Uptake of ISO 9001 in European hospitals is lower than specialised healthcare accreditation schemes (15%) of 73 hospitals in this study. So evidence on its effectiveness is weak.
“There is little hard evidence of the impact of these systems on hospitals to justify the amount of time and money spent on organizational assessment, or to choose between available programmes.”
Results “implied that hospitals that were accredited scored higher on composite measures of quality and safety than hospitals that were ISO certified.”
The effect of certification and accreditation on quality management in 4 clinical services in 73 European hospitals. Charles D. Shaw et al. 2014, International Journal for Quality in Health Care, 26(suppl_1), 100-107, 2014. https://doi.org/10.1093/intqhc/mzu023
Shaw et al had earlier published evidence in this chart:
Black box – non-ISO accreditation. Shaded box – ISO 9001 certification. White box – neither. So these interventions make little difference overall. The authors say, “This analysis of data from the MARQuIs study suggests that in the samples of hospitals the impact of ISO certification on quality and safety may be less than with hospital accreditation, but it appears that either system is better than no system.”
Despite this, for airy-fairy justification of using ISO 9001 in hospitals try,
Why adopt ISO 9001 certification in hospitals? A case study of external triggers and sensemaking in an emergency department in Norway. Dag Tomas Sagen Johannesen and Siri Wiig. Safety in Health (2017) 3:7 DOI 10.1186/s40886-017-0058-5.