In testing and calibration laboratories, the accuracy and reliability of results depend not only on technical expertise but also on the proper control and retention of documentation. Laboratories must maintain complete, traceable, and well-managed records to demonstrate the validity of their work. This requirement is one of the key aspects of ISO/IEC 17025, the international standard that outlines the general requirements for the competence of testing and calibration laboratories.
Organizations pursuing ISO 17025 Certification in Dubai must establish robust document control and record retention systems to ensure the integrity, confidentiality, and availability of data throughout its lifecycle. This article explores the essential requirements for document control and the retention of test and calibration records under ISO 17025.
Document control is the foundation of an effective laboratory management system. It ensures that all documents—such as test methods, procedures, manuals, and calibration records—are properly authorized, updated, and accessible to personnel who need them.
Under ISO 17025, document control helps laboratories maintain consistency and accuracy in operations. Controlled documents ensure that everyone follows the same validated methods and that obsolete versions are not mistakenly used. This level of control is critical in preventing errors that could compromise test results and damage the laboratory’s reputation.
ISO 17025 Consultants in Dubai often emphasize the role of document control in maintaining compliance and ensuring audit readiness. Without proper document management, even technically competent laboratories may face non-conformities during certification or surveillance audits.
ISO 17025 specifies several key requirements for controlling laboratory documents:
All documents within the management system must be reviewed and approved by authorized personnel before being issued. This ensures that only verified and relevant information is distributed across the organization.
Every document must have a unique identification, including a title, revision number, issue date, and page numbers. This allows laboratory staff to quickly verify they are using the most current version.
Documents must be reviewed at planned intervals to ensure they remain valid and up to date. Changes must be approved and communicated to all relevant personnel promptly.
Obsolete documents must be promptly removed from circulation or clearly marked to prevent unintended use. However, laboratories should retain copies of previous versions for reference or legal compliance.
Authorized personnel should have access to the documents they need at all times. Laboratories can use digital document management systems to maintain accessibility while ensuring security and traceability.
ISO 17025 Services in Dubai often assist laboratories in developing electronic document control systems that streamline updates, maintain version history, and restrict unauthorized access.
Alongside document control, the retention of records is a vital requirement of ISO 17025. Records are the objective evidence that the laboratory has performed its activities according to the established procedures and has achieved the desired quality of results.
Records can include raw data, calibration certificates, test reports, equipment maintenance logs, training records, and environmental monitoring data. These documents form the backbone of laboratory traceability and accountability.
Each record must be identifiable and traceable to a specific test, calibration, or activity. This ensures that results can be verified and linked back to the equipment, personnel, and conditions under which they were generated.
Records must be stored in a manner that prevents loss, damage, or deterioration. Laboratories must also ensure confidentiality and restrict access to authorized personnel only. Digital backups and cloud-based systems are increasingly used for secure record retention.
ISO 17025 requires laboratories to define how long records should be retained. Retention periods depend on the type of record, customer requirements, and regulatory obligations. Laboratories should document their retention policies and ensure compliance with national or industry-specific regulations.
Once the retention period has expired, records should be securely destroyed or deleted to maintain data privacy and confidentiality. However, disposal must be performed under controlled conditions, ensuring that no sensitive information is exposed.
Implementing best practices ensures smooth compliance with ISO 17025 requirements and enhances the laboratory’s efficiency.
Digitize Records: Electronic document management systems (EDMS) make it easier to control versions, track approvals, and ensure accessibility.
Maintain a Document Register: Keep a centralized record of all controlled documents with details of their current status.
Train Personnel: Ensure that all staff understand document control procedures and their role in maintaining accurate records.
Conduct Regular Internal Audits: Verify that document control and record retention processes comply with ISO 17025 requirements.
Backup Data: Use secure cloud storage or backup servers to protect against data loss due to technical failures or natural disasters.
ISO 17025 Consultants in Dubai can guide laboratories in implementing these best practices effectively, ensuring that document and record management systems align with both ISO standards and local regulatory expectations.
Improved Data Integrity: Ensures that all test and calibration results are accurate, complete, and traceable.
Enhanced Compliance: Meets ISO 17025 and regulatory requirements with ease.
Operational Efficiency: Reduces redundancy and confusion by ensuring everyone works from the latest documents.
Audit Readiness: Provides clear and accessible records during audits and assessments.
Customer Confidence: Demonstrates transparency, reliability, and professionalism to clients.
For laboratories seeking ISO 17025 Certification in Dubai, mastering document control and record retention is not merely a compliance requirement—it’s a strategic advantage. Properly managed documentation demonstrates the laboratory’s commitment to quality, accuracy, and continuous improvement.
In summary, document control and record retention form the backbone of a reliable laboratory management system under ISO 17025. By ensuring documents are current, approved, and accessible—and that records are securely stored and retained—laboratories can maintain accuracy, transparency, and confidence in their testing and calibration results.
Engaging professional ISO 17025 Consultants in Dubai can help laboratories develop, implement, and maintain these processes efficiently, while ISO 17025 Services in Dubai provide the support needed to achieve and sustain certification with confidence.
