This blog will give you an introduction into the basics of ISO 17025 and just some of the requirements which LIMS can help with.
What is ISO 18025?
ISO 17025 is a laboratory accreditation standard that all testing and calibration laboratories vie to achieve to prove their technical competence in performing an array of testing, calibration and measurements for standard, non-standard and laboratory-developed methods.
As the accreditation is almost entirely lab-centric, it comes as a no-brainer that a Laboratory and Information Management System (LIMS) has an important role to play. The central idea of ISO 17025 is recording everything that happens in the lab in terms of technical quality; as such traditional record-keeping methods like Excel, Access DB and paper do not ‘cut-it’ anymore. While for a LIMS this is part of its basic core functionality.
Why do you need accreditation in the first place?
To ensure quality of course! An ISO 17025 accreditation helps labs to improve their reputation among current and prospective clients, gain a competitive advantage, meet international compliance standards and ultimately reduce costs. With such an accreditation in place your lab is effectively providing prospective clients with the assurance that it is strongly committed to providing quality products.
What are some of these requirements?
How is a LIMS going to help you?
- End to end sample data tracking can be monitored via a comprehensive audit trail that records every single change made to a sample
- Keeps track of all staff training records and qualifications to ensure that staff are certified to conduct the testing
- Tracking the maintenance and calibration of instruments as well as notifying lab staff when they use an instrument that is out of calibration
- CFR 21Part 11 compliance provides that added level of quality to have an e-signature where validation of tests and test results are concerned
- An inventory management system for tracking all lab consumables, including quantities, expiry dates, supplier information and MSDS’s
- Managing, maintaining and updating SOP’s
- Automatically generate CoA’s
- Tracking chain of custody by recording what testing the samples have been sent out for, where they have gone and when they are due back
- CAPA (complaints and preventative actions) functionality can assist users in recording any major incident at the lab as well as the corrective and preventative actions in place to resolve the incident
As the ISO standards and regulatory requirements for analytical labs are constantly evolving, there is a need to implement a quality management system that can keep up with these requirements. Especially with increasing sampling numbers Excel and paper-based methods are no longer able to meet the demanding requirements for an ISO 17025 certification. The best method to meet these challenges is turning to automated solutions, like LIMS, that eliminate mundane tasks that exploit valuable resources.