1. Identification and Documentation of Non-Conformities
When a product, process, or component fails to meet specified requirements, it is considered nonconforming. Non-conformities may arise during manufacturing, inspection, testing, internal audits, or customer feedback.
The organization must:
- Identify nonconforming outputs promptly.
- Document the nature of the non-conformity, including evidence and where it was detected.
- Segregate or clearly mark the nonconforming product to prevent unintended use or delivery.
Records should include:ISO 13485 Certification services in Kuwait
- Description of the non-conformity
- Responsible personnel
- Actions taken (e.g., rework, scrap, return)
- Final disposition
2. Evaluation and Impact Assessment
Each non-conformity must be evaluated to determine:
- Its impact on safety, performance, and compliance
- Whether it affects previously delivered products
- Whether it reveals a systemic issue
If the non-conformity has a significant impact, the organization must notify relevant regulatory authorities and possibly initiate a recall.
3. Corrective Action Process (Clause 8.5.2)
When non-conformities indicate systemic issues, corrective action is required to eliminate the root cause and prevent recurrence. The process typically involves:
- Problem identification: Define the issue clearly.
- Root cause analysis: Use structured tools such as 5 Whys, Fishbone diagram, or FMEA to determine the underlying cause.ISO 13485 Certification process in Kuwait
- Action planning: Develop and implement a plan to correct and prevent recurrence.
- Implementation: Carry out the planned actions.
- Verification of effectiveness: Evaluate whether the corrective actions successfully eliminated the root cause.
Corrective actions must be appropriate to the risk associated with the non-conformity.
4. Preventive Action (Note)
While ISO 13485:2016 removed the standalone clause on preventive action, the risk-based approach throughout the standard encourages proactive identification of potential non-conformities and implementation of controls before they occur.
5. Review and Continuous Improvement
The effectiveness of the non-conformity and corrective action process is reviewed during:
- Internal audits
- Management reviews
- Regulatory inspections
This ensures continuous improvement of the QMS, in line with regulatory expectations and patient safety requirements.
Effective management of non-conformities and corrective actions is essential not only for compliance with ISO 13485 Implementation in Kuwait but also for maintaining product quality, patient safety, and regulatory approval.