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.
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. Pre-assessment €290 · readiness assessment €390 · sessions €120 · helpdesk €39/month after the included three · maintenance €390/year. Per laboratory, excluding VAT.
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
H
Helpdesk
Questions by email, WhatsApp, Viber or phone, answered within one working day. Included for the first three months with every pack.
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.
QR Code
Scan to open.
Print to share.
Print to share.
DocumentDownload QR
