Technical Reference · Published September 2026

ASF–ISO Crosswalk

The complete mapping showing which ASF accreditation criterion satisfies which ISO 9001:2026 clause and which ISO 15189:2022 section. Published openly so facilities, surveyors, health ministries and ISO bodies can verify the claim independently.

ASF International Standards Council · Paris, September 2026 · Version 1.0

ISO 9001:2026. ISO published the sixth edition of ISO 9001 on 16 September 2026; it replaces ISO 9001:2015, against which this module was first built. This page now refers to the 2026 edition. The ten-clause structure is unchanged. The 2026 edition adds or strengthens a small number of requirements. Those that fall inside this module have been updated below: context now includes the climate change determination (4.1), the facility decides which interested-party requirements its system addresses (4.2), planned changes are communicated, monitored and reviewed (6.3), and organisational knowledge is applied and shared (7.1.6). Five further points fall in clauses that are mapped to ASF core criteria: promotion of quality culture and ethical behaviour by top management (5.1.1), staff awareness of both (7.3), separate actions for opportunities (6.1.3), a defined objective for every internal audit (9.2.2), and changes in the needs of interested parties as a management review input (9.3.2). The ASF International Standards Council is reviewing that mapping. The figure of 32 clauses covered by core criteria was counted against the 2015 edition and is being re-verified against the 2026 edition. Readiness statements and certificates issued against ISO 9001:2015 remain valid during the transition period set by the accreditation system.

~35

ASF assessed criteria per facility type (hospital: 75, others: 32–43)

ISO 9001 clauses covered by ASF core criteria (counted against the 2015 edition; recount against 2026 in progress)

ISO 15189:2022 sections covered by ASF lab criteria

How to read this table

Each row is one ASF criterion from the Hospital standard (the largest, at 75 criteria; other facility types average 35). The Level column shows whether it is Non-Negotiable (NN) or Core. The ISO 9001 and ISO 15189 columns show which clauses or sections a facility satisfies by meeting that criterion. A facility that achieves ASF accreditation has already met the ISO clauses shown. The ISO 9001 Add-On Module covers the remaining ISO 9001 clauses not addressed by clinical criteria — primarily management system structure, design controls, and internal audit.

NN = Non-Negotiable
CORE = Core criterion
ADD-ON = ISO module additional criterion

Criterion	Level	Title	ISO 9001:2026	ISO 15189:2022
1.1	NN	Findable Before Arrival	§8.2, §8.5.1
1.2	NN	Hospital Grounds and Territory Entrance	§7.1.3, §8.1
1.3	NN	Physical Access, or a Real Plan	§7.1.3, §8.5.1
1.4	NN	Emergency Entrance, Marked and Clear	§8.1, §8.5.1
1.5	CORE	Wayfinding Without Staff Dependence	§7.4, §8.5.1
2.1	NN	Patients Know Their Rights	§8.2.1, §8.2.2
2.2	CORE	Pricing Is Disclosed Before Care Begins	§8.2.2, §8.2.3
2.3	NN	Reception Desk Accessibility	§7.1.3, §8.5.1
2.4	CORE	Health Information Is Genuinely Understandable, Not Just Provided	§7.4, §8.2.2
2.5	CORE	Waiting and Queue Time Is Actively Managed	§8.5.1, §9.1.2
3.1	NN	Water Supply Is Safe and Monitored	§7.1.3, §7.1.4
3.2	NN	Medical Equipment Is Maintained on Schedule	§7.1.3, §7.1.5	§6.3
3.3	CORE	Shared Spaces Are Genuinely Clean	§7.1.4
3.4	NN	Facility Risks Are Tracked in One Integrated Register	§6.1, §9.1
3.5	CORE	An Environmental Sustainability Programme Is Genuinely Active	§6.1, §10.3
3.6	NN	Facility Signage Is Complete, Not Just Present at Reception	§7.4, §8.5.1
4.1	NN	Consent Is Real, Not a Signature	§8.2.1, §8.5.1
4.2	NN	Staff Credentials Are Checked and Current	§7.2	§6.2
4.3	NN	New Staff Are Properly Onboarded	§7.2, §7.3
4.4	NN	Staffing Actually Matches Patient Need	§7.1.2, §7.2
4.5	NN	Hand Hygiene Actually Happens	§7.1.4, §8.5.1	§6.4.2
4.6	NN	Protective Equipment Is Actually Available	§7.1.3, §7.1.4	§6.4.1
4.7	NN	Sharps and Waste Are Handled Safely	§7.1.4, §8.5.1
4.8	NN	Every Patient Gets a Real Assessment	§8.5.1
4.9	NN	There's an Actual Care Plan	§8.5.1, §7.5
4.10	NN	Medication Prescribing Is Safe	§8.5.1, §8.7
4.11	NN	The Surgical Safety Checklist Is Actually Used	§8.5.1, §8.6
4.12	NN	Anaesthesia Is Delivered Safely	§8.5.1, §7.2
4.13	NN	Surgical Site Infection Is Actively Prevented	§8.5.1, §8.7	§6.4.2
4.14	NN	The Lab Has Quality Control	§9.1.1, §9.1.3	§7.3, §5.6
4.15	NN	Critical Lab Values Reach the Doctor Fast	§8.5.1, §9.1	§7.4.1
4.16	NN	Specimens Are Correctly Identified	§8.5.1	§7.2.2, §7.2.3
4.17	NN	Medication Storage Is Secure and Correct	§7.1.3, §8.5.4
4.18	NN	High-Alert Medications Get Extra Safeguards	§8.5.1, §8.7
4.19	NN	Medication Reconciliation Actually Happens	§8.5.1, §7.5.3
4.20	NN	Patient Identified Correctly at Every Point of Contact	§8.5.1, §8.6	§7.2.2
4.21	NN	Falls Risk Assessed and Actively Prevented	§8.5.1, §6.1
4.22	CORE	Look-Alike, Sound-Alike Medications Are Specifically Managed	§8.5.1, §8.7
4.23	CORE	Restraint and Seclusion Use Is Governed and Minimised	§8.5.1, §8.2.1
4.24	CORE	Nutrition and Therapeutic Diet Needs Are Actively Managed	§8.5.1
4.25	NN	Deteriorating Patients Are Caught Before the Crisis, Not After	§8.5.1, §9.1.1
4.26	NN	Sepsis Is Recognised and Treated Within the Hour	§8.5.1, §8.7
4.27	CORE	Pressure Injury Risk Is Assessed and Actively Prevented	§8.5.1, §6.1
4.28	CORE	VTE Risk Is Assessed Before Every Admission and Procedure	§8.5.1, §6.1
4.29	NN	Blood and Blood Products Are Verified Before Every Transfusion	§8.5.1, §8.6
4.30	NN	Handoffs Use a Structured, Verbal Process — Not Just a Written Note	§7.4, §8.5.1
4.31	CORE	Opioid Prescribing Is Deliberately Stewarded	§8.5.1, §8.4
4.32	CORE	Pain Is Formally Assessed and Reassessed, Not Just Asked About Once	§8.5.1, §9.1.2
4.33	NN	Dignity, Respect, and Non-Discrimination Are Practised, Not Just Stated	§8.2.1, §5.1
4.34	NN	Vulnerable Patients Get Real, Specific Protections	§8.5.1, §8.2.1
4.35	CORE	Advance Directives Are Sought, Documented, and Actually Followed	§8.5.1, §7.5
4.36	CORE	The Facility Tracks Its Own Infection Rate Over Time	§9.1, §9.1.3	§5.6, §7.3.2
4.37	NN	Medication Safety Doesn't Depend on Software That Isn't Actually Working	§7.1.3, §7.1.5
5.1	NN	Triage Actually Sorts Patients by Urgency	§8.5.1, §8.1
5.2	NN	Resuscitation Equipment Is Ready Right Now	§7.1.3, §8.5.1
5.3	NN	There's a Real Disaster Response Plan	§6.1, §8.1
5.4	NN	Fire Safety Is Real, Not Theoretical	§7.1.4, §8.5.1
5.5	NN	Workplace Violence Is Prevented, Not Just Responded To	§7.1.4, §8.5.1
5.6	NN	Internal Emergency Alerts Are Clear, Consistent, and Trained	§7.4, §8.5.1
6.1	NN	Every Discharged Patient Gets a Real Aftercare Plan	§8.5.1, §8.2.1
6.2	NN	A Real Mechanism Checks on the Patient After They Leave	§8.5.5, §9.1.2
6.3	NN	Patients Can Complain After Leaving, and Complaints Are Actually Read	§8.2.1, §10.2
7.1	NN	The Board Is Real and Accountable	§5.1, §5.3
7.2	NN	There Is a Written Strategic Plan	§5.1, §6.2
7.3	NN	Policy Actually Gets Followed	§5.1, §7.5
7.4	NN	Patient Information Stays Private	§7.5.3, §7.5.2	§8.4
7.5	NN	Medical Records Are Complete	§7.5, §8.5.1	§7.5, §8.4
7.6	NN	Patient Data Is Kept Secure	§7.5.2, §7.5.3	§8.4
7.7	NN	Records Are Kept Exactly as Long as Required	§7.5.2	§8.4
7.8	NN	Incidents Are Actually Reported	§10.2, §9.1.3
7.9	NN	Serious Incidents Get Properly Investigated	§10.2, §9.3
7.10	NN	Safety Culture Is Actually Measured	§9.1.2, §9.3
7.11	CORE	Patient Experience Is Measured Continuously, Not Only After Discharge	§9.1.2, §10.3
7.12	CORE	A Real Ethics Consultation Process Exists	§8.2.1, §8.5.1
7.13	CORE	Patients and Families Have a Real Voice in Governance	§8.2.1, §5.1

ISO 9001 Add-On Module — Additional Criteria

These 18 criteria are not addressed by ASF’s clinical standards because they concern quality management system structure rather than clinical practice. They form the content of the ISO 9001 Add-On Module. A facility that completes the module alongside ASF accreditation has demonstrated the ISO 9001 requirements mapped on this page. The mapping was first built against the 2015 edition; the requirements added by ISO 9001:2026 are described in the note at the top of this page.

ISO Clause	Type	Clause Name	What is assessed
ISO §4.1	ADD-ON	Context of the organisation	The facility formally documents the internal and external factors that affect its ability to achieve its quality objectives, including whether climate change is a relevant issue.
ISO §4.2	ADD-ON	Needs and expectations of interested parties	The facility identifies its key stakeholders — patients, staff, regulators, payers — and their relevant requirements, decides which of those requirements it will address through its quality management system, and reviews these annually.
ISO §4.3	ADD-ON	Scope of the quality management system	The facility defines and documents the boundaries and applicability of its QMS, including which services and locations are covered.
ISO §4.4	ADD-ON	QMS processes	The facility identifies the sequence and interaction of its key processes and assigns ownership for each.
ISO §5.2	ADD-ON	Quality policy	The facility has a documented quality policy, signed by leadership, communicated to all staff, and reviewed at each management review.
ISO §6.3	ADD-ON	Planning of changes	Changes to the QMS are planned — with objectives, resources, responsibilities and risks assessed — before implementation, including how the change will be communicated, how its effectiveness will be monitored, and how the results will be reviewed.
ISO §7.1.6	ADD-ON	Organisational knowledge	The facility identifies the knowledge critical to its operations, protects it from loss, applies and shares it, and has a process for acquiring new knowledge where gaps exist.
ISO §7.5.1	ADD-ON	Documented information — general	The facility maintains documented information required by ISO 9001 and by its own QMS, including this scope statement, quality policy, and quality objectives.
ISO §8.2.4	ADD-ON	Changes to customer requirements	When patient/service requirements change after initial agreement, the facility updates its documentation and communicates the change to relevant staff.
ISO §8.3	ADD-ON	Design and development	For any new clinical service or programme introduced, the facility follows a defined design and development process covering inputs, outputs, controls and validation.
ISO §8.4.1	ADD-ON	External providers — general	The facility maintains a register of external providers (labs, imaging, specialist referrals, maintenance contractors) and evaluates their performance against defined criteria.
ISO §8.4.2	ADD-ON	External providers — type and extent of control	For each critical external provider, the facility specifies the controls applied to verify quality of the supplied product or service.
ISO §8.4.3	ADD-ON	Information for external providers	The facility communicates its requirements clearly to external providers before work begins, and verifies that providers have understood them.
ISO §8.5.2	ADD-ON	Identification and traceability	The facility can trace any output — test result, procedure record, prescription — back to the patient, the staff member, and the date through documented identifiers.
ISO §8.5.3	ADD-ON	Property belonging to customers or external providers	The facility has a documented process for handling, storing, and returning patient property (valuables, samples, records) and notifying patients if any property is lost or damaged.
ISO §8.5.6	ADD-ON	Control of changes	Changes to production or service provision are reviewed, controlled and documented; results are retained.
ISO §9.2	ADD-ON	Internal audit	The facility conducts a planned internal audit programme covering all QMS processes at least once per year, with documented results and follow-up on findings.
ISO §10.1	ADD-ON	Improvement — general	The facility identifies opportunities for improvement using the outputs of monitoring, measurement, audit and management review, and acts on them systematically.

Legal notice

ASF accreditation and ISO 9001/ISO 15189 readiness statements confirm that a facility has demonstrated the documented requirements described in this crosswalk. They do not constitute ISO certification. Formal certification under ISO 9001 requires engagement with an IAF-accredited certification body. Formal accreditation under ISO 15189 requires engagement with a national accreditation body.

Version history

Version 1.0 — September 2026. Covers Hospital Standards core criteria (Standards 1–7, 75 criteria). Ambulatory, LTC, PHC, Telemedicine and Home Care crosswalks follow in Q1 2027. Corrections and comments: info@accreditation.ge