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ISO 17025 Certification Requirements: Explained in Details

Issued by the International Organisation of Standard (ISO), ISO 17025 is the only quality standard for testing and calibration centres all over the world. ISO 17025 certification is the basis for certifying a laboratory that examines and calibrates products or different equipment of any industry. A laboratory that has achieved ISO 17025 certification can assure its clients that it is competent and can provide accurate or foolproof calibration results of their products or equipment.

Before you know what the requirements to get certified are, here is the list of organisations that need it.

• Testing laboratories (privately owned or government-owned);
• Universities and research centres;
• Government centres, regulators and product inspection bodies;
• Product certification organizations;
• Conformity assessment bodies that test products of businesses for industrial compliance.

There are several sets of requirements that a laboratory or centre needs to meet to get certified with ISO 17025. These requirements define the preliminary scope of the standard and provide guidelines for lab professionals that will increase the reliability of their test results.

The key requirements of the standard as explained in its clauses are detailed below.

General Requirements

The general requirements discuss what steps need to be taken by the laboratory to ensure the independence and confidentiality of the test results. The standard makes it essential for the testing labs to take actions or implement practices for identifying and mitigating any risks, such as the faulty testing of the products or falsification of reports. To maintain the confidentiality of the testing reports, the standards set rules for lab professionals to store and handle the reports and release them to the concerned authority.

Structural Requirements

These include some formal conditions that the laboratory needs to fulfill to get certified. The structural requirements specify the legal status of the testing lab, the management structure, range of calibration operations, documentation of the testing procedures, and the minimum number of professionals needed to run the laboratory.

Resource Requirements

The standard specifies the requirements that every resource needs to perform the operations the testing centre has to meet. They include personnel, testing kit, system or equipment, processes, facilities used, and support services that are needed every day. The resource requirements also define the conditions that the laboratory must meet to prove its competence and accuracy in testing. This includes the educational qualifications of personnel, training, experience, and technical skills to conduct tests. Likewise, the suppliers of test equipment, systems, and other facilities are checked and evaluated to ensure their technical competency.

Process Requirements

The ISO 17025 standard also provides a possible and proficient representation of the operational and testing processes for the laboratories. Under the process requirements, it specifies the negotiating terms with tenders, contracts, or suppliers. Secondly, it mentions the suitable calibration methods such as the selection and validation of the testing methods. It also provides a sampling plan and appropriate methods of sampling to be used by the laboratory. Lastly, the standard also specifies ways to handle tested/calibrated items as well as ways to store the technical testing reports.

Bottom Line

Clearly, ISO 17025 certification is not like the other general ISO certification. Applicable only to the testing and calibration organizations, it is the only standard that proves the competency and quality of testing processes, sampling, and calibration and ensures reliable results. As explained above, a laboratory needs to comply with many general and specific requirements. While it is difficult for most laboratories or calibration centres to fulfill all the conditions, professional ISO certification agencies help them get certified by ensuring they comply with the requirements. At Compliancehelp, we can help your testing or calibration lab get certified with ISO 17025. Call us to talk to our experts!

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