Laboratories are understandably frustrated by the need to obtain duplicate accreditations for similar types of tests, measurements, and calibrations. The proliferation of accreditation bodies, each with users only accepting their preferred accreditation body tends to increase the duplication. There are numerous examples where this is the case. The point of this paper though is not to elaborate on this problem but to discuss the solution. It is generally agreed that the ideal of “one test, one accreditation — accepted everywhere” is a worthwhile and achievable aim. A2LA supports this aim and believes the way to achieve it is through Mutual Recognition Arrangements (MRAs) among the accreditation bodies themselves.
COOPERATION AT THE INTERNATIONAL LEVEL
Efforts to realize this ideal have a long history, both nationally and internationally. The International Laboratory Accreditation Cooperation (ILAC) was established 30 years ago to develop accreditation as a trade facilitation tool. If the global accreditation community were to accept the outcomes of each other’s accreditations, it would need to operate with equivalent criteria and processes. Internationally accepted standards of practice for laboratory accreditation were needed. The first international standard from the International Organization for Standardization (ISO), ISO Guide 25:1978, addressed the general requirements for the competence of laboratories based upon the work of ILAC. ASTM standard E548 served as a primary source for Guide 25 text. The latest version is now ISO/IEC (International Electrotechnical Commission) standard 17025:2005.
Beginning in the early 1980s, standards for the operation and acceptance of accreditation bodies were published. ASTM standard E994 was the U.S. equivalent (using virtually identical text) to ISO/IEC Guide 58, which was recently replaced by ISO/IEC 17011:2004. In the 1990s, ASTM Committee E36 began to adopt ISO laboratory accreditation standards, which are now the generally accepted U.S. standards. ASTM E36 is recommending the formal adoption of ISO/IEC 17011:2004 as an American National Standard. NIST, ANSI, and several federal agencies already use these standards.
ILAC also agreed to the rules for peer evaluation of accreditation bodies for Mutual Recognition Arrangements (MRAs). The foundation for realizing “one test, one accreditation — accepted everywhere” was thereby laid. Acceptance would begin with the accreditation bodies themselves. The whole purpose of an MRA is to provide a mechanism where reports from accredited laboratories can be accepted everywhere. MRAs, as agreed on the regional and international levels, oblige each signatory to recognize and promote the equivalence of the accreditations of the other signatories. The ILAC MRA was established in October 2000. ILAC works through recognized regions so that signatories to the MRAs of the European cooperation for Accreditation (EA) and the Asia Pacific Laboratory Accreditation Cooperation (APLAC) automatically become eligible for recognition under the ILAC MRA. The Inter-American Accreditation Cooperation (IAAC) is in the process of having its MRA process recognized and accepted by ILAC.
COOPERATION AT THE NATIONAL LEVEL
Laboratory accreditation has developed in many U.S. market sectors at different times and under different circumstances. As accreditations overlapped and became duplicative, ways for consolidating them have been explored.
In 1992, ACIL, ANSI, and NIST formed a tri-partite cooperation called the Laboratory Accreditation Working Group (LAWG). After five years of intense discussion of how to reduce the duplication and complexity of the U.S. laboratory accreditation scene, ACIL, ANSI, and NIST jointly established the National Cooperation for Laboratory Accreditation (NACLA) in 1997.
NACLA developed a process for evaluation and mutual recognition of accreditation bodies based upon international standards and practice. In October 2000, the first three signatories (i.e., A2LA, International Accreditation Services (IAS), and NVLAP) to the NACLA Mutual Recognition Arrangement were recognized based on peer evaluations of the APLAC MRA. NACLA has added five more signatories, but the three original signatories have since resigned from the NACLA MRA for legitimate and compelling reasons. However, A2LA continues to support the goals of NACLA and believes that an opportunity to realize these goals is at hand.
A NEW AND BETTER APPROACH BY NACLA TO ACHIEVE HARMONIZATION
NACLA has recently approached ILAC to explore acceptance as a region. However, recognized regions of ILAC must be composed of a minimum of four countries to have international credibility that the decisionmaking process is impartial. Accepting NACLA’s request requires fundamental changes to which ILAC is unlikely to agree. ILAC is much more likely to encourage interested NACLA members to participate in the ILAC mutual recognition process, either directly or through participation in the MRA of one of ILAC’s recognized regions (e.g., APLAC or IAAC). This would ensure maintenance of a truly internationally-harmonized process for mutual recognition.
NACLA also intends to pursue closer association with IAAC. The combination of each body’s limited resources would strengthen the realization of their common goals. U.S.-based accreditation bodies can be evaluated by an internationally recognized process, enabling the accreditation bodies to get international (as well as national) recognition with one evaluation, thus avoiding duplication and the distinct possibility of differing standards of practice. Conflict-of-interest issues would be resolved. Unnecessary trade barriers would be avoided. NACLA stakeholder members can participate in IAAC and ILAC and thus have more influence on the development of international standards of laboratory accreditation practice, which as noted earlier, are also the national standards.
WHY SHOULD U.S. LABORATORIES CARE?
Just as laboratories do not want duplicative assessments, accreditation bodies do not want duplicative evaluations. Separate evaluation schemes are costly and, if they are based on different standards, they are even more costly. Such costs are inevitably passed through to the accredited laboratories. If an accreditation body can get an evaluation to serve both national and international recognition, costs would be reduced.
Not withstanding growing discontent in some quarters, globalization is here to stay. This is even more valid for accreditation and mutual recognition processes and the standards by which they operate. The global MRA processes are growing in coverage, effectiveness, and acceptability. Trade agreements are beginning to include references to the ILAC MRA. Recognition and acceptance of the ILAC MRA will continue to grow in the marketplace and with federal agencies. NIST, the Navy, and the Nuclear Regulatory Commission are users of the ILAC MRA. Regulators will follow, albeit more slowly.
The U.S. with its multiplicity of accreditation bodies is not unique in the world. There are at least ten other countries with more than one accreditation body, many of which are members of ILAC. It is in the self-interest of U.S. laboratory accreditation bodies and U.S. laboratories to follow the international (national) rules no differently than other countries. Doing our own thing would be duplicative, wasteful, and ultimately counterproductive.