video Lezione 2026: ISO 15189:2022 gestione dati e informazioni requisiti di § 7.6

 https://bit.ly/15189informazioni2026

Data and Information Management: Requirements specified in Section 7.6 of ISO 15189:2022. - Lecture 2026

• May 2026

• DOI: 
• 10.5281/zenodo.20277277

Examples of the application of ISO 15189:2022 for data and information management --- 
Requirements of Section 7.6 of the ISO 15189:2022 standard.

2026 Update ---
link https://youtu.be/EN1bqwB3Dzw
---
References to SIPMeL Q181 recommendations, ISO 22367, ISO/IEC 27001, ISO 27799, CLSI AUTO16, EN 17269, (HL7) ISO 10781, (FHIR) ISO/PAS 24305, SIPMeL Recommendations M2-3, CLSI AUTO17, CLSI AUTO11, ISO 6268, EUROLAB Guide, ISO 17090, ISO 24051.
---
ISO 15189:2022 --
7.6 Control of data and information management --
7.6.2 Authority and responsibility for information management --
7.6.3 Management of information systems --
7.6.4 Contingency Plans --
7.6.5 Off-site Management
----
Cybersecurity / Cyber Protection --
• Telelaboratory and Interfaces --
• Risks and Controls --
• Cybersecurity --
----
Appendix: Artificial Intelligence and the Medical Laboratory --
ISO and Artificial Intelligence

articolo: TUTTO_MISURE N. 1-26 pp 47-50 Parole in Standard e guide usate da intelligenza artificiale e apprendimento automatico

 MEASUREMENTS IN THE MEDICAL LABORATORY: TERMINOLOGY IN GUIDELINES - Standards and guidelines used in artificial intelligence and machine learning --- MISURE NEL LABORATORIO MEDICO: LE PAROLE NELLE GUIDE - Standard e guide usate da intelligenza artificiale e apprendimento automatico

• March 2026

• DOI: 
• 10.13140/RG.2.2.25499.43046

Artificial intelligence (AI) and machine learning gather information without filtering or expert supervision and translate it into medical instructions or prescriptions. The language used in “standards” or “guidelines” is therefore becoming increasingly important. We extracted VIM3 correspondence of glossaries from a selection of CLSI documents, noting language anomalies and inconsistencies. Having a hierarchy of sources can help reduce ambiguities. TUTTO_MISURE N. 1-26 pp 47-50 https://tuttomisure.org/

ARTICOLO incertezza delle misure e conseguenze per il laboratorio medico

 

La Rivista Italiana della Medicina di Laboratorio 2026 Mar 10

DOI: 10.23736/S1825-859X.25.00313-5

Nuova definizione di incertezza delle misure e conseguenze per il laboratorio medico

https://doi.org/10.23736/S1825-859X.25.00313-5

Joint Committee for Guides in Metrology today presents a definition of measurement uncertainty that corrects the previous one and improves the management of scenarios other than scalar (quantitative) measurements, such as classificatory or qualitative (nominal and ordinal) properties. Nominal results are often found in biology and medicine. For the accreditation of medical laboratories and testing laboratories, both ISO 15189 and ISO 17025 require the management of these situations, using the professional expertise of specialists, with the support of systems and consumables manufacturers. ISO produces detailed guides for this purpose, such as ISO 20914, ISO 27877, ISO 16393, ISO 20397-2, and ISO 22692. Laboratories now have all the tools they need to meet accreditation requirements. The SIPMeL Q16 Recommendations are confirmed and reinforced.

KEY WORDS: ISO 15189; ISO 17025; Uncertainty; Vocabulary; Metrology; Qualitative examination.

articolo Measurement Uncertainty Laboratories 2026, 3,4.

 Measurement Uncertainty: New Definition, Viewpoints, and Laboratories. 

Laboratories 2026, 3,4. 

https://doi.org/10.3390/laboratories3010004 

The Joint Committee for Guides in Metrology (JCGM) today presents a definition of measurement uncertainty that modifies the previous one and improves the management of scenarios other than scalar (quantitative) measurements, such as classificatory or qualitative (nominal and ordinal) properties. Nominal results are often found in biology and medicine. For the accreditation of medical laboratories and testing laboratories, both ISO 15189 and ISO 17025 require the management of these situations, using the professional expertise of specialists with the support of manufacturers. Some of the members of JCGM WG2 developed a discussion on the concept of measurement uncertainty and raised some criticisms. ISO produces detailed guides for this purpose, such as ISO 20914, ISO 27877, ISO 16393, ISO 20397-2, and ISO 22692. Laboratories now have all the tools they need to meet accreditation requirements on uncertainty.

Keywords: 

measurement uncertainty; ISO accreditation; medical laboratories; testing laboratories; qualitative properties; NGS

video lezione postesame risultati ISO 15189

 https://bit.ly/postesame15189

ISO 15189:2022 7.4.1 Presentazione dei risultati 7.4.2 Gestione dei campioni dopo l'esame 7.4.1.1 Generalità 7.4.1.2 Revisione e rilascio dei risultati 7.4.1.3 Risultati critici 7.4.1.4 Considerazioni speciali sui risultati 7.4.1.5 Selezione, revisione, rilascio e comunicazione automatizzata dei risultati 7.4.1.6 Requisiti per i rapporti 7.4.1.7 Informazioni aggiuntive per i rapporti 7.4.1.8 Modifiche ai risultati riportati

ARTICOLO: Controllo di qualità interno: divergenze tra raccomandazioni IFCC, standard ISO e raccomandazioni SIPMeL

 

La Rivista Italiana della Medicina di Laboratorio 2025 Dicembre;21(4):271-87

DOI: 10.23736/S1825-859X.25.00292-0

Copyright © 2025 EDIZIONI MINERVA MEDICA

lingua: Italiano

Controllo di qualità interno: divergenze tra raccomandazioni IFCC, standard ISO e raccomandazioni SIPMeL

IFCC produced a Recommendation that claims to be inspired by ISO 15189:2022 but diverges from it in many places: in the glossary, in the general principles, where it introduces commutability and known values of control materials, on the objectives of IQC, not compatible with statistical rules, on control materials with commutability, in the case of control lot change or reagent change. IFCC introduces the case of multiple instruments, absent in ISO 15189:2022. IFCC proposes control repetition, absent in ISO and disapproved by subject matter experts, does not follow CLSI C24 guidance for estimation of imprecision and expected value with which to construct control rules and charts. IFCC, in addition to statistical rules and Sigma metrics, adds the additional criterion of clinically acceptable limits, without providing the scientific basis. IFCC diverges from bibliographic sources and ISO 15189:2022 on the moving average of patient and repeat patient samples, as on the mixture (pool) of patient samples, as well as on “sentinel” examinations. IFCC never considers CLSI C24 guidance. IFCC supports the comparison between instruments despite multiple critical points, contained in the references cited by IFCC too. IFCC does not correctly describe the difference between measurement uncertainty and total allowable error.

KEY WORDS: Accreditation; Medical laboratory science; Quality control

ARTICOLO NUOVA DEFINIZIONE D'INCERTEZZA Tutto misure, 2025(4), 23–28

 NUOVA DEFINIZIONE D'INCERTEZZA NEI LABORATORI MEDICI - Nuova incertezza per processi multifase e risultati qualitativi nei laboratori medici - Il dubbio per valori quantitativi e qualitativi ----- NEW DEFINITION OF UNCERTAINTY IN MEDICAL LABORATORIES - New uncertainty for multiphase processes and qualitative results in medical laboratories - The doubt for quantitative and qualitative values.

• December 2025

• DOI: 
• 10.5281/zenodo.17904914

JCGM presents a definition of measurement uncertainty that corrects the previous one and improves handling of scenarios other than scalar (quantitative) measurements, such as classificatory or qualitative (nominal and ordinal) properties. NIST shows situations in biology and medicine with nominal results. Accreditation of medical laboratories and testing laboratories is asked to handle these situations. ISO produces detailed guides. Laboratories today have all the necessary tools. ---- JCGM presenta una definizione d’incertezza di misura che corregge la precedente e migliora la gestione di scenari diversi dalle misure scalari (quantitative), come le proprietà classificatorie o qualitative (nominali e ordinali). NIST racconta situazioni in biologia e medicina con risultati nominali. Per l’accreditamento di laboratori medici e laboratori di prova si chiede la gestione di queste situazioni. ISO produce guide dettagliate. I laboratori hanno oggi tutti gli strumenti necessari. ---- Tutto misure, 2025(4), 23–28