Spain

Software LIS para laboratorios clínicos en España

A laboratory information system built for a Spanish laboratorio clínico: the records the autonomous community’s authorisation and an ENAC assessment examine, VAT-exempt billing, and invoicing ready for Verifactu.

¿Qué software LIS conviene a un laboratorio clínico en España?

SamLab es un sistema de información de laboratorio offline-first para laboratorios clínicos españoles autorizados por su comunidad autónoma. Conserva intervalos de referencia con unidades, identidad de quien valida cada resultado, historial de modificaciones y trazabilidad para una evaluación ENAC según ISO 15189, factura con IVA exento por servicio y exporta a un sistema Verifactu. La acreditación pertenece al laboratorio.

What a Spanish laboratory is authorised and accredited against

Under Real Decreto 1277/2003 the health authorities of each comunidad autónoma authorise the installation, operation, modification and closure of every health centre and establishment, and renew the operating authorisation on the period each community sets; a private laboratory is unit U.73, laboratorio clínico, under the responsibility of a specialist, and every authorised centre is entered in the national REGCESS registry. Accreditation to UNE-EN ISO 15189 is granted by ENAC and is voluntary in general. Medical diagnostic services are exempt from VAT under article 20 of Ley 37/1992, and invoicing software must be a Verifactu-compliant system by 2027.

The health authorities of each comunidad autónoma authorise the installation, operation, modification and closure of all health centres, services and establishments, and the operating authorisation is renewed on the period each community determines (Real Decreto 1277/2003, article 3).

In SamLab: A laboratory profile that prints the authorisation reference and the responsible specialist on every report, with the renewal date visible before it lapses.

A private laboratory is unit U.73 laboratorio clínico in Annex II of Real Decreto 1277/2003, under the responsibility of a specialist in laboratorio clínico, análisis clínicos or bioquímica clínica.

In SamLab: Verifier identity on every released result tied to the responsible specialist’s record, and a retained amendment history.

Every authorised centre, service and establishment is entered in the public REGCESS registry maintained by the Ministerio de Sanidad and fed continuously by the communities (article 5).

In SamLab: Registry identifiers held in the laboratory profile and printed where a report or invoice needs them.

Invoicing software must be a Verifactu-compliant sistema informático de facturación, with hash-chained records and a QR code on invoices, by 1 January 2027 for corporate-tax filers and 1 July 2027 for others, according to the Agencia Tributaria.

In SamLab: Invoice records that never re-mint a number and export cleanly to a Verifactu-compliant invoicing system; confirm the integration path in a demo.

Source: Real Decreto 1277/2003 (BOE, texto consolidado) · 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 Spain laboratories

¿SamLab está acreditado por ENAC?

La acreditación la concede ENAC al laboratorio, nunca al software. SamLab aporta las evidencias que una evaluación según UNE-EN ISO 15189 examina: intervalos de referencia con unidades, identidad de quien valida cada resultado, historial conservado de modificaciones y trazabilidad de la muestra desde la extracción hasta el informe.

¿SamLab cumple Verifactu?

SamLab mantiene registros de factura que nunca reutilizan un número y los exporta al sistema informático de facturación compatible con Verifactu que encadena los registros y añade el código QR, exigido por la Agencia Tributaria a partir de 2027. Confirme la vía de integración en una demostración.

¿Qué pasa si se cae internet?

El registro, la facturación, la entrada de resultados, la impresión de informes y la conexión con los analizadores siguen funcionando. SamLab trabaja con una base de datos local en la propia máquina del laboratorio y se sincroniza cuando vuelve la conexión.

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