Alliance of IVD manufacturer and medical laboratory for quality control of results

Author:

Pradella Marco1ORCID

Affiliation:

1. Italian Society of Clinical Pathology and Laboratory Medicine , SIPMeL , Castelfranco Veneto , Italy

Publisher

Walter de Gruyter GmbH

Reference10 articles.

1. Pradella, M. Requirements for medical, forensic, anti-doping and food laboratories: new ISO 15189 and ISO 17025. Riv Ital Med Lab 2019;15:252–62. https://doi.org/10.23736/S1825-859X.19.00033-1.

2. ISO 9000:2015. Quality management systems — fundamentals and vocabulary. Geneva: International Organization for Standardization; 2017.

3. Pradella, M. IVD manufacturer and medical laboratory allied for quality control of results: delays and novelties. Riv Ital Med Lab 2020;16:73–7. https://doi.org/10.23736/S1825-859X.19.00025-2.

4. ISO 15198:2004. Clinical laboratory medicine – in vitro diagnostic medical devices: validation of user quality control procedures by the manufacturer. Geneva: International Organization for Standardization; 2004.

5. ISO 22367:2020 Medical laboratories – application of risk management to medical laboratories. Geneva: International Organization for Standardization; 2020.

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