[Implementation of quality standard UNE-EN ISO/IEC 17043 in the External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology].
The quality standard "UNE-EN-ISO 17043: 2010. Conformity assessment. General requirements for proficiency testing" applies to centers that organize intercomparisons in all areas. In the case of clinical microbiology laboratories, these intercomparisons must meet the management and technical standards required to achieve maximum quality in the performance of microbiological analysis and the preparation of test items (sample, product, data or other information used in the proficiency test) to enable them to be accredited. Once accredited, these laboratories can operate as a tool for quality control laboratories and competency assessment. In Spain, accreditation is granted by the Spanish Accreditation Body [Entidad Nacional de Acreditación (ENAC)]. The objective of this review is to explain how to apply the requirements of the standard to laboratories providing intercomparisons in the field of clinical microbiology (the organization responsible for all the tasks related to the development and operation of a proficiency testing program). This requires defining the scope and specifying the technical requirements (personnel management, control of equipment, facilities and environment, the design of the proficiency testing and data analysis for performance evaluation, communication with participants and confidentiality) and management requirements (document control, purchasing control, monitoring of complaints / claims, non-compliance, internal audits and management reviews).
Programa de Control de Calidad SEIMC, España.
Marta
M
Poveda Gabaldón
María Rosario
MR
Ovies
Nieves
N
Orta Mira
M del Remedio Guna
Mdel R
Serrano
Javier
J
Avila
Alicia
A
Giménez
Concepción Gimeno
CG
Cardona
D000068:Accreditation / Q000331:legislation & jurisprudence / Q000592:standards; D019983:Guideline Adherence; D017408:Guidelines as Topic; D055552:Infectious Disease Medicine / Q000592:standards*; D007753:Laboratories / Q000331:legislation & jurisprudence / Q000592:standards*; D059021:Laboratory Proficiency Testing; D008330:Management Audit / Q000458:organization & administration; D008829:Microbiology / Q000592:standards*; D011309:Preservation, Biological / Q000379:methods; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000592:standards*; D058996:Quality Improvement; D012958:Societies, Scientific / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000592:standards*; D013030:Spain; D013048:Specimen Handling / Q000592:standards