ISO 13485 CERTIFICATION IN KUWAIT

ISO 13485 Certification in Kuwait

ISO 13485 Certification in Kuwait

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Our organization has established a comprehensive system for the control of documents and records in compliance with ISO 13485 Certification cost in Kuwait, Clauses 4.2.4 (Control of Documents) and 4.2.5 (Control of Records). This ensures that all documents and quality records relevant to our Quality Management System (QMS) are properly approved, updated, distributed, and retained.

Control of Documents


We maintain a Document Control Procedure that governs the creation, approval, distribution, revision, and archiving of all controlled documents within the QMS, including:

  • Quality Manual


  • Standard Operating Procedures (SOPs)


  • Work Instructions


  • Forms


  • Drawings and specifications


The key principles of our document control process include:

  1. Approval Before Use
     All documents are reviewed and approved by authorized personnel for adequacy before release. Each document includes a version number, revision history, approval signatures, and effective date.


  2. Revision and Updating
     When changes are needed, documents are reviewed, revised,ISO 13485 Certification services in Kuwait  and re-approved following a controlled process. The most current version is available to all relevant personnel, and obsolete versions are promptly removed from points of use to avoid confusion.


  3. Access and Distribution
     Documents are distributed electronically through a centralized document management system with controlled user access. Printed copies, if used, are marked as “Controlled Copy” and are tracked manually.


  4. External Documents
     Documents of external origin (e.g., customer standards, regulatory guidelines) are identified and controlled in the same manner to ensure their relevance and accuracy.



Control of Records


Records serve as objective evidence of conformity to requirements and the effective operation of our QMS. All quality records are managed according to our Record Control Procedure, which ensures:ISO 13485 Certification process in Kuwait

  1. Identification and Traceability
     Each record includes details such as title, document number, version, and the person responsible. Records are traceable to the process, product, or activity they support.


  2. Protection and Retrieval
     Records are stored in a secure and organized manner—either electronically with backups or in locked physical storage. They are easily retrievable for internal use, audits, or regulatory inspections.


  3. Retention and Disposal
     Retention periods are defined based on regulatory requirements and company policy (e.g., a minimum of 5–15 years for medical device records). Disposal of records is controlled and documented to ensure confidentiality and compliance.



Audit and Monitoring


Both document and record control processes are regularly reviewed during internal audits and Management Review Meetings. Any identified nonconformities lead to corrective actions and process improvements.

By enforcing strict control of documents and records, we ensure consistency, traceability, and full compliance with ISO 13485 Implementation in Kuwait, supporting the integrity of our Quality Management System.

 

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