Standards › Standard 15 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · OPT-SOP-003 · Version 1.0 · Approved by the ASF Expert Committee
Supports: Standard 15 (Optical and Hearing), criterion 15.6
At a glance
- Each complaint about a product or service is recorded on OPT-FRM-005.
- Returns and replacements are handled as the complaints rule sets (INC-POL-002).
- Each complaint is reviewed, and the action is recorded.
- The patient is told the outcome.
- Stop and get help straight away if: a complaint about a product is not recorded or not answered.
1. Purpose
To learn from complaints about products and services, and act on them (15.6).
2. Scope
| Applies to | Clinical and support staff in the hospital |
| Locations | All wards, clinics and departments of the facility |
| When | Whenever the activity described is carried out |
| Does not apply to | Activities covered by another document listed in section 15 |
3. Definitions
| Term | Meaning |
|---|---|
| Clinical lead | The doctor or nurse in charge of the area at the time |
4. Background
To learn from complaints about products and services, and act on them (15.6).
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Practice manager | Owns the complaints route | Manager |
| Lead optometrist or audiologist | Reviews product complaints | Clinician |
6. Materials and equipment
| Item | Requirement | Condition |
|---|---|---|
| Records and forms named in this document | Current version | Checked before use |
7. Safety
- Stop and call for help if a patient is at immediate risk. Do not delay urgent care to complete paperwork.
8. Before you start
- Confirm the forms and equipment named in this document are available and current.
9. Procedure
Step 1. Record.
- Record each complaint on OPT-FRM-005 with the product.
Key point: Every complaint.
Step 2. Review and act.
- Review the complaint and act: return, replacement or change.
Key point: Reviewed, acted on.
Step 3. Tell the patient.
- Tell the patient the outcome.
Key point: Outcome told.
10. Decision points
- No decision points in this procedure.
11. Special situations
| Situation | Action |
|---|---|
| Out of hours | Follow the same steps. Use the on-call contact on the wall of the area. |
12. Escalation
- Any serious problem goes to the duty clinical lead at once and to the clinical director the same day.
13. Monitoring
| Measure | Target | Frequency | Owner | If not met |
|---|---|---|---|---|
| Complaints recorded and answered | 100% | Monthly | Practice manager | Escalate to chief executive |
14. Records
| Record | Kept in | Retention |
|---|---|---|
| Record named in this document | Patient record or the area file | the period set by the facility’s records policy years |
15. Training
- Staff are trained in this document at induction and refreshed each year, with a recorded competency check.
16. Related documents
| ID | Title | Use |
|---|---|---|
| OPT-FRM-005 | Product complaint record | Record |
| INC-POL-002 | Complaints and feedback (existing, reused) | Policy |
17. Evidence
| Reference | Note |
|---|---|
| E-009 | Based on the ASF Expert Committee consensus and the WHO World report on hearing (2021). |
| E-006 | ASF Policy Framework v1.2. Adapted. |
| E-009 | ASF Expert Committee consensus. |
18. Change history
| Version | Date | What changed | Approval |
|---|---|---|---|
| 1.0 | the date of approval | First version | set Expert Committee approval |
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References
- Accréditation Sans Frontières (2026). ASF Policy Framework v1.2. (E-006)
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)