For many years, regulatory authorities and professional bodies conducted assessments of laboratory competence to give assurance about the calibration and test data they provided. Concerted efforts have been made internationally by laboratory accreditation experts to harmonize assessment activities through the International Laboratory Accreditation Cooperation (ILAC) and the International Organization for Standardization (ISO). Accreditation involves the assessment of the systems and methods used by a laboratory to ensure that it is competent to perform specific tests or calibrations.
ILAC, which was formed in 1977, oversaw efforts to harmonize disparate accreditation criteria and these efforts culminated with the ILAC Arrangement, a mutual recognition arrangement. The agreement was signed at meetings held in conjunction with the ILAC 2000 Conference in Washington, D.C., in November. In all, 36 laboratory accreditation bodies from 28 economies worldwide signed the document. The objectives of such laboratory assessment schemes include:
Unify laboratory accreditation schemes.
Grant formal recognition to laboratories with proven capability and competence in specific fields.
Reduce and eventually eliminate the practice of multiple assessments.
Upgrade the status and standards of laboratories.
Promote the worldwide acceptance of calibration and other tests performed by accredited laboratories.
Enhance the quality, safety, acceptability and reputation of goods in domestic and overseas markets.
Help protect the product manufac-turer or supplier against potential liability.
ISO/IEC 17025 replaces Guide 25
The ILAC Arrangement, which went into effect Jan. 31, means that a product tested in one country by a laboratory accredited for conformance with ISO/IEC 17025: 1999, General Requirements for the Competence of Testing and Calibration Laboratories, will be accepted and promoted by the other 35 signatories in their home countries. For companies and other organizations that export products that are subject to testing, this is a major step toward reducing or eliminating the need for retesting of products when they arrive in an importing country.
"The ILAC Arrangement will provide a technical underpinning to international trade by promoting cross-border stakeholder confidence and acceptance of accredited laboratory data," said Peter S. Unger, president of the American Association for Laboratory Accreditation (A2LA) and chairman of the ILAC Arrangement Management Committee. "Until now, there has been no international mutual recognition agreement in lab accreditation, which has been a hindrance for some types of international trade."
The agreement is based on ILAC's recommended implementation of ISO/IEC 17025, the successor to ISO/IEC Guide 25: 1990. Laboratories accredited to Guide 25 must be operating under the new standard by the end of 2002. The use of ISO/IEC 17025 is the basis for laboratory accreditation and eliminates the use of several standards and guides in the marketplace. The differences between the two documents align the new standard with the ISO 9000 series equipments and further clarify the technical requirement of the standard.
Until ISO/IEC 17025 was finalized, the United States and several other countries accepted the use of Guide 25, but only to a limited degree. At the same time, the European Union (EU) and other countries made use of a European Norm (EN) or individual accreditation body standards that provided calibration and testing laboratory competency requirements. National standards were applied in a few other countries, which made acceptance of laboratory results more difficult when products moved between countries in which different standards or guides were used.
The adoption of ISO/IEC 17025 as an EN standard by EU member states in 1999 was a major development toward an international arrangement. Support is growing for the United States to adopt ISO/IEC 17025 in the United States as an American National Standard. The U.S. proposal is likely to receive approval, particularly after the signing of the ILAC Arrangement by three U.S. accreditation bodies.
The ILAC Arrangement builds upon existing or developing regional arrangements established in North and South America, the Asia-Pacific region, Europe and Southern Africa. The bodies participating in these regional arrangements are responsible for maintaining the necessary confidence in accreditation bodies from their region that are signatories to the ILAC Arrangement.
"There is now a firm foundation in place for manufacturers and exporters that have their goods tested by accredited laboratories to enjoy greater market access, lower costs associated with retesting and greater overall competitiveness in global markets," said Mike Peet, chief executive officer of the South African National Accreditation System and chair of the ILAC committee that developed the Arrangement.
Another important step that is already underway involves government acceptance of the results from accredited laboratories. "Regulatory agencies around the world, including those in the United States, are beginning to accept the results from testing and calibration laboratories that are accredited by bodies such as the ILAC members without direct government review, including results from labs in other countries," said Jeffrey Horlick, a physicist with the National Voluntary Laboratory Accreditation Program (NVLAP) at NIST. For example, Australian and New Zealand regulatory agencies accept results from laboratories accredited by NVLAP, he said.
The 36 signatories are all members of ILAC, which is made up of accreditation bodies that have been peer reviewed and meet ILAC's criteria for competence. A goal is to have all ILAC members become signatories to the arrangement, as well as to provide outreach to those bodies that are in the process of becoming ILAC members.
Accreditation vs. registration
As part of the ISO 9000 series, ISO 9001 contains requirements for calibration, inspection and testing. Registration to ISO 9001 or ISO 9002 provides confidence that these activities are adequately controlled. The fundamental difference with laboratory accreditation is the emphasis placed on the competence of the work carried out as opposed to compliance with procedures. The degree of confidence that management and customers have in the results produced by a laboratory accredited to ISO/IEC 17025 or Guide 25 is significantly enhanced.
The structure of a laboratory accreditation process is somewhat different than for ISO 9001 or ISO 9002 registration. Quality systems are registered to ISO 9001 or ISO 9002 by accredited registrars adhering to ISO/IEC Guide 62 who receive their authority from quality system accreditation bodies operating to ISO/IEC Guide 61.
Testing and calibration laboratories are accredited to ISO/IEC 17025 by laboratory accreditation bodies operating to ISO/IEC Guide 58 such as the A2LA and NVLAP. Many organizations pursue both ISO 9001 and ISO 9002 registration and the accreditation of their laboratory operations to enhance their reputation and control of calibration and other testing activities or to comply with specific customer, regulatory or quality system requirements such as QS-9000.
Laboratory accreditation assessments also frequently require participation in laboratory proficiency testing schemes to ensure the reliability and consistency of results obtained by accredited laboratories.
The Registrar Accreditation Board (RAB) Advisory No. 1 (1999-04-15) allows organizations that perform calibration and testing to be registered to ISO 9001 and ISO 9002 but imposes stringent conditions. These conditions require the registrar to inform the company that is applying that ISO 9001 and ISO 9002 registration is not the same as accreditation by a recognized laboratory accreditor and the registration certificate will not reference ISO/IEC Guide 25.
Scopes of accreditation
The scope to which laboratories are accredited is more precisely defined than for ISO 9001 or ISO 9002 registration. This is to ensure that the areas accredited are clearly and completely defined, providing a basis for reference for potential customers.
Generally, these scopes are defined in accordance with ILAC Guide 4, which specifies the following:
For testing laboratories, in addition to referencing the general field of testing covered under the Arrangement's scope, the laboratories must identify:
- Groups of products, materials or items tested.
- Specific tests or types of test performed.
- Specification, standard (method) or technique used.
For calibration laboratories, in addition to referencing the general field of calibration such as electrical, dimensional, mass and radiometry, the laboratories must identify:
- Measuring instrument, type of instrument, measuring system, items or reference materials measured or calibrated.
- Specific calibrations performed, meaning the properties or quantities measured.
- Specification, where available, as well as the standard method or technique used.
- Specific ranges of measurement recognized.
- Best measurement capability recognized, expressed as an uncertainty, and the appropriate confidence level.
Individual accreditation bodies may specify its own requirements in terms of the presentation and specific content of laboratory scopes.
Some sector-specific quality system requirements based on ISO 9001, such as QS-9000 and ISO/TS 16949 in the automotive sector, specify the use of laboratories accredited to Guide 25 or ISO/IEC 17025.
Requirements of ISO/IEC 17025
Although ISO/IEC 17025 includes many of the criteria contained in ISO 9001: 1994, it has been specifically prepared with calibration and testing laboratories in mind. More emphasis is placed on quality system elements and technical competence issues that pertain to laboratory operation, such as:
- Measurement traceability and uncertainty of measurement.
- Organization of the laboratory.
- Staff qualifications.
- Key personnel.
- Approved signatories.
- Handling of calibration and test items.
- Reporting of results.
Accreditation to ISO/IEC 17025 is far more competency based than ISO 9001 or ISO 9002 registration. The team of auditors that perform laboratory accreditation assessments is required to include specialists who have a high degree of technical knowledge of the fields of calibration or testing being audited. They may comment on the appropriateness of labora-tory methods and controls, competence of personnel and the validity of results obtained. Indeed, the award of accreditation is linked to key laboratory personnel and, in certain circumstances, the use of particular technicians.
While there are many similarities between ISO 9001 and ISO/IEC 17025, the latter contains many noticeable differences, including:
- More prescriptive organizational requirements in terms of independence and bias, nomination of technical and quality management personnel and supervision of staff.
- Provision for the protection of a customer's confidential information and proprietary rights.
- Greater specificity in the areas of reviews and performance of quality control methodologies to ensure the consistency of calibration and testing.
- Emphasis on laboratory accommodation and the environment in which testing or calibration is performed, including housekeeping, segregation of incompatible areas, maintenance of equipment and reference materials and in the specific records required.
- Measurement traceability and calibration is given a high profile, especially in traceability to national and international standards of measurement and the determination of measurement uncertainty.
- Calibration and test methods are required to be developed and validated and specific requirements are given for handling, identification and storage of items and their ultimate disposal.
- Specifics about the data to be included on test and calibration reports, as this represents the fundamental data to be used by the customer.
- The subcontracting of tests and calibrations is subject to stringent controls to ensure the correct performance of work and the reporting of results.
Companies using calibration and testing services, whether it is regulatory bodies, commercial customers or consumers, require confidence in the results provided to them. Rarely does the client of laboratory services have the technical ability or the resources to assess the competence of the services provided and must trust the provider of the service to do the work in a professional and competent manner.
The agreement of an international standard defining laboratory management and technical requirements, coupled with agreed mechanisms for assessing laboratory competence worldwide, represents a major step forward in support of the global economy.