The need for continued improvement in the quality systems of healthcare delivery organizations has been well documented. Quality professionals, whether practitioners, administrators, or service and products providers, must determine what is the most beneficial, proven, and cost-effective approach. Among today’s most popular quality programs and tools – Malcolm Baldrige, Six Sigma, and ISO 9001, which can enable results that match your goals? Such goals likely include:
Six Sigma has been met with much skepticism in the healthcare field. In manufacturing, it is possible to eliminate human variability through automation, creating precise measurement of assignable causes of variation. But the delivery of patient care is largely a human process, so the causes of variability are much harder to identify. The challenge becomes finding a way to leverage the data to drive human behavior. The most successful organizations have combined a strong technical strategy, like Six Sigma, with a strong cultural strategy to drive the change. It has been established in both hospitals and health systems as a tool to improve service levels, cost productivity and customer satisfaction.
The Malcolm Baldrige National Quality Award – given to organizations judged to be outstanding in seven areas: leadership; strategic planning; customer and market focus; measurement, analysis, and knowledge management; human resource focus; process management; and results – is becoming increasingly popular in the healthcare industry. Organizations of all types can effectively apply the Baldrige criteria. When done well, self-assessments can be used as a catalyst for change, and when joined with a focused improvement effort can result in remarkable performance levels.
ISO 9001:2015 is an internationally developed and accepted set of quality system requirements. These requirements form the foundation or system for on-going quality management. Six Sigma and Baldridge (or TQM) can then become tools for continual improvement of the business processes. There are over a half million organizations worldwide that have adopted ISO 9001 and this strategy for continual improvement. Several success stories for ISO 9001 in healthcare follow.
A major hospital achieved the following benefits:
An occupational medical facility reported closing 47.1% of workers compensation cases, reducing industrial rehabilitation cases below national averages, and eliminating redundancies resulting in substantial savings.
A large managed care company noted that ISO 9001 provided the following benefits:
An ISO 9001 certified healthcare delivery organization reported improved profit, lower employee turnover, better than national performance average on benchmark indicators, and improved effectiveness and efficiency.
Each day, healthcare delivery professionals are interfacing more with ISO certified healthcare related organizations. To name just a few in which ISO 9001 registration is prevalent: providers of medical devices, durable medical equipment, pharmaceuticals, therapeutic products, laboratory chemicals, medical gases, micro-electronics, steam sterilizers, electrooptical and laser systems, surgical instruments, repair and calibration of medical instruments, medical image processing, and program safeguard contractors. These customers and suppliers have focused on improving their existing quality systems, reducing their costs, improving communications, and reducing the risk of liability.
ISO 9001 is well known and has been well accepted as a quality standard across many service and manufacturing industries throughout the USA. As a result, there are many resources available to assist with implementation, such as extensive literature, experienced quality managers, good consultants, and valuable training courses. SRI Training, to cite one, offers courses on how to Document, Interpret, and Implement ISO 9001:2015, as well as courses on Internal Auditing. A robust ISO 9001 compliant system will achieve broad industry and public recognition.
Implementing a healthcare quality management system registered to ISO 9001:2015 can lead to benefits such as:
It may not be readily apparent, but quality management systems registered to ISO 9001:2015 can be applied to address items such as: medical errors, credibility problems, medication administration issues, patient safety, and equipment up time. ISO 9001:2015 focuses on control processes which typically equate to costs in control and can lead to prevention or reduction of liability.
Six Sigma, Malcolm Baldrige, and ISO 9001 are all excellent ways to improve quality in your organization. To choose the right tool, you need to consider both your short and long term goals. For instance, with ISO 9001, the chances of maintaining your quality initiatives are greater, due to the process and system approach, and the use of annual or semi-annual surveillances of your quality management. There are many factors to take into account, and a decision should not be made lightly.
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