ISO 17025 is the international standard for testing and calibration laboratories. It's a set of requirements those laboratories use to show that they operate a quality management system and that they're technically competent to do the work that they do.
The standard is set out in five clauses:
- Normative References.
- Terms and Definitions.
- Management Requirements.
- Technical Requirements.
The main clauses of ISO/IEC 17025:2017
The 2017 version of the ISO/IEC 17025 standard, includes the following requirements:
General requirements: This clause highlights two main elements: impartiality and confidentiality. This clause ensures that the laboratory is committed to impartiality and that the risks related to impartiality are identified on a continuous basis.
Structural requirements: This clause emphasizes the legal status of the laboratory, the structure of the laboratory, the identification of the personnel and the management, as well as the availability of the personnel responsible for implementing and maintaining the integrity of the management system.
Resource requirements: This clause establishes the need for laboratories to ensure the availability of personnel, facilities, equipment, systems and support services required for the smooth performance/operations and management of all its activities.
Process requirements: This clause represents the procedures and other methods for the review of requests, tenders, and contracts. The clause covers the requests of the customers, the decision rule and the differences between tenders and requests that should be applicable to customers before any other laboratory activity takes place.
Management system requirements: This clause now provides two distinct options (Option A and Option B) for establishing a management system.
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. In most 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. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the International Organization for Standardization in 1999.
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 and is based on somewhat more technical principles.
Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body.
Benefits of ISO 17025
- By adopting or implementing the ISO/IEC 17025 standard requirements and achieving accreditation, a laboratory will gain national and international recognition, thereby making it easier for customers to readily identify and select reliable laboratories;
- By choosing an accredited laboratory, clients will experience reduction in the costs of re-testing their products;
- By complying with the requirements of the ISO/IEC 17025 standard, the laboratory will have a better control over its activities;
- When performing testing/calibration services, the laboratory managers/technicians will be able to access better and updated technologies, which will increase the confidence in generating valid results;
- An accredited laboratory will experience an increase in revenues and profits due to the laboratory°«s proficient capability to provide reliable and technically valid results;
- The laboratory will ensure the validity of standard, non-standard and laboratory developed test methods which impact the provision of reliable data to their clients.
The implementation methodology
Dynamic Strategies has developed a methodology for implementing a management system so as to ensure that all certification/accreditation and standard requirements are captured, thus aiding step-by-step systematic deployment and use. It is called the °»Integrated Implementation Methodology for Management Systems and Standards (IMS2)°… and it is based on international best practices. This methodology is based on the guidelines specified in ISO standards, which also meets the requirements of ISO/IEC 17025:2017.