ISO 13485:2016 Quality Management Systems Certification

ISO 13485:2016 is the global standard for quality management systems (QMS) specific to the medical devices industry. It applies to organizations involved in the entire lifecycle of a medical device, including design, production, storage, installation, and servicing, as well as related activities like technical support.

Benefits of ISO 13485:2016 Certification:

• Compliance: Ensures adherence to regulatory requirements.
• Risk Management: Identifies and mitigates risks associated with medical devices.
• Quality Improvement: Enhances the reliability and safety of medical devices.
• Market Access: Facilitates entry into global markets by meeting international standards.

Our Approach: At Zetcon ISO International, we guide you through the certification process with a comprehensive approach:

1. Initial Assessment:Evaluating current processes and identifying gaps.
2. Documentation: Developing necessary documentation and procedures.
3. Implementation: Assisting with the implementation of new quality management practices.
4. Internal Audit: Conducting audits to ensure compliance and readiness.
5. Final Certification Audit: Preparing for the final audit by an accredited body.

Our expert consultants offer tailored solutions to meet your specific needs, ensuring a smooth certification process.