At its core, ISO 17025 (ISO/IEC 17025) is all about being a registered, genuine laboratory using valid test methods that produce verifiable, accurate results and the organization and documentation of all of it. It is the general laboratory equivalent of the medical laboratory standard ISO 15189. The latest iteration, ISO/IEC 17025:2017, extends into more detail about tools for a quality management system (QMS) and for accuracy and reliability in testing, as well as having systems in place to achieve continual improvement.
While ISO 17025 accreditation can be achieved using manual, paper-based processes and documentation, it is incredibly time-consuming and often challenging to locate specific data, SOPs, instrument calibration histories, staff qualifications, and certifications, or other necessary documents or files, and doubly so under the pressure of ISO audits – all while trying to maintain regular daily operations and meet TAT deadlines. That’s where LIMS technology can make a real difference.
LIMS and ISO 17025 Compliance
A laboratory information management system (LIMS) simplifies the accreditation process and makes post-accreditation audits less painful. By configuring the methods and workflows for each testing process in your LIMS, you ensure that the standard, ISO 17025 compliant process is the only one that your staff follows.
Tests Must Be Performed by Qualified Staff
ISO 17025 requires that laboratories ensure their employees are qualified to perform the tests they conduct. A LIMS can help you meet that standard by maintaining employee credentials and certifications and tracks their training progress. Configurable user access profile controls can prevent employees from being assigned to tests they are not qualified to conduct.
Instruments and Test Conditions Must be Monitored
ISO 17025 accredited laboratories must monitor the condition of their instruments as well as the conditions under which they perform tests. A LIMS helps you manage and document maintenance schedules, instrument calibration records, temperature data, and other information.
Better Organization Saves Time and Stress
All your lab’s data can be stored within the LIMS database. The LIMS database should be easily searchable, instantly bringing up any documents, records or other data you need to access. This is not only a huge improvement in timesaving and stress reduction as your lab performs daily work, but also a priceless benefit during ISO 17025 audits.
To maintain accreditation, labs must have independent auditors review their quality management processes. Staying ISO 17025 compliant on a daily basis, and well as passing regular audits are made easier by a LIMS. The LIMS should store all the necessary features and functions for compliance, including automatic recording of records, review, approval with date and time stamps, and versioning.
Issue Management and Corrective Action
Another vital area of compliance with ISO 17025 is effective management of issues, and their resolution through appropriate, documented corrective and preventative action (CAPA). Crucial in the process is the correct analysis of the causes that created the issue, so that the actions taken to resolve it are indeed appropriate and effective.
A LIMS helps ensure that ISO 17025 compliance through all of the management of data mentioned above, with the ability to designate limits and specifications that can trigger flags and notifications when values are outside of them, and trending capabilities warning of impending issues.
Accurate, Complete, Accessible Data and Documentation Mean Quality and ISO 17025 Compliance
Overall, it is clear that dedicated, validated and professional LIMS data management solutions are invaluable, even essential, for labs to be able to be confident of meeting the standards and requirements of ISO 17025 – both in achieving initial accreditation and in continuing to manage operations and pass audits in compliant fashion.
LabLynx ELab LIMS helps with ISO 17025 Compliance
The LabLynx ELab LIMS does more than document your lab’s standard operating procedures and store your lab’s data. ELab LIMS houses features and functions built to streamline ISO 17025 accreditation and compliance but giving you the tools to maintain daily compliance easily and be prepared for an audit at any time.
Staff Training and Qualification Tracking in ELab LIMS
The ELab LIMS helps your lab ensure their employees are qualified to perform the tests they conduct per ISO 17025 requirements. Configurable user access profile controls can set up to prevent employees from being assigned to tests they are not qualified to conduct, as well as not even seeing menu items for functions they do not work with. Training tracking maintains employee credentials, certifications, and training progress. You can also set lead times for advance notifications of upcoming re-certification training.
Instrument Management in ELab LIMS
The ELab LIMS helps you manage your instruments for ISO 17025 compliance by helping document instrument maintenance schedules, instrument calibration records, temperature data, and other information for performing tests. Alerts can be set up to notify designated staff of upcoming calibrations or maintenance, and instruments not meeting requirements can be made unavailable for testing. Additionally, interfacing instruments directly with the ELab LIMS eliminates errors in transcription and speeds up processing and overall TAT for greater efficiency, accuracy and client satisfaction.
ELab LIMS Data Storage and Analytics
All your lab’s data are stored in one place: on the LIMS database. The ELab LIMS database is easily searchable with multiple search criteria, instantly bringing up any documents, records or other data you need to access. Nothing is ever lost, and everything is immediately at your fingertips, reducing the stress and time associated with searching for data during ISO 17025 audits. And our versatile LabVista business intelligence (BI) module lets you visualize, analyze, trend and interpret your data in whatever format communicates best – as well as allowing for any kind of formal reports you need. And because it is cloud-based, those data can be securely accessed from anywhere at any time, providing coordinated, organized collaboration capabilities.
ELab LIMS Quality Management
All of the features, functions and data that you need to be ISO 17025 compliant, and auditors require, are stored in the ELab LIMS, including the Quality Manual, containing all your standard operating procedures (SOPs), as well as employee training schedules and certifications, instrument calibration and maintenance schedules and records, QC testing data and more. All records are automatically date and time stamped and versioned. Review and approval steps can be mandated and controlled by digital and e-signatures.
ELab LIMS Issue Management and Corrective Action
The LabLynx ELab LIMS helps ensure that ISO 17025 compliance through all of the management of data mentioned above, with the ability to designate limits and specifications that can trigger flags and notifications when values are outside of them, and trending capabilities warning of impending issues. But the ELab LIMS also goes further than that. It also includes an Issue Management module where all issues and actions taken can be documented, from initial identification and cause analysis through final corrective and preventative action.
ELab LIMS and ISO 17025 Compliance
The LabLynx ELab LIMS is a dedicated, validated and professional LIMS data management solution that is invaluable for achieving initial ISO 17025 accreditation and maintaining compliance for future audits. Our trained, experienced laboratory specialists can answer any additional questions you may have, and demonstrate exactly how the LabLynx ELab LIMS solution can help ensure your lab’s ISO 17025 accreditation and continued quality performance. Contact our team here and we will be in touch quickly.