The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) collaborated to create the international standard ISO 17025, which specifies the requirements that testing and calibration laboratories must meet. Additionally, this standard specifies the criteria that testing and calibration facilities must meet, aiding in the harmonization of quality standards. Any organization that does testing, sampling, or calibration and needs trustworthy results of any size and type will find ISO/IEC 17025 useful. All sorts of laboratories are covered by ISO 17025, whether they are run by the government, business, or any other organization. Universities, research institutions, government laboratories, inspection agencies, product certification agencies, and other conformity assessment bodies that need to conduct testing, sampling, or calibration should also be aware of the ISO 17025 standard. The audit checklist is the most useful tool for determining if the system has been set up correctly or not. Here are a few of the essential elements that the ISO 17025 audit checklist has to have.
- Quality Management System (QMS): An efficient Quality Management System is the cornerstone of any ISO 17025-compliant laboratory. The audit should determine whether the laboratory’s QMS is adequately documented, implemented, and updated as needed.
- Personnel Competence: To make sure lab staff have the ability to complete their assigned responsibilities correctly, auditors should carefully examine their credentials, ISO 17025 auditor training records, and experience.
- Equipment Calibration and Maintenance: The laboratory’s equipment must be calibrated and maintained regularly to ensure the accuracy and reliability of the test and calibration results. The ISO 17025 audit checklist should verify that all equipment meets the necessary calibration standards.
- Test and Calibration Methods: The test and calibration procedures used in laboratories must be validated and properly documented in ISO 17025 Documents. The audit should verify that these procedures are consistently followed and suitable for the intended application.
- Measurement Traceability: The audit must confirm that the laboratory can prove that measurements can be traced back to regional, national, or even global standards, giving the capacity to trust that the outcomes are accurate.
- Sampling and Handling of Test Items: To avoid contaminating or degrading samples, laboratories should have established processes for handling and storing samples. The use of the checklist should confirm that these procedures are strictly followed.
- Environment and Facilities: The laboratory’s environment should be suitable for conducting tests and calibrations. The audit should examine factors such as temperature control, cleanliness, and adequate space for different activities.
- Reporting of Results: The reporting guidelines for the laboratory should be precise, thorough, and timely. Auditors must make sure that clients are given clear and accurate results communication.
- Non-Conformities and Corrective Actions: There should be a procedure in place in the laboratory to quickly identify and correct non-conformities. The effectiveness of the laboratory’s corrective measures should be evaluated during the audit.
- Management Reviews and Internal Audits: Internal audits are crucial for maintaining ISO 17025 compliance. The audit checklist requires to confirm that the laboratory regularly carries out internal audits and management reviews to evaluate the efficacy of its QMS.
In light of this, an ISO 17025 audit checklist is a useful tool for identifying areas that require improvement and can be used in advance of external or internal audits to help show clients and stakeholders that a business complies with ISO standards. outlines the requirements for sample handling, processing, and selection. definitions are given for important terminology used in the standard. discusses the physical infrastructure, machinery, and ambient factors that a laboratory needs to do accurate testing and calibration. The audit checklist can also be used to satisfy the need for managing assessments of the laboratory’s quality system, among many other advantages.