ISO 15189: the ‘world’s thinking’ on managing quality
The more exacting document control standards many laboratories are facing are part of CAP 15189 accreditation, a new initiative the CAP is offering as a complement to the Laboratory Accreditation Program. The College has now accredited three CAP 15189 labs and has applications pending from many more. “For 15189 accreditation, document management is central, and it’s probably the hardest single element in achieving accreditation under that standard,” says Dr. Gerald Hoeltge, CLSI president.
ISO 15189 is an overarching, international medical laboratory standard, developed by ISO Technical Committee 212, that includes a requirement for a Quality Management System, explains Lucia M. Berte, chair of the CLSI Standing Subcommittee on Quality Management Systems. “CLIA ’88 contains elements of quality management thinking, but it’s not a QMS. The standards of a QMS are broad and general, whereas CLIA is a very specific subset, a detailed expansion of some of the requirements in ISO 15189.”
CAP Standards Committee vice chair Dr. William Castellani says the College was involved with ISO 15189 from the outset, “when it was first proposed by NCCLS [now CLSI], because the CAP felt it was important to be involved in what was occurring internationally.”
Berte says “Quality System Essentials” is a phrase the American Association of Blood Banks coined in 1997. “QSEs create general categories of laboratory activities. For example, there is a QSE on equipment. AABB and the other various accrediting organizations’ requirements are written in such a way that if a lab built a single equipment management program that included all the requirements, it would pass that part of all inspections,” she says. The CLSI adopted 12 QSEs for the entire laboratory environment and distilled ISO 15189, CAP, AABB, COLA, and Canadian lab accreditation requirements to the least common denominator. Following all the QSEs is a convenient way to meet the requirements for Quality Management Systems, Berte says.
The 15189 standard and CLIA ’88 have very different heritages, Dr. Hoeltge points out. “CLIA is a process-based program; it seeks to ensure the reliability of data coming out of labs by process control, which is one of 12 Quality System Essentials. ISO 15189 and CLSI’s quality guidelines map the components of quality along the workflow and engineer into them assurances for a quality product or service.
“That’s why the two CAP accrediting programs are complementary—because 15189 and CLIA regulations really have little functional connection one to the other,” he says.
In general, international standards are developed to promote trade, and in the European Union, for example, ISO standards have the power of government regulation. “We don’t have anything quite like that in the U.S.,” says Dr. Hoeltge. “But for U.S.-based hospitals and labs, ISO 15189 represents the world’s thinking as to the state of the art on managing quality. So while for most U.S. labs, 15189 accreditation doesn’t give an international trade advantage one way or the other, it does make that lab potentially more competitive in the market.” The CAP accredits labs in other countries, and this program would be particularly attractive to labs that want CAP accreditation but are in a part of the world where ISO accreditation is the expectation of the payer, usually the government, he says.
CAP 15189 accreditation, Dr. Hoeltge adds, is a status that only the “best of the best” are going to try to achieve in the foreseeable future. “There’s no regulatory requirement that they have it in the United States, so the motivation is entirely internal. Accreditation under ISO 15189 means you want to do the right thing, and you want to do it at a level that will stand up to international scrutiny.”