Templates and records · ISO 17025 · Clause 7.7.1
ISO 17025 internal quality control record
The daily or per-batch monitoring that shows the method still performs as it did at validation, with data recorded so that trends show up before a wrong result goes out.
In one sentence
The internal quality control record logs, per batch or per period, the control materials, replicates or checks used, their results against defined limits, the trend and the response when a value falls outside the criteria, because clause 7.7.1 of ISO/IEC 17025 requires a procedure for monitoring the validity of results with data recorded so that trends are detectable, and 7.7.3 requires action to avoid reporting incorrect results.
- Where the standard requires it
- ISO 17025 · Clause 7.7.1 Clauses are cited using the numbering of ISO/IEC 17025:2017, the current edition and the same one the Academy uses.
- Type of information
- Mandatory record Monitoring data recorded so that trends can be detected (7.7.1 and 7.7.3)
- Who fills it in
- The technician running the batch The method lead reviews the charts and approves the response to an out-of-control result
- When
- With every batch or at the planned frequency Trends are reviewed at least monthly
- How long it is kept
- Set by the laboratory The standard requires a retention time to be defined for each record, consistent with contractual and legal obligations (8.4.2). Covering at least the accreditation cycle lets you show the history at every reassessment.
What the standard requires
What ISO 17025 demands and what it leaves to your judgement
The standard requires a planned and reviewed procedure for monitoring the validity of results. Among the options it lists are reference or quality control materials, alternative instrumentation, functional checks, check standards with control charts, intermediate checks, replicate tests, retesting of retained items, correlation of results, review of reported results, intralaboratory comparisons and blind samples.
The data are recorded so that trends are visible and, where practicable, statistical techniques are applied. The laboratory chooses the tools; what is assessed is whether they cover every accredited method at a reasonable frequency.
When data fall outside predefined criteria, action is taken to avoid reporting incorrect results: reject the batch, repeat it and review what has already been issued if necessary.
Structure
Fields the template should include
- Method and parameter
- Control tool: control material, replicate, blank, blind sample
- Material, lot and assigned value
- Warning and control limits
- Result for each batch and date
- Chart or trend analysis
- Out of control: response and decision on the batch
- Periodic review and conclusions
Example
Example: COD control in wastewater
Company, people and figures are fictitious: the example only shows what a properly completed record looks like.
| Field | Content |
|---|---|
| Method | COD by dichromate · range 30-1,000 mg/L |
| Control | 250 mg/L potassium hydrogen phthalate standard in every batch, plus a sample duplicate |
| Limits | Warning ±2 s (±12 mg/L) · control ±3 s (±18 mg/L) · duplicate ≤ 6 % |
| Batch of 7 May | Standard 271 mg/L: out of control |
| Response | Batch rejected · expired dichromate reagent · repeated with fresh reagent: 248 mg/L |
| May review | 7 consecutive values above the mean before the failure: trend not picked up in time |
| Improvement | The rule of 7 consecutive values on the same side is added as a warning signal |
At the audit
Mistakes auditors commonly flag
- Control charts that are filled in but never reviewed.
- Control limits copied from the literature instead of calculated from the laboratory’s own data.
- Out-of-control batches reported without justification.
- Accredited methods with no control tool at all.
- Only individual values are looked at, never trends.
In Kimobox
How this record is kept in Kimobox
- 1Internal quality control results are recorded with their trend, visible on a dashboard.
- 2An out-of-control result is opened as nonconforming work, linked to the earlier results it might affect.
- 3Results reports are generated from a controlled template.
Frequently asked questions
What people ask us before getting started
How many controls are needed?
The standard does not say. It is decided according to risk, volume and the stability of the method, and it must be planned. Each accredited method needs at least one control tool at a defined frequency.
And in a clinical laboratory?
ISO 15189 treats it as internal quality control with materials at clinical decision levels and defined control rules, and requires patient results to be reviewed after a control failure. This is covered in its own template.
Keep your ISO 17025 records without loose templates
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Sources
Where each figure comes from
References to the official text in force. If a standard is revised, this page is updated and the review date says so.