Dates and venue fixed for workshop to develop ISO 9000 guidelines for health care industry

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CSA International (CSA) and Standards Council of Canada (SCC) have announced that they will co-host the ISO/ITA 1 Workshop to develop guidelines for implementing ISO 9000 quality management systems in the health care sector on 18 and 19 January 2001 in Detroit, Michigan, USA.

The primary deliverable of the workshop will be the publication of sector-specific guidelines for health care organizations developing fundamental quality management systems.

The proposed guidelines will become ISO/ITA 1 - the International Organization for Standardization (ISO)'s first Industry Technical Agreement. The agreement will be based upon a quality management system standard (ISO 9004:2000). The ITA is a new alternative to developing International Standards, and is offered by ISO in cases where swift development and publication take priority. An ITA document represents a workshop consensus rather than that of a technical committee.

While it is envisaged that ISO/ITA 1 could be used in the design or improvement of quality management systems in the health care sector, themselves certifiable to ISO 9001:2000, ISO/ITA 1 is not intended for use in third-party certification. The ISO/ITA 1 document, like ISO 9004:2000, will therefore be an informative rather than a normative document.

For those interested in participating, highlights of the ISO/ITA 1 Workshop's registration are as follows:

  • In preparation for the workshop, application, registration, document receipt and response with comments will be undertaken electronically via the Internet.
  • Interested individuals must apply for registration to attend the workshop; registration will be limited to 200 registrants.
  • Eligibility for and approval of registration will be based on the following criteria: applicants must be an employee, contractor or agency in the health care industry, for example:
  • A health care organization, such as a hospital, clinic, or third-party payer including HMO's, government, etc., or
  • A health care professional, technical or trade association or
  • A certification body for quality systems certification with current health care clientele or
  • An accreditation body for health care or quality system certification or
  • A consultant or training provider with current health care industry clientele.
  • In the interest of maximizing input diversity, no more than two individuals may participate from any one organization and each organization will have one vote.
  • Global participation is anticipated for the workshop and thus the organizers have identified the need to expedite the solicitation and collation of comments to the draft ITA 1 document prior to the convening of the workshop in January. Organizers have therefore prepared a comments template provided by the workshop organizers and for the benefit of registered participants, urge the use of this template.
  • On behalf of registered participants and given the time available for the workshop, organizers state their obligation and intent to accept for consensus deliberation at the workshop only those comments relevant to the technical content of the draft ITA 1.
  • Please note that the workshop will focus on proposed comments, revisions and improvements on a draft ISO 9004:2000-based guidelines for the health care sector. Comments with regard to the merit or necessity of need on this ITA will not be accepted or deliberated at the workshop.
  • The workshop will be conducted in English. English will also be the language of ISO/ITA 1 document.
  • To help defray the costs of the workshop and its organization, a fee of USD 295 will be charged for attendance. Registered participants will be responsible for their costs - travel, accommodation, etc. - associated with attending the workshop.

Interested individuals are invited to apply for registration via the SCC Web site ( and look for the icon for the ISO/ITA 1 Workshop). Registration will be on a first-come-first-approved basis. Workshop organizers have committed to a 10-day turn around on review and approval of applications. Upon acceptance, registrants will have access to the draft ISO/ITA 1 document and the accompanying comments template, as well as information on the Workshop Programme including rules, hotel accommodation and other related information.

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