ISO 9001 Ready
Ready for ISO 9001 — documented, trained, prepared. Certified by someone else.
A separate ASF product for ambulatory clinics and hospitals: 163 bilingual documents generated for your organization, a training matrix by role, and consultancy counted in the open
Phase 1: ambulatory clinics & hospitals · EN / KA · Phase 2 (laboratories) follows once Phase 1 has real users
ISO 9001:2026 update. ISO published the sixth edition of ISO 9001 on 16 September 2026; it replaces ISO 9001:2015. The ten-clause structure is unchanged and most requirements are the same. ISO 9001 Ready document packs and courses were built to ISO 9001:2015 and are being updated to the 2026 edition. The update covers separate registers for risks and for opportunities, quality culture and ethical behaviour, planning of changes, a defined objective for every internal audit, and the new management review input. Document and course titles that name the 2015 edition will change when the updated files are released. Certification to ISO 9001:2015 remains valid during the transition period set by the accreditation system.
The line that never moves. ASF prepares organizations for ISO 9001. ASF does not certify them. The ISO 9001 certificate is issued by an independent, accredited certification body of the organization’s choice — ASF’s role stops at readiness. This product is separate from ASF Accreditation, and buying one has no bearing on the other.
ISO 9001 asks an organization to show that its quality management system exists, is documented, is followed and is improved. For a clinic that is a mountain of paperwork: procedures for governance, infection prevention, medication, records, complaints, suppliers, emergencies — and the forms that prove each is used. ASF has written that mountain once, in English and Georgian, for ambulatory clinics and hospitals: 79 procedures and 82 forms, each with a real document-control block and real citations, plus the master index and a full-pack audit.
ISO 9001 Ready turns that library into your organization’s own documentation, then helps your people learn to run it, then helps you close the gaps before your certification audit. Four stages, each optional after the first, each priced separately and openly once you have chosen your scope.
Free · then optional
A free online readiness self-assessment (twenty minutes) followed by a short call to walk through the results together. Optionally, a paid on-site assessment that verifies the self-assessment and produces a real gap report.
Start the self-assessment →
Reviewed, then generated
An intake questionnaire — your identity, your services, your responsible persons — reviewed by ASF for completeness, then a documentation pack generated for your organization: every SOP and form filled with your names, dates and logo. Nothing generic reaches you.
The intake →
By role
A role-by-role training matrix built from the responsibility tables inside the documents themselves, delivered through the ASF Academy — online, blended or in person by role.
The matrix →
Counted, not quoted
Structured sessions with a transparent count: a base of two, one per additional module, one per three to four unresolved gaps, and an optional pre-certification review before your own ISO 9001 audit.
The formula →
190 documents. 106 are universal — every organization receives them. The rest are included only when the intake says the service exists.
Tier 2
Governance — nonconformity, internal audit, management review, document control, risk, suppliers, complaints, competence.
See the list →
Tier 3
General clinical — infection prevention, sterilization, patient safety, medication, patient rights, health information, HR.
See the list →
Tier 4
Laboratory and diagnostics — included when your organization has an in-house laboratory or imaging.
See the list →
Tiers 5, 6, C
Oncology, pediatrics, dialysis — each included only when the service is in scope.
See the list →
Tier 7
Cross-cutting — emergency preparedness, suppliers, complaints, data protection, telehealth, international patients, equipment.
See the list →
Index
The document map, the records and forms index, and the full-pack quality audit report.
See the list →
04
Two products, two buyers
ISO 9001 Ready is for you if
You want a globally portable, sector-neutral quality credential — for tenders, insurers, international partners or your own governance — and you need the management system documented properly, in Georgian and English, without writing 160 documents from scratch. You may have no interest in healthcare accreditation at all. That is fine.
ASF Accreditation is for you if
You want healthcare-specific recognition of the safety and quality of care — assessed against published clinical standards by surveyors who walk your wards. It is a different product for a different purpose, at france-asf.fr/standards. Some organizations want both; neither requires the other.
05
Roadmap, stated plainly
Phase 1 — ambulatory clinics and hospitals — is complete and live on this page. Phase 2 — a separate document set for independent and reference laboratories — is deliberately not started until Phase 1 has real customers whose use tells us what a laboratory set must contain. Phase 3 and beyond are unscoped. Pricing is published only once the structure is confirmed in use; nothing on these pages is a quote.
Start where everyone starts
The free readiness self-assessment takes twenty minutes and ends with a call.
Start the self-assessment
QR Code
Scan to open.
Print to share.
