LabQMHub Editorial Team · ISO 15189:2022 Quality Management Series
If documentation describes how a laboratory intends to work, records prove that intention was actually carried out. A quality control result, a competence assessment, a calibration certificate, a signed consent form — these records are the evidence base an assessor, an auditor, or a court examines when the question becomes not what should have happened, but what actually did.
ISO 15189:2022’s Clause 8.4 governs how laboratories identify, protect, retain, and eventually dispose of these records, recognizing that a record that cannot be trusted, located, or retained for as long as needed provides no real evidentiary value at all.
What Counts as a Record, and Why Identification Matters
A record is any document that provides objective evidence of an activity performed or a result achieved — distinct from a procedure, which describes what should happen, a record captures what actually did. Clear identification of what constitutes a record for each activity, and how it will be captured, prevents gaps where important evidence is never formally created or preserved.
This identification exercise touches nearly every process covered throughout this training program — quality control results, competence assessments, calibration certificates, complaint logs, corrective action files, and management review minutes are all records requiring the same disciplined control this chapter addresses.
Amendment: Correcting Records Without Destroying History
When a record needs correction, the original entry must remain legible and traceable — a correction should be made in a way that shows what was originally recorded, what the correction is, who made it, and when, rather than obscuring or deleting the original entry entirely. This preserves the historical integrity of the record while still allowing genuine errors to be fixed.
This amendment discipline applies equally to electronic and paper records, though the specific mechanism differs — electronic systems typically use audit trails to capture amendment history automatically, while paper records require a specific, trained technique such as a single strike-through with initials and date.
Storage, Protection, and Retention Periods
Records must be stored in a way that protects them from damage, loss, deterioration, and unauthorized access or alteration, for a retention period appropriate to the record type — some records, particularly those related to patient results, often require retention for many years, sometimes decades, reflecting the long timeframes over which they may become clinically or legally relevant.
Retention requirements should be defined explicitly for each category of record, referencing applicable regulatory and accreditation requirements, since retention obligations can vary significantly by jurisdiction and record type, and a laboratory operating across multiple regions needs to apply the most stringent applicable requirement to avoid a compliance gap.
Retrieval and Eventual Disposal
A record that exists but cannot be promptly located when needed — during a patient care question, an audit, or a legal inquiry — provides little practical value; retrieval systems, whether physical filing or electronic indexing, should be designed and periodically tested for genuine, timely accessibility, not merely theoretical existence.
Once a record’s retention period has genuinely expired, disposal should follow a defined, documented process — particularly for records containing patient information, where secure destruction protects confidentiality even at the very end of a record’s lifecycle, connecting back to the confidentiality principles covered early in this program.
Frequently Asked Questions
How is a record different from a procedure or document?
A procedure describes how an activity should be performed; a record provides objective evidence of what actually happened when that activity was carried out.
How should an error in a laboratory record be corrected?
The original entry should remain legible, with the correction, the person making it, and the date clearly indicated, rather than obscuring or deleting the original text.
How long should laboratory records be retained?
Retention periods vary by record type and jurisdiction, with patient-related records often requiring retention for many years; laboratories should apply the most stringent applicable regulatory or accreditation requirement.
Key Takeaways
- Records provide objective evidence that an activity or process actually occurred as documentation intended, distinct from procedures themselves.
- Nearly every process across the laboratory generates records requiring the same disciplined identification and control.
- Amendments must preserve the original entry’s legibility and traceability, showing what was changed, by whom, and when.
- Retention periods vary by record type and jurisdiction, with patient-related records often requiring many years of retention.
- Records must be genuinely, promptly retrievable when needed, not merely theoretically existing in storage.
- Disposal of expired records, especially those containing patient information, must follow a defined, secure, documented process.
Conclusion
Records are the quiet proof behind every claim a laboratory makes about its own quality — that staff were competent, that equipment was calibrated, that a result was verified before release. Without disciplined record control, these claims are just assertions.
ISO 15189:2022’s requirements ensure this evidence base remains trustworthy, complete, and accessible for as long as it might genuinely be needed, protecting both the laboratory and the patients whose care it documents.
Learn how risk management and continual improvement build on this record foundation in the next course of this ISO 15189:2022 training series.
Source note: this article draws on “Quality Management in Clinical Laboratory Demystified” by Dr. Taleb Chalab Cham, ISO 15189:2022, and widely recognized clinical laboratory quality references including CLSI guidelines, CAP accreditation checklists, and WHO laboratory quality guidance.
