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Interpretative analysis of ISO 15189 standard: Post-examination phase aspects

Annales de biologie clinique, 2012
The requirements related to post-examination phase (chapters 5.7 and 5.8) and to advisory services (4.7, 5.1.4 et 5.1.12) of the standard ISO 15 189 and requirements of the French regulation, as included in the COFRAC document SH REF 02, are applied into actions to display, documents to write and to make available and traceability to ensure.
A, Perrin   +4 more
openaire   +2 more sources

Comparison of performance indicators of MGIT primary culture to assess the impact of implementation of ISO 15189:2012 standards

Indian Journal of Tuberculosis, 2022
Performance indicators are key component and plays a major role for monitoring and continuous quality improvement of the test results. The NABL certificate of accreditation is issued in accordance with the standard ISO 15189:2012 requirements. As part of the accreditation process, the laboratory has acquired knowledge and implemented the quality system
S. Balaji   +9 more
openaire   +2 more sources

Establishing an Iranian medical laboratory standard based on ISO 15189

Accreditation and Quality Assurance, 2014
To strengthen clinical laboratories’ capabilities, the Reference Health Laboratory (RHL) of the Ministry of Health decided to compile a national professional laboratory standard to be followed by all medical laboratories in the country. Providing a national laboratory standard, as approved criteria for competency assessment, is also essential for ...
Nooshafarin Safadel   +5 more
openaire   +1 more source

IMPLEMENTATION OF LEAN SIX SIGMA IN DIAGNOSTIC LABORATORIES WITH QUALITY STANDARD ISO 15189

2023
Lean Six Sigma is the potential improvement, successful strategy and most widely apply in all sectors. Previously it was implemented in manufacturing sectors and after tremendous success and highly improvement in manufacturing companies of all departments, many other sectors started Lean Six Sigma approach and their tool.
Rajal Dave, Ajay Kumar Prajapati
openaire   +1 more source

Interpretative analysis of the ISO 15189 standard: Pre-examination phase

Annales de biologie clinique, 2010
We described the requirements of chapters 4.7 and 5.4 of the standard into action to be realized, documents to be drafted, traceability to be assured with proofs, mandatory. The various documents realized by the working-group are placed in front of the chapters of the standard and the documents required.
openaire   +2 more sources

Upgrading the Iranian national laboratory standard to conform to ISO 15189:2012

Accreditation and Quality Assurance, 2019
The Reference Health Laboratory (RHL) of Iran is the national authority responsible for making policies and plans for providing quality laboratory services throughout the country. RHL composed a national laboratory standard in 2007 as the minimum mandatory quality requirements for clinical laboratories. The reference of that standard was ISO 15189:2007,
Nooshafarin Safadel   +4 more
openaire   +1 more source

Interpretation and analysis of the requirements of the standard EN ISO 15189: 2012

Annales de biologie clinique, 2013
The requirements related to quality management system of the standard EN ISO 15189 (2012) and the requirements of the French regulation as reported in the COFRAC document SH REF 02, are applied into actions to display, documents to write and to make available and traceability to ensure (records).
openaire   +2 more sources

Accreditation of the medical-biochemistry laboratory in Croatia According to ISO 15189 standard

Clinical chemistry and laboratory medicine, 2007
Development of the complete quality management system in medical biochemistry laboratories according to international standards requires monitoring and supervision of all laboratory processes which end as laboratory test result report. Therefore, advantages of accredited laboratory are documented management system, continuous improvement and training ...
Flegar- Meštrić, Zlata   +10 more
  +5 more sources

[Standard NF EN ISO 15189: comparative analysis with GBEA and implementation of the new reference support].

Annales de biologie clinique, 2010
Within reflexions of the healthcare system in France, Ballereau's report published in 2008 suggests modifications of medical biology supports by quality. The new reference system will be ISO 15189 which provides requirements for competence and quality.
Julien, Rogowski, Véronique, Annaix
openaire   +2 more sources

EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes

Clinical Chemistry and Laboratory Medicine (CCLM)
Abstract The EN ISO 15189:2022 standard, titled “Medical laboratories – Requirements for quality and competence,” is a significant update to the regulations for medical laboratories. The revised standard was published on December 6, 2022, replacing both EN ISO 15189:2012 and EN ISO 22870:2016.
Solveig Linko   +14 more
openaire   +5 more sources

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