Healthcare Guidelines Proposed as First ITA Document

The Industry Technical Agreement (ITA) is a new way for ISO to quickly issue documents through open workshops involving the interested parties. The first proposal for an ITA deliverable is a draft 70-page document named “Quality Management Systems – Guidelines for Process Improvements in Healthcare Organizations”.

The ASQ Healthcare Division and the Automotive Industry Action Group (AIAG) jointly developed the proposed guidance to help healthcare organizations prevent errors, reduce variation, and continuously improve. The guidance is addressed to healthcare organizations such as private practices, dental offices, hospitals, clinics, pharmacies, and home care to help them implement or improve their quality management systems.

If the ISO Technical Management Board approves the proposed ITA, a workshop will be held in the October 2000 timeframe to seek consensus on the guidance. If all goes well, the document could be issued by the end of this year.

The proposed ITA document uses ISO 9004:2000 and is not meant for registration purposes. By using the 9004 standard instead of ISO 9001 as the core guideline, the ASQ and AIAG groups were able to keep the health-care specific content to a minimum.

The proposed guidelines will apply to healthcare providers, not medical device manufacturers and clinical labs since they have separate standards (ISO 13485, ISO 17025, and ISO 15189).

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