Quality Health Care--A Path Forward

ASQ Division, AIAG and accreditation bodies develop guidance document based on ISO 9004

by R. Dan Reid

If all goes according to plan, sometime in the next two months a new guidance document based on ISO 9004:2000 will be released for health care organizations' use in implementing or improving their quality systems.

This document is the result of intensified efforts this year by the ASQ Health Care Division, more than 2,000 health care practitioners and the Automotive Industry Action Group (AIAG), including GM, Ford, DaimlerChrysler and the United Auto Workers, with the help of U.S. health care accreditation bodies.

What is not clear at the time of this writing is when or whether the guidance document will be released as an International Organization for Standardization, known as ISO, document.

Why the automobile industry cares

There are a couple of reasons the automobile industry is working on a health care initiative. In 1997, a senior GM executive asked if ISO 9000 could be applied to health care to improve quality and lower costs as had been accomplished for the automotive production supply chain through QS-9000. In automotive supplier surveys, it has been documented that QS-9000 provides up to a 3:1 return for all (internal and external) compliance related costs and a nearly 17:1 return for out-of-pocket certification costs.1

In the most recent survey, the suppliers, who averaged $130 million in annual sales, reported average savings of 6% of sales or about $8 million as a result of QS-9000. In addition to improvements in cost and quality, suppliers also reported improved processes and delivery, better understanding of jobs and tasks, and improved morale.

Readers should be aware that health care cost is the largest purchased component of a vehicle. Health care costs the domestic automotive industry billions per year. Even a 1% reduction in cost would save millions annually.

Several groups met with President Clinton last December to discuss plans to improve patient safety in the United States through medical error reduction. The discussions stemmed from an Institute of Medicine report that estimated that as many as 98,000 people die annually in the United States from preventable medical errors in hospitals. This is reported to be more than those who die from causes such as car accidents, AIDS, workplace injuries or breast cancer.2 On average, this number equates to more than one life each day among those GM alone covers with health insurance.

The latest research shows that almost every tenth patient suffers from preventable harm and adverse effects related to his or her care and that variation among health care providers is big and cannot be explained by patient characteristics.3

Isn't health care accreditation enough?

In the United States, health care organizations are accustomed to accreditation. But considering the number of errors and variation in health care, the basic principles of process management are still a challenge.4 In the June issue of Quality Progress, Paul Schyve, M.D., of the Joint Commission for Accreditation of Healthcare Organizations (JCAHO) wrote, "Quality approaches initially developed for other industries hold promise for improving the performance of health care organizations."5 ISO 9000 was specifically mentioned.

Crosswalks between ISO 9001 and the existing health care accreditation criteria, for example, JCAHO, the National Committee for Quality Assurance and URAC (formerly known as the American Accreditation Healthcare Commission) have revealed significant gaps in the health care criteria when compared to the ISO 9001 elements.

Areas with gaps include document control, purchased product control, control of inspection, measuring and test equipment, inspection and test status, and internal auditing. One area cited as poorly managed is the accuracy of medical technology, particularly the calibration of equipment and devices.6

Adding ISO 9001 to the equation

ISO 9001 defines the generic minimum requirements for a fundamental quality system. The ISO 9000 series is written to apply to all types of companies, but the upcoming revision will improve its applicability to service sectors, such as health care.

The model now being offered by the joint ASQ Healthcare Division and AIAG group is that ISO 9004:2000 should be used to define the fundamentals of the quality system and should support the use of the existing relevant health care sector documents, such as accreditation criteria and regulatory requirements.

There is concern that some health care organizations opting for ISO 9000 certification are using it as a substitute for accreditation. But both ISO 9000 and accreditation are needed to address the specific quality management needs of health care organizations (see Figure 1). In fact, the Malcolm Baldrige Quality Award and similar criteria can also be added to the fundamentals in defining a world-class health care quality system.

Use of ISO 9000 in health care is on the rise globally. There are now more than 300 ISO 9000 certifications worldwide that we know of. A recent study by John Sweeney and Catherine Heaton revealed at least seven different documents created by national bodies as guidelines for the interpretation of ISO 9001 and ISO 9002 for health care. The countries involved are Australia, Ireland, Israel, New Zealand, Switzerland, the United Kingdom and the United States. In addition, five countries have made use of ISO 9002 interpretations but have not generated guidelines.7

The documents discussed above do not include the potential myriad documents generated by consultants or certification bodies for use by their health care clients. Further compounding the problem is that these interpretations provide conflicting information. Some would have only minor impact on the overall quality management system, but Sweeney and Heaton say others "would completely alter the perception of the system" and point to several examples of significant discrepancies in the areas of design control, servicing, and the definitions of "supplier" and "product."8

The problem with the existing ISO 9000 documents

A review of several of the health care guidelines such as CEN/TC 251 Health Informatics, which is being developed, and NCCLS GP-26A-A Quality System Model for Healthcare: Approved Guideline (10/99)9 shows that none define the term "product."

An organization's product is integral to ISO 9000. The Draft International Standard (DIS) ISO 9001:2000 specifies quality system requirements where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements and creates customer satisfaction.10

This use of the word "product" has been a stumbling block for most service sectors who believe that they do not provide product. The DIS ISO 9000:2000 defines product as the "result of a process" and identifies four generic product categories in a note: services, software, hardware and processed materials. Thus, it is clear that services are, in fact, addressed in the ISO 9000 family of documents. Further, health care clearly involves processes and the use of the term "process."

Design control is another element of major conflict in the existing manuals. Tor Janson and Roland Jonsson of SWEDAC are quoted in ISO 9000+14000 News as saying, "The particular version of the standard that is most applicable to a health or dental clinic is ISO 9002, or ISO 9001 for those that perform research and development."11

Others also believe that only those organizations that develop health care protocols and the like would use ISO 9001. This again reflects a misunderstanding of the term "product."

In the new document to be released (as of this writing), the ISO 9000 definition of product has been retained, but for health care it has been further refined as "typically the planning, design and delivery of patient care, service, training or other, for example, research, radiograph..."12 If you consider this definition, it is clear that the primary product of the health care provider is the care plan.13 The provider must diagnose the patient's problem and design and implement the care plan.

To say health care providers are not design responsible is analogous to saying chefs are not design responsible for the meal because they did not design the ingredients they chose to use or that an airline is not design responsible for flight service because it did not design the aircraft.

To make sense of the ISO 9001 standard, it is critical to identify the organization's product. Then you can identify the customer and components of the process, such as the inputs and outputs. Identification of the product is also important when seeking third-party certification of the system, as it will be used to define the scope of registration.

True, health care providers do not typically design the protocols used, but they design the product (health care) that they deliver and are compensated for. A scope of registration should accurately define what specific product or service is provided by the organization.

The issue of design control is often further confused with the issue of subcontracted design services. ISO 9001 has been used for two-party (customer and supplier) contractual situations. In this context, one party has to be ultimately design responsible for the product supplied in the transaction.

If the customer is not design responsible, then the supplier must be. If the supplier chooses to subcontract the design, it must still be responsible for the design to the customer. If, on the other hand, the customer selects a third-party design provider as a condition of the transaction, the provider is then design responsible in the contract.

This understanding can be particularly helpful in health care where physicians are typically not employees of the hospital in which they practice and where health care is provided to a given patient across a number of providers. This continuum of care can be understood within the ISO 9001 model when you understand the product that each provider offers across the continuum.

For example, a patient goes to the doctor with various complaints. The doctor provides a diagnosis, designs and implements a care plan for that patient and is compensated for that service.

The plan, however, may call for X-rays and referrals to various other specialists or to rehabilitation or home care services. Each of these provides a service to the patient and is compensated for that service. Thus, each one provides a unique product to the customer (patient).

This is a critical issue that goes well beyond the quality management system--that is, typically no one practitioner is ultimately responsible for the coordination of the health care services across the continuum of care by a number of providers. With no one ultimately in charge of the quality of the total care across providers, there can be problems--for example, prescriptions issued by different providers can have adverse effects when used in combination for the same patient.

Purchased product

Practitioners have also identified another common problem in health care. Hospitals often run short of supplies during off shifts such as weekends. The method of obtaining replacement supplies is not well understood in the organizations.

An effective method of inventory management, the pull system, was identified in other industries such as retail and automotive years ago. Pull involves replenishment of stock based on consumption. In the automotive industry, pull is an enabler of lean manufacturing, which has proved to be much more effective and efficient than the traditional mass production inventory management method. The latter is called push and involves replenishment of stock based on forecast. Pull has been incorporated into the new health care guidance document as a recommendation.

An opportunity to harmonize

In the new health care guidance document, additions to ISO 9004:2000 have purposely been kept to a minimum to promote its use. Most of the additions provide information on ISO's common definitions and health care examples for the ISO 9004:2000 generic text. Examples of additional content to drive improvements are error proofing, control of measuring and monitoring devices (supplemental to ISO 9004), business planning and managing patient care processes.

The guidance document has been offered to ISO as a baseline document to encourage the harmonization of the conflicts in the existing ISO based health care documents. It has been written at the most fundamental level for quality systems in order to complement, rather than replace, existing health care sector documents that assume the fundamentals and press on with technical content.

Earlier this year the European Accreditation Cooperative announced it was launching a new group to do the same thing. Discussions are now underway to see if these United States and European efforts can be combined.

In August, the ISO Technical Management Board (TMB) approved a proposal to develop an ISO Industry Technical Agreement (ITA) document using the ASQ/AIAG guidance document as the base. The member bodies voting for were from France, Germany, Malaysia, Japan, Australia, Canada, Sweden and Switzerland. The United Kingdom and United States voted against and Colombia and South Africa did not vote.

A delay was experienced when the United States, represented by ANSI, requested that the issue be further discussed at the next TMB meeting at the end of September. At the September meeting, the TMB approved the ITA proposal but requested a delay in the writing workshop until the first quarter of 2001. The guidance document proposers were still developing their response to this delay at press time.

ITAs were introduced by ISO as a means for a fast track release of a document. An ITA represents consensus of a work group and does not require consensus of an ISO technical committee. In fact, there can be competing ITAs on the same subject in the ISO design. If ANSI prevails, the document will likely be published by AIAG and others.

As in sports, you don't win the game without being sound in the fundamentals. We all have a vested interest in the health care sector getting good at the fundamentals of its game. This subject has already been the topic of a lot of interesting discussion. We who develop standards and standards related documents value your feedback. If you would like to help, discuss this initiative with your own health care providers and with your company's health care benefits representative. Together we can make a difference.


1. "1997 ASQ/AIAG Quality Survey Results" presented at the 1997 Quality Survey Workshop, March 17 in Novi, MI.

2. Janet M. Corrigan, Molla S. Donaldson and L.T. Kohn, eds., To Err Is Human: Building a Safer Health System (Washington: National Academy Press, 2000).

3. "The Quality of Healthcare/Hospital Activities," unpublished report by The Working Party on Quality Care in Hospitals, HOPE, The Subcommittee of Coordination.

4. Ibid.

5. Paul Schyve, M.D., "A Trio for Quality," Quality Progress, June 2000, p. 53.

6. "The Quality of Healthcare/Hospital Activities" (see reference 3).

7. "Interpretations and Variations of ISO 9000 in Acute Healthcare," a report by John Sweeney of the Irish Society for Quality in Healthcare (www.isqh.net/) and Catherine Heaton of CASPE Research (www.expert-caspe.demon.co.uk/).

8. Ibid.

9. NCCLS GP-26A-Quality System Model for Healthcare: Approved Guidelines, www.nccls.org

10. Draft International Standard ISO 9001:2000, clause 1.1.

11. ISO 9000+14000 News, Mar./Apr., 1999, p.12.

12. "Committee Draft 4-Quality Management Systems-Guidelines for Process Improvements in Health Care Organizations," clause 3.1.13, guidelines under revision by ASQ Healthcare Division and the Automotive Industry Action Group.

13. Ibid, clause 0.2.1.

R. DAN REID is manager of advanced technology purchasing at GM Powertrain and co-author of the three editions of QS-9000, ISO Technical Specification 16949; the Chrysler, Ford, GM Advanced Product Quality Planning With Control Plan; the Chrysler, Ford, GM Production Part Approval Process Third Edition; and the Chrysler, Ford, GM Failure Modes and Effects Analysis manuals. He was also delegation leader of the International Automotive Task Force and is or was on numerous ISO committees, working groups and task groups, including the group developing the guidance document based on ISO 9004:2000 for health care organizations. He can be reached at dan.1.reid@gm.com

If you would like to comment on this article, please post your remarks on the Quality Progress Discussion Board, or e-mail them to editor@asq.org.

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