LAB ACCREDITATION
IS ALL OVER THE MAP

The assurance of valid test data is becoming an international priority

Helen Gillespie

INTEGRITY QUESTIONS
The vast array of international products available to consumers worldwide underscores the growing globalization of the marketplace. Corresponding market complexity has made buyers increasingly dependent on formal methods and procedures to ensure that all the products, services, and systems that they purchase consistently meet their needs.

In many industries, certain product characteristics are instrumental for safe and effective performance, and many of these characteristics cannot be evaluated simply by picking up the product and examining it. Such characteristics need to be determined and assessed, with assurance provided to the buyer that the product conforms to requirements and that conformance is consistent from product to product. For example, if a buyer determines that a particular airplane part must be able to withstand pressure of at least 5,000 kilograms per square centimeter, then the buyer needs assurance that none of the purchased parts will fail to withstand such pressure. There is no way to determine whether a part meets this requirement by simply looking at it; the integrity of the product can only be ensured through lab test results that can be validated.

The pharmaceutical drug industry offers another example. Just fifty years ago, US drug manufacturers could produce and sell drugs without testing them on either animals or humans and without any kind of government approval. In fact, governmental action could be taken only against drugs that were misbranded or adulterated. This changed in 1937 with the deaths of 107 people, mostly children, from a liquefied version of the then wonder drug sulfa. The drug was recalled, and the tragedy led to the enactment of the 1938 Food, Drug, and Cosmetic Act, which requires that drugs be tested and approved by the Food and Drug Administration (FDA) before marketing. As new capabilities and technology have become available and incorporated into product development and manufacturing processes, government and certification programs have grown in both size and complexity.

The rise in certification programs to address product safety and effectiveness has driven a corresponding rise in the need for lab accreditation to ensure the validity of test results. However, the result is the creation of numerous specialized accreditation programs for each industry.

TOO MANY PROGRAMS
The need for a single lab accreditation standard is being driven by several factors, not the least of which is industry confusion concerning the validity of test data. This confusion is caused in part because although evidence of a calibration system is necessary for a manufacturer to receive quality system certification, such as ISO 9000, there previously has been no internationally recognized US accreditation program that assesses the competency of the labs that perform those calibrations.

This is not the case overseas, where a majority of the accreditation bodies are government organizations. In the US, laboratory accreditation schemes are operated by all levels of government and by the private sector. Indeed, more than 700 organizations are involved in standards including: 178 private sector organizations that perform certification, thirty-one federal government lab accreditation programs, twenty-one state programs, and eleven local programs.

These programs assess and certify the capability of a laboratory to conduct testing. However, the requirements and assessments vary considerably by organization and program. Whereas some programs are quite comprehensive, others involve only minimal review of a laboratory's qualifications. In addition, many of the accreditation programs are industry or application specific.

For instance, there are accreditation programs for labs involved in fields as diverse as medicine and forensics. The Commission on Laboratory Accreditation of the College of American Pathologists accredits hospitals and independent medical laboratories. An accreditation to the American Society of Crime Lab Directors ASCLD/LAB program is gaining importance in the field of criminology as a result of the intense scrutiny on chain-of-custody issues in court. The American Association for Laboratory Accreditation has accredited more than 900 laboratories in several testing fields, including food testing, where new regulations are beginning to take effect.

Although these programs zero in on criteria specific to a particular field, there is no overall nationally recognized laboratory accreditation standard. This omission highlights the need for a general lab accreditation program to ensure consistency of inspections, with supplements that can address specific applications.

NIST CREATES NACLA
The National Technology Transfer and Advancement Act of 1995 attempted to address the confusion concerning laboratory accreditation. This act required the National Institute of Standards and Technology (NIST) to coordinate federal, state, and local technical-standard and conformity assessment activities with private sector technical-standard and conformity activities. The goal was to eliminate unnecessary duplication in the development and promulgation of conformity assessment requirements and measures.

TO SIDEBAR: Criteria for Laboratory Evaluation

Conformity assessment can verify that a particular product meets a given level of quality or safety and can provide the user with explicit or implicit information about its characteristics, the consistency of those characteristics, and/or the performance of the product. It is the first step in specifying the criteria necessary for laboratory accreditation (see sidebar above).

Not only must the laboratory be accredited, but the certifier and the registrar must also be formally recognized. As part of this effort, NIST spearheaded the development of the National Council for Laboratory Accreditation (NACLA), a working group also sponsored by the American Council for Independent Laboratories (now known as ACL) and the American National Standards Institute.

A voluntary program, NACLA is chartered to be a partnership between the public and private sectors. It is currently developing procedures and bylaws and intends to have a fully operational system for recognizing the competence of testing and calibration laboratories by May 1998. The goal is for accreditation in a given field by a NACLA-recognized body to both meet domestic needs and result in worldwide acceptance of a laboratory's test data, thus making tested products available to the entire global marketplace.

NACLA plans to coordinate US positions for regional and international activities such as the International Laboratory Accreditation Cooperation, the Asia Pacific Laboratory Accreditation Cooperation, and the European Cooperation for Accreditation of Laboratories. In addition, NIST recognizes accreditation programs through its National Voluntary Conformity Assessment System Evaluation Program. This program enables the Department of Commerce, acting through NIST, to evaluate and recognize accreditation bodies that meet established requirements.

LAB ACCREDITATION BASICS
Accreditation is defined in ISO/IEC Guide 2 as a "procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks" (1). In the case of laboratory accreditation, the tasks are tests or specific types of tests.

Laboratories can be accredited in several ways. One way is for the laboratory to be accredited to test in an entire field of testing. A laboratory can also be accredited in a scientific discipline such as biochemistry, in a specific technology such as gene splicing, or in relation to specific products such as blood product testing. Accreditation can also be limited to the conduct of specified test methods.

In general, the broader the scope of approval, the more difficult and time-consuming it is for the accrediting body to thoroughly assess the laboratory's ability to perform all test methods and test all sizes and types of products within that scope. However, the narrower the scope of accreditation, the more likely it is that a laboratory performing a broad range of testing will obtain multiple accreditations.

Because most US laboratory accreditation programs were designed to meet particular governmental or private sector needs, such programs tend to take distinctive forms and use different sets of procedures to ensure that a laboratory has sufficient competence to perform the specified testing. Some programs involve only a simple review of data submitted by a laboratory, with no attempt at verification. Others require a full-scale on-site evaluation of the laboratory's facilities, staff, and equipment as well as a review of the results of internal audits, quality system reviews, and proficiency testing. To state that a lab is accredited may be true but misleading. There is little consistency from one program to the next, even within comparable programs that may be conducted by the same organization or government agency.

As a result, it is necessary to have a standard that can form the basis for all accreditation programs. The most widely recognized lab accreditation standard is the ISO/IEC Guide 25, General Requirements for the Competence of Calibration and Testing Laboratories (see sidebar, below).

TO SIDEBAR: General Requirements...

ISO/IEC GUIDE 25
ISO 25 is one of several international standards developed by the International Organization for Standardization based in Geneva, Switzerland. Accreditation to ISO 25 should not be confused with registration to other ISO standards, in particular ISO 9002. There are significant differences between the two. ISO 9002 focuses on conformance to a quality system, whereas ISO 25 establishes a laboratory's technical competence. Technical credibility and competence are not addressed in ISO 9002.

The standards are closely linked, however, with accreditation to ISO 25 requiring that a laboratory have a quality system similar to ISO 9002. With such a quality system in place, ISO 25 then requires criteria specific to the goal of ensuring valid test data. For instance, ISO 25 states that "in addition to periodic internal audits, the laboratory shall ensure the quality of results by monitoring test and/or calibration methods...using statistical techniques, proficiency testing programs, certified reference materials, replicate tests using the same or different methods; retesting; correlation of results for different characteristics of an item. The selected methods should be appropriate for the nature of the work undertaken" (2). ISO 9002 does not require the organization to monitor performance or perform proficiency tests. There are more incidences of such specific direction, particularly under the technical requirements section, that further underscore the differences between ISO 25 and ISO 9002 (see sidebar, below).

TO SIDEBAR: Documentation Differences...

Thus, although an organization may be certified to a quality system standard, such certification does not ensure lab competency. Laboratories, therefore, can be accredited for specific tests or measurements and for particular products and test specifications to provide such assurance. However, although laboratory accreditation ensures the validity of test data, ISO 25 does not provide industry-specific criteria. As a result, supplements that provide even more specificity have arisen, such as the food lab accreditation standards being developed by the Food Laboratory Accreditation Working Group (FLAWG).

FLAWG determined that systems developed for the food lab accreditation program should be consistent with ISO Guides 25, 43, and 58 and recognized by government and industry. The group has developed two draft guides covering basic quality systems for microbiology and for chemistry. The FLAWG guides follow ISO 25 closely, providing an interpretation of the general requirements in each section of ISO 25 with specific requirements for operating a food microbiology or food chemistry testing laboratory. For instance, because food microbiology involves the testing of foods and related substances for bacteria, yeasts, and molds, the microbiology guide offers specific direction regarding the examination of food products; ingredients in the production of food; in-process food samples; environmental samples pertinent to foods (swabs, debris, scrapings, air, condensate); and final products for those substances.

With ISO 25 as the internationally acceptable standard, labs can be accredited to both ISO 25 and any supplementary standards such as FLAWG that are based on ISO 25 and recognized worldwide through both accreditations, thereby streamlining product acceptance in the global marketplace.

WORLDWIDE ACCEPTANCE
A consistent laboratory accreditation standard that includes laboratory testing of products, accreditation of competent laboratories, certification of products against recognized standards, and registered assessment of process quality according to international standards helps ensure product acceptance in foreign markets.

Not only has it often been difficult for lab test data generated in the US to gain acceptance in many other countries, but non-US exporters and their governments also have had trouble understanding US requirements and identifying the agency responsible for a particular product. The efforts of NIST, NACLA, FLAWG, and other similar programs will go a long way toward standardizing lab accreditation criteria and addressing international demands for a single, consistent US lab accreditation standard that satisfies both export and import criteria.

Recognizing the importance of accreditation to ISO/IEC Guide 25 and becoming accredited to that standard assures that the lab meets minimum standards of competence and provides valid test results.

REFERENCES

SEE OTHER HOT ARTICLES FROM THE MARCH ISSUE:
The Thermal Desorption Alternative
The Tedious Hunt for Cryptosporidium