ISO 9001:2015 standard implementation in clinical trial centers: An exploratory analysis of benefits and barriers in Italy

Author:

Franchina V.,Stabile S.ORCID,Cenna R.,Mannozzi F.,Federici I.,Testoni S.,Sinno V.,Cagnazzo C.ORCID

Publisher

Elsevier BV

Subject

Pharmacology,General Medicine

Reference16 articles.

1. An evaluation of ISO 9001:2008 and ISO 9001:2015 standard changes in quality management system world academy of science;Esorz;Eng. Technol. Int. J. Economics Manag. Eng.,2017

2. Celeste Cagnazzo - new requirements for phase I trials: a challenge for Italian clinical research;Marchesi;Tumori,2020

3. Hipskind - Medical Error Reduction and Prevention – [Book] in: StatPearls;Rodziewicz,2022

4. - Lean methodology in health care;Kimsey;AORN J.,2010

5. At al. Certification ISO 9001 in clinical ethics consultation for improving quality and safety in healthcare;Tozzo;Int. J. Qual. Health Care,2018

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