ISO 15189:2022 · Section 7 · Process requirements
Clause 7.7: Complaints
Check the exact requirement in your licensed copy of the standard.
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What this clause is about
Complaints provide information about how laboratory services affect patients, clinicians and other users. A useful process makes concerns easy to raise and handles them consistently, whether received by telephone, email, a clinical meeting or a formal letter. Staff should recognize a complaint even when the person raising it does not use that word. Explain how concerns can be submitted and what the laboratory will do with them, without creating unnecessary administrative barriers.
Record the concern, establish whether it relates to laboratory activities and identify any immediate patient-safety issue. A complaint about a delayed urgent result may require immediate clinical contact before the full investigation begins. Assign an owner, gather relevant records and distinguish verified facts from assumptions. Protect confidential information while obtaining enough detail to understand the problem. Where several organizations are involved, coordinate the response without leaving the complainant to navigate internal boundaries alone.
Fairness matters as much as speed. People who review and approve the outcome should not have been involved in the original activity under complaint. A small laboratory may need an appropriate independent colleague or external arrangement. Keep the complainant informed as appropriate, explain the outcome clearly and communicate completion. Do not promise a fixed resolution date when an investigation genuinely needs more time; instead explain the next update.
Review complaints together to identify recurring service weaknesses, communication gaps or inequitable access. Not every complaint proves a nonconformity, but each deserves assessment. Where a failure is confirmed, connect it to corrective action and check whether the action worked. LabToolkit Pro can support complaint forms, investigation records and controlled response procedures while the laboratory determines fair decisions and appropriate follow-up.
What assessors typically ask to see
- How can a patient or service user learn how to complain without needing a personal contact inside the laboratory?
- How do staff recognize urgent safety concerns and escalate them while the broader complaint is being investigated?
- Can a completed complaint demonstrate receipt, factual investigation, progress communication and a clearly communicated outcome?
- Who reviews and approves the outcome, and how is independence from the original activity demonstrated?
- How are repeated complaints translated into service improvement rather than treated as unrelated individual incidents?
Documents and records that usually provide evidence
- Accessible complaints procedure describing submission channels, responsibilities, investigation stages and communication arrangements.
- Complaint register with receipt dates, assigned owners, current status and links to supporting investigation records.
- Investigation notes separating the reported concern, verified facts, patient impact and reasons for the decision.
- Outcome review records identifying an approver who was not involved in the activity under complaint.
- Correspondence documenting appropriate acknowledgement, progress updates, outcome communication and notice of completion.
- Trend reviews linking recurring complaints to improvement decisions, corrective actions and follow-up effectiveness checks.
Ready-made forms mapped to clause 7.7: Customer Complaint Form, Complaints Register.
Common findings to avoid
- Recording only written formal complaints while excluding concerns received by telephone or through clinical teams.
- Allowing the person responsible for the disputed activity to approve the final complaint outcome alone.
- Closing complaints when a reply is sent without considering whether an underlying service failure needs action.
- Including unnecessary patient information in widely circulated complaint summaries or management meeting attachments.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 7.7 becomes effective, it counts as direct evidence on the readiness dashboard for ISO 15189:2022; links from other standards through the crosswalk are shown separately as indicative coverage. Gaps appear clause by clause, so you can see which parts of 7.7 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Must every complaint become a corrective action?
No. Investigate the concern and decide whether a failure occurred. A misunderstanding may need explanation or better communication, while a confirmed recurring failure may require root-cause investigation and a documented effectiveness check.
Can an anonymous complaint be investigated?
Yes, where sufficient information is available. Record the limits caused by missing details, assess any credible safety concern and investigate available evidence. Lack of contact information may prevent updates but does not remove the value of the concern.
How should small laboratories arrange independent review?
Use a competent person who was not involved in the activity, potentially through an agreed external arrangement. Address confidentiality, access to evidence and decision authority before a complaint requires urgent review.
Check the exact requirement in your licensed copy of the standard.
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