ISO 15189 Work Advances at Meeting in Vancouver

Delegates to ISO Technical Committee 212 gathered for their annual working session

CEO SUMMARY: Laboring quietly out of the public eye, an international work team of professionals, including representatives from the CDC, the FDA, and global in vitro diagnostics (IVD) manufacturers, has spent the past 14 years developing an important series of quality and safety standards for medical (clinical) laboratories. Here’s a report on events at the most recent international assembly of ISO Technical Committee 212, which gathered earlier this month in Vancouver, British Columbia.

EARLIER THIS MONTH, VANCOUVER, BC, was a hotbed of quality management and laboratory safety activity. Members of ISO Technical Committee 212 and observers from across the globe gathered to continue the work of international standards for clinical laboratory testing, including ISO 15189.

First up on May 31-June 1 was the “Quality Conference Weekend Workshop,” offered by the University of British Columbia (UBC) Department of Pathology and Laboratory Medicine and open to the laboratory public. It was organized by Michael Noble, M.D., Professor and Chair, Clinical Microbiology Proficiency Testing program and Program Office for Laboratory Quality Management at the UBC Department of Pathology and Laboratory Medicine. THE DARK REPORT conducted a session at this workshop.

Unfamiliar Topics For Labs

This quality workshop offered a number of topics and experts seldom heard at laboratory programs in the United States. These topics ranged from root cause analysis to risk management tools, such as “failure mode and effects analysis” (FMEA). Collectively, these presentations provided insights into how laboratory operations will evolve toward a more sophisticated environment of evaluating both analytical and operational processes.

For example, failure mode and effects analysis is a risk management tool that can be used to predict the effects of problems that could develop in the processes being studied. “Fault tree analysis” (FTA) is a complementary risk management tool and can be used to identify problems in laboratory testing processes, both prospectively and retrospectively.

The presentation on FMEA and FTA was delivered by Donald M. Powers, Ph.D., who is the Chair of ISO Technical Committee 212 (TC 212). Powers is the principal of Powers Consulting, based in Pittsford, New York. He served as a clinical chemist at Hahnemann University in Philadelphia and worked for many years at in vitro diagnostics (IVD) firms such as Ortho-Clinical Diagnostics and Kodak.

Powers explained the evolution of risk management in the automobile and medical device manufacturing industries. “It was in the early 1990s that failure mode and effects analysis was adopted by IVD manufacturers for risk management purposes,” observed Powers. “In 2006, FMEA arrived in healthcare. New Joint Commission directives require healthcare organizations to include FMEA in their programs to prevent or eliminate errors and reduce risk to patients.”

Significant Development

FMEA’s arrival in healthcare is a significant development and will eventually work its way into clinical and pathology laboratory operations. THE DARK REPORT will be providing further intelligence about fault mode and effects analysis, fault tree analysis, and similar disciplines that are focused on improving processes and identifying sources of errors.

Another presentation with implications for laboratories in the United States was delivered by Gregory J. Flynn, M.D., pathologist and Managing Director of the Quality Management Program–Laboratory Services, of the Ontario Medical Association in Toronto, Canada.

Flynn discussed how and why the province of Ontario had implemented a new, more rigorous scheme of laboratory accreditation and regulation. “ Five years ago, provincial health authorities decided to base laboratory accreditation in Ontario on ISO 15189,” stated Flynn. “By the end of 2008, there will be at least 200 laboratories that have achieved ISO 15189 accreditation.”

Ontario Lab Accreditation

One consequence of Ontario’s use of ISO 15189 for laboratory accreditation has been a shake-out of smaller laboratory companies. “There has been a decline in the number of small lab firms that operate in Ontario,” explained Flynn. “Smaller labs have chosen not to devote the resources and management involvement necessary to achieve accreditation under ISO 15189. Instead, they either closed or were purchased by larger lab companies.”

Following UBC’s “Quality Conference Weekend Workshop,” ISO Technical Committee 212 convened and conducted sessions on June 2, 3, and 4. Technical Committee 212 (TC 212) was responsible for developing ISO 15189, along with 22 other international standards for clinical laboratories and IVD manufacturers.

Official participants on TC 212 are delegates representing medical laboratory and IVD interests from 33 countries and several international organizations, such as WHO. Registered observers are allowed to monitor the plenary sessions and offer comments in working sessions. There were approximately 120 delegates and observers present at the opening plenary session on June 2.

Plenary and working sessions over the next several days provided invaluable insight about ISO 15189 and its ongoing development. Because an ISO standard has global credibility and because of momentum that has built since ISO 15189 was published in 2003, pathologists and laboratory directors in the United States and internationally will want to stay informed on this subject.

Lab Standardization

First, a quick history. It was in 1995 when, under the sponsorship of the Clinical and Laboratory and Standards Institute (CLSI, then NCCLS), delegates from national standards bodies around the world came together with a common interest in improving laboratory quality by developing international standards specific to medical laboratory testing. This group of pioneers received official recognition as a technical committee of the International Organization for Standardization (ISO), and began work on a body of standards that included ISO 15189, which was published in 2003.

Another little-known fact among the laboratory profession is that ISO 15189 is just one of many ISO standards for which the committee is responsible. So far TC 212 has published 17 standards, with six more to be published in the next year. A few of the subjects encompassed by TC 212’s working charter:

  • ISO TS 22367: Reduction of error through risk management and continual improvement
  • ISO 22870: Point-of-care testing
  • ISO 15190: Requirements for Safety
  • ISO 18113: Information Supplied with IVD Medical Devices (Labeling)
  • ISO 15198: Validation of User Quality Control Procedures by IVD Manufacturers
  • ISO 15197: Requirements for blood-glucose monitoring systems for managing diabetes mellitus
  • ISO/TS 25680: Calculation and expression of measurement uncertainty for medical laboratories
  • ISO 17511: Traceability of values assigned to calibrators and control materials

Single Global Standard

In upcoming issues of THE DARK REPORT, additional intelligence briefings will provide more depth and detail about this comprehensive effort to align technologies and processes across the manufacturing, laboratory medicine profession, and patient self- testing segments based on ISO standards. These efforts are undertaken with a goal of creating global standards that will be supported by government regulatory agencies of most nations.

Also, the U.S. Technical Advisory Group to ISO TC 212 welcomes more participants willing to contribute their expertise. Individuals with experience in clinical laboratory medicine or in vitro diagnostics manufacturing are needed to formulate the U.S. positions on the international standards or to participate in developing or revising the standards. Clients and readers of THE DARK REPORT interested in participating should contact editor Robert L. Michel at He will facilitate contacts with CLSI or other national standards organizations.

ISO “Certification” Versus “Accreditation”

IT IS IMPORTANT FOR LABORATORY DIRECTORS AND PATHOLOGISTS to understand the concepts of “accreditation” and “certification” as it applies to ISO:15189 Medical Laboratories.

This month, in an article in Quality Magazine, author Roger Muse offered the following insights about “accreditation” versus “certification”:

Among the several terms that have been identified for third-party conformity assessment activities, two rise to the top because of common usage:

Accreditation is a “third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks”, as defined by ISO/IEC 17011 Conformity Assessment–General Requirements for Accreditation Bodies Accrediting Conformity Assessment Bodies.

Certification is a “third-party attestation related to products, processes, systems or persons,” as defined by ISO/IEC 17000 Conformity Assessment–Vocabulary and General Principles.

The hierarchy is structured in such a way that accreditation is one step higher than certification. Accreditation is reserved for those bodies performing some type of certification service. This might be an ISO/IEC 17025 accredited lab issuing an accredited calibration or testing certificate, an accredited certification body issuing an ISO 9001 (management system requirements) certificate, or an accredited product or personnel certifier whose responsibility is to certify a product.

Given the global awareness of the ISO management system standards, certification is most often associated with ISO 9001 and the environmental management systems standard ISO 14001. However, accredited certification programs exist for a range of management systems.


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