ISO 13485 CERTIFICATION IN KUWAIT

ISO 13485 Certification in Kuwait

ISO 13485 Certification in Kuwait

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ISO 13485:2016 requires medical device manufacturers to establish and maintain processes for identifying, documenting, evaluating, ISO 13485 Certification cost in Kuwait and correcting non-conformities to prevent recurrence. This is addressed primarily under Clause 8.3 (Control of Nonconforming Product) and Clause 8.5.2 and 8.5.3 (Corrective Action and Preventive Action).

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.

 

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