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Quality Digest

FDA Compliance

ISO Publishes Guidance for Health Care Sector

Published: Monday, November 21, 2005 - 22:00

The International Organization for Standardization recently published a new version of International Workshop Agreement 1, which provides additional guidance for the health care sector. IWA 1:2005 has been made more user-friendly by incorporating improvements suggested by health care providers since the original guidance document was published in 2001. The new guidelines include much of the text of ISO 9004:2000, supplemented by text specifically aimed at assisting health care organizations to implement quality management systems—regardless of whether they pursue registration to ISO 9001. The objective of the guidance document is systematic process improvement, the prevention of error and other adverse outcomes, and the reduction of variation and organizational waste.

Principal improvements to the new version of IWA 1 include:

  • The translation of quality-related terminology into language and situations readily understood by health care professionals
  • The addition, after the description of many ISO 9004 requirements, of related advice on “what to look for” and other examples

Mickey Christensen, chair of the committee that developed the original proposal for IWA 1, cites the case of Southern Pharmaceutical Corp. as an example of the benefits of ISO 9001 implementation, supplemented by guidance from IWA 1. The Gulfport, Mississippi-based company, which delivers medicines and vital medical equipment to patients at their homes, was severely damaged by Hurricane Katrina.

“The owner stated that because of their ISO 9001 system and having planned for disasters with documented procedures, they were back in business within a matter of hours, providing the home-care patients the service they needed,” Christensen says.

For more information, visit www.iso.org.


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