International (ISO/TC 212); adopted as EN ISO 15189:2022, AS ISO 15189:2023, I.S. EN ISO 15189:2022 and others

ISO 15189:2022

195 controls. 248 other frameworks in our corpus share controls with it. Here is all of it, and how much of it you are already doing.

Page built . This page is derived from the framework corpus, which changes when the corpus is extended rather than daily.

195 controls 248 frameworks share controls with it International (ISO/TC 212); adopted as EN ISO 15189:2022, AS ISO 15189:2023, I.S. EN ISO 15189:2022 and others verified against its source document

Every control below is one this framework asks for. The right hand column counts how many other frameworks in our corpus carry the same control, which is the difference between doing this work once and doing it again for the next standard.

There is no implementation kit for this framework yet. The control list and the overlap above are free and complete.

What you already have

Frameworks whose controls overlap this one, most first. If you run any of them, the count is roughly what you have already evidenced.

If you runShared controls
ISO/IEC 17025:201715measure it →
PIC/S Guide to Good Manufacturing Practice for Medicinal Products11measure it →
ICH Q109measure it →
South Korea ISMS-P9measure it →
Singapore Government Instruction Manual on ICT&SS Management (IM8)8measure it →
21 CFR Part 2117measure it →
Annex 11 to EU GMP7measure it →
ISO 20400:20177measure it →
ISO 28001:2007 Supply Chain Security Management7measure it →
ISO/IEC 27003:20177measure it →
NIST Cybersecurity Framework 2.07measure it →
NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security7measure it →

Every control

CodeControlAlso in
27006-6.1Competence of personnel0
27006-6.2Personnel Records0
6.8Externally Provided Products and Services1
8.9Management Reviews2
A.1Point-of-Care Testing Additional Requirements75
ISO-15189-4.1Impartiality0
ISO-15189-4.2Confidentiality4
ISO-15189-4.3Requirements regarding patients1
ISO-15189-5.1Legal entity135
ISO-15189-5.2Laboratory director0
ISO-15189-5.3Laboratory activities0
ISO-15189-5.4Structure and authority135
ISO-15189-5.5Objectives and policies0
ISO-15189-5.6Risk management81
ISO-15189-6.2Personnel65
ISO-15189-6.3Facilities and environmental conditions10
ISO-15189-6.4Equipment2
ISO-15189-6.5Equipment calibration and metrological traceability10
ISO-15189-6.6Reagents and consumables0
ISO-15189-6.7Service agreements135
ISO-15189-6.8Externally provided products and services60
ISO-15189-7.2Pre-examination processes0
ISO-15189-7.3Examination processes0
ISO-15189-7.4Post-examination processes11
ISO-15189-7.5Nonconforming work1
ISO-15189-7.6Data and information management1
ISO-15189-7.7Complaints0
ISO-15189-7.8Continuity and emergency preparedness27
ISO-15189-8.1General requirements36
ISO-15189-8.2Management system documentation3
ISO-15189-8.3Control of documents2
ISO-15189-8.4Control of records14
ISO-15189-8.5Actions addressing risks and opportunities0
ISO-15189-8.6Improvement2
ISO-15189-8.7Nonconformities and corrective actions0
ISO-15189-8.8Evaluations0
ISO-15189-8.9Management reviews2
4.14.1 Impartiality0
4.24.2 Confidentiality0
4.2.14.2.1 Management of information0
4.2.24.2.2 Release of information0
4.2.34.2.3 Personnel responsibility0
4.34.3 Requirements regarding patients0
5.15.1 Legal entity0
5.25.2 Laboratory director0
5.2.15.2.1 Laboratory director competence0
5.2.25.2.2 Laboratory director responsibilities0
5.2.35.2.3 Delegation of duties0
5.35.3 Laboratory activities0
5.3.15.3.1 Laboratory activities: general0
5.3.25.3.2 Conformance with requirements0
5.3.35.3.3 Advisory activities0
5.45.4 Structure and authority0
5.4.15.4.1 Structure and authority: general0
5.4.25.4.2 Quality management0
5.55.5 Objectives and policies0
5.65.6 Risk management0
6.16.1 Resources: general0
6.26.2 Personnel0
6.2.16.2.1 Personnel: general0
6.2.26.2.2 Competence requirements0
6.2.36.2.3 Authorization0
6.2.46.2.4 Continuing education and professional development0
6.2.56.2.5 Personnel records0
6.36.3 Facilities and environmental conditions0
6.3.16.3.1 Facilities and environmental conditions: general0
6.3.26.3.2 Facility controls0
6.3.36.3.3 Storage facilities0
6.3.46.3.4 Personnel facilities0
6.3.56.3.5 Sample collection facilities0
6.46.4 Equipment0
6.4.16.4.1 Equipment: general0
6.4.26.4.2 Equipment requirements0
6.4.36.4.3 Equipment acceptance procedure0
6.4.46.4.4 Equipment instructions for use0
6.4.56.4.5 Equipment maintenance and repair0
6.4.66.4.6 Equipment adverse incident reporting0
6.4.76.4.7 Equipment records0
6.56.5 Equipment calibration and metrological traceability0
6.5.16.5.1 Calibration and traceability: general0
6.5.26.5.2 Equipment calibration0
6.5.36.5.3 Metrological traceability of measurement results0
6.66.6 Reagents and consumables0
6.6.16.6.1 Reagents and consumables: general0
6.6.26.6.2 Reagents and consumables: receipt and storage0
6.6.36.6.3 Reagents and consumables: acceptance testing0
6.6.46.6.4 Reagents and consumables: inventory management0
6.6.56.6.5 Reagents and consumables: instructions for use0
6.6.66.6.6 Reagents and consumables: adverse incident reporting0
6.6.76.6.7 Reagents and consumables: records0
6.76.7 Service agreements0
6.7.16.7.1 Agreements with laboratory users0
6.7.26.7.2 Agreements with POCT operators0
6.86.8 Externally provided products and services0
6.8.16.8.1 Externally provided products and services: general0
6.8.26.8.2 Referral laboratories and consultants0
6.8.36.8.3 Review and approval of externally provided products and services0
7.17.1 Process requirements: general0
7.27.2 Pre-examination processes0
7.2.17.2.1 Pre-examination processes: general0
7.2.27.2.2 Laboratory information for patients and users0
7.2.37.2.3 Requests for providing laboratory examinations0
7.2.3.17.2.3.1 Examination requests: general0
7.2.3.27.2.3.2 Oral requests0
7.2.47.2.4 Primary sample collection and handling0
7.2.4.17.2.4.1 Primary sample collection and handling: general0
7.2.4.27.2.4.2 Information for pre-collection activities0
7.2.4.37.2.4.3 Patient consent0
7.2.4.47.2.4.4 Instructions for collection activities0
7.2.57.2.5 Sample transportation0
7.2.67.2.6 Sample receipt0
7.2.6.17.2.6.1 Sample receipt procedure0
7.2.6.27.2.6.2 Sample acceptance exceptions0
7.2.77.2.7 Pre-examination handling, preparation, and storage0
7.2.7.17.2.7.1 Sample protection0
7.2.7.27.2.7.2 Criteria for additional examination requests0
7.2.7.37.2.7.3 Sample stability0
7.37.3 Examination processes0
7.3.17.3.1 Examination processes: general0
7.3.27.3.2 Verification of examination methods0
7.3.37.3.3 Validation of examination methods0
7.3.47.3.4 Evaluation of measurement uncertainty0
7.3.57.3.5 Biological reference intervals and clinical decision limits0
7.3.67.3.6 Documentation of examination procedures0
7.3.77.3.7 Ensuring the validity of examination results0
7.3.7.17.3.7.1 Ensuring the validity of results: general0
7.3.7.27.3.7.2 Internal quality control0
7.3.7.37.3.7.3 External quality assessment0
7.3.7.47.3.7.4 Comparability of examination results0
7.47.4 Post-examination processes0
7.4.17.4.1 Reporting of results0
7.4.1.17.4.1.1 Reporting of results: general0
7.4.1.27.4.1.2 Result review and release0
7.4.1.37.4.1.3 Critical result reports0
7.4.1.47.4.1.4 Special considerations for results0
7.4.1.57.4.1.5 Automated selection, review, release and reporting of results0
7.4.1.67.4.1.6 Requirements for reports0
7.4.1.77.4.1.7 Additional information for reports0
7.4.1.87.4.1.8 Amendments to reported results0
7.4.27.4.2 Post-examination handling of samples0
7.57.5 Nonconforming work0
7.67.6 Control of data and information management0
7.6.17.6.1 Control of data and information management: general0
7.6.27.6.2 Authorities and responsibilities for information management0
7.6.37.6.3 Information systems management0
7.6.47.6.4 Downtime plans0
7.6.57.6.5 Off-site management0
7.77.7 Complaints0
7.7.17.7.1 Complaints: process0
7.7.27.7.2 Receipt of complaint0
7.7.37.7.3 Resolution of complaint0
7.87.8 Continuity and emergency preparedness planning0
8.18.1 General requirements0
8.1.18.1.1 Management system: general0
8.1.28.1.2 Fulfilment of management system requirements0
8.1.38.1.3 Management system awareness0
8.28.2 Management system documentation0
8.2.18.2.1 Management system documentation: general0
8.2.28.2.2 Competence and quality0
8.2.38.2.3 Evidence of commitment0
8.2.48.2.4 Documentation0
8.2.58.2.5 Personnel access0
8.38.3 Control of management system documents0
8.3.18.3.1 Control of management system documents: general0
8.3.28.3.2 Control of documents0
8.48.4 Control of records0
8.4.18.4.1 Creation of records0
8.4.28.4.2 Amendment of records0
8.4.38.4.3 Retention of records0
8.58.5 Actions to address risks and opportunities for improvement0
8.5.18.5.1 Identification of risks and opportunities for improvement0
8.5.28.5.2 Acting on risks and opportunities for improvement0
8.68.6 Improvement0
8.6.18.6.1 Continual improvement0
8.6.28.6.2 Laboratory patients, user and personnel feedback0
8.78.7 Nonconformities and corrective actions0
8.7.18.7.1 Actions when nonconformity occurs0
8.7.28.7.2 Corrective action effectiveness0
8.7.38.7.3 Records of nonconformities and corrective actions0
8.88.8 Evaluations0
8.8.18.8.1 Evaluations: general0
8.8.28.8.2 Quality indicators0
8.8.38.8.3 Internal audits0
8.98.9 Management reviews0
8.9.18.9.1 Management reviews: general0
8.9.28.9.2 Review input0
8.9.38.9.3 Review output0
AAnnex A (normative): additional requirements for POCT0
A.2A.2 POCT governance0
A.3A.3 POCT quality assurance programme0
A.4A.4 POCT training programme0
ANNEXES-B-CAnnexes B and C (informative): comparisons with ISO 9001:2015 and ISO/IEC 17025:20170
CLAUSES-1-3Clauses 1 to 3: scope, normative references, terms0
STANDARDISO 15189:2022: the standard and what is held0
TRANSITIONEdition history and the 2022 to 2025 transition0

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What this page is

A control-level reference for ISO 15189:2022, drawn from our framework corpus. Control codes and titles are references to the standard, not reproductions of it. The overlap counts and the auditor artefacts are our own work and are the part you will not find elsewhere.

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