Validation and verification of examination procedures in medical laboratories: opinion of the EFLM Working Group Accreditation and ISO/CEN standards (WG-A/ISO) on dealing with ISO 15189:2012 demands for method verification and validation.
Clin Chem Lab Med
; 58(3): 361-367, 2020 02 25.
Article
em En
| MEDLINE
| ID: mdl-31714885
ABSTRACT
This paper reflects the opinion of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO). It aims to provide guidance for drawing up local/national documents about validation and verification of laboratory methods. We demonstrate how risk evaluation can be used to optimize laboratory policies to meet intended use requirements as well as requirements of standards. This is translated in a number of recommendations on how to introduce risk evaluation in various stages of the implementation of new methods ultimately covering the whole process cycle.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Técnicas de Laboratório Clínico
/
Acreditação
Tipo de estudo:
Diagnostic_studies
/
Guideline
Limite:
Humans
País/Região como assunto:
Europa
Idioma:
En
Revista:
Clin Chem Lab Med
Ano de publicação:
2020
Tipo de documento:
Article