Standards & accreditation

ISO/IEC 17025 complaints: handling under clause 7.9

Clause 7.9 requires a documented process for receiving, evaluating and deciding on complaints. This guide covers the requirements, a seven-step workflow and typical assessor findings.

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In short

Clause 7.9 of ISO/IEC 17025:2017 requires the laboratory to have a documented process for receiving, evaluating and making decisions on complaints. A description of the process is available to any interested party on request. The laboratory acknowledges receipt, investigates and informs the complainant of the outcome. People who investigate and decide must not have been involved in the laboratory activities in question. A complaint is an expression of dissatisfaction that expects a response, not every question; records and links to corrective action (8.7) and management review (8.9) belong to the process.

Complaint vs. feedback: what counts?

The standard defines a complaint as an expression of dissatisfaction by any person or organization to a laboratory, relating to the activities or results of that laboratory, where a response is expected. A plain question about a report is not a complaint; a remark that a measured value is implausible can be one. Clause 8.6 separately requires collecting customer feedback, positive and negative. The two are often handled together in practice but are distinct in the standard.

Rule of thumb: anything that expresses dissatisfaction and expects an answer gets recorded. When in doubt, record and evaluate rather than treat it as an enquiry and lose it in a mailbox.

What clause 7.9 requires

SubclauseRequirement
7.9.1The laboratory has a documented process to receive and evaluate complaints and make decisions on them.
7.9.2A description of the handling process is available to any interested party on request. On receipt the laboratory confirms whether the complaint relates to its laboratory activities and, if so, deals with it.
7.9.3The laboratory is responsible for all decisions at all levels of the handling process.
7.9.4Investigation and decision are made by persons not involved in the laboratory activities in question.
7.9.5The process includes at least: a description of receipt, validation and investigation; tracking and recording, including actions; ensuring that appropriate action is taken.
7.9.6The laboratory acknowledges receipt and provides the complainant with progress reports and the outcome.
7.9.7The outcome is communicated to, or reviewed and approved by, persons not involved in the original activities.
7.9.8Where possible, the laboratory gives formal notice of the end of complaint handling.

A seven-step workflow

  1. 1

    Record receipt

    Give each complaint a number, date, sender, channel (email, phone, portal) and the core of the issue. Oral complaints are recorded as well.

  2. 2

    Acknowledge

    Tell the complainant in writing that the complaint arrived, who handles it and when to expect an answer.

  3. 3

    Validate

    Does it relate to the laboratory activities? If not, explain why. If yes, identify the order, report and people involved.

  4. 4

    Investigate independently

    Someone not involved in the testing reviews raw data, report, calibration status and conditions. Record findings and cause.

  5. 5

    Decide and define actions

    Correct the report, repeat the test, provide an explanation or reject the complaint as unfounded. For a real error also assess nonconforming work (7.10) and corrective action (8.7).

  6. 6

    Communicate the outcome

    Inform the complainant of result and actions, communicated or reviewed by an uninvolved person. For report changes under 7.8.8, identify the amended report clearly.

  7. 7

    Close and evaluate

    Close on time and feed the evaluation of all complaints into management review: number, themes, handling time, repeats.

Typical assessor findings

  • No documented complaints process, or it is not available to customers.
  • Complaints arrive by email but are not recorded centrally; no list, no numbers.
  • Receipt is not acknowledged; progress and outcome are not communicated.
  • The person who performed the test also investigates the complaint.
  • Justified complaints trigger no corrective action and no review of other jobs.
  • Complaint evaluation is missing from management review.

Tools and data sources

A register with number, status, owner and deadlines is enough. What matters is that the investigation gets to the raw data fast: which sample, which instrument, which measurement series, which version of the report?

TestLabIQ links orders, test items, measurement data, deviations, reports and an audit log of all changes, and in the customer portal clients see the status of their orders. That shortens the investigation. The application does not offer a dedicated complaints register with deadlines and escalation; a maintained table or your QMS covers that.

Frequently asked questions

What does clause 7.9 of ISO 17025 require?

A documented process to receive, evaluate and decide on complaints, with acknowledgement, independent investigation, recorded actions and communication of the outcome to the complainant.

Who may investigate a complaint?

Persons not involved in the laboratory activities in question. The outcome is also communicated or reviewed by someone uninvolved.

Are there fixed deadlines?

The standard names none. Set your own, for example acknowledgement within two working days and closure within 30 days, and document them in the process.

Is every customer question a complaint?

No. A complaint expresses dissatisfaction and expects a response. Plain questions are not, but when in doubt record and evaluate.

How do complaints relate to corrective action?

A justified complaint often points to nonconforming work (7.10) and triggers corrective action (8.7). Complaints are an input to management review (8.9) and can update the risk register (8.5).

Trace complaints back to the raw data quickly

TestLabIQ links orders, measurements, reports and changes so investigations don't stall on searching.

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This guide is editorial orientation and not an interpretation of the standard. Always check the current standard text and your accreditation body's requirements.