What are the ISO/IEC 17025 Measurement Techniques and It’s Significance?

How does ISO/IEC 17025 help to enhance laboratory testing? Today’s industry research and development greatly depends on accurate measurement. Modern laboratories must make use of top-notch measurement apparatus to be able to achieve that criterion. The laboratory must take an organised approach to the measuring process to get the right measurement result.

The numerous activities that might influence a measurement result are amply illustrated by the process approach to this subject. Mapping the procedures and activities involved in the measurement test should be the first step in any test you want to get accredited for. Then, take a look at the risks to decide which controls need to be implemented.

• Competence management for personnel
• Control of procedures’ documentation
• Technically sound records
• Suitable infrastructure and circumstances
• Appropriate, calibrated machinery
• Authenticated references
• Appropriate reagents
• The best test procedure
• Verified techniques
• Correct collection of samples

Determining Measurement Techniques

The laboratory must choose suitable methodologies and working practices that outline the performance standards and correct care for measuring instruments. Two possibilities exist for such procedures:

• Internal measurement process. If a laboratory has created its measurement procedure, it must validate it first to show that it is appropriate, then show that it is pertinent, and ultimately show that the findings of the measurement are accurate and of high quality. All subsequent steps taken during the measurement process must be clearly defined, the risks must be understood and managed, and reproducibility must be established. The laboratory must demonstrate its capacity to explain and prove measurement accuracy during this method process for it to give a verified performance that fulfils the expectations of the customers.
• A process that conforms to the specifications of a determining standard that is specifically applicable. A technique needs to be assessed, tested, and applied for new clients while adhering to a particular measurement standard. It must include instructions on how to handle equipment for staff as well as performance standards. The process must be repeatable for new clients, cover all components of the equipment, take environmental factors into account, and take volatility into account. Mathematical computations and extra evaluations for potential quality improvement, revaluation, or customer complaints must also be included.

ISO/IEC 17025 Compliance

Accuracy in the measurement results and conformity in the measuring methods are brought about by monitoring the total process and controlling the actions. Laboratories need to hire qualified employees and develop a control system. The intended performance of the procedure to provide an accurate measurement result is ensured by operation complying with procedural ISO 17025 documents and proper use of the measuring equipment.

The Significance of The Measurement Techniques

Technical records kept by laboratories should show that measurement processes are under control, enabling traceability and unbiased proof of compliance. Adhering to a controlled, proven approach guarantees quality and dependability and reassures regulatory bodies and clients. If variations happen, the lab must look into them and fix the problem, whether it was brought on by faulty machinery, worker inattention, or erroneous direction.

Mandatory Procedures Required for ISO/IEC 17025 Accreditation of Testing and Calibration Laboratories

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.