Common Nonconformances in ISO 17025: What Labs Need to be Know

Achieving and maintaining ISO 17025 accreditation is crucial for laboratories to demonstrate competence, reliability, and technical excellence. However, many labs encounter nonconformances during audits, which can delay certification and create compliance challenges. Identifying and understanding these common issues is the first step toward maintaining a seamless accreditation process.

1. Incomplete or Inadequate Documentation

ISO 17025 requires thorough documentation of procedures, records, and quality management systems. Many labs struggle with outdated, incomplete, or inconsistent records, which can lead to audit findings.

2. Insufficient Training and Competence Records

A key requirement of ISO 17025 is ensuring that personnel are qualified and competent to perform their assigned tasks. Nonconformances often arise when training records are missing, outdated, or fail to demonstrate ongoing competence evaluations.

3. Equipment Calibration and Maintenance Issues

Labs rely on calibrated and well-maintained equipment for accurate testing and measurement. Findings related to improper calibration, lack of traceability, or overdue maintenance are common areas of concern in ISO 17025 audits.

4. Poor Control of Test and Calibration Methods

Consistency in test and calibration methods is essential. Nonconformances often occur when procedures are not properly validated, lack traceability, or are inconsistently applied across laboratory personnel.

5. Deficiencies in Measurement Uncertainty Evaluation

Many labs struggle with defining and documenting measurement uncertainty in a way that aligns with ISO 17025 requirements. Without proper evaluation, labs risk audit findings related to incomplete or unreliable uncertainty estimates.

6. Noncompliance with Internal Audit and Corrective Actions

Internal audits are a key component of ISO 17025, ensuring continuous improvement and compliance. Many nonconformances result from missed internal audits, lack of follow-up on findings, or inadequate corrective action processes.

7. Sample Handling and Traceability Concerns

Maintaining accurate tracking, labeling, and storage of samples is essential to ensure integrity and compliance. Any inconsistencies or gaps in sample handling procedures can lead to nonconformances that impact test reliability.

Addressing Nonconformances the Right Way

While these common nonconformances can create challenges for laboratories, the right support and guidance can make ISO 17025 compliance manageable. At PrecisionPath ISO Solutions, we help labs identify, address, and prevent nonconformances with a strategic, hands-on approach.

Looking to streamline your ISO 17025 compliance? Contact us today to learn how we can support your accreditation journey!