The ISO 17025 standard is internationally recognized as the main quality standard for calibration and testing laboratories. Obtaining ISO 17025 accreditation not only raises the laboratory’s operational standard, it also assures customers and stakeholders that test results are accurate and reliable. In this article, we will explore in detail the steps required for a laboratory to become ISO 17025 accredited laboratory, covering everything from basic concepts to practical implementation and maintenance of accreditation.
1. Understanding ISO 17025
ISO 17025 was established by the International Organization for Standardization (ISO) and addresses two main components: management and technical competence. The aim of the standard is to ensure that laboratories operate competently and are capable of generating technically valid results.
2. Management Requirements
Management requirements include aspects such as confidentiality, integrity and impartiality in the conduct of tests. This implies:
- Adequate documentation : Maintain all procedures and policies documented in accordance with the standard guidelines.
- Quality management system : Implement a system that covers all laboratory processes, from customer service to the final test report.
- Contract review : Evaluate and ensure that test requirements are well understood and agreed with the customer prior to execution.
3. Technical requirements
These requirements ensure that the laboratory is equipped to perform tests competently and include:
- Personnel Competence : All operators, technicians and scientists must be adequately qualified and continuously trained.
- Suitable environment : Environmental conditions must be controlled to ensure the integrity of the tests.
- Equipment and calibration : Instruments must be calibrated and maintained in ideal conditions to carry out the tests.
4. The Accreditation Process
To be accredited, a laboratory must follow a detailed process, which includes:
- Self-assessment : The laboratory must carry out an internal assessment to verify that it meets all ISO 17025 requirements.
- Choosing an accreditation body : Select a recognized accreditation body that will assess compliance with the standard.
- Document preparation and submission : Submit all necessary documents proving compliance with the standard to the accreditation body.
- Initial audit : Receive auditors from the accreditation body for an on-site assessment, where all processes and procedures will be verified.
5. Maintenance of Accreditation
After initial accreditation, the laboratory must maintain its compliance with the standard through:
- Follow-up audits : Regularly, the accreditation body will carry out audits to ensure that the laboratory continues to meet standards.
- Continuous improvement : Implement a continuous improvement process to improve quality and technical management systems.
Conclusion
ISO 17025 accreditation not only reinforces a laboratory’s competence in performing tests and calibrations reliably, but also provides an important competitive differentiator in the market. Although the accreditation process can be demanding, the long-term benefits to laboratory operation and reputation are significant. With proper preparation and commitment to quality standards, any laboratory can achieve and maintain this prestigious accreditation.
This guide provides a comprehensive overview of the process and steps involved in obtaining and maintaining ISO 17025 accreditation, essential for laboratories that want to not only improve their operations, but also ensure confidence in their test and calibration results.
