In scientific research in general, results should be accurate, reproducible, and obtained in a clear and transparent way. This demands consistency and high quality during all phases of an animal experiment, such as those shown in Table 4.1. With its emphasis on high-quality product development and consumer satisfaction, the ISO process can be a powerful management tool for an organization.
The ISO standard most commonly applied to organizations with animal care and use programs is ISO 9000, the standard for quality systems. The former ISO 9000 family of standards was upgraded in 2000 and is now identified as ISO 9000-2000. According to the official ISO Web site, ISO 9000-2000 contains "standards and guidelines related to management systems, and related supporting standards on terminology and specific tools, such as auditing (the process of checking that the management system conforms to the standard)."12
For organizations with animal care and use programs, ISO 9001-2000 is most applicable, because it "specifies quality system requirements for use where a supplier's capability to design and supply conforming products needs to be demonstrated."13 It is also a standard against which requirements of a system can be certified by an external organization. In the animal research context, researchers are the "consumers" of the products — which can range from providing and maintaining appropriate animals, to performing a complete study (e.g., contract research organizations).
ISO 9001-2000 has eight parts, with five of the eight identifying the requirements of the standard. These five parts are titled Quality Management System, Management Responsibility, Resource Management, Product Realization, and Measurement, Analysis, and Improvement. The core philosophy of the standard is defined by taking a slightly closer look at each of the five parts.
The quality-management system part of ISO 9001-2000 includes, in addition to general requirements, that a company document what the system is and how it works. In addition, the quality system must be defined in writing in a quality manual. Finally, there must be a control system for documents and records.
The management-responsibility part clearly and specifically assigns the responsibility for creation, implementation, documentation, and improvement of the quality system squarely to an organization's
Table 4.1 Phases of an Animal Experiment to which ISO is Applicable
Check financial and scientific solidity Design outline of study protocol Check legal and ethical aspects Plan, define, and verify requirements "Test substance"
Animals (e.g., housing, feed, destination at end of study) Facilities (e.g., equipment, operating rooms, biohazards) Staff (e.g., number, techniques, trained) Paperwork (e.g., study protocol, instruction, registration) Perform study
Animals: order, receive, verify that specifications are met, house Perform techniques needed (e.g., administration of test substance)
Obtain data and samples (e.g., collection of blood, feces, urine, body weight, observations) Analyze samples and data Write report, paper Archive senior management. This is one of the most significant parts of ISO 9001-2000. Management's commitment to quality, listening to the customer, and planning for quality are included. In addition, a regular, documented review of the quality program, with an eye toward continuous improvement, is required. While all of senior management is identified as responsible, a single person (e.g., a director of animal laboratories or a study director) is identified as the management representative appointed by top management to ensure that the quality-management system is established, implemented, maintained, and improved.
Resource management emphasizes that human resources must be competent and available in sufficient numbers to assure quality work. This part also requires that the facilities, equipment, supporting services, and training programs are sufficient to assure product quality (e.g., healthy animals, humanely cared for and appropriately used animals). The need for an appropriate work environment is also required.
Product realization focuses on the quality of the product and the need to listen carefully to the customer to assure that requirements are well understood. How design decisions are made, reviewed, validated, and controlled is emphasized. The purchase of anything used to produce data, healthy animals, or good animal care is included in this part. Vendor audits must be conducted to help assure that purchased materials meet specifications. The last requirement of this part is for a company to take total responsibility for the quality of its goods and services.
The fifth part is termed Measurement, Analysis, and Improvement. Decisions about processes and goods and services must be made by reviewing adequate data obtained from rigorous measurements and audits. The data is then analyzed to assure continual improvement in all areas. This part also contains the need for a strong corrective and preventative action program. An analogy to fixing a roof may help in understanding this. If a leaking roof is fixed, it is a repair. If the leaking roof is replaced, it is corrective action. If a roof is inspected at appropriate intervals and replaced before it leaks, that is preventative action.
Registering with ISO 9001-2000 is a voluntary process. An organization begins by creating a quality system, a quality manual, and all the processes and systems that assure the quality of its goods and services. One important distinction is that management responsibility in ISO 9001-2000 extends to support groups. In other words, everything purchased is subject to the standard, which in the case of animal care and use programs, would include animals, feed, bedding, caging, etc. An ISO inspection is a rigorous process, entailing such elements as a visit to the facility's boiler room to determine if the building maintenance staff has adequate training and processes and is following specific written procedures.
As noted in the Background section of this chapter, AAALAC International is a nonprofit corporation. Governance of the corporation is through a board of trustees comprised of representatives from scientific, professional, and nonprofit organizations involved with or otherwise interested in the humane care and use of laboratory animals, including the American Association for Laboratory Animal Science, Federation of European Laboratory Animal Science Associations, International Council on Laboratory Animal Science, International Association for Gnotobiology, Federation of American Societies for Experimental Biology, et al. A complete list of these organizations can be found on the AAALAC International Web site.15
Through this structure, the direction and policies followed by AAALAC International are established and driven by the communities to which AAALAC International programs are directed. The founders of AAALAC International recognized that the involvement of end-users of an accreditation program would be beneficial in several ways. First, involving laboratory-animal specialists and other scientists in the process would ensure that AAALAC International programs would be based on scientific principles, with the standards and procedures employed more likely to be based on empirical scientific data and professional judgment. Second, those who would be subject to the accreditation process would be far more likely to be receptive to standards and procedures they had a role in developing.
For practically the entire 37 years of its existence, AAALAC International has relied on the Guide for the Care and Use of Laboratory Animals (Guide)16 as the principal standard against which animal programs are evaluated. This continues to be true in the United States and in countries that do not have at least equivalent standards. For countries with existing laws, regulations, or other standards dealing with research-animal care and use, the Guide serves as an adjunct in areas not covered by national standards. In addition to the Guide, AAALAC International employs a number of resources (referred to as "Reference Resources") in specific areas that provide more detailed information than the Guide, e.g., for agricultural animals, occupational health and safety, euthanasia, and numerous other topics.17 It is important to note that national requirements always serve as the baseline for AAALAC International accreditation, and organizations must be in full compliance with their own national laws, regulations, and policies before they can hope to achieve AAALAC International accreditation.
Similar to the ISO registration process, the AAALAC International accreditation process begins with a form of internal self-assessment. For accreditation, this involves a description of an organization's animal care and use program through completion of a standard outline provided by AAALAC International, and which closely follows the sections of the Guide (see Table 4.2). In 2002, the Guide was available in eight languages, and those seeking accreditation outside the United States may prepare the Program Description (PD) in their native language.
Upon acceptance of the Program Description (and its translation, if necessary) an on-site evaluation by AAALAC International representatives is scheduled. The site-visit team is comprised of at least one member of AAALAC International's Council on Accreditation, along with one or more additional individuals from a group of AAALAC International ad hoc consultants and specialists. The Council on Accreditation is comprised of 32 individuals with knowledge and experience in research-animal care, use, or oversight and are elected by their peers. All are recognized experts active in their fields of endeavor. Ad hoc consultants and specialists are also elected by the Council on Accreditation, and are chosen based on their knowledge, experience, and area of expertise to allow AAALAC International to tailor site-visit teams to meet any special circumstances at the organization seeking accreditation.
The site visit is the first of several levels of peer review in the AAALAC International process. The on-site evaluation begins with a review of the organization's Program Description with appropriate staff, and additional verification that actual practices correspond to their descriptions. Review of records, interviews with personnel, and evaluations of the animal facility, support areas, and research laboratories are also conducted to assess the degree to which AAALAC International standards are met. The site visit concludes with an exit briefing, at which the site visitors provide a summary of their observations and preliminary findings. This also provides the organization with an opportunity to correct mispercep-tions and ensure that there are no errors-in-fact in the site visitors' preliminary findings. Following the site visit, the team prepares a draft report, which is distributed to several other council members for review. This second level of peer review precedes a meeting of the full council (which meets three times a year), at which the council member who led the site visit presents his or her report, along with a
Table 4.2 AAALAC International Program Description Outline
A. Institutional policies and responsibilities
1. Monitoring the care and use of animals
2. Veterinary care
3. Personnel qualifications and training
4. Occupational health and safety of personnel
B. Animal environment, housing, and management
1. Physical environment
2. Behavioral management
4. Population management
C. Veterinary medical care
1. Animal procurement and transportation
2. Preventive medicine
4. Pain, distress, analgesia, and anesthesia
D. Physical plant recommendation for accreditation status. The reviewer's comments are discussed, and the council votes on final accreditation status, completing the third level of peer review.
Organizations are informed of their accreditation status through a letter report that includes commendations, findings, and recommendations. For new applicants, possible outcomes include full accreditation, provisional status, or withhold accreditation. Fully accredited organizations are revisited every three years, and may receive continued, full, deferred continued, or probationary accreditation, or, under extreme circumstances, may receive an Intent to Revoke notice. Any report of status other than full accreditation will include a description of findings that must be corrected before full accreditation can be restored (known as "mandatory items") and any additional suggestions for improvement. Full accreditation reports may also include suggestions for improvement. To maintain accreditation, annual reports are required, and organizations must complete updated Program Descriptions and be revisited every three years.
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