ISO/IEC 17025 clause 7.5.2: preserve the history of record changes
Clause 7.5.2 requires amendments to technical records to remain traceable to earlier versions or original observations. Both original and amended data and files must be retained, with the date, the aspects changed and the person responsible. The aim is a trustworthy history, not a prohibition on correcting mistakes.
What clause 7.5.2 requires in practice
Clause 7.5.2 is the change-control rule for technical records. Whenever a record is amended, the laboratory must be able to trace the amended version to the earlier version or to the original observation. Both the original and the amended data and files are kept, together with the date of the change, an indication of which aspects were altered and the person responsible.
Nothing in the clause forbids correction; it expects corrections to be visible. It applies equally to paper worksheets, instrument files, spreadsheets and databases, and to changes made before or after a report is issued. It also sits alongside, rather than replaces, the separate controls for amending an issued report and for handling nonconforming work. A sound arrangement lets a reviewer see what a record said before, what it says now, who changed it and when.
Make the original and the change visible
For a paper record, choose a correction method that leaves the original information legible and records the change appropriately. For electronic records, use reliable version or audit-history arrangements that preserve the necessary information. The standard does not prescribe one software product or a particular coloured pen.
Define who may amend records and how technical significance is reviewed. A spelling correction in a nontechnical description and a changed measurement input can have very different effects. The history must remain clear in either case, while the response should address the actual significance.
Preserve data, not just a note saying it changed
A change log stating “worksheet updated” may be inadequate if the original data file has been overwritten. Retain the original and amended information so a reviewer can identify what changed. Record the responsible person rather than relying on a shared account that cannot establish individual responsibility.
Consider linked calculations and exports. Changing a source value may update several outputs automatically. The laboratory needs to understand which results or reports were affected and preserve enough history to evaluate that effect. Coordinate with information-system controls and record retention rather than treating versioning as an isolated IT feature.
Connect record corrections with result decisions
If a change reveals nonconforming work, evaluate it through clause 7.10. If an issued report must change, apply clause 7.8.8. Preserving the worksheet history does not itself inform the customer or replace the required report-amendment process.
Documenting the reason for a significant correction is a useful practice and may be necessary through related processes, even though clause 7.5.2 specifically lists the date, changed aspects and responsible personnel. Do not mislabel every recommended explanatory field as an explicit standalone requirement of this subclause.
Why clause 7.5.2 matters to the laboratory
Records change for good reasons all the time: a transcription slip, a late correction factor, a recalculated result. What matters to a customer or assessor is whether the laboratory can prove the change was legitimate. If the original has been overwritten, a reviewer cannot judge whether a correction was accurate, and suspicion falls on every other record. Preserved history also helps the laboratory itself: it lets staff find out how an error entered a calculation, which jobs it touched and whether issued reports need action. In short, a visible change trail turns an embarrassing mistake into a manageable event and protects the credibility of the whole record set.
How to implement clause 7.5.2
Decide the rules once and apply them to every medium the laboratory uses. Test the rules on a real correction before they become routine, because awkward steps are quickly bypassed under workload.
- List the places technical records are held, such as paper books, instrument files, spreadsheets and any information system.
- For paper, define a correction method that keeps the original legible, adds the new value and identifies the person and date.
- For electronic files, switch on version history or audit trails, or save dated copies under a fixed naming rule, and keep them with the job.
- Restrict who may amend records and require individual log-ins so changes can be attributed.
- Set a rule that anything affecting a result triggers a check on whether a report has already been issued.
- Make a short guide, with examples, for the common correction types so staff do not improvise.
- Test the trail by selecting an edited record and retrieving its previous version, and repeat after software updates or migrations.
Evidence an assessor expects for clause 7.5.2
The best evidence is a real edited record that can be traced backwards. An assessor may pick a worksheet with a correction and ask to see the original entry, the date, what changed and who changed it. For electronic files, they may ask for the history from the system or for the stored earlier version. Interviews help too: analysts explaining how they correct an entry, and a manager describing who may amend a calculation file. Supporting items include written correction rules, user-access lists showing individual accounts, and records of a past investigation where the change trail was used to decide whether any report needed action. Gaps tend to appear when systems are replaced or a backup is the sole copy.
Two illustrative amendment histories
A testing analyst discovers that a value was copied into the wrong row on a paper worksheet. The correction preserves the original entry, identifies the corrected value and records the date and responsible person. The laboratory checks the effect on calculations before release.
A calibration laboratory identifies an incorrect factor in a saved calculation file after a certificate was issued. It preserves both file versions, establishes who changed the factor and when, evaluates affected results and follows the report-amendment process where necessary. Replacing the file silently would destroy part of the evidence needed to assess the problem.
Common weaknesses and checks
Test whether the laboratory can retrieve a previous version after a record has been edited. Check whether exported PDFs retain the history needed or whether it exists only in a system that is later decommissioned. Backups are valuable, but an unmanaged backup collection is not automatically a clear amendment trail.
Avoid deletion followed by re-entry, undocumented spreadsheet overwrites, and changes made under generic logins without another reliable identity record. Also avoid blocking legitimate correction so completely that staff keep unofficial records outside the controlled system.
Frequently asked questions
Are corrections to laboratory records allowed?
Yes. They must remain traceable, with original and amended information retained and the required date, changed aspects and responsible person recorded.
Is an automatic backup enough to meet this requirement?
Not necessarily. The laboratory must be able to trace the amendment and identify the relevant original and revised information. A backup may support that arrangement without providing it alone.
Does this rule apply before a report is issued?
Yes. Technical-record amendments need traceability regardless of report status. Issued-report changes are additionally subject to the separate reporting requirements in clause 7.8.8.
Turn this requirement into reliable laboratory practice
Sterling can help review how your laboratory corrects records and traces the effect on customer results. Discuss an anonymised paper or electronic example in a free consultation to identify practical improvements in responsibility, preservation and review.
Build the team's understanding through Documented Information Management. Discuss the relevant scope, employee learning and agreed access to Effivity ISO & GRC automation software with Sterling; laboratory technical decisions remain with competent, authorised personnel.
ISO/IEC 17025 requirements hub · Technical records · Amend issued reports · Evaluate nonconforming work