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Mandatory Documents Required for 17025 Certification in UAE

The ISO 17025 Standard requires maintaining a set of mandatory documents for compliance. The Quality Management System promotes risk-based thinking.

It emphasizes data management, record-keeping, sample management, easy information recovery and retrieval, quality of testing, etc., to determine the competence of the laboratory.

The documentation of the activities of performing testing and calibration, the procedures, process, latest operations manual, etc., digital and paper-based must be stored in a central repository and must be accessible to the person concerned all the time.

Also, the organization responsibilities of the team or employees in the laboratory and how the documents are created, approved, distributed, used, reviewed, revised, disposed of must be also in the master document.

All internal and external documents, record register, and registry of documents for retention must be kept along with the master documents in the central repository.

The quality policy is the core document that emphasis the service quality and improvement aspect. The Laboratory’s commitment to competence and consistency is stated in the policy.

The objectives listed in the quality policy are measurable short and long-term plans for the laboratory. It is used for planning, monitoring, and assessing the progress of the laboratory. Also, employee awareness is a major aspect of the quality policy.

This documentation is to reduce human error in the laboratory, A Standard operating procedure is prepared and all personnel are provided with competence training and awareness training.

It is aimed at reducing risks involved in laboratory operations and streamline the operations.

The documentation must include the personnel requirements, training delivered, competence evaluation, training needs, continuous improvement practices, and more.

Recording the customer requests, tenders, and contracts is helpful to enhance customer satisfaction. The procedure can include a diagram of the process flow and all activities related to the customer service process can be listed in the procedure template.

 It will help in addressing customer complaints effectively and helps in assessing customer satisfaction levels and take corrective actions accordingly. Customer service is an integral part of a quality management system.

The right test and calibration methods adopted by the laboratory must be documented. It will help in the future to serve the customers better and always to use the correct calibration methods while testing the samples.

The documentation is also in use for detailing the test method development, verification, validation, and performance assessment.

The quality assurance procedure checks on the validation process of all testing and calibration activities.

It includes the use of certified materials and guidelines to conduct test runs on determining the efficiency of the test centers.

ISO 17025 is for use by laboratories in developing their management system for quality, administrative and technical operations. Laboratory customers, regulatory authorities, and accreditation bodies may also use it in confirming or recognizing the competence of laboratories. Qdot provides  ISO 17025 Certification in UAE  Services. and it is not intended to be used as the basis for the certification of laboratories.