You may be saying to yourself, "We're already doing some of those things." Remember, we have noted that much of Six Sigma is not new. In fact, many of our consulting partners (clients) will tell you these type program assessments and "new" healthcare programs have already been implemented with our practice-specific, tailored Transition Plans. What is new is the integration we offer, bringing leadership and three separate quality-based management programs into a coherent strategy for implementation.

So, what do all these diagrams and models mean? In simplest terms, the statistical process is used to monitor key factors, and when something starts to deviate from the target, it is assessed by the leadership and assigned to a Green Belt team to find out why and to take corrective action.

Bear in mind that Six Sigma is a gradual process. It starts with your dream and a vision. A goal of near-perfect delivery of services and superb client satisfaction must be part of the process. The core values must lead to inviolate standards of care, which are implemented with outstanding medical records providing a continuity of care that prevents embarrassment for the past or present provider, staff, or client. The pillars of CQI must be in place, and practiced on a continuing basis; the staff must believe the pillars of CQI are real.

ISO 9000 - IWA 1 Quality Management Standards

ISO 9000 is a generic international standard that describes the requirements for establishing, maintaining, and continually improving the Quality Management System.

 A quality system is the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

 Quality management is that aspect of the overall management function that determines and implements the quality policy.

 The quality policy is practice-specific and a well-defined set of integrated systems, processes, standards, and tools, to drive doing the right things right all the time.

Guidelines for implementing ISO 9000 quality management systems in the healthcare sector were published by ISO (International Organization for Standardization) on September 20, 2001, as its first "International Workshop Agreement" (IWA).

 IWA 1, Quality Management Systems - Guidelines for Process Improvements in Health Service Organizations, 68 pages, is available from ISO national member institutes. A complete list is posted on ISO's Web site: www.iso.org and from ISO Central Secretariat sales@iso.ch.

 The guidelines are based on ISO 9004:2000, Quality Management Systems -Guidelines for Performance Improvements. For a wide selection of North American ISO 9000 resources, contact: www.aqapress.com/pCat90.html.

 IWA 1 contains much of the text of ISO 9004:2000, supplemented by specific guidance for its implementation in the healthcare sector. The document provides a framework for the design and improvement of process-based quality management systems by healthcare organizations. The guidelines are voluntary and they are not intended for certification or accreditation.

 IWA 1 is based on an earlier draft, jointly developed by the American Society for Quality (ASQ) and the Automotive Industry Action Group (AIAG), which is a global industry association, representing automotive companies, including the "Big Three": Ford, Daimler-Chrysler, and General Motors. The healthcare costs to these three companies is $8 billion a year for insurance and healthcare coverage of their employees. As a major employer, the automotive sector deals with thousands of healthcare providers and spends substantial amounts on healthcare programs.

 The generalized implementation of ISO 9000 quality management systems by healthcare establishments is seen as a means of rationalizing client-supplier relationships and an opportunity to improve the quality of healthcare, while reducing the costs.

The IWA-1 draft was considered by healthcare sector stakeholder groups represented at an ISO workshop on January 18-19, 2001, in Detroit, Michigan, USA. The workshop was co-hosted and organized by the Standards Council of Canada and Canadian Standards Association (SCC/CSA), who hold the Secretariat of ISO/TC 176, the ISO technical committee responsible for the ISO 9000 standards.

At that meeting, approximately one hundred thirty-five healthcare experts from twenty countries discussed and improved the guidelines. The Institute of Medicine (IOM) 2001 report stated, "Americans now invest annually $1.1 trillion, or 13.5% of the USA GDP in the healthcare sector", so we know there is a major interest in higher productivity driving lower costs.

The meeting was followed by a sixty-day consultation and vote period on the guidelines, ending on March 30, 2001. The consultation period was adopted to give participants adequate time to receive input from their respective stakeholder groups.

An International Workshop Agreement is one of several new alternatives offered by ISO to developing international standards for cases where swift development and publication takes priority. Compared to the traditional ISO process of developing international standards through the technical committee structure, IWAs are developed in open workshops and organized by an ISO member body. The IWA was first introduced under the designation of Industry Technical Agreement (ITA), but this was modified to reflect the fact that ISO's work addresses not only the needs of industry, but also those of numerous stakeholder groups in society as a whole.

Figure 19: Model of ISO 9000 - IWA 1

Michael Stoecklein, ASQ's healthcare market development manager, and Mickey Christensen, Health Care Division standards committee chair, developed an overview in Quality Progress (Volume 35, Issue 9, September 2002) of the Institute of Medicine's 1999 report, To Error Is Human: Building a Safer Health System". They reported that there has been increased interest in trying to identify and use methods to help reduce errors and improve safety, while simultaneously improving a healthcare organization's operating margin. Other industries have proven ISO 9000 is a very powerful quality management tool, and some healthcare service organizations have found it can help provide better healthcare systems and reduce the incidence of avoidable adverse events.

 ASQ's Health Care Division and the Automotive Industry Action Group collaborated to develop ISO 9004:2000-based document guidelines for process improvements in health service organizations. ASQ's Health Care Division helped lead the group effort in drafting the document. At the international workshop in 2001 (mentioned above), attendees modified the draft, which was later accepted for publication by ISO. After the workshop in Detroit, the attendees voted to publish the ISO IWA-1 document.

 The IWA-1 document can be used by healthcare organizations to implement an ISO 9000 quality-based management system and make accreditation with other agencies easier, thereby minimizing the number of resources required to comply. IWA-1 contains much of the text of ISO 9004:2000, but also includes specific guidance for its implementation in the healthcare sector.

 The guidelines are voluntary and not intended for certification or accreditation. Copies of the IWA-1 document and the reports published by the Institute of Medicine are available from ASQ Quality Press, http://qualitypress.asq.org.

 ASQ has also developed a training course, IWA 1 -- Train the Trainer, and some training materials. For course schedules, go to: www.asq.org/courses/iwa-healthcare-train.html.

 In addition, ASQ recently began hosting quality conversations on a variety of topics, the most recent being one about Six Sigma in healthcare.