Healthcare Agreement Revision Nears Release

by R. Dan Reid

The first revision of the International Organization for Standardization (ISO) Interna-tional Workshop Agreement (IWA 1) should be released this month if all goes according to plan.

At the time of this writing, the proposed revision was approved via
ballot to the original workshop distribution and forwarded to ISO for publication by the workshop executive committee.

ISO IWA 1 evolved from a joint effort of the Automotive Industry Action Group (AIAG) and the ASQ Healthcare Division. This action was prompted largely by the 2000 Institute of Medicine (IOM) report that indicated up to 98,000 deaths per year were attributable to preventable systemic based medical error.1

The number reflects deaths only in hospital settings and exceeds the number of fatalities due to car accidents, breast cancer or AIDS. The nursing shortage in the years since the release of the original IOM report has probably resulted in an even higher number of annual deaths.

Last year, the National Committee for Quality Assurance reported 57,000 die annually due to “inappropriate care,” such as care inconsistent with known medical science.2

These deaths are in addition to the deaths resulting from medical error. If you also add the deaths due to medical error that occur outside hospital admissions and then consider the near misses that do not result in death but create harm as a result of care, the picture is worse.

The Centers for Medicare and Medicaid Services in 42 CFR Part 4823 report the healthcare community acknowledges errors are most likely underreported due to malpractice threats and practitioner confidentiality concerns. According to the U.S. Department of Health and Human Services, even though the majority of medical liability cases never come to trial, it costs an average of $24,669 to defend each claim.4

Significantly, a survey published by the American College of Healthcare Executives5 listed hospital CEO top concerns as reimbursement issues, personnel shortages and capacity. Items of least concern included quality, technology, patient safety, patient satisfaction and biodisaster preparedness.

IWA 1 Background

In 1998, work groups from ASQ and AIAG, representing a large group of payers of healthcare costs, began work on similar ISO 9000:2000 series based applications documents for healthcare organizations. Agreement was reached in 2000 to work together on a common document, HC 1, released in January 2001.

Interest from other countries led AIAG and ASQ to propose release of HC 1 under the auspices of ISO as an IWA, a new category of ISO document. In September 2000, ISO approved this proposal, and an international workshop was convened in January 2001. Agreement was subsequently reached, and IWA 1 was released the following September. IWA 1 contains all of ISO 9001 and most of ISO 9004 guidance. It is voluntary.

What’s New in the Revision

ISO requires a review of standards every three years. For procedural and content reasons, the IWA 1 revision was designed to preserve the content and intent of the original workshop agreement.

But there continues to be a significant challenge in translating the language of ISO 9000 into the language of healthcare. For example, a “nonconformance” in ISO 9000 is an “adverse event” in healthcare, and “work instructions” would likely be known in healthcare as “pathways” or “protocols.”

To address these differences, IWA 1 contains 25 definitions of key terms used in the document. Further, the revision adds “what to look for” information and additional guidance and examples.

Here is a summary of the new content, in no particular order:

Quality management system: The ISO 9000 series pertains to the organization’s quality management system (QMS). In the IWA 1 revision, there is a further description of what this means in terms of content and intent.

Other additions include:

  • An explanation of the relationship of policy and procedures manuals currently used in healthcare to the QMS.
  • Examples of ancillary support services and typical outsourced services.
  • Further description of QMS documentation both in content and intent.
  • A discussion of the importance of quality objectives and quality policy deployment through the organization.
  • Examples of objectives.
  • Further explanation of internal audit methodology.

Document control: One of the most difficult challenges for an organization is to manage and control communication of information, making certain everyone who needs to know in fact does know and those who do not need to know in fact do not. This is a primary purpose of document control, the subject of one of the ISO 9001 clauses for which organizations are most frequently cited for noncompliance in certification audits.

The additional guidance in the IWA 1 revision further discusses document access, review, approval and change control. Documents are contrasted with records in detail, and examples of both are provided to emphasize the difference and explain the role of each in the QMS.

The revision also provides examples of typical communication channels and information structure and adds examples of electronic communications to various clauses.

Process tools: The revision enhances information on tools helpful in defining and documenting processes and amplifies the need to clearly define roles, responsibilities and authorities:

  • It introduces the RASIC (responsible, approve, support, inform, consult) chart, which is similar in function to the Six Sigma accountability matrix, as a tool to easily define roles and responsibilities for each step in a process (see Figure 1).
  • It emphasizes the use of job descriptions and documentation of training requirements.
  • It further explains failure mode effects analysis and fault tree analysis tools.

Role of top tanagement: The revision contains more emphasis on the role of top management in quality management, specifically its need to work collaboratively to coordinate and integrate all the activities in the organization that affect quality, especially those designed to improve clinical services. In particular, guidance regarding customer satisfaction management has been added.

Patient/client safety: The revision adds information on developing a culture of patient/client safety, particularly in patient care practices guidance. Other changes include:

  • Definition of areas that need clear procedures, including various types of regulatory issues and the need to consider patient rights, wishes and preferences.
  • The addition of the practice of evidence based medicine to various clauses.
  • New content pertaining to medication management, the use of specialists in emergency care settings, medical record and chart management, involvement of workers’ input in design of the work environment, intraorganization transfer of patients, process validation, traceability of patient/clients and supplies, data and information management, and food and nutrition.

Business planning: The revision lists additional considerations for the business plan of the organization, such as disaster preparedness, clinical planning, policy development, oversight of quality, capital and facility planning, error proofing and resource planning.

Other business planning changes include:

  • Addressing management of the effects of worker fatigue due to prolonged work hours, a subject that has been well documented outside of IWA 1.
  • Adding the use of benchmarking inside and outside the healthcare sector to various clauses.
  • Adding guidance on cost management with specific activities.

Purchased product control: In IWA 1, control of purchased product was identified as a need in healthcare organizations. The revision provides additional guidance in supplier management and examples of how to identify, procure and receive purchased product and monitor supplier performance. It contains further explanation regarding inventory management and handling of nonconforming product.

Format Improvements

IWA 1 used a combination of boxed and regular text to identify which text was from ISO 9001, which was from ISO 9004 and which was added through the workshop process. This made the original text appear somewhat busy and confusing.

In the revision, only the ISO 9001 text is boxed. This will highlight those requirements in IWA 1 that are necessary for third-party certification if the organization elects this option. Color-coding of text has been adopted for identification of the added content.

Taking Standardization For Granted

W. Edwards Deming pointed out standardization is something all of us take for granted.6 He cites as examples voltage, electrical currency, electrical outlets, lamp sockets, men’s shirt sizes, traffic signals, tires and wheels among other items that are standardized across the land. We probably could not imagine what our lives would be like without such standardization, yet standardization activities are not generally rewarded in organizations.

In a subsequent 2001 report, IOM said the healthcare system should focus greater attention on the development of care processes for the 15 to 25 common, mostly chronic conditions that afflict many people and account for the majority of healthcare services.7 These include cancer, diabetes, emphysema, high cholesterol, HIV/AIDS, hypertension, ischemic heart disease, stroke, arthritis and asthma.

The report recommends healthcare organizations, clinicians, purchasers and other stakeholders work together to organize evidence based care processes consistent with best practices and organize major prevention programs to target key health risk behaviors associated with the onset or progression of these conditions.

It is time for the healthcare sector to reengineer its delivery processes using this approach to standardize the care plans for these conditions and use international consensus quality system standards such as ISO 9000 as a basis for quantum improvements in patient safety and cost reduction.

IWA 1 provides application guidance for ISO 9001 for healthcare organizations but also provides tools and guidance beyond the fundamentals of quality to take the organizations toward world-class quality and greater efficiency. IWA 1 also emphasizes organizations can use high leverage activities, which offer a big return for the amount of effort required.

Raising Expectations

In his Sept. 2, 2004, acceptance speech at the Republican National Convention, President Bush coined an interesting phrase in discussing education: challenging the soft bigotry of low expectations. This also could probably apply to healthcare.

Consistent with the IOM recommendations, purchasers of healthcare need to set more rigorous quality expectations for their healthcare plans and providers.

IWA 1 guidance can also be used as a basis for a specification between the customer and supplier in a contractual relationship. Such a specification could drive cost reduction through requiring process efficiencies and the reduction of waste in the organization and its supply chain.

Many of the tools referenced in IWA 1 are common with or analogous to those used in Six Sigma project by project improvement. They would provide positive momentum in the healthcare sector toward the type of change the IOM has called for in its reports.

Where To Get IWA 1

You can purchase IWA 1 and the revision after release from the Automotive Industry Action Group (www.aiag.org, 248-358-3003), ASQ (www.asq.org, 1-800-248-1946 or 414-272-8575) or your national standards body (in the United States, the American National Standards Institute (www.ansi.org, 212-642-4980).


  1. Institute of Medicine, To Err Is Human, National Academy Press, Washington, DC, 2000, p. 26.
  2. The State of Health Care Quality 2003—Industry Trends and Analysis, National Committee for Quality Assurance, 2003, p. 6.
  3. Federal Register, Vol. 68, No. 16, Jan. 24, 2003, pp. 34-36.
  4. “The Medical Liability Crisis and the Litigation Explosion,” American College of Surgeons, www.facs.org/ahp/litexplosion.html, July 8, 2003.
  5. “Research Notes, Top Issues Confronting Hospitals,” Healthcare Executive, March-April 2004.
  6. W. Edwards Deming, Out of the Crisis, MIT Press, 1986, p. 300.
  7. Institute of Medicine, Crossing the Quality Chasm—a New Health System for the 21st Century, National Academy Press, Washington, DC, 2001,
    pp. 9-10.

R. DAN REID, an ASQ Fellow and certified quality engineer, is a purchasing manager at GM Powertrain and a member of the American College of Healthcare Executives. He is co-author of the three editions of QS-9000 and ISO/TS 16949; the Chrysler, Ford, GM Advanced Product Quality Planning With Control Plan; Production Part Approval Process; and Potential Failure Modes and Effects Analysis manuals; ISO 9001:2000; and ISO IWA 1. Reid also was the first delegation leader of the International Automotive Task Force.

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