Use ISO 9001:2015 for Better Health Care Outcomes at Lower Cost-Aug 21st, 2019

William A Levinson, Live Date: 08/21/2019

Live Date: Aug 21st, 2019

Live Time: 3:00 PM EST

Course Duration:60 min


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Use ISO 9001:2015 for Better Health Care Outcomes at Lower Cost-Aug 21st, 2019

Napoleon Bonaparte said, "Doctors will have more lives to answer for in the next world than even we generals" and, even in the 21st century, medical mistakes are the third leading cause of death (after cardiovascular disease and cancer). Most of these "mistakes" are however due primarily to deficiencies in the systems in which health care professionals must work—the same kinds of deficiencies the ISO 9001:2015 quality management system is designed to address. This presentation will show how ISO 9001 can protect medical practitioners and hospitals as well as patients from system-related problems, remove waste (muda), and deliver lower health care costs for patients along with higher compensation for health care professionals.
Why one should attend the training:

30 to 50 cents of every health care dollar were squandered on the costs of poor quality at the beginning of the 21 st century and, while some improvements have taken place, the costs are still enormous in terms of patient safety and money alike. The total costs come to $1 trillion to $2 trillion a year, or $3100 to $6200 per person. Attendees will learn how ISO 9001 can prevent most (roughly 5 out of 6) malpractice incidents, reduce the costs of poor quality, and share the gains with all relevant interested parties including patients, health care practitioners, and health care system investors. This is especially important for Medicare providers because 90 percent of Medicare fee for service (FFS) payments will be tied to quality and value starting in 2018. In addition, Medicare will no longer pay for preventable poor quality in the form of "never events."

Reference for the 30 to 50% information: Blanton Godfrey, 2000. "Managing Key Suppliers." Quality Digest, September, 2000, p. 20

Learning objectives of the Topic:

1. Know that the increasing complexity of health care systems (like that of manufacturing more than 100 years ago) creates numerous risks that are not under the control of any individual practitioner. The quality systems approach recognizes that, just as no individual trade worker could ensure quality in a factory with interacting processes, no individual doctor or nurse can control quality or patient safety in a modern health care system.

2. Use the proven success of the systems approach—dating back almost 100 years—to gain buy-in from all stakeholders (management, health care professionals, insurers, and patients) in the language of not only money but quality (good rather than bad patient outcomes).

3. Recognize how this systems approach evolved into ISO 9001 and the health care sector specific IWA (International Workshop Agreement) standard, and recognize the role of ISO 9001 in health care systems.

  • The traceability clause 8.5.2, for example, helps ensure that patient test results will not be mixed up—a common problem that, for example, causes unnecessary surgery on people who do not have cancer, and cancer being missed in other patients.
  • Clause 8.6, Release of products and services, relates directly to the "five layers of safety" for donated blood.

4. Use the "Can't rather than don't" error proofing principle to make certain medical errors, such as connecting an enteric feeding system to an intravenous line, confusion of medications with similar names, or an accidental needle stick, impossible rather than relying on vigilance (administrative controls) to avoid errors.

  • The Army's Risk Management process, and also ISO 45001, stress the superiority of engineering controls that make errors impossible over administrative controls that rely on vigilance and compliance.

5. Recognize that almost all health care activities are processes as opposed to individual activities (such as provided by doctor's offices 50 or 60 years ago, when doctors still made house calls). Processes use inputs (including information) to generate outputs (including test results as well as treatments). Processes also require specific individual responsibilities, as something that is Everybody's job soon ends up being Nobody's job—with potentially fatal results as shown by loss of a patient and two sets of transplant organs due to a blood type mixup.

  • Adapt job safety analysis (JSA) to ensure patient and healthcare professional safety, e.g. the latter from accidental needle sticks.

6. Encourage relevant interested parties including doctors, nurses, patients, and visitors to use the hiyari hatto ("experience of almost accident situation"), the near-miss report that is standard practice in occupational health and safety (OHS) to initiate corrective action for situations that could have resulted in harm to a patient or health care provider.

  • The near-miss report is emphatically not a mechanism for "getting somebody into trouble" for making mistakes but rather for exposing weak points in the system and the process that allow mistakes to happen.
Areas will be covered during the Session:
  1. The problem with today's health care system, the enormous opportunity for improvement, and proven results that were achieved almost 100 years ago through the application of industrial methods to health care
  2. The systems approach, which recognizes that health care is now a system of interrelated processes with inputs, outputs, and handoffs to other processes
  3. How ISO 9001, which was designed originally for (primarily) manufacturing, carries over directly into health care
  4. How error-proofing (poka-yoke, can't rather than don't) makes many medical errors, and what is often thought of as malpractice, impossible
  • The "tall man" lettering system for look-alike medications is an example
  • Special markings on high-concentration heparin vials are another

5. Application of job safety analysis to health care with regard to patient safety and also practitioner safety (e.g. prevention of accidental needle sticks)

6. Use of near-miss reports (hiyari hatto) to ensure that near-misses never have the opportunity to develop into actual incidents

Who Will Benefit:
  • Hospitals
  • Clinics
  • Doctor's Offices
  • Health care insurance companies
About, William A. Levinson,

William A. Levinson, P.E., is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer, and Six Sigma Black Belt. He holds degrees in chemistry and chemical engineering from Penn State and Cornell Universities, and night school degrees in business administration and applied statistics from Union College, and he has given presentations at the ASQ World Conference, TOC World 2004, and other national conferences on productivity and quality.

Levinson is also the author of several books on quality, productivity, and management. Henry Ford's Lean Vision is a comprehensive overview of the lean manufacturing and organizational management methods that Ford employed to achieve unprecedented bottom line results, and Beyond the Theory of Constraints describes how Ford's elimination of variation from material transfer and processing times allowed him to come close to running a balanced factory at full capacity. Statistical Process Control for Real-World Applications shows what to do when the process doesn't conform to the traditional bell curve assumption.


President, Levinson Productivity Systems, P.C. Wilkes-Barre PA US


  • B.S. Pennsylvania State University
  • M.Eng. Cornell University
  • MBA Union College (night school)
  • M.S. in Operations Research and Applied Statistics (Union College, night school)

William A Levinson
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