ISO/IEC 17025 is the international standard that sets out the general requirements for the capable, impartial, and constant operation of laboratories. It specifies the activities that must be involved in laboratory operations to promote assurance in its capability to produce valid and constantly reliable testing, calibration, and sampling results. Whereas certification according to ISO 9001 or ISO 14001 is recognition that an actual management system is in place, ISO/IEC 17025 contains recognition of the technical capability of laboratories. Accreditation is a formal statement by an Accreditation Body, after assessment and confirmation, that a laboratory is operative in meeting the requirements of ISO 17025 to perform tests according to its accredited scope.
The standard and accreditation are used by independently owned and operated laboratories, as well as those that are part of greater organizations, regardless of the industry and size, which are complex in sampling or measurement activities. This contains regulated government and public sectors, as well as non-regulated sectors.
Mandatory Procedures for ISO/IEC 17025:2017 Documentation:
The ISO 17025 documents have certain requirements as mandatory procedures that must have to define according to ISO 17025:2017 during accreditation audit. Keep in mind that if eliminate some of the clauses from the scope of implementation, then documents for those clauses will not be essential for lab.
- Document and Record Control Procedure:
The documentation of the events of performing testing and calibration, the measures, process, latest operations manual, etc., digital and paper-based essential be stored in a central repository and must be available to the person concerned all the time. Also, the organization responsibilities of the team or staffs in the laboratory and how the documents are created, permitted, distributed, used, revised, disposed of must be also in the principal document. All internal and external documents, record register, and registry of documents for retention must be kept along with the principal documents in the essential repository.
- Quality Policy and Objectives:
The quality policy is the essential document that emphasis the service quality and improvement feature. The Laboratory’s commitment to competence and constancy 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 preparation, monitoring, and assessing the progress of the laboratory. Also, employee awareness is a major part of the quality policy.
- Competence, Training, and Awareness Procedure:
This documentation is to decrease human error in the laboratory, A Standard operating procedure is organized and all personnel are provided with capability training and awareness training. It is intended at decreasing risks involved in laboratory operations and streamline the operations. The documentation must contain the personnel requirements, training distributed, competence evaluation, training needs, constant improvement practices, and more.
- Products and Services Procedures:
All the externally supplied items in use by the laboratory must be appropriate to use and have approved the quality tests. The suppliers must undergo periodic evaluations, monitoring, re-evaluations, etc., to confirm the laboratory equipment’s, consumables, supplies are all good to use.
- Facilities and Environmental Control Procedures:
The environmental situations of the laboratory must be monitored and are to be confirmed whether it is suitable to perform the essential testing and calibrations. Environmental factors essential not adversely affect the validity of test results. Sufficient evidence to the same and all control systems must be in place for effective unbiased testing and generating the sample results.
- Equipment and Calibration Procedure:
The devices in use necessity be checked for the right calibration and must be functioning the correct way. A record of all equipment in use must be kept and the process of handling, transporting, storage, and maintenance of the equipment must be defined and practiced to prevent mal-functioning. Periodic calibration testing and documentation of the measures must be recorded for taking corrective actions in the future.
- Customer Service Procedure:
Recording the customer requests, tenders, and contracts is helpful to improve customer satisfaction. The procedure can include a diagram of the process flow and all activities associated to the customer service process can be listed in the process template. It will help in addressing customer complaints efficiently and helps in assessing customer satisfaction levels and take corrective actions accordingly. Customer service is an essential part of a quality management system.
- Test and Calibration Method Procedure:
The correct test and calibration methods accepted by the laboratory must be documented. It will help in the future to assist the customers better and always to use the right calibration methods while testing the samples. The documentation is also in use for detailing the test method development, verification, validation, and performance assessment.
- Quality Assurance Procedure:
The quality assurance procedure checks on the authentication process of all testing and calibration activities. It contains the use of certified materials and rules to conduct test runs on determining the competence of the test centers.
- Sampling Procedure:
The systematic sampling of a smaller population of materials or parts from the selected space under measured conditions using statistical methods.
- Handling of Items Received for the Testing procedure:
The requirements to guard the integrity of all test and calibration items used for testing or measurement are documented. It is developed to confirm the organizations and the customers are covered and item traceability is prioritized.
- The complaint, Non-Conformity, and Corrective Action Procedure:
All the corrective action and non-conformities and compliances are to be noted in the log. It is an actual way to analyses the causes of a potential fault.
- Testing Report Procedure:
The exact requirements for reporting the test results are documented here. It delivers the control needed to declare the report’s authenticity.
- Calibration Report and Certificate Requirements Procedures:
All the calibration reports and certificates delivered for external and internal use must be organized with the right information as per the supervision of the ISO 17025:2017 standard.
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