ISO 15189 Ready · Assessments and consultancy
Assessments and consultancy — pick what you need
Everything online. Everything optional. Most laboratories need the two assessments and four to eight sessions; the pre-assessment tells you exactly
Two assessments · seven session types · helpdesk · annual maintenance
The line that never moves. ASF prepares medical laboratories for ISO 15189. ASF does not accredit them. ISO 15189 accreditation is granted by a national accreditation body — in Georgia the Georgian Accreditation Centre; elsewhere the ILAC-recognised body of your country — after its own assessment. ASF takes no commission and recommends none. ISO 15189 Ready is a separate product from ISO 9001 Ready and from ASF healthcare accreditation.
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The Readiness Guarantee. If our readiness assessment tells you that you’re ready and the certification audit still finds you’re not, the extra sessions needed to close the gap are on us. We can’t guarantee an independent auditor’s decision — we can guarantee our own work.
Start with the pre-assessment. It tells you which sessions you need and how many — and after it, the count is firm. Everything is delivered online; on site only where it changes the result, at cost for travel.
A
Pre-assessment
Where you are now. Document review plus a 2–3 hour video walkthrough of the laboratory with the quality manager and section heads. You get a written gap report by clause.
Online · half a day
B
Readiness assessment
Are you ready for the accreditation body's assessment? Same method, before you apply. You get a readiness statement.
Online · half a day
1
Kick-off
Roles, the document map, who adopts what and when.
Online · 90 min
2
Document rollout
How to adopt, sign, distribute and train on the documents.
Online · 90 min
3
Discipline session
One per section — biochemistry, hematology, coagulation, immunology, urinalysis — with the section head: SOPs, IQC, EQA, verification files.
Online · 90 min each
4
Gap-closure session
One per group of gaps from the pre-assessment.
Online · 90 min each
5
Mock internal audit
We audit one section live while your auditors watch, then they audit the next one while we watch.
Online · 2 h
6
First management review
We chair your first management review with you, with the inputs ISO 15189 requires.
Online · 90 min
7
Pre-assessment review
The final walkthrough, with the list of what the accreditation body's assessor will ask — including the verification files, EQA records and measurement-uncertainty estimates.
Online · 2 h
9
CAPA support
Drafting and closing a specific corrective action — yours or one the accreditation auditor raised — with the consultant who knows your system, not a generic template.
Online · 90 min
8
Accreditation-day standby
A consultant reachable by call or WhatsApp for the duration of your real accreditation audit, to answer a question the moment it comes up. Doesn’t replace the auditor being independent — it means you’re not facing it alone.
Online · on the day
H
Helpdesk — Standard
Questions by email or WhatsApp, answered within one working day. Included for the first three months with every pack.
Ongoing
P
Helpdesk — Priority
Same channels plus phone, answered the same working day, with one included check-in call a month. For laboratories that want a standing point of contact, not just a mailbox.
Ongoing
M
Annual maintenance
Document updates when the standard or the law changes, one refresher course, one session before your surveillance assessment, helpdesk included.
Yearly
Start with the pre-assessment
Book it after the free Simulation — it turns your results into a firm plan.
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