We prepare your organisation for ISO certification.
An independent body issues the certificate.
Gap analysis, documentation, training, and readiness review — all the hard preparation work, done by ASF. When you’re ready, an accredited certification body of your choice (Bureau Veritas, SGS, Lloyd’s, TÜV, and others) conducts the audit and issues your ISO certificate.
across 5 facility types
for medical laboratories
libraries included
September 2026 edition
Photo: Mike Hindle / Unsplash
You need ISO consulting if:
A quick self-check — if any of this sounds like your organisation, an ISO conversation is worth having.
Who does what — and why it matters
Under international accreditation rules, the body that helps you prepare for certification cannot also be the body that certifies you. This keeps the certificate credible. ASF plays the preparation role. Your certifier is independent.
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ASF provides
- GAP analysis against ISO requirements
- Complete documentation libraries (policies, SOPs, forms, records)
- Role-specific ISO preparation training
- Process design and implementation guidance
- Internal audit methodology and templates
- Management review facilitation
- Pre-certification readiness review
- Post-certification maintenance support
- Preparation for annual surveillance audits
- Support through the 3-year renewal cycle
Certification bodies provide (not ASF)
- Stage 1 audit (document and system review)
- Stage 2 audit (on-site conformity assessment)
- Certification decision and certificate issuance
- Annual surveillance audits (mandatory, 12-month cycle)
- 3-year recertification assessment
- Certificate suspension or withdrawal
Accredited certification bodies you can use: Bureau Veritas, SGS, Lloyd’s Register, TÜV Rheinland, TÜV SÜD, Intertek, DNV, or any IAF/ILAC-accredited body operating in your country.
The complete ISO certification journey — all seven phases
ISO certification is not an event — it is a three-year cycle of implementation, annual surveillance, and renewal. The timeline below shows every phase: where ASF works with you, and where the certification body takes over.
Situation Review & GAP Analysis
Where ASF starts
ASF maps your current management system against the ISO standard clause by clause. You receive a scored GAP report showing which requirements you already meet, which need development, and a prioritised action plan. This becomes the roadmap for all subsequent phases.
Scored GAP reportClause-by-clause matrixPrioritised action planEstimated timeline to certification
Training — Leadership, Process Owners & Internal Auditors
Builds internal capacity
ISO implementation only works when the people responsible for it understand the standard. ASF delivers role-specific training: awareness sessions for leadership, working-level training for process owners, and internal auditor certification for your audit team. Delivered at your facility or through GMJ Academy.
Leadership awareness sessionProcess-owner working courseInternal auditor courseTraining completion records
Documentation & System Development
ASF’s key differentiator
This is where ASF’s ISO Ready document packages make the biggest difference. Rather than building every policy, procedure, and form from scratch — a process that typically takes 3–6 months — your organisation downloads ASF’s complete, implementation-ready library and customises it to your processes. See the full ISO 9001 Ready and ISO 15189 Ready packages. Covers risk-based thinking, process approach, monitoring and measurement, nonconformity control, corrective actions, and management review.
Full document library (EN / KA)Process maps and interaction diagramRisk register templateMonitoring and measurement frameworkInternal audit programmeManagement review agenda & minutes
Internal Audit & Management Review
Required before certification
Before any certification body can certify you, the standard requires evidence that your system is operating — not just documented. Your trained internal auditors run at least one full audit cycle. Nonconformities are raised, corrective actions are implemented, and a management review is held. ASF reviews the evidence package and confirms it meets certification requirements.
Internal audit schedule & reportsNonconformity and CAR registerManagement review minutesEvidence readiness sign-off from ASF
Certification Audit — Stage 1 & Stage 2
Certification body
Stage 1 (document review): The certification body reviews your management system documentation against the ISO standard. They identify any major gaps that must be resolved before the on-site audit. ASF helps you address any Stage 1 findings.
Stage 2 (on-site audit): Auditors visit your facility to verify that the implemented system matches your documentation and genuinely operates as described. Nonconformities raised at Stage 2 must be corrected — minor ones before certificate issue, major ones before the audit closes.
ISO certificate (valid 3 years)Certificate issued by your chosen certifier
Did the Stage 2 audit close without major nonconformities?
Annual Surveillance Audits — Year 1 & Year 2
Every 12 months
Every 12 months after certification, the certification body returns for a surveillance audit. This is not a full recertification — it checks that your system is still operating, still improving, and has addressed any previous nonconformities. Organisations that stop maintaining their system fail surveillance audits and lose their certificate. ASF can prepare your evidence pack and run a mock surveillance audit before the certifier arrives.
Updated internal audit evidenceManagement review for the periodCorrective action closure recordsASF mock surveillance support (optional)
3-Year Recertification
Every 3 years
After three years the full certification cycle repeats: a fresh Stage 2 audit by the certification body. Organisations with well-maintained systems and clean surveillance audit records find recertification straightforward. ASF prepares a full evidence review, updates your document library to any revised standard version, and confirms readiness before you engage the certifier again.
Three-year evidence summaryDocument library update to current standard versionRecertification readiness review
ISO Consulting Services — booked by engagement
Every phase above can be run by your own team using ASF’s documents and training alone — or you can bring ASF in directly to do the work with you. These are the hands-on, scoped engagements organisations actually book, each delivered by ASF’s own consultants, not subcontracted.
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GAP Analysis & Readiness Assessment
1–3 days
ASF reviews your current management system clause by clause against ISO 9001 or ISO 15189 and delivers a scored report with a prioritised action plan and realistic timeline to certification.
Internal Auditor Training
1–2 days
Certifies your own staff to run the internal audits every ISO standard requires before certification and at every surveillance cycle. Delivered on-site or through GMJ Academy.
Photo: Arisa Chattasa / Unsplash
Full Implementation Support
Managed, 3–6 months
ASF manages Phases 1–4 end to end alongside your team: GAP analysis, training, document customisation, and internal audit & management review, until you are ready for the certification body.
Certification Readiness Review
1–2 days
A mock Stage 2 audit run by ASF before your real certification body arrives — surfaces nonconformities while they are still cheap and quiet to fix.
Surveillance & Recertification Support
Annual / 3-year
Keeps a certificate you already hold. ASF prepares your evidence pack and runs a mock surveillance audit each year, and a full readiness review ahead of your 3-year recertification.
Free Initial Consultation
No cost
A 30-minute call to understand your facility, which standard fits, and roughly what certification will take — before you commit to anything. No obligation.
Training isn’t an add-on here — it’s a working academy
Most ISO consultancies treat training as a slide deck bolted onto a GAP analysis. ASF runs an actual academy platform — GMJ Academy — with dozens of structured, role-based courses already live and a growing library of ISO-specific modules being published on top of it. Training runs alongside preparation from day one, not as an afterthought once the documents are done.
Self-paced e-learning
Structured modules staff work through on their own schedule, each ending in a graded 80% pass quiz.
QR certificate & ASF Passport
A pass issues an automatic certificate carrying a QR code, filed into the learner’s ASF Passport record.
Priced per organisation
Unlimited staff, one price per facility — not per seat, and not per head as your team grows.
Live workshops for audit
Internal-auditor courses are the exception: a live online workshop with a graded mock audit, not self-paced e-learning.
Course pages for the ISO 9001 Ready and ISO 15189 Ready catalogues are being published progressively on GMJ Academy. Until a specific module goes live, its link currently routes to the general academy course catalogue.
Photo: Bryn Young / Unsplash
ISO Ready document packages — Phase 3, done for you
The most time-consuming part of ISO preparation is building the document system from scratch. ASF’s ISO Ready packages give you a complete, implementation-ready library — customise, not create. Available in English and Georgian.
ISO 9001 Ready
Complete document libraries for five healthcare facility types — ambulatory clinic, hospital, fitness & wellness, primary health clinic, and long-term care. Updated to the latest ISO 9001:2026 edition (published September 2026).
ISO 15189 Ready
184 documents covering ISO 15189:2022 for medical laboratories across five analytical disciplines. Simulate a full accreditation assessment before committing to a certification body — validate your readiness at no cost.
ASF–ISO Crosswalk
A clause-by-clause mapping showing where ASF accreditation standards align with ISO 9001 and ISO 15189. Organisations already working toward ASF accreditation can use this to understand how much ISO preparation work has already been done.
Not just documents — a full toolkit
ASF is not a PDF vendor. Every stage of ISO preparation above is backed by a live, interactive tool on this site — test your readiness, generate your documents, book your engagement, and check out, all without leaving the platform.
Free Self-Assessment & Simulation
Score your facility against ISO 9001 or simulate a full ISO 15189 assessment in minutes — free, no account, no obligation.
Intake & Auto-Generation Platform
Answer a structured intake about your facility and ASF’s platform assembles your customised, clause-mapped document set.
Training Catalogue
40 role-based ISO 9001 courses plus a dedicated ISO 15189 curriculum — from leadership awareness to internal auditor.
Consultancy & Assessment Booking
Book GAP analysis, mock audits, or implementation support directly — scoped and quoted for your facility.
Order & Checkout
Buy your document package directly — fixed price, instant access, no sales call required.
ISO standards ASF covers
ISO 9001:2026 — Quality Management Systems
The world’s most widely adopted management system standard. Applicable to any organisation in any sector. ASF’s healthcare-focused implementation covers all ten clauses with facility-specific guidance for clinics, hospitals, fitness centres, PHCs, and LTC facilities.
ISO 15189:2022 — Medical Laboratory Accreditation
The international standard for competence and quality in medical laboratories. Covers both management and technical requirements. ASF’s ISO 15189 Ready package spans five analytical disciplines with fully documented procedures.
ISO 9001 + ASF Accreditation — dual-benefit pathway
Organisations pursuing ASF accreditation have already met a significant proportion of ISO 9001 requirements. The ASF–ISO Crosswalk maps the overlap exactly, so you can pursue both simultaneously without duplicating effort.
Coming — ISO 45001 & ISO 14001
Occupational health & safety (ISO 45001) and environmental management (ISO 14001) document packages for healthcare facilities are in development. These will integrate with existing ISO 9001 documentation for an integrated management system approach.
See the full range — ISO Standards We Cover
Beyond ISO 9001 and ISO 15189, ASF now consults across a curated set of ISO management-system standards spanning quality, health & laboratory, food safety, and environment & safety — GAP analysis and readiness preparation for each.
Why prepare with ASF rather than a generic ISO consultancy
Healthcare-specific
Generic ISO consultancies write generic documents. ASF’s materials are built for healthcare facilities — ambulatory clinics, hospitals, laboratories — and reflect the real operational context your auditors will assess.
Documents, not hours
Most consultancies charge by the hour and build documents from scratch — a process that typically takes an organisation 3–6 months (see Phase 3 above). ASF gives you a complete, implementation-ready library of 163+ to 184 documents upfront. You customise and implement; you don’t wait months for documents to be written.
Accreditation connection
If your facility is also pursuing ASF accreditation, you are already working through requirements that significantly overlap with ISO 9001. The Crosswalk maps the overlap so you never prepare the same thing twice.
Bilingual EN / KA
Every document in ASF’s ISO Ready packages is available in both English and Georgian — ready to use in an international audit environment and with your Georgian-speaking workforce simultaneously.
Full-cycle support
Most consultancies focus on initial certification. ASF supports the full cycle — preparation, certification readiness, annual surveillance, and 3-year renewal — so you don’t lose your certificate between audits.
Updated to ISO 9001:2026
ISO published the sixth edition of ISO 9001 in September 2026. ASF’s document packages are already updated to the new edition. Organisations certified under ISO 9001:2015 will need to transition by the standard’s transition deadline.
Fixed, transparent pricing
Document packages are listed at a fixed price up front — no hidden fees. Larger consulting engagements (GAP analysis, implementation support, mock audits) are scoped individually and quoted before you commit to anything.
No conflict of interest
ASF prepares — it never certifies. Because ASF is never the body auditing you, there is no incentive to wave through a weak system or fail a strong one. Your certifier is independent, and so is ASF’s advice.
Not sure where to start? Book a free 30-minute call — or go straight to a consulting engagement or a document package for your facility type.
Book a Free Consultation
See Consulting Services
ISO 9001 Ready Packages
ISO 15189 Ready (Labs)
Free GAP Crosswalk
ISO Training Courses