What Requirements Exist for Document Control and Retention of Test and Calibration Records?

In any laboratory setting, whether dealing with testing or calibration, maintaining accurate and well-controlled documentation is vital. Laboratories must ensure the integrity, traceability, and availability of records for both internal quality control and external audits. ISO/IEC 17025, the international standard for testing and calibration laboratories, sets clear guidelines on document control and the retention of records. Adhering to these requirements ensures data reliability, legal compliance, and improved quality performance.

If you’re seeking ISO 17025 Certification in Bangalore, understanding these requirements is critical. Let’s explore what ISO 17025 expects when it comes to document control and record retention.

1. Document Control Requirements Under ISO 17025

ISO 17025 mandates that laboratories establish and maintain a robust document control system. This includes not just test and calibration methods but also quality manuals, procedures, and work instructions.

Key document control requirements include:

• Approval and Review: All documents must be reviewed and approved by authorized personnel before issue. Revisions must go through the same approval process.

• Identification and Version Control: Documents should be uniquely identified, including version numbers, issue dates, and revision history to avoid confusion and ensure traceability.

• Availability at Point of Use: Current versions of documents must be accessible to all personnel who need them for performing tasks.

• Prevention of Obsolete Use: Obsolete documents should be promptly removed from points of use or marked to prevent accidental use.

• Protection of Integrity: Whether in paper or electronic form, documents must be protected from loss, unauthorized access, or unintended changes.

With the assistance of experienced ISO 17025 Consultants in Bangalore, your laboratory can develop an efficient document control process tailored to your operations.

2. Retention of Test and Calibration Records

Test and calibration records form the core evidence of a laboratory’s technical competence and the reliability of its results. ISO 17025 requires that these records be maintained in a way that safeguards their accuracy and completeness.

Important retention requirements include:

• Record Content: Records must include all relevant data, including test/calibration results, environmental conditions, equipment used, and personnel involved.

• Legibility and Traceability: Records should be clear and traceable to the original observations and measurements.

• Retention Period: ISO 17025 does not specify a fixed retention period. Laboratories must define appropriate retention times based on legal, regulatory, or contractual obligations.

• Format and Storage: Records may be stored electronically or in physical form, but adequate backups and security measures must be in place to prevent data loss.

• Amendments and Corrections: Any corrections to records must be clearly identified, and the original data must remain legible. All changes should be signed or initialed and dated by the person making them.

Proper record retention ensures the laboratory can demonstrate compliance during audits or investigations and provides assurance to clients and stakeholders.

3. Benefits of Complying with ISO 17025 Document Requirements

Adhering to the document control and record retention requirements of ISO 17025 improves:

• Data Integrity and Reliability

• Audit Preparedness

• Operational Efficiency

• Customer Confidence

• Regulatory Compliance

For laboratories aiming for ISO accreditation, professional ISO 17025 Services in Bangalore can provide essential support, including gap analysis, document preparation, staff training, and internal audits.

Conclusion

Document control and retention of test and calibration records are not just ISO 17025 requirements—they’re pillars of a laboratory’s quality management system. Complying with these guidelines ensures your lab produces reliable, traceable, and legally defensible results. If you are planning to upgrade your lab’s quality systems, obtaining ISO 17025 Certification in Bangalore with the support of qualified ISO 17025 Consultants in Bangalore can help you achieve compliance smoothly and effectively. Explore professional ISO 17025 Services in Bangalore today to elevate your lab’s credibility and performance.