ISO 17025 and the Art of Recordkeeping: A Guide for Laboratories

In the realm of testing and calibration laboratories, adherence to international standards is not just a mark of quality; it is a fundamental requirement for ensuring the reliability and accuracy of results. Among these standards, ISO/IEC 17025 stands as a benchmark for the competence of testing and calibration laboratories. One of the key elements of this standard, often overlooked yet critical to its implementation, is recordkeeping. Proper recordkeeping is the backbone of any quality management system and in the context of ISO 17025, it plays a pivotal role in maintaining traceability, ensuring compliance and supporting continuous improvement.

Understanding ISO 17025

ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories. It is applicable to all organizations performing laboratory activities, regardless of the number of personnel. The standard covers two main areas: management requirements and technical requirements. Management requirements relate to the operation and effectiveness of the quality management system within the laboratory, while technical requirements address the competence of staff, the methodology and equipment used and the quality of the test and calibration results.

Recordkeeping underpins both these areas, serving as a tool for demonstrating that the laboratory meets all the standard's criteria. Records provide the evidence that the laboratory's activities are carried out as per the documented procedures and that the results generated are reliable and reproducible.

The Importance of Recordkeeping in ISO 17025

Recordkeeping is not merely an administrative task; it is a vital component of the laboratory's quality management system. Effective recordkeeping ensures that all laboratory activities are documented and that these documents are readily accessible for review and audit. This documentation is essential for several reasons:

Traceability and Transparency: 

In testing and calibration, traceability is a crucial aspect. Every test or calibration performed in the laboratory must be traceable back to the documented procedures, the equipment used and the personnel involved. This traceability ensures that results can be verified and reproduced, which is essential for the credibility of the laboratory. Proper records ensure that there is a clear trail of documentation that can be followed, providing transparency in the laboratory's operations.

Compliance and Accreditation: 

For a laboratory to be accredited under ISO 17025, it must demonstrate that it has a robust quality management system in place, supported by comprehensive records. These records are reviewed during audits and assessments to verify that the laboratory meets all the requirements of the standard. Without proper records, it is impossible to demonstrate compliance, which can lead to non-conformities and potentially jeopardize the laboratory's accreditation status.

Continuous Improvement: 

One of the core principles of ISO 17025 is continuous improvement. Laboratories are required to regularly review their processes and procedures to identify areas for improvement. Recordkeeping plays a crucial role in this process by providing the data and evidence needed to analyze performance and identify trends. By maintaining accurate records, laboratories can monitor their operations, detect deviations and implement corrective actions to enhance their performance.

Risk Management: 

ISO 17025 emphasizes the importance of risk-based thinking in laboratory operations. Effective recordkeeping helps laboratories manage risks by providing a detailed account of past activities, including any issues encountered and the actions taken to address them. This historical data is invaluable for assessing risks and making informed decisions about future activities. Moreover, in the event of disputes or legal challenges, comprehensive records can serve as crucial evidence to protect the laboratory's interests.

Best Practices for Recordkeeping in ISO 17025

To ensure that recordkeeping meets the requirements of ISO 17025, laboratories should adopt best practices that align with the standard's guidelines. Here are some key practices to consider:

Document Control: 

Laboratories should establish a document control system to manage the creation, review, approval and distribution of records. This system should ensure that all documents are current, correctly formatted and easily accessible to authorized personnel.

Data Integrity: 

Records should be accurate, complete and protected from unauthorized access or alterations. This includes maintaining electronic records with appropriate security measures and ensuring that paper records are stored in a secure and organized manner.

Retention and Disposal: 

Laboratories must establish clear policies for the retention and disposal of records. The retention period should be based on the laboratory's needs and any regulatory or accreditation requirements. Records should be disposed of in a manner that protects confidentiality and complies with legal obligations.

Training and Awareness: 

All laboratory personnel should be trained in the importance of recordkeeping and the specific procedures related to their roles. Regular training and awareness programs can help reinforce the significance of maintaining accurate records and ensure that all staff members are aligned with the laboratory's quality management objectives.

Audit and Review: 

Regular internal audits and management reviews should be conducted to assess the effectiveness of the recordkeeping system. These reviews should identify any gaps or areas for improvement and ensure that the laboratory's recordkeeping practices continue to meet the requirements of ISO 17025.

In the pursuit of excellence and credibility, recordkeeping is a cornerstone of ISO 17025 compliance. It is through meticulous and disciplined recordkeeping that laboratories can demonstrate their competence, ensure the reliability of their results and maintain their accreditation status. By adopting best practices in recordkeeping, laboratories not only comply with the standard but also lay a strong foundation for continuous improvement, risk management and long-term success in their operations.

As laboratories navigate the complexities of ISO 17025, they must recognize that recordkeeping is not just a regulatory obligation but a critical tool for achieving their quality management goals. With the right approach to recordkeeping, laboratories can build a robust quality management system that supports their mission of delivering accurate, reliable and trustworthy results.