December 12, 2019
Different analytical testing laboratories often produce different test results for a given sample due to a variation in staff competency, equipment used, and Standard Operating Procedures (SOPs) followed while performing the test. These variations are due to the use of uncalibrated and unmaintained instruments, laboratory environmental factors, and the competence level of a laboratory technician conducting a test. Another reason for this variation is the fabrication of potency reports to increase retail value. This is often done by manipulating sampling procedures and test results. Well, there can be countless factors contributing to the inconsistency and inaccuracy of test results and the decisions derived from them!
So, are there any regulations that a testing laboratory can follow to ensure consumer safety and product quality?
ISO/IEC 17025 is one such regulation that includes a list of requirements for testing laboratories. Testing laboratories need to get accredited to ISO/IEC 17025 to demonstrate their technical competency and to ensure the accuracy of the test results. In this article, we'll highlight the significance of ISO/IEC 17025 accreditation for your laboratory.
Firstly, ISO/IEC 17025 is one of the most significant accreditations for all types of laboratories, universities, and research centers performing tests and calibration. ISO/IEC 17025 includes management and technical requirements that enable a testing or calibration laboratory to claim their technical competency. Secondly, having accreditation by regulatory bodies certifies that the results are consistent and accurate and are generated using industry-standard protocols.
ISO/IEC 17025 is an international standard for continuous improvement and self-correction. A laboratory that complies with ISO/IEC 17025 benefits in the following ways:
It enhances the reliability of test results generated by the laboratory
It can establish technical competency in the event of a speculation and/or legitimacy issues
The efficiency of the laboratory increases, customer complaints are reduced, the laboratory gains a strong competitive edge, and the operational expenditure is reduced
The regulation facilitates traceability of measurements and calibrations to optimum standards, establishes technical competency of staff, maintains a record of test equipment, ensures the accuracy of test results, validity and correctness of test and calibration methods, appropriate handling and movement of test items, and the quality of the testing environment and sampling
It is crucial to keep track of revisions and changes in the standard and prepare your laboratory to comply.
ISO/IEC 17025 was revised due to an increase in error instances and data inaccuracy. ISO/IEC 17025 has had two revisions so far, it was first revised in 2005 and then in 2017 to stay up-to-date with the industry and to follow the ISO 9001:2015 standard as closely as possible.
ISO/IEC 17025 was updated to accommodate the latest changes in the laboratory environment and work practices. The latest updates to ISO/IEC 17025 include a new chapter on risk-based thinking, control of nonconforming testing and calibration work, the addition of new terminologies, incorporation of computer systems and control of data, and the scope to cover testing, calibration, and sampling as well. The process approach now matches new standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1 (which states the requirements for auditing and certification bodies).
The ISO 17025 standard is vast and complex and thus, requires a thorough understanding, and training for following its guidelines. Since the objective is to standardize processes of all testing laboratories and to ensure the validity of the data generated, conducting regular internal audits to prepare a laboratory for third-party assessments turns out to be a major challenge. Additionally, finding a dependable and unified software solution that helps fulfill the regulatory requirements is challenging as well.
Implementing a Laboratory Information Management System (LIMS) that helps your laboratory to meet ISO/IEC 17025 guidelines and other state and local regulations is imperative. A LIMS not only enables you to meet the management and technical requirements of ISO/IEC 17025 but also helps your laboratory meet other regulatory guidelines, such as ISO 9001:2015, GLP/GALP, and 21 CFR Part 11.
The main reason behind implementing a LIMS is that it becomes your one-stop, dependable system with functionalities that enable your lab to follow all the guidelines laid out under the ISO 17025 regulation. The regulation’s requirements are divided into two parts, Management and Technical. Management requirements refer to the laboratory's operation and effectiveness of the quality management system. These include specifications for control of records, document control, internal audits for every step performed in the laboratory, organizational structure, review of the test orders received from clients, and purchase of services and supplies such as reagents, consumables, etc. Technical requirements address the competence of staff, sampling, and testing methods used, types of equipment, quality, and reporting of test and calibration results. It is only because of its seamless application and multi-facet abilities to fulfill all these requirements that you need to implement a LIMS in your laboratory.
Thus, ISO/IEC 17025 is by far the primary international standard for establishing laboratory competence and quality. It also facilitates cooperation between testing laboratories and other bodies by establishing wider acceptance of results between countries and organizations. Test reports and Certificates of Analysis (CoA) can be accepted by organizations present in different countries without the need for further testing, which leads to better international trade. Furthermore, achieving ISO/IEC 17025 accreditation might be challenging at times, but one can always utilize the right training and tools (for example, a LIMS) to win over the obstacles and reap the benefits of being an ISO 17025 accredited laboratory.