LIS Software for Swedish Laboratories — Swedac & IVO
A laboratory information system built for a Swedish care provider registered with IVO: the quality-management records SOSFS 2011:9 requires, the ISO 15189 evidence a Swedac assessment examines, and Peppol e-invoices for the regions.
Vilket laboratoriesystem passar ett privat laboratorium i Sverige?
SamLab är ett offline-first laboratorieinformationssystem för svenska laboratorier registrerade hos IVO. Det håller de processunderlag Socialstyrelsens föreskrifter om ledningssystem kräver, referensintervall med enheter, vem som godkänt varje resultat och en bevarad ändringshistorik för en Swedac-bedömning mot ISO 15189, tar fram Peppol-fakturor till regionen och fortsätter fungera utan internet. Ackrediteringen tillhör laboratoriet.
What a Swedish laboratory is registered and assessed against
Anyone intending to run care covered by the Patientsäkerhetslag must register the business with IVO at least one month before starting and report changes within a month; since July 2023 IVO can enforce registration with a conditional fine. Socialstyrelsen’s SOSFS 2011:9 requires every provider to run a ledningssystem for systematic quality work. Swedac accredits medical laboratories to SS-EN ISO 15189 on a voluntary basis, with surveillance about every sixteen months and a full renewed assessment every four years. Tests taken as part of health care are exempt from VAT, and suppliers to the public sector must send Peppol e-invoices.
Anyone who intends to run a business covered by IVO’s supervision under the Patientsäkerhetslag must notify IVO of the new business no later than one month before it starts, and since 1 July 2023 IVO may enforce this with a conditional fine.
In SamLab: A provider profile holding the IVO registration and its dates, printed on reports, and a change log that supports the one-month change-reporting duty.
SOSFS 2011:9 requires the care provider to be responsible for a ledningssystem for the business and to identify, describe and establish the processes needed to secure its quality.
In SamLab: Documented process records — QC per analyzer, verification, amendments, corrective actions — that print as the evidence a ledningssystem review reads.
Swedac accredits medical laboratories to SS-EN ISO 15189 on a voluntary basis, with checks as a rule every sixteen months and a full renewed assessment every four years.
In SamLab: Reference ranges with units, verifier identity on every result, a retained amendment history with the earlier value, and specimen traceability from collection to report.
Suppliers must send e-invoices to the public sector for purchases under the procurement acts, a PDF invoice is not an e-invoice, and the recommended format is Peppol BIS Billing 3.
In SamLab: Invoices with the structured fields a Peppol BIS Billing 3 e-invoice needs, exported for the access point that submits them to the region.
Source: IVO — Vårdgivarregistret, anmälan enligt patientsäkerhetslagen · checked 2026-09-03. Accreditation is granted to the laboratory, not to its software — what SamLab provides is the records an assessor asks to see.
Runs when the internet doesn’t
Registration, billing, result entry and reports work with the connection down and sync when it returns. Prices are shown in your own currency.
Questions from Sweden laboratories
Är SamLab ackrediterat enligt ISO 15189?
Ackreditering beviljas laboratoriet av Swedac, aldrig programvaran. SamLab ger de underlag en bedömning mot SS-EN ISO 15189 granskar: referensintervall med enheter, vem som godkänt varje resultat, en bevarad ändringshistorik och spårbarhet från provtagning till svar.
Kan SamLab skicka e-faktura till regionen?
SamLab tar fram fakturor med de strukturerade fält en Peppol BIS Billing 3-faktura kräver och exporterar dem till den accesspunkt som skickar dem till regionen. Analyser som ingår i sjukvården hanteras momsfritt per tjänst.
Vad händer om internet försvinner?
Registrering, fakturering, resultatinmatning, svarsutskrift och instrumentkoppling fortsätter att fungera. SamLab arbetar mot en lokal databas på labbets egen dator och synkroniserar när anslutningen är tillbaka.
Try the whole lab, free for 7 days.
No card. No catch. Run SamLab on your own data — online or offline — and feel the difference before you pay anything.