by Bill Craddock
Editor’s Note: This article takes a look at ISO 9001 and the Baldrige Framework for Excellence (which has been used by numerous health care organizations for quality improvement), comparing the two as they apply in the health care setting, and showing how ISO 9001 – often associated only with manufacturing and service industries – can effectively help health care organizations improve their quality management systems.
Documenting and following processes to ensure quality is good, right? What about reducing errors and meeting customer expectations? Again, good – check!
Manufacturers have been addressing these issues for three decades through voluntary adherence to ISO 9001, a management framework recognized worldwide, which lines out requirements for building quality management systems that adhere to internationally accepted standards. ISO 9001 can successfully be applied to both large, global organizations and small organizations that solely serve a local community. And it’s not limited to manufacturers.
ISO 9001 was completely revised in 2015, and that revision greatly increased the overlap between the ISO 9001:2015 requirements and those of the Baldrige Framework for Excellence, another internationally recognized management excellence framework. Even though the two use somewhat different terminologies, their underlying core principles and values are essentially the same and occasionally use the same words in describing those principles and values.
There are three versions of the Baldrige Criteria, and one is specifically devoted to health care. At the national level, at least one hospital (or hospital system) has been recognized as a Baldrige Recipient every year from 2002 to 2017, the most recent award year. With a few terminology tweaks, for example referring to patient expectations instead of customer expectations, ISO 9001:2015 (the quality standard primarily used in manufacturing and service industries) also can be used by hospitals and other health care organizations to improve their quality management processes.
Two Birds? One Stone?
Should a hospital pursue a Baldrige-based Award or ISO 9001:2015 certification? Stop! That’s a trick question, and it’s posed purely as an either/or decision.
Yet there is no reason why a hospital can’t pursue both. Because of the increased overlap in the requirements since the 2015 revision of ISO 9001, there are potentially many “two birds with one stone” opportunities.
The quality management system (QMS) is at the heart of achieving ISO 9001’s two overall purposes. The first purpose is to ensure the products produced and services provided meet the needs and expectations of customers and other key stakeholders (e.g., regulators). The second purpose is to enhance customer satisfaction through the effective use of the QMS. And so, ISO 9001’s purposes fall directly in line with the quality and continuous improvement that are the hallmarks of today’s health care enterprise.
One primary difference in the two systems is that there is no required follow-up after an organization receives the Baldrige Award, while certified ISO 9001 organizations must undergo routine audits and recertification, usually every three years. This may make ISO 9001 even more useful for health care because providers must undergo audits and recertification by regulators on a routine basis as well.
The latest ISO revision also spells out the personal responsibilities of the organization’s senior leaders – those responsibilities that cannot be delegated to others in the organization. These responsibilities include routinely meeting to review the status of the QMS – is it accomplishing the quality objectives, does it have sufficient resources, and have there been any changes in the strategic direction of the organization that would require changes to the quality management system?
Having senior leaders lock in on these responsibilities, dedicating themselves to constantly addressing progress and needed changes in the QMS, is documented to improve process outcomes.
Serving the Customer
All patients obviously want successful clinical outcomes, and hospitals are mandated to collect, review and report a significant number of performance metrics that address these. But patients also have other expectations and requirements that aren’t necessarily covered by these clinical metrics alone.
Patient perceptions of how they are treated are also important. To be sure, hospitals measure these as well, but perhaps in a different manner or frequency than is introduced with the ISO 9001 QMS. For a hospital, the management review required by ISO 9001 should result in a regular, holistic study by senior leaders of the hospital’s performance compared to the expectations of patients and others.
As the late-night infomercials say, but wait – there’s more. The 2015 revision of ISO 9001 also has additional updated requirements that increase its overlap with the Baldrige Criteria, creating more “two birds with one stone” opportunities. One of these comes to light when describing the context of the organization.
In Baldrige terminology, the “context” is the “organizational profile.” In simple terms, ISO 9001 defines the context of the organization as the sum of the internal and external issues that can have an impact on an organization’s ability to ensure all customer requirements are understood and met. It is likely that the internal and external issues of an 850-bed hospital are different than those of a 50-bed hospital. These differences would lead to different organizational contexts.
Not “One Size Fits All”
Recognizing these different contexts, the ISO 9001 standard is definitely not “one size fits all.” It uses the term “interested parties” to cast a larger net in trying to determine requirements and expectations that could impact the QMS. Obviously, patients are interested parties whose requirements need to be understood and met. But the list probably should also include patient families, the workforce, physicians and others who provide care but are not hospital employees, suppliers, regulators, local communities, and the list goes on. The focus is then narrowed to the relevant interested parties; i.e., those groups or individuals whose requirements and expectations must be addressed in the quality management system.
The revised ISO standard also requires risk-based thinking. This is essentially thinking ahead with an eye toward preventive actions – anticipating potential problems and taking the best action based on the information available at the time. In Baldrige language, this is similar to “intelligent risk taking.” A risk is a future, uncertain event that may or may not occur, and if it does occur, the result may be favorable or unfavorable. This is nothing new to the health care world. Individuals providing care for patients make decisions daily based on the best information available, knowing that there is always uncertainty.
Whenever a requirement uses the phrase “as appropriate,” there is risk-based thinking required. The primary focus of risk-based thinking in both manufacturing and health care is in planning discussions – thinking about and discussing various options and choosing the best option given the information available.
Another expectation in ISO 9001:2015 is that quality processes are integrated with business processes. This helps organizations function in a holistic way, rather than in silos. Effective leaders enable and continually promote this approach.
ISO Version Changes and Health Care
Changes from the 2008 version of ISO 9001 to the 2015 version created a greater overlap with the Baldrige Excellence Framework and, therefore, a more holistic view of an organization. However, this does not mean that the ISO 9001:2008 version did not create value when applied to the health care sector.
James Levett, MD and Robert Burney, MD wrote about their individual journeys using the prior version, ISO 9001:2008. Dr. Levett practices adult cardiac, vascular and thoracic surgery. Dr. Burney is an anesthesiologist. Their book, Using ISO 9001 in Healthcare, 2nd edition, describes how a quality management system is comprehensive and supports clinical and non-clinical areas.
The authors explain in the book’s preface: “We had seen how ISO improved the efficiency of our very different organizations, and we wrote this book to explain these benefits to others.”
Drs. Levett and Burney also discuss a hospital accreditation alternative that meets the Medicare Conditions of Participation by using ISO 9001. They also note that ISO 9001 certification of health care organizations is more prevalent outside the United States than inside.
ASQ’s 10 Key Elements
More recently, the American Society for Quality (ASQ) Healthcare Technical Committee published its initial monograph in the Improving Healthcare Monograph Series. This monograph,
A Hospital-Based Healthcare Quality Management System Model, was prepared jointly by the Healthcare and Quality Management Divisions of ASQ. The Monograph describes a hospital-based QMS that has ten key elements, including leadership commitment, planning and review; compliance with requirements; and the management of change. (See Figure 1.)
The authors put the patient experience in the middle of this QMS model. Patient requirements and expectations are identified as Exceptional Quality, Safety and Patient Outcomes.
The value of a QMS, whether this one published by ASQ or one of the many others currently in use, is that it provides a structure to organize the many inherent processes, procedures, policies and other practices to consistently ensure the organization meets the needs and expectations of its relevant interested parties – customers, patients, patient families and loved ones, regulators, accreditors, the workforce, third-party providers, etc.
In a summary of the return on investment (ROI) of various quality practices published by ASQ for the 2015 World Quality Month, the value of participation in ISO 9001 was highlighted and brings into perspective just how much health care can learn from the world of manufacturing.
Utilizing a 2010 Harvard Business School working paper that examined almost 19,000 organizations, conclusions indicated “higher rates of survival” for organizations adopting ISO 9001 as compared to comparable organizations that did not do so.
This is a compelling argument for ISO 9001 implementation, particularly for organizations in rapidly changing sectors such as manufacturing – and health care. After all, the survival of today’s health care organizations is critical for the survival of our nation’s population. Taking cues from manufacturing to improve processes and systems only makes sense.
Bill Craddock is a global trainer, author and management consultant. He previously led staff and operations groups for a Fortune 300 company and now works with organizations to improve strategy and overall organizational effectiveness. Bill has a Doctorate in Higher Education and is a Registered Professional Engineer and Project Management Professional. As a senior member of the Board of Examiners for the Arkansas Governor’s Quality Award and the national Malcolm Baldrige Performance Excellence Award, Bill has served as a team leader and trainer for both programs. He is also a member of the group that makes recommendations for the U.S. position on updates to ISO quality standards and other specifications. Bill can be reached at wtcraddock@conwaycorp.net.
The above article is from the Spring 2018 edition of Arkansas Hospitals, a quarterly magazine published by the Arkansas Hospital Association. Vowell, Inc. produces Arkansas Hospitals on behalf of the Arkansas Hospital Association. This article is reprinted with permission.
