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iso 13485 certification

ISO 13485:2016 is a Quality Management System standard for Medical Devices, has been harmonized with European Medical Devices Directives i.e MDD, AIMDD, and IVDD. EN ISO 13485:2012 is now updated as ISO 13485:2016, in the EU Official Journal, with the date of u2018cessation of presumption of conformity of EN ISO 13485:2012 stated as 31 March 2019.

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iso 13485 certification

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  1. ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) specifically for organizations involved in the medical device industry. This standard focuses on meeting regulatory requirements and ensuring the consistent quality of medical devices throughout their lifecycle, from design and production to installation and servicing. Importance of ISO 13485 Certification Achieving ISO 13485 certification is crucial for organizations in the medical device sector. It demonstrates a commitment to quality and regulatory compliance, ensuring that products are safe and effective for patients. Certification can facilitate market access, especially in regions where regulatory bodies require compliance with ISO standards before granting approvals. Benefits of ISO 13485 Certification 1.Regulatory Compliance: ISO 13485 helps organizations adhere to regulatory requirements, reducing the risk of non-compliance and associated penalties. 2.Enhanced Product Quality: By implementing a robust QMS, organizations can improve product quality, leading to reduced defects and recalls. 3.Increased Market Opportunities: Certification can enhance a company’s reputation, making it more competitive and attractive to customers and partners in the medical device market. 4.Risk Management: The standard promotes proactive risk management practices, ensuring that potential issues are identified and addressed before they affect product quality or safety. Steps to Achieve ISO 13485 Certification 1.Training and Awareness: Educate staff on ISO 13485 requirements and the importance of a quality management system in the medical device industry. 2.Conduct a Gap Analysis: Assess current practices against ISO 13485 standards to identify areas needing improvement. 3.Develop and Implement a QMS: Create and implement a quality management system tailored to the organization’s specific processes and regulatory requirements. 4.Internal Audits: Regularly evaluate the effectiveness of the QMS through internal audits to identify non-conformities and opportunities for improvement. 5.Certification Audit: Engage a third-party certification body to conduct an official audit and achieve ISO 13485 certification. Conclusion ISO 13485 certification is essential for organizations in the medical device industry committed to maintaining high-quality standards and regulatory compliance. By investing in this certification, companies can enhance product safety, improve market competitiveness, and ultimately contribute to better patient outcomes.

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