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ISO 9002 for intensive care unit (ICU): quality improvement, process control or marketing?: a case study on a 75-bed adult and pediatric ICUs of a private hospital in São Paulo, Brazil


Although ISO standards have been largely adopted for the industrial sector, its use in the health sector has been mostly limited to clinical laboratories and blood banks units [1,2,3].


The development of research in intensive care units aimed to answer two major questions. How efficient and applicable could a model developed for industrial processes be for health services directly related to patient care? What were the contributing and limiting factors during the ISO implementation and what were the results obtained 2 years after the certification?


Case-study research was conducted to understand the perception of the leaders of ISO9002 certified ICU units of a 460-bed acute care hospital. Leaders in both adult and pediatric units include the head physician, head nurse, quality co-ordinator and supervisors. The nine interviews were based on a semistructured questionnaire, totaling 16 h of interview. The analysis of the interviews was done based on qualitative methods.


During the implementation, the most important contributing factors were the multiprofessional structure of the Quality Committee and the need for exactness and preciseness in the patient care-related services. The main limiting factors were the difficulty on comprehension and adaptation of the model to the patient care services and the characteristic of autonomy of the medical practice. As a result of the process, it was clear for the leaders that the greatest benefits were related to process control mechanisms. These include the following: standardization and documentation of policies, technical procedures and administrative routines; mandatory records for critical process; internal and external auditing systems; and equipment maintenance control. Concerning the use of ISO as a tool for marketing promotion, leaders agreed that the certification did not impact positively on the demand of the services. One final result relates to its ineffectiveness in implementing a quality management system, due to its lack on leadership and quality improvement requirements.


Results indicate that ISO9002 can be a possible and useful alternative for health care services, mainly if effective mechanisms for standardization and control of their processes are not yet in place. Also, ISO implementation may be useful for services with little experience on quality initiatives that are willing to adopt it as a first step towards a quality management system.


  1. NBR ISO 9002 - Sistemas da qualidade: modelo para garantia da qualidade em produção, instalação e serviços associados. ABNT -Associação Brasileira de Normas Técnicas, Rio de Janeiro, 1994.

  2. Associação Brasileira de Normas Técnicas. Coletanea de Normas de Sistemas da Qualidade, Rio de Janeiro: ABNT, 1995.

  3. Patrus P Fabio. Implantação do Modelo ISO 9002 na área da saúde: a visão do gestor da qualidade em quatro unidades de um Hospital do Municipio de São Paulo em 2000. São Paulo, Dissertacao (Mestrado em Administracao de Empresas). Escola de Administracao de Empresas de São Paulo, Fundação Getulio Vargas.

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Patrus, F., Knobel, E. ISO 9002 for intensive care unit (ICU): quality improvement, process control or marketing?: a case study on a 75-bed adult and pediatric ICUs of a private hospital in São Paulo, Brazil. Crit Care 5 (Suppl 3), P85 (2001).

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