Interpretations and variations of ISO 9000 in acute health care

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? DESIGN: 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. SETTING: Worldwide in the acute health care sector (excluding that of laboratories). STUDY PARTICIPANTS: 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. CONCLUSION: 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.