ISO/IEC 17025 clause 7.9: handle laboratory complaints impartially
Clause 7.9 requires a documented process for receiving, evaluating and deciding complaints. The laboratory must determine whether the complaint concerns activities for which it is responsible and, if so, address it. It remains responsible for decisions throughout the process, including where external help is used.
What clause 7.9 requires in practice
Clause 7.9 asks the laboratory to run a documented process to receive, evaluate and decide on complaints. On receipt, the laboratory checks whether the complaint concerns laboratory activities it is responsible for and, if so, deals with it. It owns every decision at every level of the process.
The process description is available to interested parties on request. At minimum it explains how complaints are received, validated, investigated and decided, how complaints and the actions taken are tracked and recorded, and how the laboratory ensures that appropriate action actually happens. The laboratory gathers and verifies the information needed to validate the complaint.
Where possible, it acknowledges receipt, reports progress and communicates the outcome. The outcome is made by, or reviewed and approved by, people who were not involved in the original work, and the standard notes that this can be external personnel. Where possible, formal notice of closure is given.
Make the process accessible and substantive
A description of the complaint-handling process must be available to interested parties on request. The process must cover receipt, validation, investigation, decisions and appropriate action, with tracking and records. Recognise the substance of dissatisfaction rather than insisting on a particular label before considering it.
Gather and verify the information necessary to validate the complaint. This does not mean the complainant must already prove the laboratory was wrong. Review relevant contracts, technical records and communications, and distinguish an error, a misunderstanding and a disagreement with a technically supported result.
Protect independence in the outcome
The outcome communicated to the complainant must be decided by, or reviewed and approved by, people not involved in the original laboratory activities concerned. External personnel can perform this role where appropriate. This is a specific independence requirement, not merely a suggestion to be polite.
For a small laboratory, plan how that independent review will be obtained. The person investigating technical detail may need input from those who performed the work, but the required outcome decision or approval cannot simply be left to the same involved individual without the prescribed independent involvement.
Communicate and close appropriately
Whenever possible, acknowledge receipt, provide progress information and communicate the outcome. Whenever possible, provide formal notice that handling has ended. The standard does not impose one universal response deadline; establish workable expectations and meet applicable contractual or regulatory requirements.
Preserve confidentiality, including information from third-party sources. If investigation identifies nonconforming work or a system cause, apply the relevant work-control and corrective-action processes. Closing the complaint correspondence does not remove those technical duties.
Why impartial complaint handling matters to the business
A complaint is a customer telling the laboratory something went wrong, often before it threatens the relationship. Handled well, it is one of the cheapest sources of improvement. Handled badly, it turns a technical question into a reputational one.
The independence requirement matters commercially. A customer who sees that the person who made the disputed call also judges the dispute will rarely accept the answer. Independent review gives the outcome credibility, and the record of tracking and closure gives the laboratory evidence that it acts on feedback. Assessors also treat complaint handling as a window into how accurate the whole system is.
How to implement clause 7.9
Build the process around how complaints actually arrive, including informal ones, rather than around a form. Small laboratories often find independence the hardest part, so plan it early. The same routine should cope with a courteous query and a formal dispute, with the same fairness and record in each case.
- Write a short description of the complaint process that can be given to any interested party who asks for it.
- Decide how staff recognise a complaint in an email, call or meeting, whatever words the customer uses.
- Set up a single log that records each complaint, the investigation, the decision and the actions taken.
- Define who gathers and verifies the facts, and make sure that person has access to contracts, technical records and communications.
- Arrange independent review of every outcome, for example a manager from another area or an external reviewer for a small laboratory.
- Agree how acknowledgement, progress updates and the formal closing notice are sent, and link findings to nonconforming work and corrective action.
Two illustrative complaints
A construction customer disputes a result because it delays a project. The laboratory checks the method, records and agreed decision basis, obtains the required independent outcome review and explains the supported conclusion. Commercial pressure does not justify changing the result merely to resolve dissatisfaction.
A calibration customer reports that a certificate contains the wrong equipment identity. The laboratory investigates the record trail, evaluates whether other results are affected and issues any necessary correction through controlled reporting. It records the complaint and action instead of treating the issue only as a customer-service email.
Evidence and common weaknesses
Retain the complaint, relevant information, investigation, decisions, actions and communication through the tracking process. Ensure the independent outcome review is identifiable. A separate complaints committee is not mandatory, but an effective arrangement is.
Avoid requiring customers to use a complex form before acknowledging a genuine issue, allowing the original analyst to approve the outcome alone, or promising that every complaint will be upheld. A credible process is fair, evidence-based and clear about the technical basis of its response.
Frequently asked questions
Must someone independent investigate every detail of the complaint?
The specific requirement concerns the outcome: it must be made by, or reviewed and approved by, individuals not involved in the original laboratory activities concerned.
Can a small laboratory use an external reviewer?
Yes. The standard recognises external personnel for the required independent outcome role, while the laboratory retains responsibility for the complaint-handling decisions and process.
Does a complaint automatically mean the result is wrong?
No. Investigate and verify the relevant information. The outcome may confirm the result, identify an error or reveal a communication problem, with appropriate action based on evidence.
Turn this requirement into reliable laboratory practice
Sterling can help design a complaint route that works for your laboratory size and responsibilities. Bring a typical disputed-result scenario to a free consultation to clarify investigation, independent review and customer communication.
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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