QUERI – Quality Enhancement Research Initiative

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Quality Improvement Methods

21. ISO 9000

a. Definition

ISO-9000 is a set of standards from the International Standards Organization to assure that technical standards are followed on a worldwide basis. ISO is an independent, non-governmental international organization based in Switzerland. The ISO 9000 standard focuses on quality and provides tools and certification for organizations assuring that they meet customer's requirements. Specific guidelines for healthcare are published. Healthcare providers can implement ISO 9000 standards based on publications and a survey. In some ways it is similar to the Baldrige Award process as a way to verify meeting quality standards. (See Section 5)

b. Literature

  • Sweeney, John, and Catherine Heaton. "Interpretations and variations of ISO 9000 in acute health care." International journal for quality in health care 12.3 (2000): 203-209.
  • Staccini, Pascal, et al. "Mapping care processes within a hospital: from theory to a web-based proposal merging enterprise modelling and ISO normative principles." International journal of medical informatics 74.2 (2005): 335-344.

c. Example

Usage of an ISO standard (there are several) is somewhat similar to use of the Baldrige (See Section 5). It is necessary to learn the requirements for approval, implement necessary changes to meet the standard and then apply to the appropriate authority for acceptance. In both cases much of the benefit derives from the ongoing impact of maintaining the quality standard.