SIST EN ISO 15195:2019/oprA1:2026

• Status: Not Published
• Public Enquiry End Date: 29-Sep-2026
• ICS: 11.100.01 - Laboratory medicine in general
• ICS: 11.100.99 - Other standards related to laboratory medicine
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 30-Jul-2026
• Due Date: 17-Dec-2026
• Completion Date: 07-Oct-2026
• Ref Project: EN ISO 15195:2019/prA1 - Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026)

• Amends: SIST EN ISO 15195:2019 - Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
• Effective Date: 03-Dec-2025

SIST EN ISO 15195:2019/oprA1:2026 is the Slovenian draft amendment aligned with ISO 15195:2018/DAM 1:2026 from ISO. It concerns laboratory medicine and the competence requirements for calibration laboratories that use reference measurement procedures. In practice, it is for laboratories, assessors and quality staff who need the updated wording of the base standard.

What does SIST EN ISO 15195:2019/oprA1:2026 specify?

SIST EN ISO 15195:2019/oprA1:2026 is an amendment to ISO 15195:2018. The amendment text is focused on Subclause 6.4 and changes one sentence in that clause.

For a reader using the standard in practice, this means the amendment is not a standalone replacement for the whole document. It is read together with ISO 15195:2018 so that the base requirements and the amended wording are applied as one current set of instructions.

What are the key requirements of SIST EN ISO 15195:2019/oprA1:2026?

The amendment makes one targeted technical change, and that change sits in Subclause 6.4. The practical effect is that readers must use the revised wording of that clause, not the deleted sentence.

• Subclause 6.4, third sentence - deleted wording about equipment capability.
  The amendment removes the sentence stating that all equipment relevant to the measurements concerned shall be capable of achieving the required measurement accuracy. In practice, laboratories and auditors should check the final integrated text of Subclause 6.4 rather than relying on the older sentence.

• The change affects how equipment is described in relation to measurement accuracy.
  The deleted sentence was the only explicit wording in the amendment about equipment and accuracy. That means the amendment is important wherever a laboratory’s equipment is reviewed against the competence requirements in the base standard.

• The amendment applies at the level of a clause within the base standard.
  Users should not treat this as a broad rewrite of the document. It is a precise editorial and technical update tied to one subclause, so implementation work should focus on the affected clause only.

What terms does SIST EN ISO 15195:2019/oprA1:2026 define?

The amendment itself is short, but these are the key terms and abbreviations used in the document.

• ISO - the International Organization for Standardization, the body identified as publisher and developer of the document.
• SIST - the Slovenian Institute for Standardization, which issues the Slovenian national standard page.
• TC 212 - ISO Technical Committee 212, the committee named as responsible for the document on medical laboratories and in vitro diagnostic test systems.
• Calibration laboratories - laboratories whose competence is addressed by this standard when they use reference measurement procedures.
• Reference measurement procedures - the procedures that provide the reference basis for calibration work in this field.
• Measurement accuracy - the performance concept referred to in the deleted sentence in Subclause 6.4.
• Amendment 1 - the first formal change package applied to ISO 15195:2018.

Who uses SIST EN ISO 15195:2019/oprA1:2026?

SIST EN ISO 15195:2019/oprA1:2026 is used by calibration laboratories in laboratory medicine, especially those working with reference measurement procedures. It is also relevant to quality managers, auditors and assessors who check whether laboratory competence is being judged against the current wording.

Manufacturers, buyers and accreditation bodies may also need it when they specify or review laboratory services that depend on reference measurement work. The amendment matters because a small wording change can affect how competence evidence is documented and assessed.

What changed in SIST EN ISO 15195:2019/oprA1:2026 from the previous edition?

This document is Amendment 1 to ISO 15195:2018. The stated change is in Subclause 6.4, where the third sentence is deleted.

Which standards are used with SIST EN ISO 15195:2019/oprA1:2026?

The amendment is used with ISO 15195:2018, which is the base standard being amended. The page also identifies the European equivalent draft as EN ISO 15195:2019/prA1.

The foreword refers to ISO/IEC Directives, Part 1 and ISO/IEC Directives, Part 2 as the rules used to develop and edit the document. It also notes that the document belongs to the ISO 15195 series.

What does the SIST EN ISO 15195:2019/oprA1:2026 document contain?

The document contains the title pages, draft notices, the foreword, and one amendment instruction. The amendment instruction gives a single change in Subclause 6.4, identified by the sentence to be deleted.

The front matter also states that the document is a draft circulated for comments and approval, with voting dates and copyright and patent notices. For a technical user, the important part is the amendment text itself and its link to the base standard.

SLOVENSKI STANDARD
01-september-2026
Laboratorijska medicina - Zahteve za usposobljenost kalibracijskih laboratorijev z
uporabo referenčnih merilnih postopkov - Dopolnilo 1 (ISO 15195:2018/DAM
1:2026)
Laboratory medicine - Requirements for the competence of calibration laboratories using
reference measurement procedures - Amendment 1 (ISO 15195:2018/DAM 1:2026)
Laboratoriumsmedizin - Anforderungen an die Kompetenz von Kalibrierlaboratorien mit
Referenzmessverfahren - Änderung 1 (ISO 15195:2018/DAM 1:2026)
Biologie médicale - Exigences relatives à la compétence des laboratoires d'étalonnage
utilisant des procédures de mesure de référence - Amendement 1 (ISO
15195:2018/DAM 1:2026)
Ta slovenski standard je istoveten z: EN ISO 15195:2019/prA1
ICS:
11.100.01 Laboratorijska medicina na Laboratory medicine in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
Amendment
ISO 15195:2018/
DAM 1
ISO/TC 212
Laboratory medicine —
Secretariat: ANSI
Requirements for the competence
of calibration laboratories using
Voting begins on:
2026-07-21
reference measurement procedures
Voting terminates on:
AMENDMENT 1 2026-10-13
Biologie médicale — Exigences relatives à la compétence des
laboratoires d'étalonnage utilisant des procédures de mesure de
référence
AMENDEMENT 1
ICS: 11.100.99
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO 15195:2018/DAM 1:2026(en)
DRAFT
ISO 15195:2018/DAM 1:2026(en)
Amendment
ISO 15195:2018/
DAM 1
ISO/TC 212
Laboratory medicine —
Secretariat: ANSI
Requirements for the competence
of calibration laboratories using
Voting begins on:
reference measurement procedures
Voting terminates on:
AMENDMENT 1
Biologie médicale — Exigences relatives à la compétence des
laboratoires d'étalonnage utilisant des procédures de mesure de
référence
AMENDEMENT 1
ICS: 11.100.99
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document has not been edited by the ISO Central Secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2026
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior writt
...