HORIBA India Pvt. Ltd. completed the Surveillance – I audit for IOAS-accredited ISO 13485:2016 Certification Medical Devices – Quality Management System (QMS). The scope of the certification includes the Manufacture and Distribution of in – Vitro Diagnostic Reagents.
Along with this, HORIBA India Pvt. Ltd. can also go for ISO 9001:2015 Certification for Quality Management Systems (QMS) to eliminate duplication of errors and maintain consistent product quality. The organization can also apply for ISO 14001:2015 Certification for Environment Management Systems (EMS) to identify and mitigate business processes and activities that might cause negative environmental impacts and achieve sustainable growth.
HORIBA India Pvt. Ltd. can apply for ISO 45001:2018 Certification for Occupational Health and Safety Management Systems (OHSMS) to adopt appropriate health and safety standards to ensure employees’ safety.
What is ISO 13485:2016 Certification?
ISO 13485 is a universal standard that provides a framework for a quality management system (QMS) tailored to the medical device industry. The standard ensures that organizations consistently meet regulatory requirements for customer expectations concerning medical devices and related services. ISO 13485 emphasizes an organization to maintain regulatory compliance to ensure the products meet safety standards. The certification focuses on maintaining an effective QMS through risk management, process validation, and comprehensive documentation for traceability and accountability.
Benefits of ISO 13485 for HORIBA India Pvt. Ltd.
ISO 13485 standard offers a goldmine of benefits for HORIBA India Pvt. Ltd. These are:
- ISO 13485 ensures that medical devices produced by HORIBA India Pvt. Ltd. meet international safety and performance standards. Moreover, it facilitates smoother regulatory approval processes and saves time and cost.
- Compliance with ISO 13485 standard requirements demonstrate HORIBA India Pvt. Ltd.’s commitment to safety and quality, which is crucial for meeting the strict requirements of various regulatory bodies worldwide.
- Implementing ISO 13485 provides HORIBA India Pvt. Ltd. with a robust quality management system (QMS) to enhance product consistency and reduce defects. The standard focuses on improving product quality for better customer experience and overall product performance and reliability.
- ISO 13485 standard encourages continuous improvement, which helps HORIBA India Pvt. Ltd. to regularly refine its processes. Moreover, it promotes innovation and enables the organization to respond to changing market needs, thereby increasing customer trust and satisfaction.
Conclusion
HORIBA India Pvt. Ltd.’s achievement of IOAS-accredited ISO 13485:2016 Certification marks a significant milestone in its commitment to quality and regulatory compliance. Moreover, the ISO 13485 standard ensures that HORIBA India Pvt. Ltd. products meet international safety and performance measures by streamlining regulatory requirements and demonstrating its dedication to excellence.
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