controls covered
10%
NIST SP 800-190
9 source controls mapped|4 target controls covered
10%
OWASP SAMM
9 source controls mapped|6 target controls covered
10%
ISO 27043
9 source controls mapped|7 target controls covered
10%
OWASP MASVS
9 source controls mapped|6 target controls covered
10%
FFIEC IT Examination Handbook
9 source controls mapped|7 target controls covered
10%
NIST SP 800-146
9 source controls mapped|4 target controls covered
10%
NIST SP 800-123
9 source controls mapped|7 target controls covered
10%
ISO 27018
9 source controls mapped|4 target controls covered
10%
PTES
9 source controls mapped|7 target controls covered
10%
UNECE WP.29 R155
9 source controls mapped|6 target controls covered
10%
IEC 60601-1 - Medical Electrical Equipment Safety
9 source controls mapped|5 target controls covered
10%
SSAE 18 - Attestation Standards (SOC Reporting)
9 source controls mapped|5 target controls covered
10%
PCI P2PE
9 source controls mapped|7 target controls covered
10%
ISO 14064 - Greenhouse Gas Accounting and Verification (Parts 1-3)
9 source controls mapped|2 target controls covered
10%
ISO 27017
9 source controls mapped|4 target controls covered
10%
PCI PIN Security
9 source controls mapped|7 target controls covered
10%
PSD2 SCA
9 source controls mapped|7 target controls covered
10%
OWASP ASVS
9 source controls mapped|7 target controls covered
10%
AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
9 source controls mapped|6 target controls covered
10%
O-RAN WG11 Security Specification
9 source controls mapped|5 target controls covered
10%
Open Banking Security
9 source controls mapped|7 target controls covered
10%
OSFI B-13
9 source controls mapped|7 target controls covered
10%
AICPA Privacy Management Framework (PMF)
9 source controls mapped|2 target controls covered
10%
IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1)
8 source controls mapped|3 target controls covered
9%
French Sapin II Law (Law No. 2016-1691)
8 source controls mapped|2 target controls covered
9%
NIST SP 800-53 Rev 5
8 source controls mapped|12 target controls covered
9%
NIST Privacy Framework 1.0
8 source controls mapped|9 target controls covered
9%
Philippines Cybercrime Prevention Act (RA 10175)
8 source controls mapped|2 target controls covered
9%
NATO AQAP 2110 - Quality Assurance Requirements for Design, Development, and Production
8 source controls mapped|7 target controls covered
9%
Automotive SPICE (ASPICE) v4.0 - Process Assessment Model
8 source controls mapped|3 target controls covered
9%
FBI CJIS Security Policy
8 source controls mapped|6 target controls covered
9%
Pakistan Personal Data Protection Bill 2023
8 source controls mapped|4 target controls covered
9%
Serbia Law on Personal Data Protection (2018)
8 source controls mapped|5 target controls covered
9%
Portugal Law No. 58/2019 - Data Protection Implementation Act
8 source controls mapped|7 target controls covered
9%
Netherlands GDPR Implementation Act (UAVG - Uitvoeringswet AVG, 2018)
8 source controls mapped|6 target controls covered
9%
Oman Personal Data Protection Law (Royal Decree 6/2022)
8 source controls mapped|5 target controls covered
9%
MDS2 (Medical Device)
8 source controls mapped|3 target controls covered
9%
FTC GLBA Safeguards Rule (16 CFR Part 314)
8 source controls mapped|2 target controls covered
9%
ISO/IEC 23837 - Security Requirements for Quantum Key Distribution
8 source controls mapped|7 target controls covered
9%
IEC 62351 - Power Systems Communication Security
8 source controls mapped|3 target controls covered
9%
RFC 2350 - Expectations for Computer Security Incident Response (BCP 21)
8 source controls mapped|6 target controls covered
9%
UK Open Banking Standard
8 source controls mapped|5 target controls covered
9%
Aged Care Quality Standards (Australia)
8 source controls mapped|6 target controls covered
9%
Sigstore - Software Artifact Signing and Verification
7 source controls mapped|6 target controls covered
8%
ISO 27001:2022
7 source controls mapped|9 target controls covered
8%
Security of Critical Infrastructure Act 2018 (SOCI)
7 source controls mapped|6 target controls covered
8%
Singapore Model AI Governance Framework (2nd Edition)
7 source controls mapped|2 target controls covered
8%
ISO/IEC 29115:2023 - Entity Authentication Assurance Framework
7 source controls mapped|5 target controls covered
8%
ISO/IEC 38500:2024 - Governance of IT
7 source controls mapped|4 target controls covered
8%
ISO/IEC 27557:2022 - Organisational Privacy Risk Management
7 source controls mapped|8 target controls covered
8%
ISO/IEC 27031:2011
7 source controls mapped|4 target controls covered
8%
NIST Post-Quantum Cryptography Standards (FIPS 203, 204, 205)
7 source controls mapped|6 target controls covered
8%
US NRC 10 CFR 73.54 - Cyber Security for Nuclear Power Plants
7 source controls mapped|3 target controls covered
8%
Tennessee Information Protection Act (TIPA)
7 source controls mapped|3 target controls covered
8%
WCAG 2.2
7 source controls mapped|3 target controls covered
8%
ISO 22739:2024 - Blockchain and Distributed Ledger Technologies Vocabulary
7 source controls mapped|6 target controls covered
8%
TNFD Recommendations
7 source controls mapped|3 target controls covered
8%
AASB S2 Climate-related Disclosures
7 source controls mapped|2 target controls covered
8%
Turkey Personal Data Protection Law (KVKK - Law No. 6698)
7 source controls mapped|5 target controls covered
8%
Regional Comprehensive Economic Partnership (RCEP) - E-Commerce Chapter
7 source controls mapped|3 target controls covered
8%
Russia Federal Law on Personal Data (152-FZ)
7 source controls mapped|5 target controls covered
8%
ISO 37000:2021 - Governance of Organizations
7 source controls mapped|4 target controls covered
8%
SOC 2
7 source controls mapped|4 target controls covered
8%
W3C Verifiable Credentials (VC) Data Model 2.0
7 source controls mapped|5 target controls covered
8%
ISO 22320:2018
7 source controls mapped|4 target controls covered
8%
ISO 19650 - Organisation and Digitisation of Information about Buildings and Civil Engineering Works (BIM)
7 source controls mapped|4 target controls covered
8%
Oman National Cybersecurity Framework
7 source controls mapped|6 target controls covered
8%
OCC Heightened Standards (12 CFR Part 30, Appendix D)
7 source controls mapped|4 target controls covered
8%
NIS2 Directive Implementing Acts
7 source controls mapped|7 target controls covered
8%
IAIS Insurance Core Principles (ICPs)
7 source controls mapped|3 target controls covered
8%
ICAO Annex 17 - Aviation Security (AVSEC)
6 source controls mapped|3 target controls covered
7%
German Supply Chain Due Diligence Act (LkSG)
6 source controls mapped|3 target controls covered
7%
FedRAMP Rev 5
6 source controls mapped|4 target controls covered
7%
TSA Pipeline Security
6 source controls mapped|4 target controls covered
7%
US Executive Order 14028 - Improving the Nation's Cybersecurity
6 source controls mapped|3 target controls covered
7%
Telecommunications Sector Security Reforms (TSSR)
6 source controls mapped|7 target controls covered
7%
ICH E6(R3) - Good Clinical Practice
6 source controls mapped|2 target controls covered
7%
ISO/IEC 27701:2019
6 source controls mapped|1 target controls covered
7%
South Korea PIPA
6 source controls mapped|1 target controls covered
7%
ITU Radio Regulations and Space Security Standards
6 source controls mapped|1 target controls covered
7%
Israel Protection of Privacy Law (5741-1981)
6 source controls mapped|2 target controls covered
7%
IATA Operational Safety Audit (IOSA) Standards Manual
6 source controls mapped|1 target controls covered
7%
ISO/IEC 27004:2016
6 source controls mapped|3 target controls covered
7%
ISO/IEC 30111:2019
6 source controls mapped|3 target controls covered
7%
ISO/IEC 29147:2018
6 source controls mapped|3 target controls covered
7%
ISO/IEC 29100:2024
6 source controls mapped|3 target controls covered
7%
ISO/IEC 29134:2023
6 source controls mapped|3 target controls covered
7%
US Foreign Corrupt Practices Act (FCPA)
6 source controls mapped|1 target controls covered
7%
ISO/IEC 27007:2020
6 source controls mapped|1 target controls covered
7%
ISO/IEC 27050 - Electronic Discovery (Parts 1-4)
6 source controls mapped|1 target controls covered
7%
UK Building Safety Act 2022
6 source controls mapped|2 target controls covered
7%
ISO 26262:2018 - Functional Safety for Road Vehicles
6 source controls mapped|1 target controls covered
7%
SANS Incident Handler's Handbook and PICERL Methodology
6 source controls mapped|2 target controls covered
7%
Barbados Data Protection Act 2019
6 source controls mapped|1 target controls covered
7%
PCAOB AS 2201 - Audit of Internal Control Over Financial Reporting (ICFR)
6 source controls mapped|3 target controls covered
7%
UK Bribery Act 2010
6 source controls mapped|3 target controls covered
7%
Notifiable Data Breaches Scheme (Australia)
6 source controls mapped|1 target controls covered
7%
NATO STANAG 4774 (Confidentiality Metadata Labels) and STANAG 4778 (Metadata Binding)
6 source controls mapped|5 target controls covered
7%
Rwanda Law No. 058/2021 Relating to the Protection of Personal Data
6 source controls mapped|4 target controls covered
7%
US Children's Online Privacy Protection Act (COPPA) and COPPA 2.0 Proposed Updates
6 source controls mapped|1 target controls covered
7%
COBIT 2019
6 source controls mapped|1 target controls covered
7%
US SEC Digital Assets and Crypto Regulatory Framework
6 source controls mapped|2 target controls covered
7%
South Korea Korea Internet Self-Governance Organisation (KISO) Code of Ethics
6 source controls mapped|1 target controls covered
7%
Proposal for a Directive on improving working conditions in platform work (COM(2023) 491)
6 source controls mapped|6 target controls covered
7%
Union Customs Code (UCC) - Regulation (EU) No 952/2013
6 source controls mapped|2 target controls covered
7%
Uzbekistan Law on Personal Data (No. ZRU-547)
6 source controls mapped|4 target controls covered
7%
Panama Law on Personal Data Protection (Law No. 81 of 2019)
6 source controls mapped|4 target controls covered
7%
Poland Act on Personal Data Protection (Ustawa o ochronie danych osobowych, 2018)
6 source controls mapped|5 target controls covered
7%
Romania Law No. 190/2018 on Data Protection Measures (GDPR Implementation)
6 source controls mapped|6 target controls covered
7%
Qatar Personal Data Privacy Protection Law (Law No. 13 of 2016)
6 source controls mapped|4 target controls covered
7%
UNCITRAL Model Law on Electronic Commerce (1996, updated 2005)
6 source controls mapped|4 target controls covered
7%
Vietnam Law on Cybersecurity (No. 24/2018/QH14)
6 source controls mapped|5 target controls covered
7%
Uruguay Personal Data Protection Act (Law No. 18.331)
6 source controls mapped|5 target controls covered
7%
Spain Organic Law 3/2018 on Data Protection and Digital Rights (LOPDGDD)
6 source controls mapped|3 target controls covered
7%
Singapore Payment Services Act (PSA) - Digital Payment Token Regulation
6 source controls mapped|2 target controls covered
7%
Tanzania Personal Data Protection Act (Draft)
6 source controls mapped|4 target controls covered
7%
Trinidad and Tobago Data Protection Act 2011
6 source controls mapped|4 target controls covered
7%
Saudi PDPL
6 source controls mapped|1 target controls covered
7%
Switzerland New Federal Act on Data Protection (nFADP/nDSG, 2023)
6 source controls mapped|1 target controls covered
7%
FedRAMP High
6 source controls mapped|1 target controls covered
7%
NIST SP 800-53 Revision 5.1 HIGH
6 source controls mapped|1 target controls covered
7%
FedRAMP Moderate
6 source controls mapped|1 target controls covered
7%
NIST SP 800-53 Rev 5 MODERATE
6 source controls mapped|1 target controls covered
7%
NIST SP 800-53 Rev 5 LOW
6 source controls mapped|1 target controls covered
7%
UK GDPR (UK General Data Protection Regulation)
6 source controls mapped|1 target controls covered
7%
Science Based Targets initiative (SBTi) Corporate Standard
6 source controls mapped|2 target controls covered
7%
Singapore Cybersecurity Act 2018
6 source controls mapped|1 target controls covered
7%
Albania Law on Protection of Personal Data (Law No. 9887, 2008, amended 2014)
6 source controls mapped|2 target controls covered
7%
ISO 8000 - Data Quality
6 source controls mapped|2 target controls covered
7%
Sri Lanka Personal Data Protection Act (No. 9 of 2022)
6 source controls mapped|1 target controls covered
7%
UK Construction (Design and Management) Regulations 2015 (CDM 2015)
6 source controls mapped|3 target controls covered
7%
South Africa Promotion of Access to Information Act (PAIA)
6 source controls mapped|1 target controls covered
7%
Sweden Data Protection Act (Dataskyddslag, 2018:218)
6 source controls mapped|1 target controls covered
7%
Nigeria Data Protection Act 2023 (NDPA)
6 source controls mapped|2 target controls covered
7%
Azerbaijan Law on Personal Data (2010)
6 source controls mapped|1 target controls covered
7%
Austria Data Protection Act (Datenschutzgesetz, DSG, amended 2018)
6 source controls mapped|2 target controls covered
7%
Paraguay Law on Protection of Personal Data (Law No. 6534/2020)
6 source controls mapped|1 target controls covered
7%
Singapore Payment Services Act 2019 (PSA) - Digital Payment Token Provisions
6 source controls mapped|1 target controls covered
7%
ASD Strategies to Mitigate Cyber Security Incidents
6 source controls mapped|5 target controls covered
7%
South Korea Credit Information Act
6 source controls mapped|1 target controls covered
7%
Virginia Consumer Data Protection Act (VCDPA)
6 source controls mapped|1 target controls covered
7%
UK Defence Standard 05-138 - Cyber Security for Defence Suppliers
5 source controls mapped|4 target controls covered
6%
UK FCA/PRA Operational Resilience Framework
5 source controls mapped|2 target controls covered
6%
Tunisia Organic Law on Personal Data Protection (Law No. 2004-63)
5 source controls mapped|3 target controls covered
6%
SA8000:2014 - Social Accountability Standard
5 source controls mapped|2 target controls covered
6%
OWASP Top 10 for LLM Applications 2025
5 source controls mapped|5 target controls covered
6%
ACSC Essential Eight
5 source controls mapped|15 target controls covered
6%
MITRE D3FEND
5 source controls mapped|2 target controls covered
6%
MARS-E
5 source controls mapped|5 target controls covered
6%
ISMAP (Japan)
5 source controls mapped|3 target controls covered
6%
NIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI)
5 source controls mapped|9 target controls covered
6%
Secure by Design: A Guide for Manufacturers (CISA)
5 source controls mapped|4 target controls covered
6%
ISO 27799
5 source controls mapped|4 target controls covered
6%
Spain ENS
5 source controls mapped|3 target controls covered
6%
Saudi NCA ECC
5 source controls mapped|3 target controls covered
6%
BSI IT-Grundschutz
5 source controls mapped|3 target controls covered
6%
3GPP 5G Security Architecture (TS 33.501)
5 source controls mapped|5 target controls covered
6%
NIST SP 800-66
5 source controls mapped|4 target controls covered
6%
IATF 16949:2016 - Quality Management System for Automotive Production
4 source controls mapped|3 target controls covered
4%
GS1 Global Standards - Supply Chain Traceability and Data Security
4 source controls mapped|3 target controls covered
4%
GLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6
4 source controls mapped|2 target controls covered
4%
GAMP 5 - Good Automated Manufacturing Practice
4 source controls mapped|3 target controls covered
4%
ISO/IEC 27010:2015
4 source controls mapped|3 target controls covered
4%
Authorised Economic Operator (AEO) Programmes - Global Standards
4 source controls mapped|5 target controls covered
4%
APRA CPS 230 Operational Risk Management
4 source controls mapped|7 target controls covered
4%
Vermont Artificial Intelligence and Consumer Data Act (AICDA)
4 source controls mapped|3 target controls covered
4%
Bermuda Monetary Authority (BMA) Cyber Risk Management Code of Conduct
4 source controls mapped|2 target controls covered
4%
HKMA SPM
4 source controls mapped|2 target controls covered
4%
HKMA Cyber Resilience Assessment Framework (C-RAF)
4 source controls mapped|2 target controls covered
4%
GLI-33 - Gaming Laboratories International Event Wagering Systems
4 source controls mapped|2 target controls covered
4%
GLBA
4 source controls mapped|2 target controls covered
4%
Ghana Cybersecurity Act
4 source controls mapped|2 target controls covered
4%
FISMA
4 source controls mapped|2 target controls covered
4%
Federal Decree-Law No. 45 of 2021 on the Protection of Personal Data (UAE PDPL)
4 source controls mapped|3 target controls covered
4%
FDA 21 CFR Part 11
4 source controls mapped|2 target controls covered
4%
FCC Customer Proprietary Network Information (CPNI) and Data Breach Rules (47 CFR 64.2001-2011)
4 source controls mapped|5 target controls covered
4%
SOC for Cybersecurity - Cybersecurity Risk Management Examination
4 source controls mapped|5 target controls covered
4%
OWASP API Security Top 10 - 2023
4 source controls mapped|5 target controls covered
4%
Belgium CyberFundamentals
4 source controls mapped|2 target controls covered
4%
EASA Part-IS - Information Security in Aviation
4 source controls mapped|4 target controls covered
4%
ISO 31000
4 source controls mapped|4 target controls covered
4%
NFPA 1600 - Standard on Continuity, Emergency, and Crisis Management
4 source controls mapped|5 target controls covered
4%
NIST SP 800-30
4 source controls mapped|4 target controls covered
4%
NIST SP 800-37
4 source controls mapped|4 target controls covered
4%
NIST SP 800-39
4 source controls mapped|4 target controls covered
4%
API 1164
3 source controls mapped|3 target controls covered
3%
ISO 22318
3 source controls mapped|3 target controls covered
3%
ISO 27019
3 source controls mapped|4 target controls covered
3%
UK ONR Cyber Security and Information Assurance (CSIA) for Nuclear Facilities
3 source controls mapped|3 target controls covered
3%
IEC 62443
3 source controls mapped|3 target controls covered
3%
Solvency II
3 source controls mapped|4 target controls covered
3%
NERC CIP
3 source controls mapped|4 target controls covered
3%
ISO 22316
3 source controls mapped|3 target controls covered
3%
NIST SP 1800-32
3 source controls mapped|3 target controls covered
3%
SASB Standards (ISSB Integrated)
3 source controls mapped|4 target controls covered
3%
SASB Standards
3 source controls mapped|4 target controls covered
3%
ISO 22317
3 source controls mapped|3 target controls covered
3%
FSSC 22000 - Food Safety System Certification
3 source controls mapped|1 target controls covered
3%
Italy Personal Data Protection Code (Legislative Decree No. 196/2003, amended 2018)
3 source controls mapped|1 target controls covered
3%
India Account Aggregator Framework (RBI)
3 source controls mapped|1 target controls covered
3%
IMO Maritime Cybersecurity Guidelines (MSC-FAL.1/Circ.3/Rev.2)
3 source controls mapped|1 target controls covered
3%
HL7 FHIR Security Framework
3 source controls mapped|2 target controls covered
3%
FIDO2 / WebAuthn
3 source controls mapped|2 target controls covered
3%
FATF Recommendation 16 - Virtual Asset Travel Rule
3 source controls mapped|1 target controls covered
3%
Peru Personal Data Protection Law (Law No. 29733)
3 source controls mapped|3 target controls covered
3%
Ukraine Law on Personal Data Protection (Law No. 2297-VI)
3 source controls mapped|3 target controls covered
3%
Senegal Law on Personal Data Protection (Law No. 2008-12)
3 source controls mapped|3 target controls covered
3%
Philippines Data Privacy Act (RA 10173)
3 source controls mapped|3 target controls covered
3%
Belgium Data Protection Act (Wet van 30 juli 2018, Loi du 30 juillet 2018)
3 source controls mapped|2 target controls covered
3%
IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems
3 source controls mapped|2 target controls covered
3%
NIST Privacy Framework Version 1.0
3 source controls mapped|3 target controls covered
3%
TSA Pipeline Cybersecurity Directives
3 source controls mapped|1 target controls covered
3%
AML/CTF Act 2006 (Australia)
3 source controls mapped|2 target controls covered
3%
SWIFT Customer Security Programme (CSP)
3 source controls mapped|3 target controls covered
3%
PropTech Security Standards - Smart Building Cybersecurity
3 source controls mapped|3 target controls covered
3%
Zimbabwe Data Protection Act (2021)
3 source controls mapped|2 target controls covered
3%
Voluntary Principles on Security and Human Rights (VPs)
3 source controls mapped|1 target controls covered
3%
ISO 9001
3 source controls mapped|3 target controls covered
3%
ISO 45001
3 source controls mapped|1 target controls covered
3%
ISO 37001
3 source controls mapped|1 target controls covered
3%
ISO 55001
3 source controls mapped|1 target controls covered
3%
ISO 37301
3 source controls mapped|1 target controls covered
3%
ISO 22000
3 source controls mapped|1 target controls covered
3%
ISO 30401
3 source controls mapped|1 target controls covered
3%
COSO Internal Control - Integrated Framework (2013)
3 source controls mapped|2 target controls covered
3%
WELL Building Standard v2 (International WELL Building Institute)
3 source controls mapped|1 target controls covered
3%
Washington My Health My Data Act (MHMD)
3 source controls mapped|1 target controls covered
3%
UNESCO Recommendation on the Ethics of AI
3 source controls mapped|1 target controls covered
3%
Modern Slavery Act 2018 (Australia)
2 source controls mapped|2 target controls covered
2%
OECD Guidelines for Multinational Enterprises on Responsible Business Conduct (2023 Update)
2 source controls mapped|1 target controls covered
2%
Space ISAC (Information Sharing and Analysis Center) - Threat Framework
2 source controls mapped|1 target controls covered
2%
Responsible Minerals Initiative (RMI) - Responsible Minerals Assurance Process
2 source controls mapped|3 target controls covered
2%
WCO Authorised Economic Operator (AEO) Framework
2 source controls mapped|2 target controls covered
2%
UK Security and Emergency Measures Direction (SEMD) - Water Industry
2 source controls mapped|1 target controls covered
2%
ISO 26000:2010
2 source controls mapped|1 target controls covered
2%
Ontario Accessibility for Ontarians with Disabilities Act (AODA) - IASR Web Standard
2 source controls mapped|1 target controls covered
2%
BREEAM - Building Research Establishment Environmental Assessment Method
2 source controls mapped|1 target controls covered
2%
NIST SP 800-218
2 source controls mapped|5 target controls covered
2%
Montana Consumer Data Privacy Act
2 source controls mapped|1 target controls covered
2%
Minnesota Consumer Data Privacy Act
2 source controls mapped|1 target controls covered
2%
Mexico LFPDPPP
2 source controls mapped|1 target controls covered
2%
Mauritius DPA
2 source controls mapped|1 target controls covered
2%
Maryland Online Data Privacy Act of 2024
2 source controls mapped|1 target controls covered
2%
Malaysia PDPA 2010
2 source controls mapped|1 target controls covered
2%
Liechtenstein DPA
2 source controls mapped|1 target controls covered
2%
LGPD
2 source controls mapped|1 target controls covered
2%
Ley Orgánica de Protección de Datos Personales (LOPDP)
2 source controls mapped|1 target controls covered
2%
Law No. 172-13 on the Protection of Personal Data
2 source controls mapped|1 target controls covered
2%
Kentucky Consumer Data Protection Act
2 source controls mapped|1 target controls covered
2%
Jamaica Data Protection Act 2020
2 source controls mapped|1 target controls covered
2%
Iowa Consumer Data Protection Act
2 source controls mapped|1 target controls covered
2%
Indonesia PDP Law
2 source controls mapped|1 target controls covered
2%
Indiana Consumer Data Protection Act
2 source controls mapped|1 target controls covered
2%
India DPDP Act
2 source controls mapped|1 target controls covered
2%
Iceland Data Protection and Processing of Personal Data Act (Act No. 90/2018)
2 source controls mapped|1 target controls covered
2%
HITECH Act
2 source controls mapped|1 target controls covered
2%
Family Educational Rights and Privacy Act (FERPA)
2 source controls mapped|1 target controls covered
2%
New Jersey Data Privacy Act
2 source controls mapped|1 target controls covered
2%
Utah Consumer Privacy Act
2 source controls mapped|1 target controls covered
2%
APPI
2 source controls mapped|1 target controls covered
2%
Taiwan PDPA
2 source controls mapped|1 target controls covered
2%
Switzerland FADP
2 source controls mapped|1 target controls covered
2%
Oregon Consumer Privacy Act
2 source controls mapped|1 target controls covered
2%
Nebraska Data Privacy Act
2 source controls mapped|1 target controls covered
2%
Turkey KVKK
2 source controls mapped|1 target controls covered
2%
Nigeria Open Banking Regulatory Framework (CBN, 2023)
2 source controls mapped|1 target controls covered
2%
Nigeria Data Protection Regulation (NDPR)
2 source controls mapped|1 target controls covered
2%
PDPA Thailand
2 source controls mapped|1 target controls covered
2%
Vietnam PDPD
2 source controls mapped|1 target controls covered
2%
Tennessee IPA
2 source controls mapped|1 target controls covered
2%
Philippines DPA
2 source controls mapped|1 target controls covered
2%
PDPA Singapore
2 source controls mapped|1 target controls covered
2%
NIST SP 800-122
2 source controls mapped|1 target controls covered
2%
Rwanda DPL
2 source controls mapped|1 target controls covered
2%
New Hampshire Data Privacy Act
2 source controls mapped|1 target controls covered
2%
UK Data Protection Act 2018
2 source controls mapped|1 target controls covered
2%
Privacy Act 2020
2 source controls mapped|1 target controls covered
2%
Privacy Act 1988 (Australia)
2 source controls mapped|1 target controls covered
2%
US ITAR and EAR - Export Control and Data Security
2 source controls mapped|2 target controls covered
2%
Saudi Arabia PDPL
2 source controls mapped|1 target controls covered
2%
POPIA
2 source controls mapped|1 target controls covered
2%
Texas Data Privacy Act
2 source controls mapped|1 target controls covered
2%
Uruguay DPL
2 source controls mapped|1 target controls covered
2%
Virginia CDPA
2 source controls mapped|1 target controls covered
2%
Qatar DPL
2 source controls mapped|1 target controls covered
2%
Bahrain PDPL
2 source controls mapped|1 target controls covered
2%
Peru DPL
2 source controls mapped|1 target controls covered
2%
Personal Data Act (personopplysningsloven)
2 source controls mapped|1 target controls covered
2%
ITU-T X.805 - Security Architecture for End-to-End Communications
2 source controls mapped|1 target controls covered
2%
Bank Secrecy Act / Anti-Money Laundering (BSA/AML)
2 source controls mapped|1 target controls covered
2%
US Consumer Product Safety Commission (CPSC) - Connected Product Safety
2 source controls mapped|1 target controls covered
2%
US EPA Safe Drinking Water Act (SDWA) - Cybersecurity Requirements
2 source controls mapped|1 target controls covered
2%
Armenia Law on Protection of Personal Data (2015)
2 source controls mapped|1 target controls covered
2%
US Maritime Transportation Security Act (MTSA) and USCG Cybersecurity Requirements
2 source controls mapped|1 target controls covered
2%
BS 65000:2014 - Guidance on Organizational Resilience
2 source controls mapped|2 target controls covered
2%
FFIEC Cybersecurity Assessment Tool (CAT)
2 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
1%
IEEE 1686
1 source controls mapped|3 target controls covered
1%
NSA Guidance for Transition to Quantum-Resistant Cryptography
1 source controls mapped|3 target controls covered
1%
Act on the Implementation of the General Data Protection Regulation (OG 42/2018)
1 source controls mapped|1 target controls covered
1%
Tonga Communications Act (2015) - Privacy & Data Protection
1 source controls mapped|3 target controls covered
1%
ANSSI Cybersecurity Framework
1 source controls mapped|1 target controls covered
1%
Nevada Gaming Control Board Cybersecurity Requirements
1 source controls mapped|1 target controls covered
1%
US Automated Commercial Environment (ACE) - CBP Trade Data Requirements
1 source controls mapped|1 target controls covered
1%
Samoa Telecommunications Act (2005) - Privacy & Data Protection
1 source controls mapped|2 target controls covered
1%
Uganda Data Protection and Privacy Act (2019)
1 source controls mapped|1 target controls covered
1%
Lloyd's of London Cyber Insurance Requirements and Underwriting Standards
1 source controls mapped|1 target controls covered
1%
Japan AI Guidelines
1 source controls mapped|3 target controls covered
1%
UAE Virtual Asset Regulatory Authority (VARA) Regulations
1 source controls mapped|1 target controls covered
1%
OECD AI Principles
1 source controls mapped|3 target controls covered
1%
Singapore AI Governance Framework
1 source controls mapped|3 target controls covered
1%
APRA SPS 220 Risk Management (Superannuation)
1 source controls mapped|3 target controls covered
1%
Own Risk and Solvency Assessment (ORSA) - NAIC Model Act
1 source controls mapped|2 target controls covered
1%
UK AI Regulation Framework
1 source controls mapped|3 target controls covered
1%
NRF Cybersecurity and Data Privacy Framework (National Retail Federation)
1 source controls mapped|3 target controls covered
1%
SEC Cybersecurity Disclosure Rules
1 source controls mapped|2 target controls covered
1%
OECD Recommendation on Artificial Intelligence (2024 Update)
1 source controls mapped|1 target controls covered
1%
SEC Climate Disclosure Rule
1 source controls mapped|3 target controls covered
1%
Compare ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence with NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements

Frequently Asked Questions

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

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence is a compliance framework from International (ISO) with 11 domains and 89 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.

How many controls does ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence have?

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence has 89 controls organised across 11 domains. The largest domains are Clause 7: Process Requirements (19 controls), Clause 8: Management System Requirements (18 controls), Clause 6: Resource Requirements (16 controls). Each control defines specific requirements that organisations must implement to achieve compliance.

What frameworks does ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence map to?

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence maps to 417 other compliance frameworks. The top mapping partners are NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements (24% coverage), PIC/S Guide to Good Manufacturing Practice for Medicinal Products (22% coverage), ISO/IEC 17025:2017 - General Requirements for Testing and Calibration Laboratories (21% coverage). Use our comparison tool to explore control-level mappings between frameworks.

How do I get started with ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence compliance?

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 89 controls and track your progress.

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