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Healthcare in Crisis




Despite superior technology and some of the best educated and most talented staff and physicians, patient care in U.S. hospitals is in crisis. Poor communication among hospital staff overworked or minimally trained workers and a faulty system of checks and balances result in medical errors that claim an estimated 98,000 lives each year.¹ And the saddest part is, nearly all of these deaths are preventable. The cause is directly attributable to a lack of a formal quality management system and related standard operating procedures.


Every year nearly 2 million people contract infection while hospitalized, resulting in 100,000 deaths.² Such numbers underscore a systemic failure due, for the most part, to a lack of formalized procedures (or the enforcement thereof). “Starbucks has more procedures in place for catching errors than many hospitals have,” says Dr. Carolyn Clancy, head of the Agency for Healthcare Research and Quality (AHRQ).³  Common medical errors, including everything from incorrectly administered medication to equipment failure, plague our healthcare system and are costing the industry  millions of dollars in litigation and increasing insurance rates. These problems are exacerbated by a shrinking number of qualified nurses and patient care-givers. According to the American Nurses Association there will be a shortage of 139,000 registered nurses this year and 275,000 by 2010.


Now more than ever a systematic approach to quality is needed in U.S. hospitals. A quality system that can ensure a checks and balances necessary to prevent problems; A system that can optimize process flow and promote continual improvement; A system that can ensure the integrity of medical equipment and a safe and sanitary environment; a system that can control the quality of suppliers; a system that can optimize training and reduce human error; a system that can save money while providing better quality care – now more than ever, hospitals and patient-care facilities need a quality management system.


Introducing ISO 9001:2000


The most universally applied and widely-accepted quality management system is the ISO 9000:2000 series of standards that has at its core ISO 9001:2000. The ISO standards were developed by The International Organization for Standardization, to ensure that products and services of member countries secure global acceptance. Being by design a standard for universal application, ISO 9000 is readily implemented in both product-based and service-based organizations. Its universal applicability is achieved by broadly defining requirements and leaving the manner of how the requirements are fulfilled to the organization. In other words, the focus is on what needs to be done and not on how it is to be carried out.  The basics of ISO are simple: align your processes to be compliant with the Standard, document your processes as procedures, and adhere to those procedures in your day-to-day activities (while providing “objective evidence” that you are doing so).


According to ISO 9000, quality is defined as the totality of features or characteristics of a product or service that bear on its ability to satisfy customer needs. In other words, quality service means meeting customer needs. As it is both customer and quality service focused, ISO is not only well suited for healthcare applications, it  should be deemed “requisite”, as being in the best interest of those the system is designed to serve.


Benefits of ISO for Healthcare


For healthcare organizations, quality service that is capable of meeting the needs of the patient (customer) might include the timely delivery of care; an accurate assessment of needs; repeatability of performance, availability of services to those that need them; and the demonstration of social graces (courtesy, politeness, etc.) in service delivery.


The implementation of ISO brings about various benefits that include less firefighting or need for constant intervention in day-to-day operations. This is achieved by providing staff the means to control their own operations (while yielding the desired results). ISO also provides a means for documenting experience, providing a basis for education/training and for systematic improvement of performance. Most importantly, it provides the means for enabling everyone to perform tasks right the first time. This is achieved by providing work instructions, effective controls, adequate resources, training, motivation and an environment conducive to quality.


For health services organizations, true service must have the desires and needs of the patient (customer) as the desired end result. But trying to achieving such a goal without a formal quality management system has, to date, been a quagmire for the healthcare industry, resulting in increased incidents of malpractice, preventable infection, increased patient mortality, escalating litigation and skyrocketing insurance premiums. That is why more and more hospitals and health services organizations have discovered that that the only sure way to ensure the delivery of consistent quality care is through the implementation and maintenance of a quality management system.


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 1. According to the Center for Disease Control and Prevention: 2. According to the Institute of Medicine of the National Academy of Sciences; 3. Part of the U.S. Department of Health and Human Services.



Text by Stephen Rubino -  all rights reserved. RH Andersen and Team ISO are registered trademarks of RH Andersen Consultants. All rights reserved.


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