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ISO 17025 is an international standard that specifies the general requirements for the competence of testing and calibration laboratories. It provides a framework for laboratories to demonstrate their ability to produce precise and accurate results. This article explores the five key requirements of ISO 17025.
The first requirement of ISO 17025 is the establishment and implementation of a quality management system. This includes documented policies, procedures, and records to ensure consistency and control of laboratory operations. Management must also provide resources, training, and support to foster a culture of quality and continuous improvement within the laboratory.
Another key management requirement is the appointment of a laboratory manager who has the authority and responsibility to oversee all activities. The manager should have sufficient technical knowledge and experience to effectively manage laboratory personnel, equipment, and processes. Additionally, the laboratory must establish a clear organizational structure and define the roles and responsibilities of all personnel.
ISO 17025 emphasizes the importance of technical competence in laboratories. This includes having appropriate equipment, facilities, and trained staff to perform tests and calibrations. The laboratory must ensure that its equipment is properly calibrated and validated to provide accurate and reliable results. They should also have procedures in place for the maintenance, handling, and storage of all equipment and samples.
Another technical requirement is the use of validated test methods and procedures. These methods must be suitable for the intended purpose and produce valid and reliable results. The laboratory must establish and maintain detailed procedures for each test and calibration carried out, including sample preparation, handling, and analysis. They must also document any deviations or modifications made to the standard methods.
Quality Assurance Requirements
ISO 17025 requires laboratories to establish a comprehensive quality assurance program. This includes regular internal audits to monitor compliance with documented procedures and identify areas for improvement. The laboratory must also participate in external proficiency testing programs and ensure that its results are comparable to those of other laboratories.
Document control is another important aspect of quality assurance. The laboratory must maintain up-to-date and controlled documents, including test methods, procedures, and records. These documents should be easily accessible and protected from unauthorized changes or alterations.
The final requirement of ISO 17025 relates to reporting. The laboratory must ensure that all results are accurately recorded and reported. This includes proper documentation of test or calibration results, uncertainties, and any decision rules applied. The laboratory should also have procedures in place to handle non-conforming work and address customer complaints or feedback.
Additionally, the laboratory must maintain confidentiality and impartiality in its reporting. They should have policies in place to prevent conflicts of interest and ensure that their results are not influenced by external factors.
In conclusion, ISO 17025 sets out five key requirements for testing and calibration laboratories: management, technical competence, quality assurance, and reporting. By adhering to these requirements, laboratories can demonstrate their ability to produce reliable and accurate results, instilling confidence in their services.
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