ISO 23788 is officially titled:
"General requirements for the competence of testing and calibration laboratories — Guidelines for the implementation of record-keeping systems"
This standard provides practical guidance on:
ISO 23788 serves as a companion document to ISO/IEC 17025 and is applicable to testing, calibration, and medical laboratories.
Laboratory records are critical for:
However, challenges such as data manipulation, loss, or unauthorized access can compromise the entire process. ISO 23788 addresses these risks by offering clear, actionable guidelines for record-keeping best practices, especially in computerized environments.
Implementing ISO 23788 provides several operational and compliance benefits:
Reduces errors, omissions, and data tampering in test results and logs.
Implements access controls, audit trails, and validation protocols.
Supports accurate, timestamped, and traceable entries across systems.
Meets requirements of authorities such as FDA, EMA, and ISO/IEC 17025 auditors.
Helps laboratories shift from paper-based to digital systems with confidence.
By adopting ISO 23788, your organization gains multiple strategic and technical advantages:
Provide consistent, auditable, and trusted test data to clients and regulators.
Minimize the risk of failed audits, regulatory sanctions, or rejected data.
Transition safely to LIMS, ELNs, and other digital systems with proper controls in place.
Streamline data entry, access, and retrieval processes.
Align with ISO/IEC 17025, GxP, and data integrity frameworks like ALCOA+.
Assure clients of your laboratory's professionalism and data management maturity.
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