ISO 17025 and LIMS | Accreditation Compliance Guide

What is ISO/IEC 17025?

ISO/IEC 17025 is an international standard that determines the competence of testing and calibration laboratories. This standard is used to assess laboratories' technical capabilities, quality management systems and the reliability of their results. In Turkey, the Turkish Accreditation Agency (TURKAK) is responsible for audits and accreditation processes under this standard.

With the ISO 17025:2017 revision, the standard introduced more comprehensive requirements in areas such as risk-based thinking, impartiality and information technology management. These new requirements have made the use of LIMS nearly mandatory, especially in data management and information technology.

Standard Clauses That Require LIMS

Many clauses of the ISO 17025 standard contain requirements that can effectively be met only with LIMS software. Here are the most critical ones:

Clause 7.5 - Technical Records

The standard requires laboratories to keep complete technical records of every activity, preserve original data when records are modified, and record the person who made the change. LIMS records every data change with a full audit trail -- who changed what, when, and why. This level of traceability is practically impossible with paper-based systems.

Clause 7.7 - Ensuring the Validity of Results

Laboratories must implement procedures to monitor the validity of their results. This includes tracking quality control samples, proficiency testing and inter-laboratory comparison results. LIMS automatically creates control charts, performs trend analyses and generates alerts when deviations occur.

Clause 7.11 - Control of Data and Information Management

This clause sets clear requirements for the validation of laboratory information management systems (including LIMS), preservation of data integrity, backup procedures and prevention of unauthorized access. LIMS provides role-based authorization, encrypted connections, automatic backups and data verification mechanisms.

Clause 6.4 - Equipment

Calibration, maintenance and usage records of laboratory equipment must be maintained. LIMS automatically meets these requirements through instrument inventory management, calibration scheduling, maintenance planning and usage logging. Automatic notifications are sent for instruments approaching their calibration due date.

Traceability and Audit Trail

Traceability is one of the most frequently questioned topics during accreditation audits. Auditors expect that all processes of any test result can be traced back: Which sample was it taken from? Who performed the test? Which instrument was used? Was the instrument's calibration current? Who approved the results?

LIMS provides an infrastructure that can instantly answer all of these questions. Every operation is recorded with a timestamp and user information. The entire process from sample reception to report delivery is digitally documented and can be traced back from any point.

The Role of LIMS in Accreditation Audits

Accreditation auditors also examine data management systems when evaluating how well laboratories meet ISO 17025 requirements. Common issues frequently encountered in paper-based or Excel-based systems include:

Lack of audit trail: Uncertainty about when and by whom data was entered
Data integrity risk: Excel files being copied, modified or deleted
Authorization weakness: Everyone being able to access and modify all data
Reporting inconsistencies: Format and content differences in manual report preparation
Inadequate instrument tracking: Inability to track calibration due dates

Laboratories using LIMS do not encounter these problems. During audits, any requested data can be instantly accessed from the system, audit trail reports can be automatically generated and complete documentation of all processes can be proven.

Data Integrity and Security

ISO 17025 mandates the preservation of laboratory data integrity. This includes protecting data from unauthorized access, backing it up, maintaining change logs and securely storing electronic data.

Modern LIMS solutions like WiseLIMS meet these requirements through the following mechanisms:

Role-Based Authorization

With 11 different permission types, each user can only access and work with data they are authorized for.

Full Audit Trail

Every data change is recorded with user, timestamp, old value and new value information.

Automatic Backup

Data is regularly backed up and protected with disaster recovery procedures.

Database Isolation

Separate database for each customer. Your data belongs only to you and is completely isolated from other customers.

Accreditation Compliance with WiseLIMS

WiseLIMS is designed to meet all requirements of ISO 17025 and ISO 17020 standards. Including industry-leading organizations such as Intertek Turkey, many ISO 17025 accredited laboratories have been successfully using WiseLIMS for years. WiseLIMS contributes to the accreditation process in the following ways:

Significantly reduces audit preparation time; every data auditors request is instantly accessible.
Minimizes non-conformance risk; automatic controls instantly detect deviations from the standard.
Systematically tracks corrective and preventive actions (CAPA).
Ensures version control of procedures and instructions through document management.
Manages the personnel competency matrix, ensuring only competent personnel perform tests.

Conclusion

ISO 17025 accreditation is essential for proving the reliability and competence of laboratories. The data integrity, traceability, quality management and documentation requirements needed to achieve and maintain this accreditation cannot be effectively met without modern LIMS software. WiseLIMS simplifies and strengthens your laboratory's accreditation process with solutions specifically developed for the accreditation landscape.

Why is LIMS Essential for ISO 17025 Accreditation?