Understanding ISO 17025 Clause 7.9 - Complaints

7.9

Understanding Complaints – Why They Matter in an Accredited Laboratory

Complaints are an unavoidable part of professional laboratory work. Even the most competent, well‑managed and technically strong laboratories will receive complaints at some point. Clause 7.9 ensures that complaints are handled in a structured, transparent and impartial manner. A complaint is not a sign of failure — it is a sign of engagement. It shows that clients care about the work, the service and the outcomes. How a laboratory responds determines whether trust is strengthened or damaged.

A complaint is any expression of dissatisfaction relating to the laboratory’s activities. It may involve turnaround time, communication, staff behaviour, reporting clarity, perceived impartiality, or the validity of results. Clause 7.9 requires laboratories to treat every complaint seriously, regardless of its tone or origin. Complaints must be acknowledged, documented, investigated and resolved in a way that protects both the client and the laboratory.

The purpose of Clause 7.9 is to ensure that complaints do not become hidden issues. A complaint that is ignored becomes a risk. A complaint that is mishandled becomes a reputational threat. A complaint that is addressed professionally becomes an opportunity for improvement. Laboratories that embrace Clause 7.9 demonstrate maturity, accountability and transparency.

The core principle: complaints are not interruptions — they are quality inputs. They reveal gaps, highlight misunderstandings, expose weaknesses and identify opportunities for better communication. Clause 7.9 ensures that laboratories respond with professionalism, impartiality and technical discipline.

Receiving and Recording Complaints – Capturing the Full Picture

Clause 7.9 requires laboratories to receive and record complaints in a structured, traceable and transparent manner. The way a complaint is captured determines the quality of the investigation that follows. A complaint that is poorly recorded cannot be properly resolved. A complaint that is accurately documented becomes a reliable source of information.

Receiving a complaint begins with listening. Technicians and administrative staff must remain calm, respectful and professional. Defensive behaviour escalates tension and damages trust. Clause 7.9 requires laboratories to acknowledge complaints promptly, ensuring clients feel heard and respected.

Recording a complaint requires accuracy and completeness. Laboratories must document:

  • The nature of the complaint
  • The date and time it was received
  • The person who received it
  • The complainant’s details
  • The specific laboratory activity involved
  • Any supporting evidence provided
  • Initial observations or context
  • The steps taken to acknowledge the complaint

Records must be clear, factual and free from emotional language. Complaints must be logged in a controlled system — not in personal notebooks or informal communication channels. Proper documentation ensures traceability, protects impartiality and supports consistent handling.

Clause 7.9 emphasises that complaints must be treated as formal quality events. They must be captured with the same discipline applied to nonconformities, corrective actions and technical records. A well‑documented complaint is the foundation of a fair, objective and defensible investigation.

Investigating Complaints – Objective, Evidence‑Based and Impartial

Investigating complaints is one of the most sensitive responsibilities in an ISO/IEC 17025 laboratory. Clause 7.9 requires investigations to be objective, evidence‑based and free from bias. The goal is not to defend the laboratory — it is to understand the issue fully and respond fairly.

An investigation begins by reviewing the complaint record. The laboratory must determine whether the complaint relates to its activities and whether it involves technical work, communication, turnaround time, staff behaviour or perceived impartiality. Investigations must be thorough and must consider all relevant evidence: technical records, reports, communication logs, environmental conditions, equipment performance, staff actions and method behaviour.

Investigators must remain impartial. Personal opinions, assumptions or defensiveness compromise the process. Clause 7.9 requires laboratories to identify whether the complaint reveals a nonconformity, a misunderstanding, a communication gap or a process weakness. Investigations must determine whether corrective action is required and whether the issue affects other results or clients.

Findings must be documented clearly and factually. Laboratories must avoid vague statements or unsupported conclusions. The investigation record must show what was reviewed, what was found and what decisions were made. Transparency protects credibility.

Clause 7.9 ensures that investigations are not rushed, superficial or biased. They must be technically sound, professionally executed and aligned with the quality system. A well‑conducted investigation strengthens trust and demonstrates accountability.

Communicating Outcomes – Clarity, Honesty and Professionalism

Once a complaint has been investigated, Clause 7.9 requires laboratories to communicate the outcome to the complainant clearly, respectfully and completely. The way a laboratory communicates the outcome often matters more than the complaint itself. Professional communication strengthens trust; poor communication destroys it.

The response must explain:

  • What was investigated
  • What evidence was reviewed
  • What findings were made
  • Whether corrective action is required
  • What actions will be taken
  • Whether the complaint affects other results
  • How the laboratory will prevent recurrence

Responses must be factual, respectful and free from defensive language. Even when the laboratory is not at fault, communication must remain empathetic and professional. Clients must feel that their concerns were taken seriously and addressed thoroughly.

Clause 7.9 requires laboratories to avoid vague or incomplete responses. Statements such as “We will look into it” or “The matter is resolved” are insufficient. Clients must understand the full outcome. Transparency protects credibility and reduces the likelihood of escalation.

Communication must be documented. The laboratory must record what was communicated, when it was communicated and to whom. These records support traceability and demonstrate compliance during audits.

Clause 7.9 ensures that complaint outcomes are communicated with clarity, honesty and professionalism. A well‑handled complaint strengthens relationships and reinforces trust in the laboratory’s competence and integrity.

Technician and Management Responsibilities – Professional Conduct and Accurate Records

Technicians and management play critical roles in the complaint process. Clause 7.9 emphasises that complaints must be handled with professionalism, impartiality and technical discipline. The behaviour of staff determines whether complaints escalate or resolve smoothly.

Technicians often receive complaints first. Their responsibilities include:

  • Listening respectfully and without defensiveness
  • Avoiding arguments or emotional reactions
  • Documenting complaints accurately and completely
  • Recording facts, not opinions
  • Escalating complaints promptly
  • Maintaining confidentiality
  • Always remaining impartial

Technicians set the tone for the entire process. A respectful, calm and professional response builds trust and prevents escalation.

Management carry the responsibility of overseeing investigations and authorising outcomes. Their responsibilities include:

  • Ensuring investigations are objective and evidence‑based
  • Verifying that records are complete and traceable
  • Confirming that responses are clear, factual and professional
  • Ensuring corrective actions are implemented when required
  • Protecting impartiality throughout the process
  • Ensuring the complaint process aligns with the quality system

Management provide the authoritative assurance that the complaint was handled correctly. Their involvement demonstrates accountability and reinforces the laboratory’s commitment to transparency.

Together, technicians and management form a dual‑layer defence that protects the integrity of the complaint process. Clause 7.9 ensures that complaints are not ignored, minimised or mishandled — they are addressed with professionalism, clarity and technical competence.

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