The major focus of this content is to emphasize the meaning of ISO 17025 and uses. ISO 17025 is a quality management system and the main standard for testing and calibration laboratories. It can also be said be the standard for which most labs must hold accreditation in order to be deemed technically competent.
The basic role of ISO 17025 is the accreditation purpose. To achieve ISO 17025 accreditation, the laboratory’s quality management system and technical competence is evaluated thoroughly by a third-party. Audits are conducted on a regular basis to maintain accreditation. ISO 17025 accreditation can only be granted by an authorized accreditation body. Accreditation means that the laboratory has met the Management Requirements and Technical Requirements of ISO17025 and is deemed technically competent to produce calibration and testing results.
ISO, which means the international organization for standardization, is a worldwide federation of national standards bodies. ISO is a nongovernmental organization that comprises standards bodies from more than 160 countries, with one standards body representing each member country.
The last version of ISO/IEC 17025 was published in 2005 and, since then, market conditions and technology have changed. The new version covers technical changes, vocabulary and developments in IT techniques. It also takes into consideration the latest version of ISO 9001.
Difference Between 9001 and 17025 is that ISO 17025 and ISO 9001 have disagreeing scopes and the requirements. The requirements for ISO 17025 are specific to testing and calibration laboratories only. Meanwhile, ISO 9001 applies to organizations in all industries.
The Meaning of ISO 17025 and Uses
Having briefly discussed the meaning of ISO 17025 and uses, more attention will be paid to the uses of this very effective platform where the original standard for laboratory calibrations and accreditation are duly considerable. Below are its uses:
- ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world.
- It also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade.
- ISO/IEC 17025 is useful for any organization that performs testing, sampling or calibration and wants reliable results. This includes all types of laboratories, whether they be owned and operated by government, industry or, in fact, any other organization.
- It is also useful to universities, research centers, governments, regulators, inspection bodies, product certification organizations and other conformity assessment bodies with the need to do testing, sampling or calibration
- It enables a hierarchical order and clear job responsibilities for all the employees. Procedures and policies that the laboratory establishes will determine which actions are required from the personnel. They will follow established procedures, policies and work rules, and will fulfil the company’s expectations.
- ISO 17025 allows accredited laboratories to determine whether they are performing their work correctly and to appropriate standards and provides them with a benchmark for maintaining that competence.
Accreditation Standards for Laboratories on ISO 17025
- 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
Basic Features of ISO 17025
- Scope – Discusses the objective of the standard, who can use it, and what ISO 17025 is for
- Normative References – Highlights brief details on how certain guides and standards are referenced in ISO 17025
- Terms and Definitions – Defines the terminology used in the standard
- General Requirements – Covers the two main requirements of the standard which are:
- Impartiality (laboratories won’t let any commercial, financial, or other pressuring factors manipulate, compromise, or alter the quality of the testing results)
- Confidentiality (laboratories are required to ensure that the results and other key information are kept private)
- Structural Requirements – Outlines a laboratory’s basic organizational structure and components, its processes, and its adherence to an efficient management system
- Resource Requirements – Contains the 6 clauses that specify the necessary components a laboratory must have:
- General
- Personnel
- Facilities and environmental conditions
- Equipment
- Metrological traceability
- Externally provided products and services
- Process Requirements – Details the 11 key processes on how to improve and implement the efficiency of the standard’s requirements:
- Review of requests, tenders, and contracts
- Selection, verification, and validation of methods
- Sampling
- Handling of test or calibration items
- Technical records
- Evaluation of measurement uncertainty
- Ensuring the validity of results
- Reporting of results
- Complaints
- Nonconforming work
- Control of data and information management
- Management System Requirements – Emphasizes the two options available for organizations complying with the standard, the differences between the two, and the various activities involved in this section:
- Options
- Option A – Applies to laboratories that have separate QMS from any other management system
- Option B – Applies to laboratories that are part of larger organizations or if they have their own established management systems aligned with ISO 9001:2015
- Management system documentation
- Control of management system documents
- Control of records
- Actions to address risks and opportunities
- Improvement
- Corrective actions
- Internal audits
- Management reviews
- Options
