Marco Pradella

Società Italiana di Patologia Clinica e Medicina di Laboratorio (SIPMeL) · Commissione Nazionale Qualità e Accreditamento

https://labmedico.blogspot.com/2024/11/congresso-nazionale-newmicro-bardolino.html ---- Atti Congresso Nazionale NewMicro Bardolino (VR) 27-28 Settembre 2024 ---- curatori Giovanni Casiraghi & Marco Pradella ---- https://zenodo.org/communities/newmicrobardolino2024/about

Poster n° 190. Le criticità della statistica utilizzata nella guida CLSI EP09 sono state recentemente descritte in letteratura e vengono riassunte nella Tabella 1. La Tabella 2 riporta una sintesi dei punti operativi critici del confronto tra metodi descritto da CLSI EP31, EP21 e EP09 --- The critical points of the statistics used in CLSI EP09 hav...

ISO 860:2007 (Terminology work - Harmonization of concepts and terms) tells us that despite all efforts to coordinate terminologies as they develop, it is inevitable that overlapping and inconsistent terminologies will continue to be used because documents and policies are produced in different contexts. Differences between concepts and misleading...

•nuova ISO 15189 7 Requisiti di processo 7.3 Processi di esame 7.3.7 Garantire la validità dei risultati degli esami •fonti SIPMeL Raccomandazioni Q19 Q19 Articolo RIMeL su risultati per ISO Articolo Controllo di qualità interno: statistica avversaria della metrologia? Articolo Nuova legge europea per la diagnostica e standard ISO nella fase p...

Cibersicurezza / ciberprotezione • telelaboratorio e interfacce • rischi e controlli • cibersicurezza ---- Cyber security / cyber protection - telelaboratory and interfaces - risks and controls - cyber security ---- ISO 15189, ISO 22367, ISO/IEC 27001, CLSI AUTO11, ISO 27799, ISO 6268, WHO 2024, ISO/AWI 24051

Certificazione vs Accreditamento ISO vs Accreditamento SSN raccomandazioni CASCO ISO TC212 WG1#project revision team Capitolo 6, le risorse Raccomandazioni SIPMeL Risorse e accreditamento ISO nella Rivista SIPMeL 6.2.1 Generalità SIPMeL su POCT ISO/TS 22583.2024 6.2.2 competenza: requisiti 6.2.2 competenza: documenti CLSI QMS16 Gestione del persona...

ISO 15189:2022 Capitolo 6, le risorse 6.3 spazi e ambiente Raccomandazioni SIPMeL Risorse e accreditamento ISO nella Rivista SIPMeL 6.3.1 Generalità ISO 22583:2024 POCT CLSI QMS04 Progettazione del laboratorio 15190 nella rivista SIPMeL ISO 15190:2020 Laboratori medici Requisiti di sicurezza CLSI GP17-A3 Clinical Laboratory Safety 6.3.2 Co...

• 6 Requisiti delle risorse • Raccomandazioni SIPMeL Q20 • 6.4 Attrezzature 6.6 Reagenti e materiali di consumo • selezione, l'approvvigionamento, l'installazione, le prove di accettazione • accesso, manutenzione e sostituzione • inventario • accettazione • conservazione • Istruzioni per l'uso • Manutenzione e riparazione • eventi avversi...

• 6.7 Accordi di servizio • Carta dei servizi • 6.7.2 Accordi con gli utilizzatori POCT • Allegato A: Requisiti aggiuntivi per esami point-of-care (POCT) • A.2 Direzione. • A.3 Programma di garanzia della qualità • A.4 Programma di addestramento • ISO/TS 22583.2024 Guidance for supervisors and operators of point-of-care testing (POCT) devices...

• Raccomandazioni SIPMeL prelievi • “incertezza definizionale” • consenso informato • ISO 20658 • società di prelievo indipendente • 4.2.2 Imparzialità 4.2.3 Riservatezza • 5.3.5 Situazioni di emergenza • 6.2 Personale 6.3 Spazi e condizioni ambientali 6.4 Attrezzature, reagenti e materiali di consumo • 6.2.2 Addestramento 6.2.3 Valutazione...

• 7.3 Processi di esame • Indicazioni ISO per esami sviluppati in laboratorio, tecnologie emergenti, validazione e verifica • ISO Guidance on the validation and verification - WG1 – ISO 17849 PWI • Westgard Tipologie di esami • Qualità dei metodi di sequenziamento massivo parallelo/sequenziamento di nuova generazione (MPS/NGS) • metodi preferi...

• 7.3 Processi di esame • 1. Intervalli descrittivi della popolazione • rivisti e modifiche a un metodo • presenza o l'assenza di una caratteristica • forniti dal fabbricante • EFLM Working Group on Biological Variation • CLSI intervalli di riferimento • CLSI EP44 ED4PD:2024 • EP28IG Guida all'attuazione della verifica degli intervalli di ri...

• 7.3.7 Garantire la validità dei risultati degli esami • Raccomandazioni SIPMeL Q19 • 7.3.7.2 Controllo di qualità interno (CQI) • materiale di controllo • metodi alternativi • regole • IVDR e ISO 20416 • Controllo di qualità interno ISO 15198:2004 • C24-Ed4 | Statistical Quality Control • Regole Equivoco del CQI: la regola 1-2s • Westgard...

• Raccomandazioni SIPMeL Q20 • 7 Requisiti di processo • accesso ai dati • ISO 22367:2020 A.13 • EN ISO/IEC 27001:2023 • ISO/AWI 27799 • safety ➔ security • ISO/IEC 27001:2022 Allegato A • 7.6.2 Autorità e responsabilità • 7.6.3 Gestione dei sistemi informativi (a) • interfacce tra il sistema informativo di laboratorio e altri sistemi •...

informatica nel laboratorio informatica delle connessioni interoperabilità semantica standard semantici standard e ICA criticità della semantica -------------- computing in the lab connection computing semantic interoperability semantic standards standards and HCIs criticality of semantics

The new SIPMeL Recommendations for IT address some specific requirements for ISO accreditation, they do not replace the previous Recommendations, which were developed for a broader range of topics, such as the presentation of examination results. ISO 15189 states the validity of the requirements for both computerised and paper-based systems, but in...

The revised ISO 15189 standard was published on December 6th; 2022. SIPMeL provides Italian medical laboratories with a series of Recommendation documents. In SIPMeL Recommendations Q20-1 the requirements in chapter 6 (resources), those in clause 6.2 (personnel) and clause 6.3 (space, physical and environmental facilities) are presented. In SIPMeL...

La norma ISO 15189 revisionata è stata pubblicata il 6 dicembre 2022, quasi un anno dopo il termine previsto. SIPMeL, dopo aver partecipato attivamente al processo di revisione, mette a disposizione una serie di documenti di Raccomandazioni, con i principali contenuti della norma ISO in lingua italiana, qualche riflessione critica, e le indicazioni...

https://www.sipmel.it/it/lineeguida/approvate/122160 ------ Documento approvato dal Consiglio Nazionale in data 27/10/2024 ------ INDEX Coding of this document:. 1 Normative references . 2 Introduction: the revision of ISO 15189 . 4 Spelling notes. 5 Organisation and management requirements (Chapter 5) 6 NOTE on Legal Entity in public and private l...

I laboratori medicisono forse la maggiore industria di misurazioni al mondo, con numeri e fatturati da capogiro e un impatto profondo sulla salute e la nostra vita quotidiana. Presentiamo ora un’analisi un po’ più sistematica della terminologia della metrologia nelle norme tecniche e nelle linee guida per i laboratori medici. Questa nota sarà segui...

VIDEO https://youtu.be/ZSKe540Fm5U ------------------ ISO 15189:2022: #7.3.4 incertezza di misura, MU --- UNI CEI EN ISO/IEC 17025:2018#7.6 Valutazione dell'incertezza di misura --- ISO/IEC 17000:2020(en)#Conformity assessment — Vocabulary and general principles --- International Vocabulary of Metrology Fourth edition – Committee Draft (VIM4 CD)...

Gestation and birth of ISO 15189:2022 § 6.2 Human resources in laboratories and POCTs --- https://www.youtube.com/watch?v=CTXdXKE6jww

https://youtu.be/d7RzL0PjmLc ---------------------------------- https://doi.org/10.5281/zenodo.11355450 ---------------------------------- REGOLAMENTO (UE) 2017/746 ISO/TR 20416:2020 “Medical devices — Post-market surveillance for manufacturers” UNI EN ISO 15189:20237.3.7 Garantire la validità dei risultati degli esami … 7.3.7.2 Controllo di qualit...

1. The requirements of UNI EN ISO 15189:2023 as good laboratory practice 2. Sampling points and point-of-care testing services (POCT) included in the ISO requirements, regardless of formal ownership 3. Compliance with ISO 9001 makes compliance with ISO 15189 easier 4. Laboratory documents, including ISO standards to be consulted, written in Italia...

NGS are used in Italy by some ISO 15189-accredited medical laboratories, in addition to others that are not accredited, while in Europe it is about 10 percent of molecular examinations. Determining whether a given allele is present in a DNA is arrived only at the end of a complex measurement process with quantitative steps. ISO 20397-2 provides man...

It is not yet clear what terminological choices will be implemented in the next edition of the VIM, which is expected to have a whole new chapter devoted to classification properties and their evaluation. As we discussed in the previous article under this heading, these terminological decisions must be made in such a way as to ensure the consistenc...

https://www.sipmel.it/it/lineeguida/approvate/121380 ---- Documento approvato dal Consiglio Nazionale in data 27/10/2024 --- INDEX Coding of this document Normative references Introduction: the revision of ISO 15189 Spelling NOTE Medical laboratory resources (ISO 15189 chapter 6) Equipment calibration and metrological traceability (ISO 15189 6.5) N...

https://www.sipmel.it/it/lineeguida/approvate/121254 ----- INDEX Coding of this document: 1 Normative references 2 Introduction: the revision of ISO 15189 4 Spelling NOTE 5 Medical laboratory resources (ISO 15189 chapter 6) 6 NOTE Support services 6 Personnel (ISO 15189 clause 6.2) 6 NOTE Health and safety 7 Competence requirements (6.2.2) 7 NOTE....

https://www.sipmel.it/it/lineeguida/approvate/121256 ----- INDEX --- Coding of this document: 1 Normative references 2 Introduction: the revision of ISO 15189 4 Spelling NOTE 5 Medical laboratory resources (ISO 15189 chapter 6) 6 NOTE Support services. 6 Equipment, reagents and consumables (clauses 6.4 and 6.6) 6 6.4 Equipment 6 6.6 Reagents and...

https://www.sipmel.it/it/lineeguida/sviluppo/121264 --- INDEX -- Coding of this document: 1 Normative references 2 Changes in this version 2 Introduction: Revision of ISO 15189 4 Spelling notes 5 Ensuring the validity of examination results 6 Internal Quality Control (IQC) 6 NOTE on IQC and uncertainty 6 NOTE on ISO 15198 and CLSI C24. 6 Materials...

https://www.sipmel.it/it/lineeguida/approvate/121260 --- Index -- Coding of this document: 1 Normative references 2 Introduction: the revision of ISO 15189 3 ISO 15189 7.6 data and information management 4 UNI EN ISO 22367:2020 cyber risk in medical laboratories 4 NOTE cyber security 5 ISO/IEC 27001, ISO/IEC 27002, ISO 27799 and information securit...

https://www.sipmel.it/it/lineeguida/approvate/121258 --- https://www.sipmel.it/download/121390-Q17preesame15189_okCN_27feb24_pw.pdf ----------------- Summary -- Coding of this document: 1 Normative references 2 Introduction: the revision of ISO 15189 4 Spelling NOTE 6 The specific standard for sampling: ISO 20658 8 NOTE. Sampling under laboratory...

La recente pubblicazione della norma ISO 15189:2022 ha dato un forte impulso al rinnovamento della terminologia (la sezione "Termini e definizioni" di questa norma contiene ben 32 voci), e perciò a essa la SIPMeL ha dedicato una particolare attenzione, rilevando punti critici per esempio a proposito di definizioni di concetti come "misurando" (meas...

The GTFI document (DOI: 10.23736/S1825-859X.23.00204-9) has the merit of inducing laboratories to reflect on methods and activities related to forensic toxicology examinations, avoiding the uncritical passive application of procedures, and of promoting harmonisation between laboratories. However, one cannot fail to notice a certain mismatch between...

SIPMeL actively participates in the standardisation work carried out in the Technical Committee UNI 044 'Biomedical and Diagnostic Technologies' and through this in at least two international technical committees, one in Europe (CEN/TC 140) and one worldwide (ISO/TC 212). The work of the European committee is intensive and of great relevance to med...

The European Committee for Standardisation (CEN) prepares two documents for examination workflows with NGS methods: CEN/TS 17981-2 (Examination of human RNA) and CEN/TS 17981-1 (Examination of human DNA). Critical points in the definitions of some glossary entries are studied here. In the CEN standards examined, clinical, metrological, numerical a...

The clinician’s view of digital data management in the medical laboratory is undoubtedly more important for quality and patient safety than that of the laboratory itself. This is clear from international standards: European standards such as the International Patient Summary (IPS) and the Pharmacotherapy Decision Support System (CEN ISO/TS 22756:20...

ISO/AWI TS 5441 (Competence requirements for biorisk management consultants), working item approved 19 September 2022) is being developed within ISO/TC 212/WG 5 from May 2022. Planned publication on 29 November 2023. ISO 5441 will become an indispensable complement for the organisation of laboratories accredited with ISO 15189.

- Emerging technologies -- ISO Resolution 612: PWI on Guidance for emerging technologies for use in medical laboratories. -- PWI on Guidance for emerging technologies -- Provisional structure -- Table 1. High Complexity Examination Configuration -- Validation and verification -- ISO Resolution 577: Registration of PWI on Guidance on the validation...

The clinician’s view of digital data management in the medical laboratory is undoubtedly more important for quality and patient safety than that of the laboratory itself. This is clear from international standards: European standards such as the International Patient Summary (IPS) and the Pharmacotherapy Decision Support System (CEN ISO/TS 22756:20...

The issue of digital medical laboratory data can be approached from two perspectives: that of the laboratory and that of the clinician. The latter is undoubtedly more important for quality and patient safety. The clinical point of view emerges strongly from international standards. The European ones are represented by the international patient summ...

There is a hierarchy for words in measurement, which has VIM at the top. Using VIM as reference, we noted curious phenomena, ambiguities, repetitions, useless synonyms in standard ISO and CEN documents. Timely word-for-word translation into national languages is also needed to promote understanding of meanings and combat the phenomenon of "false fr...

We are now witnessing a renewed interest in words, symbols and graphics in science subjects, including in the technical field of laboratories, with interesting spin-offs for medical laboratories. We do not yet have a certain, unassailable reference for words in the life and health sciences. Although a certain hierarchy can be identified, at the top...

POCT in the ISO 15189 revision process; criteria for new 15189 and POCT; RIMeL POCT article; POCT types; ISO 22853 operators and supervisors; POCT in ISO 15189 (all types); ISO 15189 Annex A POCT; ISO 15189 and measurement uncertainty; ISO 15189 MU note7 calibrator and CQI; ISO 15189 MU note1 systematic deviation and 3. 29 accuracy; ISO 15189 types...

ISO's concern about the neglected quality of MPS/NGS is more than well-founded. Laboratory operations are considered analogous to a manufacturing process where the industrial process is replaced by the measurement process, the output of which is the results of examinations. Process control is therefore an essential element of the quality management...

Pacchetto ISO laboratori medici • Nuova ISO 15189 • POCT da 22870 a nuova 15189 con SIPMeL • POCT in nuova ISO 15189 ---- ISO package medical laboratories - New ISO 15189 - POCT 22870 to new 15189 with SIPMeL - POCT in new ISO 15189 ----- https://youtu.be/gLDpuSNz0tw

The GdS-I SIPMeL Informatics punctually follows the UNINFO Commission UNI/CT 527 Medical Informatics. The area of activity of the UNINFO Commission is divided according to the topics of Diagnosis and Therapy, Prevention and Promotion of Health Wellbeing, Public Health and Epidemiology, and Clinical Research. UNINFO adds that Medical Informatics enc...

Consenso implicito o contitolarità? Implied consent or co-ownership? Il consenso implicito è una fattispecie molto utilizzata nella pratica clinica. Implied consent is a widely used case in clinical practice. Non sembra di vedere una fonte normativa solida, ad eccezione forse dell’analogia rappresentata nel documento Linee guida per le procedure in...

L'attività ISO di produzione di standard sta aumentando molto e influenzerà pesantemente l'organizzazione dei laboratori medici. È quindi interesse di tutti studiare i documenti e prepararsi ad applicarli, per quanto possibile. I percorsi di preparazione degli standard non sono sempre semplici e lineari, al contrario emergono spesso criticità non t...

Pacchetto ISO per i laboratori. Tempistica recizione 15189. Articolo RIMeL revisione 15189 da 17025. Prescrizioni ISO CASCO su 15189. Prescrizioni ISO TC212 su 15189. Concetto di POCT. Norma ISO 22870. Raccomandazioni SIPMeL Q13 su POCT. Articolo RIMeL su POCT 22583. Concetto autonomo da laboratorio. PNRR e POCT. Documento ISO 22583. Contenuti ISO...

To the Editor Most test results in medical laboratories are numbers, known as “quantitative results” if they have linearity (a ratio or interval scale) and are related to the international/national reference standard. Results consisting of nouns or adjectives (known as “qualitative results”) are less frequent but no less important to service qualit...

ISO published the draft for final approval of the revision of ISO 15189 standard. Following ISO directives, ISO 15189 must be aligned with ISO/IEC 17025:2017 and should be less prescriptive. Draft ISO/DIS 15189 deviates in some points from ISO 17025 and the ISO indications to limit prescriptiveness: equipment, uncertainty, quality control. This do...

Performing and interpreting laboratory tests: the topic has its own complexity. Let's try to shed some light on it, starting with the recent technical report ISO/TR 27877. -- https://www.uni.com/index.php?option=com_content&view=article&id=11805

ISO published the draft for final approval of the revision of ISO 15189 standard. Following ISO directives, ISO 15189 must be aligned with ISO/IEC 17025:2017 and should be less prescriptive. Draft ISO/DIS 15189 deviates in some points from ISO 17025 and the ISO indications to limit prescriptiveness: equipment, uncertainty, quality control. This do...

Background: ISO 15189:2012 point 3.15 defines the terms "primary sample" and "specimen" as synonyms. ISO/TC 212 WG1 started the activity “13.3 Harmonization of terminology across ISO TC212”. ISO/TS 20658:2017 in the same definition modified "specimen" in "sample". Besides "Term and definition" and "Bibliograhy" sections, ISO/TS 20658 has no recurre...

The revision of ISO 15189 retains the requirement for uncertainty estimation, referring to ISO/TS 20914 for implementation. [1] With document Q16 [2], SIPMeL collects the main ISO, literature, and CLSI guidance on the topic. Typical examples of application of the Q16 Recommendations are presented here to demonstrate their ease of use. Methods: The...

Background: The Eurachem/CITAC Guide Assessment of Qualitative Analysis [1] is an innovative document, very useful for laboratories. False qualitative analysis results are extremely relevant, e.g., in forensics or doping analysis and in medical examinations. We see at least two critical issues in the EURACHEM document: lack of the precision compone...

The Eurachem/CITAC Guide Assessment of Qualitative Analysis is an innovative document, very useful for laboratories. We compared EURACHEM statements with ISO 3534-2, International vocabulary of metrology (VIM), ISO Guide 99, ISO 17025, ISO 15189, ISO 20914, ISO 16393 and ISO 27877 statements. We see at least two critical issues in the EURACHEM docu...

ISO 17025 chiede l'incertezza dei risultati ma non distingue tra quantitativi e qualitativi. La Guida EURACHEM/CITAC ha quindi una importanza straordinaria per risollevare il tema ad un livello paragonabile agli altri che compongono la complessa costruzione del sistema di gestione della qualità. È un vero peccato che la Guida EURACHEM/CITAC abbia s...

Eurachem/CITAC published a very useful and important Guide on Uncertainty of Qualitative Results. However, the Guide does not include the evaluation of precision, and does not address the alternative of uncertainty of qualitative results obtained from quantitative measurements described by ISO documents. Keywords: Uncertainty; Qualitative; Precisio...

Scientific evidence shows for artificial intelligence and machine learning a future and sometimes even a present as a valuable resource for medicine in general. The laboratory is being transformed by it, willingly or unwillingly, as it continues to change in the digital revolution. The SIPMeL document of recommendations on informatics (DOI 10.1007/...

Obiettivo La revisione di ISO 15189 mantiene il requisito della stima dell'incertezza, riferendo a ISO/TS 20914 le modalità di applicazione. [1] [2] Con il documento Q16, SIPMeL raccoglie le principali indicazioni ISO, della letteratura e di CLSI sul tema, che riguardano sia i risultati quantitativi che quelli qualitativi, nominali e ordinali. Qui...

Part one: ISO accreditation in the national and international regulatory context. Part two: the ISO package of standards for medical laboratories. Criticalities of Eurachem/CITAC Guide: Assessment of performance and uncertainty in qualitative chemical analysis. LDE(T)Laboratory Developed Examination (Test) (ISO/AWI 5649).

Il documento SIPMeL sull'informatica descrive il nuovo paradigma dei risultati. L'uso di sistemi di supporto alle decisioni cliniche (CDSS) comporta ancora maggiore attenzione al valore clinico ed alla affidabilità del singolo dato, non più agli aspetti formali ed alle aggregazioni di risultati dal punto di vista del laboratorio, diverso da quello...

Measurement uncertainty is required for the accreditation of medical laboratories. Documents of the International Organization for Standardization (ISO), as well as various documents of the Clinical & Laboratory Standards Institute (CLSI), provide guidance for the estimation of uncertainty, both for quantitative and qualitative results. The Recomme...

La revisione di ISO 15189 mantiene il requisitola della stima dell'incertezza, riferendo a ISO/TS 20914 le modalità di applicazione. Con il documento Q16 (DOI: 10.13140/RG.2.2.31013.63207/2), SIPMeL raccoglie le principali indicazioni ISO, della letteratura e di CLSI sul tema. Qui si presentano esempi tipici di applicazione delle Raccomandazioni Q1...

The points of the 2019 Croatian Recommendations for post-examination processes (CR) that merit revision are selected, in comparison with SIPMeL Recommendations on informatics in the medical laboratory (SR) and the review made by Cappelletti (PC) that compared IFCC. This topic has become very relevant for the 2022 revision of ISO 15189. The fast ev...

Nel documento vengono puntualmente considerate le indicazioni delle norme internazionali in materia, nonché il contesto molto modificato in cui i sistemi si trovano ad operare, rispetto a quello di solo pochi anni fa. Sono cambiate le aziende sanitarie, sono cambiati gli strumenti analitici e persino le aziende che forniscono servizi informatici. L...

The estimation of measurement uncertainty is required for accreditation of medical laboratories, according to the International Organization for Standardization (ISO). ISO provides adequate indications to obtain uncertainty and above all precision and repeatability with simplicity in laboratories of any type and size, both for numerical quantitativ...

https://www.sipmel.it/it/lineeguida/approvate/118096 --- https://www.sipmel.it/download/118104-Q16incertezzaISO20914_agg7sept21_pw.pdf --- The ISO 15189 standard for medical laboratories is in the middle of its revision process. The working group, structured in drafting groups for individual parts of the standard, receives some guidance from the I...

The estimation of measurement uncertainty is required for accreditation of medical laboratories, according to the International Organization for Standardization (ISO). ISO provides adequate indications to obtain uncertainty and above all precision and repeatability with simplicity in laboratories of any type and size, both for numerical quantitativ...

17.00 Introduction to the proceedings 17.10 First part Medical devices and diagnostics in the new European legislation for CE marking. 17.30 Second part Role of manufacturers and experts in the lifecycle of devices. 17.50 Third part European Regulation, classification of devices, framework of obligations obligations of manufacturers 18.15 Fourth pa...

Are we going to see some sort of conflict between Europe and America over internal quality control management? The Westgard concerns are well founded and can be shared. The so-called "recommendations" of the Milanese metrologists are the result of their personal position, not supported by official documents of bodies or associations. Most medical l...

The Italian Society of Clinical Pathology and Laboratory Medicine (SIPMeL) Quality and Accreditations Commission produced its recommendations on this matter [3] acknowledging ISO 15198:2004 [4] document, confirmed for the first time in 2008 and revised with a positive result in December 2018. Key points are shared responsibility between the laborat...

Parte prima: accreditamento ISO nel contesto normativo nazionale ed internazionale. Parte seconda: il pacchetto ISO delle norme per i laboratori medici. - Part one: ISO accreditation in the national and international regulatory context. Part two: the ISO package of standards for medical laboratories. -

La traduzione ufficiale in italiano dei documenti ISO compete a UNI nell’ambito dell’attività di normazione. Il documento SIPMeL L5Q15 non traduce integralmente alcune norme, ma propone soluzioni solo per le parole definite nei capitoli “Termini e definizioni” dei principali documenti ISO dedicati al rapporto tra laboratorio e fabbricante di dispos...

ISO 15189 accreditation of medical laboratories requires the comparability of results between different laboratories, preferably by means of metrological traceability to the international system (SI). The twin standards ISO 17511 and ISO 21151 draw a robust framework to provide laboratory methods with calibration, harmonization and standardization,...

The new European regulations, and in particular that on in vitro diagnostics, have made the principles already developed by ISO and CEN mandatory obligations. In particular, in post-market surveillance laboratories and manufacturers are now obliged to share important information throughout the life cycle of devices. Both serious accidents with the...

La norma ISO 15189, actualmente en fase de desarrollo, supone tener que reevaluar el rendimiento de los métodos, esto es, realizar un control de calidad (QC), tal como se define en la sección 3.3.7 de la norma ISO 9000. La Comisión de Calidad y Acreditaciones de la Sociedad Italiana de Patología Clínica y Medicina de Laboratorio (SIP-MeL) emitió su...

On 5 April 2017 the European Parliament approved the two new EU regulations relating to medical devices. The regulations entered into force on May 26, 2017. In spring 2022, the IVDR one for in vitro diagnostics will be applied. ISO contributes to the quality of in vitro diagnostics with ISO 13485, ISO 14971, ISO 15198 and ISO 20916 documents. ISO /...

LA TARATURA NELLA NUOVA ISO 15189 PER I LABORATORI MEDICI La nuova ISO 15189 per l'accreditamento dei laboratori medici, prevista per il 2022, contiene requisiti per la confrontabilità tra diversi laboratori e la riferibilità metrologica dei risultati al sistema internazionale delle misure (SI), con materiali di riferimento conformi a ISO 17034, ta...

The L5Q15 document proposed by the SIPMeL Quality and Accreditation Commission intends to offer diagnostic manufacturers and laboratories a tool for the correct use in Italian of the terms defined in the new ISO 17511 and 18113 standards, as well as in the ISO 15198 document for quality control. The official translation of ISO documents into Italia...

https://www.sipmel.it/en/lineeguida/sviluppo/118107 L5Q15 Recommendations for the glossary in the new ISO standards for medical laboratories on calibration and "labels" (ISO 17511, ISO 18113, and 15198) In the complex articulation of the ISO 18113 family of documents, some elements are of absolute importance. First, the use of terms corresponding t...

Nell'articolazione complessa dei documenti della famiglia ISO 18113 sono di assoluta rilevanza alcuni elementi. Innanzitutto, l'uso di termini corrispondenti alle definizioni date dalla norma ISO, per evitare evidenti rischi di fraintendimento. Si introduce il sistema unico di identificazione dei dispositivi (UDI). Viene promosso l'aggiornamento ai...

These notes can serve both for labs to set purchasing specifications and for manufacturers who have to meet these specifications. ISO 15189 accreditation of medical laboratories requires comparability of results between different laboratories, preferably by means of metrological traceability to the SI. The twin standards ISO 17511 and ISO 21151 dra...

The SIPMeL Q12BC1 recommendation document represents the transposition of the ISO/TS 20658: 2017 standard and highlights its most significant and perhaps critical points, in light of the exponential increase in the sampling points for laboratory tests, the evaluation of which for accreditation may present significant difficulties. SIPMeL recommenda...

ISO, the International Organization for Standardization, is preparing document ISO/TS 17822-2 on the quality control of nucleic acid amplification techniques (NAAT). ISO 17822-2 takes into consideration many aspects that affect quality. ISO 17822 prescribes the use of control materials and describes different types of them. ISO 17822-2 states that...

● ISO ● AI ML ● CDSS (farmaci) ● IPS ● Neuromorfismo ● Laboratori, gestione rischi ● Nuovo paradigma risultati ● Raccomandazioni ● ISO ● AI ML ● CDSS (drugs) ● IPS ● Neuromorphism ● Laboratories, risk management ● New results paradigm ● Recommendations

The ongoing revision of ISO 15189, the standard for accreditation of medical laboratories that will be launched in 2022, shall use ISO/IEC 17025:2017 as a model. The most significant changes of ISO 17025 are introduced in the management system, now aligned with that of the ISO 9001:2015 standard. The ISO 9001:2015 standard introduced several innova...

The ongoing revision of ISO 15189 for accreditation of medical laboratories, includes the references to ISO 15190, for occupational safety in medical laboratories.. With ISO 35001, the 'ISO package' of standards for medical laboratories is enriched with a new, indispensable element: biohazard management. It is not a guideline, but the imperative to...

The new ISO 15189 for medical laboratories should incorporate the requirements of ISO 22870 for POCTs. The SIPMeL Quality and Accreditation Commission has identified ISO 22870 standard points which should be absorbed by the corresponding ISO 15189 points, other ISO 15189 points which should be modified in light of the specific requests of ISO 22870...

ISO 22367 revision 2019 contains some precise messages: risk assessment is indispensable for ISO 15189 accreditation; the IVD manufacturer shares the responsibility for risks with the laboratory as also described in ISO 15198; the IVD manufacturer is required to comply with ISO 14971; risks include operator safety as described by ISO 15190; risks f...

Società Italiana di Patologia Clinica e Medicina di Laboratorio Componente della World Association of Societies of Pathology and Laboratory Medicine www.sipmel.it Commissione Nazionale Qualità ed Accreditamento Coordinatore: Marco Pradella GdS-VEA Variabilità Extra-Analitica del dato di Laboratorio Coordinatore: Margherita Morandini GdS-MS Manageme...

dalla presentazione al Corso Residenziale: Statistica del controllo di qualità interno per l'accreditamento ISO 15189, 11 maggio 2018 - Santorso (VI), Sala Convegni Bolla Rossa Ulss 7, Pedemontana, Ospedale Alto Vicentino e dalla presentazione al seminario Informatica e statistica del controllo di qualita' interno nel laboratorio medico per l'accre...

La revisione in corso di ISO 15189, norma per l’accreditamento dei laboratori medici che vedrà la luce nel 2022, prevede diversi requisiti sulla sicurezza degli operatori e l’inserimento dei riferimenti a ISO 15190, la norma per la sicurezza sul lavoro dei laboratori medici. - The ongoing revision of ISO 15189, a standard for medical laboratory acc...

Commissione Nazionale Qualità ed Accreditamento Coordinatore: Marco Pradella - Gruppo di Studio Informatica GdS-I Coordinatore: Marco Pradella - versione 1,0 documento Q11P1 ISO 15198 e controllo di qualità 20/3/2019 Raccomandazioni per il controllo di qualità interno: compiti del produttore di diagnostici in vitro - Riferimenti normativi • UNI EN...