ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories. ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.
Why this standard is important
Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 to confirm or recognize the competence of laboratories. The standard promotes confidence in the operation of laboratories.
ISO/IEC 17025 accreditation is the single most important standard for calibration and testing laboratories around the world. ISO 17025 accredited laboratories have demonstrated that they are technically proficient and able to produce precise and accurate test and calibration data.
In most major countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited.
Laboratories that conform to this document will also operate generally in accordance with the principles of ISO 9001.
Faster identification and resolution of issues regarding methods, personnel or equipment, improved customer satisfaction, meeting quality requirements of specialized customers, and overall increased laboratory business are all the result of implementing an effective quality system.
The two main sections in ISO/IEC 17025 are Management Requirements and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements include factors that determine the correctness and reliability of the tests and calibrations performed in laboratory.
Laboratories are required to plan and implement actions to address risks and opportunities. Addressing both risks and opportunities establishes a basis for increasing the effectiveness of the management system, achieving improved results and preventing negative effects. The laboratory is responsible for deciding which risks and opportunities need to be addressed.
Compliance with regulatory and safety requirements (such as OSHA) on the operation of laboratories is not covered by ISO/IEC 17025.
Accreditation: Third party auditing (assessment) of the laboratory is normally carried out by the national organization responsible for accreditation. Laboratories are therefore accredited under ISO/IEC 17025, rather than certified or registered. Accreditation is a voluntary, third party-reviewed process. As part of accreditation, a laboratory's quality management system is thoroughly evaluated on a regular basis to ensure continued technical competence and compliance with ISO/IEC 17025. Laboratory accreditation can only be granted by an accreditation body, or AB. Although there are a number of accreditation bodies in the U.S., customers should choose calibration and testing laboratories accredited by ABs having an MRA with ILAC.
- The ANSI-ASQ National Accreditation Board
- The American Association for Laboratory Accreditation (A2LA)
- Perry Johnson Laboratory Accreditation (PJLA)
- American Industrial Hygiene Association
- International Accreditation Service, Inc. (IAS)
Accredited laboratories usually issue test or calibration reports bearing the accreditation body’s symbol or endorsement as an indication of their accreditation. Clients are encouraged to check with the laboratory as to what specific tests or measurements they are accredited for, and for what ranges or uncertainties. This information is specified in the laboratory’s scope of accreditation, issued by the accreditation body. The description in the scope of accreditation also has advantages for the customers of laboratories in enabling them to find the appropriate laboratory or testing service.
Many accreditation bodies also publish a directory of their accredited laboratories, which includes the laboratories’ contact details plus information on their testing capabilities.
Laboratory accreditation bodies use the ISO 17025 standard for:
- Traceability of measurements and calibrations to national standards
- Technical competence of staff
- Maintenance of test equipment
- Quality assurance of test and calibration data
- Validity and appropriateness of test methods
- Appropriate handling and transportation of test items
- Quality of testing environment and sampling
To ensure continued compliance, accredited laboratories are regularly re-assessed to check that they are maintaining their standard of technical expertise. These laboratories are also required to participate in regular proficiency testing programs as an ongoing demonstration of their competence.
A prerequisite for a laboratory to become accredited is to have a documented quality management system. The usual contents of the quality manual follow the outline of the ISO/IEC 17025 standard.
In common with other ISO quality standards, ISO/IEC 17025 requires continual improvement. Regular internal audits are expected to indicate opportunities to make the test or calibration better than it was. Additionally, the laboratory will be expected to keep abreast of scientific and technological advances in relevant areas.
ILAC & MRA: In order for accreditation bodies to recognize each others' accreditations, the International Laboratory Accreditation Cooperation (ILAC) developed a standard for accreditation bodies: ISO/IEC 17011. ABs having a Mutual Recognition Arrangement (or MRA) with ILAC agree to maintain conformity with the current version of 17011 and to regularly submit themselves and their own quality management systems to peer review. By complying with ISO/IEC 17011, ABs demonstrate that they are capable of accrediting testing and/or calibration laboratories to the ISO/IEC 17025 standard. In essence, the ILAC arrangement guarantees that test results are mutually acceptable between different governmental and regulatory organizations on regional, national and international levels and that these test results meet the same minimum standards for quality regardless of the lab's accreditation body.
Originally known as ISO/ International Electrotechnical Commission (IEC) Guide 25, ISO/IEC 17025 was initially issued by the International Organization for Standardization in 1999. It is the single-most important standard for calibration and testing laboratories around the world. Laboratories that are accredited to this international standard have demonstrated that they are technically competent and able to produce precise and accurate test and/or calibration data.
There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence, and applies directly to those organizations that produce testing and calibration results.
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