ISO 14000
Patient Safety



Patient Safety, Six Sigma &
ISO 9000 Quality Management

A new emphasis on quality management is
essential to improve U.S. health care.

by Michael G. Crago, Ph.D.


It's a given in today's world of advancing technology that health care delivery represents an extremely complex collection of diagnostic, operational and administrative processes, all of which must be highly coordinated to ensure the delivery of quality patient care. Yet the health care industry's implementation and practice of quality measures causes it to operate at a low three-sigma to four-sigma quality level, compared to the five-sigma to six-sigma quality of the aerospace, information technology, telecommunications, or medical device and in-vitro diagnostics industries. With health care performing at this significantly lower level, is it any wonder that (according to Lucian Leape, an adjunct professor of health policy at the Harvard School of Public Health) an estimated 120,000 deaths occur every year due to medical mistakes?1 Compare this to National Safety Council figures of 41,200 deaths from motor vehicle accidents, 16,600 from falls, 4,100 from drowning and 3,700 from fires. The Institute of Medicine reported that medical mistakes in the United States cause as many as 98,000 hospital deaths per year. 2 Dr. William C. Richardson, chair of the committee that wrote this report and president/CEO of the W. K. Kellogg Foundation, articulates it best when he asserts, "these stunningly high rates of medical errors--resulting in deaths, permanent disability and unnecessary suffering--are simply unacceptable in a medical system that promises to do no harm." 3

 Why is there a problem with quality in health care today? Is the health care industry really so very different from other industries that have successfully implemented ISO 9000 quality management systems in an effort to realize Six Sigma quality results?

 It's true that health care in the United States requires a heterogeneous mix of people to support the operation of its multifaceted industry. The Partnership for Patient Safety describes these many interactive groups as including "consumers, clinicians, hospital organizations, ambulatory care providers, employers that purchase health care from providers for their employees, suppliers of health care medicines and other products, purchasers of medical products, regulators and lawmakers, lawyers, and the media," among others.4 It's also true that health care quality assurance organizations have sought for decades to standardize clinical performance for activities that affect patient safety and the quality of health care. The respected Joint Commission on Accreditation of Healthcare Organizations (JCAHO) describes its approach to quality as endeavoring to improve patient care by "addressing the organization's level of performance in key functional areas." 5 However, as in any other industry, quality in health care delivery requires the congruent system integration and synchronization of all essential operational, clinical, and administrative process inputs and outputs to optimize and ensure a synergistic realization of the organization's common goals and purpose. To paraphrase the basic tenant of systems analysis theory, no part is of greater importance than the whole.

 In the attempt to establish a process quality goal for health care, it's important to understand the applicability of Six Sigma quality and ISO 9000 quality management. Let's begin by defining sigma as it relates to a business or manufacturing process. Six Sigma Qualtec, a leading Six Sigma consulting firm, defines sigma as "…a metric that indicates how well that process is performing. The higher the sigma value, the higher the performance quality of the organization's process. Sigma measures the capability of the process to perform defect-free work, with a defect being anything that results in customer dissatisfaction."6 The International Organization for Standardization (ISO) defines Six Sigma as a "statistical business-improvement approach that seeks to find and eliminate defects and their causes from an organization's processes, focusing on outputs of critical importance to customers." 7 With a similar philosophical intent, ISO defines quality management as "all activities of the overall management function that determine the quality policy, objectives and responsibilities and implement them by means such as quality planning, quality control, quality assurance and quality improvement within the quality system." 8 ISO further defines the quality system as "the organization structure, procedures, processes and resources needed to implement quality management."9 Therefore, ISO 9000 provides a methodology and framework to evaluate whether an organization has efficiently and effectively defined, organized, integrated and synchronized its operational resources to optimize performance and ensure customer satisfaction. Moreover, ISO 9000 synergistically augments and enhances the long-standing benefits of health care accreditation and government regulation and produces continuous quality improvement to effectively respond to technology's fast-moving continuum of change.

 Dr. Paul M. Schyve, senior vice president of JCAHO, has acknowledged that the solution to medical mistakes is "to change the systems and processes within which people work in order to make it harder for errors to occur."10 He further concludes that accreditation and ISO 9000 can fit well together and complement each other.

 Large numbers of both U.S. health care providers and their patients are less than satisfied with the industry's mechanisms for attempting to balance health care quality, accessibility and costs today. For far too many U.S. residents, the health care industry's attempts at cost containment have become synonymous with ineffectual hurry-up-and-wait patient care. Neither the health care industry's internal customers (represented by the health care professionals themselves) nor its external customers (represented by the patients) seem satisfied with the quality status of health care today. This management trend is the result of conflict between the clinicians' need for professional autonomy and the health care industry management's corresponding mandate to impose reasonable administrative controls on clinical practice. Clinical autonomy should clearly translate into efficacious patient care, and good administrative practice should systematically translate into efficient and effective use of resources to promote profitability, budgetary enhancements or both. When these conditions appropriately manifest themselves, a state of synergy exists between managers and clinical care providers, and the needs and expectations of those most fundamentally important people affected by the quality, accessibility and cost equation--that is, the patients--are better served. However, when management practice is driven by cost measures that aren't derived from a systems-process approach that effectively inculcates all activities of the overall management function (i.e., to determine a quality policy, objectives and responsibilities and implement them accordingly), there is no quality system. Health care quality and accessibility suffer, the health care industry continues to muddle through at a three-sigma to four-sigma quality level, and patient safety is described by medical mistakes that represent the highest cause of accidental death in America.11 Such a conclusion is, by definition, the antithesis of quality management.

 To be fair, in considering health care quality, accessibility and cost, not all emerging interactive problems can be solved by the health care industry. Technology is expensive and will continue to remain so, and the U.S. health care consumer will continue to expect the best that technology can provide. However, increased costs associated with increased capital investments in technology don't necessarily result in increased quality or customer satisfaction. Increasing costs can correspondingly reduce the health care consumer's access to expensive new technologies. In other words, can or will a patient be able to pay for more expensive diagnostic and treatment services? And will the health care organization, in an effort to offer affordable health care, be reasonably willing to routinely utilize more costly services prescribed by its clinical providers in the face of increased operating costs? Or does the health care organization's management administratively obfuscate clinical diagnosis and treatment processes in order to rein in the organization's clinicians and inhibit them from referring their patients for more costly diagnostic procedures or treatment regimens? These are but a few issues that are plaguing the health care industry today.

 Clearly, across health care's delivery landscape, health services managers have their work cut out for them. They must start doing what the leadership in the other high-tech industries have been doing for more than 10 years--be willing to start looking for more creative, nontraditional solutions. Health care's leadership should innovatively consider that the worldwide standard for five-sigma to six-sigma quality is, historically, ISO 9000.

 ISO 9000 is a proven methodology that will effectively help health care organizations to better manage continuous quality improvement while facilitating synergy between accreditation and regulatory processes. There is no better proven way for the health care industry to address the problem of patient safety while simultaneously pursuing a five-sigma to six-sigma quality end-state. The mediocrity of three-sigma to four-sigma quality is indefensible in today's Six Sigma quality environment, especially when juxtaposed with the issue that deaths due to medical mistakes is an abomination that has finally escaped Pandora's box and is out on the street. Having ushered in the 21st century, it's time for the health care industry to acknowledge that the efficacy of a system-process approach toward quality is tantamount to a system-process approach toward patient safety. The industry can no longer make excuses, and the alternative--continuing to beg the question--borders on insanity. As Leape puts it, when comparing patient safety and the health care industry to commercial aviation and the aerospace industry, health care's three-sigma to four-sigma quality is "roughly equivalent to a jumbo jet crashing every day."12

 ISO 9000 quality management, along with the demonstrated performance of health care accreditation and government regulation, will be instrumental in helping to restore the public's confidence in the health care industry. ISO 9000 quality management can do for the health care industry what it has systematically succeeded in doing for the automotive, aerospace, information technology, telecommunications, machinery, electrical products, pressure equipment and transportation industries: facilitating performance excellence and the achievement of a five-sigma to six-sigma quality end-state.


1. Gerlin, Andrea. "How Your Hospital Could Kill You." Reader's Digest, June 2000, p. 174.

2. Tickner, Neil and Megan O'Neill. "Preventing Death and Injury From Medical Errors Requires Dramatic, Systemwide Changes." press release, Institute of Medicine, Division of Health Care Services, November 29, 1999.

3. Ibid.

4. Partnership for Patient Safety Web site,, home page, July 2000.

5. Joint Commission for Accreditation of Healthcare Organizations' Web site,, "What We Do," July 2000.

6. Six Sigma Qualtec International Web Site,, "Glossary of Terms for Six Sigma," August 2000.

7. Shaw Resources' Web Site,, "Six Sigma: A New Strategy for Health Care?" Article 4, August 16, 2000.

8. International Standard, Quality Management and Quality Assurance--Vocabulary. International Organization for Standardization (ISO) 8402:1994 (E/F/R), Second Edition, 1994-04-01, p. 16.

9. Ibid, pg. 14.

10.  Schyve, Paul M., M.D. "A Trio for Quality: Accreditation, Baldrige and ISO 9000 Can Play a Role in Reducing Medical Errors." Quality Progress, June 2000.

11.  Gerlin, "How Your Hospital Could Kill You," p. 174.

12.  Ibid, p. 172.

About the author

 Michael G. Crago, Ph.D., a health services manager with more than 20 years of international experience in health and human services, is the manager for health care certification with the Medicine, Health and Sports Division of TÜV Management Service/TÜV Product Service Inc. TÜV performs quality systems registration of medical devices and in vitro diagnostics and FDA 510(K) third-party assessment activities and is a European Union Notified Body for the Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic directives, offering ISO 9000, EN 46000 and ISO 13485/88 registration activities. Contact the author at .

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