Procedure · SOP-07
Complaints Handling
Receipt, validation, investigation, response and closure of complaints, independent of the people involved.
Purpose
To define how the Laboratory receives, acknowledges, validates, investigates, resolves and closes complaints in a way that is independent of the persons involved in the original work, and how complaints are used to improve the management system.
What is inside
11 sections, about 3 pages when printed.
- 1. Purpose
- 2. Scope
- 3. References
- 4. Definitions
- 5. Responsibilities
- 6. Process overview
- 7. Procedure
- Records generated by this procedure
- Monitoring and performance indicators
- Assessment readiness notes
- Related documents
Records it generates
Applying this procedure produces the following records, which are the evidence an assessor samples.
- –Complaints log
- –Complaint investigation reports with evidence, review and response
- –Correspondence with the complainant
- –Associated CAR and nonconforming work records
What an assessor looks for
The document closes with these points, so you can check your own practice before someone else does.
- –Whether the process description is genuinely available to interested parties (website, terms of business).
- –Whether every complaint in the period, including verbal ones and those handled by sales staff, appears in the log.
- –Whether the investigator and the person approving the outcome were independent of the original work, and how that is evidenced.
- –Whether the complainant was told when handling ended.
- –Whether an upheld technical complaint led to an impact assessment on other results.
Before you use it
- Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
- Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
- Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
- Record the document in your own document register and set its review date.
- Delete the assessment readiness notes if you do not want them in your controlled version; they are guidance for you, not requirements.
Related documents
- QM-01
Quality Manual
Top-level description of the management system against every clause of ISO/IEC 17025:2017.
- FRM-11
Complaints Log
Register of complaints received, validation outcome, owner, status and closure.
- FRM-12
Complaint Investigation Report
Investigation, findings, response to complainant and independent review of a complaint.
- CHK-01
ISO/IEC 17025:2017 Gap Analysis and Self-Assessment
Clause-by-clause self-assessment with evidence, gap and action columns.
- SOP-01
Control of Documents
Creation, review, approval, issue, change and withdrawal of internal and external documents.
- SOP-02
Control of Records and Technical Records
Identification, storage, protection, retention, amendment and disposal of quality and technical records.
- SOP-03
Internal Audit
Planning, conducting, reporting and following up internal audits of the management system and technical activities.
- SOP-04
Management Review
Annual top-management review with every input and output the standard requires.