After discussing over the past month food safety and quality management through posts about international standards and ISO standards, we will today present the ISO 17025.
This standard sets skill requirements for testing and calibration laboratories. The compliance to this ISO norm increases data quality and the efficiency of testing laboratories. The certification also serves as basis for the establishment and the compliance to other quality systems such as the GMP or the ISO 9001.
Basis and structure of the ISO 17025 standard
The standard is divided into two large parts: management requirements and technical requirements.
- Management requirements are mainly based on the ISO 9001 norm and depict the business and the quality management system efficiency.
- Technical requirements are more focused on the employee skills, testing methods and equipments used.
The norm also contains guidelines regarding training, documentation handling, management of test tools, validation and internal auditors.
Structure of the ISO 17025
The ISO 17025 standard is structured as following:
- Normative references
- Terms and definitions
- General requirements
- Structural requirements
- Resource requirements
6.3 Laboratory facilities and environmental conditions
6.5 Metrological traceability
6.6 Externally provided products and services
- Process requirements
7.1 Review of requests, tenders and contracts
7.2 Selection, verification and validation of methods
7.4 Handling of test or calibration items
7.5 Technical records
7.6 Evaluation of measurement uncertainty
7.7 Assuring the quality of results
7.8 Reporting of results
7.10 Management of nonconforming work
7.11 Control of data Information management
- Management requirements
8.2 Management system documentation (Option A)
8.3 Control of management system documents (Option A)
8.4 Control of records (Option A)
8.5 Actions to address risks and opportunities (Option A)
8.6 Improvement (Option A)
8.7 Corrective action (Option A)
8.8 Internal audits (Option A)
8.9 Management reviews (Option A)
Testing and accreditation
The content of the ISO standard consists in regular testing through internal audit. The standard requires a complete documentation of every operational processes concerned by the norm. Once the internal audit has been made, the results will be evaluated to develop corrective actions.
In most cases, the implementation of an ISO standard leads to the accreditation of the testing and calibration laboratory. With the official accreditation, the test results of this laboratory will be internationally recognized and increase the credibility and the quality of the laboratory.
The accreditation is operated by national accreditation body and occurs through questionnaires checking the complete compliance to the ISO standard requirements.
To help you prepare the accreditation, you can find here the requirements for accrediation of ISO 17025 Laboratories in the US.
Background information and revisions of the ISO 17025 Standard
The norm for testing and calibration of laboratories was first developed in 1999 by the ISO - International Organisation for Standardization. Since then, the standard has been revised once in 2005 but with few modifications. The norm is currently being revised again and will add critical improvements regarding the impartiality of laboratories, data safety and strong processes orientation. It will also be closely bound to the ISO 9001 standard.
Read more about the coming revisions of the ISO 17025 standard:
- Official website of the International Organization for Standardization
- Official website of the International Laboratory Accreditation Cooperation
You can find here further information regarding the information interpretation of accreditation criteria for specific applications.
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