Interpretations and variations of ISO 9000 in acute health care. International Organization for Standardization.
OBJECTIVE
This paper aims to address two questions related to the implementation of the ISO 9000 Quality Management System standard in the acute health care sector: which countries have developed specific nationwide guidelines/interpretations? and what variances exist between the different interpretations of the ISO 9002 standard?


METHODS
The study was carried out via an assessment of the available guideline documents for the use of ISO 9000 in the acute health care sector. The interpretation of each document was examined for common elements and deviations from the commonly agreed terms.


METHODS
Worldwide in the acute health care sector (excluding that of laboratories).


METHODS
Eighty-two international ISO members and/or quality health care organizations.


RESULTS
The results showed variation in the interpretations of the ISO 9000 standard. In total, 16 of the clauses/subclauses note distinct variations, between one or more of the documents, which could alter the perception of the system.


CONCLUSIONS
From examination of the six identified guideline documents, the claim that ISO 9000 introduces quality systems which are comparable from one country to another is unfounded in the acute health care sector.
Sweeney
J
J
Irish Society for Quality in Healthcare, Dublin. jsisqh@iol.ie
Heaton
C
C
D000068:Accreditation; D000208:Acute Disease; D001315:Australia; D002568:Certification; D004282:Documentation; D019983:Guideline Adherence / Q000706:statistics & numerical data*; D017408:Guidelines as Topic; D006302:Health Services Research; D006801:Humans; D007494:Ireland; D007557:Israel; D009520:New Zealand; D013557:Switzerland; D017749:Total Quality Management / Q000592:standards*; D014481:United States