ISO 15189:2022 · Section 8 · Management system requirements
Clause 8.4: Control of records
Check the exact requirement in your licensed copy of the standard.
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What this clause is about
Records show what happened, who performed the work and what decisions were made. Unlike a procedure that tells staff what to do, a completed record provides evidence of an actual activity. Laboratory records include examination data, equipment checks, quality control results, staff authorization, report amendments, purchasing decisions and management reviews. Define which records are needed to reconstruct important work without creating unnecessary duplication.
Make entries when the activity occurs, with sufficient identification to connect the record to the specimen, equipment, person or event involved. Records should remain legible and retrievable throughout their retention period. When an error is corrected, preserve the original information and make the correction attributable, including relevant timing. For electronic records, assess how the system protects entries and retains a meaningful history of changes. A clean final printout may hide information needed to investigate an incident.
Set retention arrangements using applicable legal, contractual and professional requirements together with laboratory needs. Different record categories may require different periods; there is no universal period suitable for every laboratory record. Address storage conditions, backup, migration, access restrictions and secure disposal. Retaining files without the software or equipment needed to read them is not effective retention. Test retrieval from archives rather than assuming that successful storage guarantees future access.
Assign responsibility for paper and electronic records, including records held by external providers. Protect confidentiality during retrieval, transfer and disposal, not just during routine use. LabToolkit Pro can support forms, logs, document approvals and related records, but the laboratory must set its retention schedule, verify complete exports or archives where needed and ensure that records remain available when service arrangements or technologies change.
What assessors typically ask to see
- Can the laboratory reconstruct a selected examination using identifiable, legible records from receipt through reporting and any later amendment?
- How are corrections made without concealing the original entry or losing the identity of the person making the change?
- What determines retention periods for different record categories, and how are applicable external obligations considered?
- Can older records be retrieved promptly with the information, software and context needed to interpret them correctly?
- How are confidentiality, authorized access and secure disposal maintained for both paper archives and electronic records?
Documents and records that usually provide evidence
- Records-control procedure covering creation, identification, corrections, storage, access, retrieval, retention and secure disposal.
- Retention schedule listing record categories, applicable obligations, defined periods and responsibility for final disposal decisions.
- Completed technical records linking specimens, operators, equipment, examination conditions, results and authorization where relevant.
- Correction examples or electronic change histories preserving original information and identifying who changed it and when.
- Archive retrieval and restoration checks demonstrating that retained records remain readable, complete and connected to their context.
- Access permissions and disposal records showing protection of confidential information throughout the full record lifecycle.
Ready-made forms mapped to clause 8.4: Meeting Minutes, Archiving and Removal Form, Documents & Records Backup Log, Records Access Form, Documents & Records Retention Schedule, Archiving & Destruction Form.
Common findings to avoid
- Overwriting incorrect entries so that the original information and reason for a changed result cannot be established.
- Applying a single unexplained retention period to all records without considering different legal or clinical requirements.
- Archiving electronic files without checking that their formats, attachments and necessary reading software remain available.
- Keeping completed logs with missing dates or identities, preventing reliable reconstruction of who performed essential checks.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 8.4 becomes effective, it counts as direct evidence on the readiness dashboard for ISO 15189:2022; links from other standards through the crosswalk are shown separately as indicative coverage. Gaps appear clause by clause, so you can see which parts of 8.4 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
How long should laboratory records be kept?
Determine periods by record category using applicable obligations and laboratory needs. Document the basis and any triggering event for the period. Do not adopt an arbitrary period simply because another laboratory uses it.
Can paper records be scanned and destroyed?
Possibly, subject to applicable requirements. Establish scanning quality checks, completeness, indexing, authenticity, access and backup arrangements first. Confirm whether originals must be retained and authorize disposal only after the replacement record is reliable.
Does a blank form count as a record?
A blank form is normally a controlled document that guides data capture. Once completed, it becomes a record of an activity. Control the form version while protecting completed entries under the records arrangements.
Check the exact requirement in your licensed copy of the standard.
Put it into practice
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