ISO/IEC 17025 clause 7.10: control nonconforming laboratory work
Clause 7.10 requires a procedure used when laboratory activities or results do not meet the laboratory's procedures or agreed customer requirements. It covers more than failed final reports: unsuitable equipment, environmental excursions and monitoring failures can trigger the process before a result is issued.
What clause 7.10 requires in practice
Clause 7.10 requires a procedure for use whenever laboratory activities or results fail to meet the laboratory's own procedures or the customer's agreed requirements. Typical triggers include equipment or environmental conditions outside their limits, or monitoring results that miss their criteria.
The procedure defines responsibilities and authorities, and bases actions on the risk levels the laboratory has set. Those actions include halting or repeating work and withholding reports where necessary. It requires an evaluation of how significant the nonconforming work is, including an analysis of the impact on earlier results, and a decision about whether the work is acceptable. Where necessary, the customer is told and work is recalled. It also names who may authorise a restart.
Records are kept of the nonconforming work and of the actions in the risk-based, evaluation, acceptance, notification and restart steps. Where the problem could recur, or the management system itself is in doubt, corrective action follows.
Evaluate significance and previous results
Clause 7.10.1 requires evaluation of the nonconforming work's significance, including effects on earlier results. Determine the possible extent using technical evidence such as equipment history, monitoring data, method versions and affected jobs. Neither “all previous work is invalid” nor “only this job matters” should be assumed without evaluation.
Decide whether the nonconforming work is acceptable. Where necessary, notify the customer and recall work. These are technical and communication decisions based on significance, not matters left solely to commercial preference. Keep the reasoning clear enough for a competent reviewer to understand.
Control resumption and recurrence
Define who may authorise work to resume. Establish that necessary correction or verification has occurred and that relevant controls are restored. Resumption should not happen automatically because production pressure increases or an instrument returns from repair.
Where the evaluation indicates possible recurrence or doubt about conformity with the laboratory's own management system, implement corrective action. That connects to clause 8.7 under Option A or the corresponding effective system arrangements under Option B. Immediate correction and prevention of recurrence are different questions.
Why nonconforming work control matters to the business
Every laboratory eventually finds a fault: an instrument drifts, a room goes out of range, an old calculation turns up in a live job. The commercial question is what happens in the hours that follow. Customers value a laboratory that stops, evaluates and tells them promptly over one that quietly carries on.
A clear procedure limits the damage, because it forces a decision on the reach of the problem before more reports go out. It also protects the laboratory from the larger cost of reporting results that later prove unreliable. Assessors read nonconforming work records closely, since they show whether the system works under pressure.
How to implement clause 7.10
Test the procedure against the faults your laboratory is most likely to meet, not against a theoretical list. Practise the procedure on a rehearsal scenario, because the first real event is a poor time to discover that nobody knows who can say stop. Keep the wording short and decisions clear.
- Name the person or role who manages nonconforming work and who may decide to stop, repeat or withhold work.
- Define the laboratory's risk levels in plain terms, so a minor administrative slip and a possibly invalid result get different responses.
- Make sure the stop or hold status is real in every system, including portals and automated release steps.
- Set out how to judge significance, including a review of earlier jobs using equipment history, monitoring data and method versions.
- Decide when the customer must be told and how recalled work is handled.
- Name who may authorise resumption, and connect the procedure to corrective action for causes that could recur.
Two illustrative work-control cases
A testing laboratory discovers that an obsolete calculation was used for several jobs. It controls further use, identifies affected results, evaluates their significance and decides what reporting or customer action is needed. Replacing the spreadsheet alone would leave earlier results unresolved.
A calibration laboratory records conditions outside those required for a method. It evaluates the effect on the work, withholds affected reporting as appropriate and defines the checks necessary before resumption. It does not assume that returning the room to normal proves the earlier measurements were valid.
Evidence and common mistakes
Retain records of the nonconforming work and the actions and decisions required under clause 7.10.1(b)–(f): response, significance, acceptability, customer or recall action where needed and resumption authority. A particular form is optional, but the evidence must preserve those decisions.
Avoid treating every incident as a paperwork correction, omitting retrospective impact analysis, leaving resumption authority unclear or closing repeated failures without corrective action. Also avoid customer notifications that overstate or understate the technical effect; communicate what the evaluation supports.
Frequently asked questions
Must every nonconformity lead to a report recall?
No. Evaluate significance and affected results, then notify customers or recall work where necessary. The decision must be technically supported and recorded.
When is corrective action required?
When evaluation indicates that the work could recur or creates doubt about conformity with the laboratory's management system, corrective action must be implemented.
Can work restart as soon as the immediate problem is corrected?
Only through the defined resumption authority and appropriate verification that controls are restored. Correction alone may not resolve technical impact or recurrence concerns.
Turn this requirement into reliable laboratory practice
Ask Sterling to review how your laboratory moves from a detected problem to a justified technical decision. A free consultation can identify gaps in containment, impact evaluation, customer communication and corrective-action follow-up.
Build the team's understanding through Nonconformity 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.
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