ISO 17025 standard
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
Standard ISO 17025 General Requirements for Accreditation of Testing and Calibration Laboratories.
This standard is one of the most important basic standards and an international reference for laboratories; the latest version was updated and published by the International Organization for Standardization (ISO) and the International Electrotechnical Committee (IEC) in 2017.
Standard 17025 is specific to testing and calibration laboratories, which confirms the qualifications of these laboratories. And it applies to all laboratories that perform testing and calibration tests.
This standard guarantees that the laboratories that include this certificate are designed based on a strong and quality-based management system and provide their services with the best quality to their customers.
The new edition of the ISO 17025 standard includes the following requirements:
- General requirements
- Structural requirements
- Resource requirements
- Process requirements
- Management system requirements
In this part of the ISO 17025 standard, the two factors of neutrality and confidentiality are examined. And this part ensures that the laboratory is neutral and responsible for all the information obtained during the operation of the laboratory and keeps all the information confidential.
This section emphasizes the legal and structural status of the laboratory. The laboratory must be a legal entity or a specific part of a legal entity. The scope of all laboratory activities, organizational structure, responsibilities, and employee relations affecting the laboratory activities are specified, and laboratories document the method.
Resource requirements section to ensure the availability of staff, equipment, facilities, and all support services to manage and carry out all planned laboratory activities.
This section describes other methods for reviewing applications, tenders, and contracts. This clause includes customer requests, the decision rule, and the difference between tenders and requests that must be applied to customers before any other laboratory activity. This process ensures that the laboratory uses appropriate methods and procedures. Also, the laboratory will ensure that it uses the latest valid method version. The process requirements section emphasizes that the laboratory must have a specific plan and method for sampling materials or products during testing or calibration.
Management system requirements:
This department currently offers two options (a. Web) to create a management system. In addition to meeting the previous requirements (parts 4 to 7 of the standard), the laboratory must establish a management system that can support and prove the sustainable achievement of the requirements of this standard and guarantee the quality of the laboratory results.
Option ‘a expresses a set of minimum requirements for the laboratory to create a management system.
The minimum requirements for the implementation of the management system, according to choice ‘A’, are as follows:
– Documenting the management system
-Management system documentation control
– Records control
– Actions to eliminate threats and opportunities
– Internal audits
– Management reviews
Option ‘b’ provides and maintains a management system following the requirements of ISO 9001. As a laboratory has already implemented ISO 9001, option ‘b’ may allow more flexibility in implementing ISO/IEC 17025. : 2017 to create for it.