WELDON BIOTECH (INDIA) PRIVATE LIMITED completed the initial audit for IOAS-accredited ISO 13485:2016 Certification for Medical Devices – Quality Management System (MD – QMS).
The scope of the certification includes the Trading, Supply, Installation and After Sales Service of 3 Part Hematology Analyzer, Clinical Chemistry Analyzer, Electrolyte Analyzer and Fully Automatic Chemistry Analyzer.
Apart from this, WELDON BIOTECH (INDIA) PRIVATE LIMITED can also apply for ISO 9001:2015 Certification for Quality Management System (QMS) and ISO 14001:2015 Certification for Environmental Management System (EMS) to adopt eco-friendly manufacturing practices and achieve sustainable growth.
The organization can apply for ISO 41001:2018 Certification for Facility Management – Management System to provide clients and customers more hassle-free and smooth facility system.
What is ISO 13485:2016 Certification?
ISO 13485:2016 is a globally recognized quality management system (QMS) standard tailored for the medical device industry. The standard covers the design, production, installation, servicing, and manufacturing of medical devices. ISO 13485 is a benchmark for quality to enhance organizational credibility with regulators, stakeholders, and customers.
ISO 13485 certification helps organizations streamline their product’s path to market by ensuring compliance with international laws and regulations. The standard provides a robust risk management framework to identify and address potential threats while maintaining thorough documentation and traceability throughout the product lifecycle. It aligns with regulatory requirements by supporting adherence to global quality and safety standards.
Benefits of ISO 13485:2016 standard for WELDON BIOTECH (INDIA) PRIVATE LIMITED
WELDON BIOTECH (INDIA) PRIVATE LIMITED can obtain the following benefits by implementing ISO 13485:2016 certification. These are as follows:
- ISO 13485:2016 aligns closely with global regulatory requirements and helps WELDON BIOTECH (INDIA) PRIVATE LIMITED meet strict medical device standards of international markets.
- The standard requires WELDON BIOTECH (INDIA) PRIVATE LIMITED to comply with the legal and standard quality regulations to avoid legal complications. As a result, it eliminates the risk of product defects to ensure that medical devices are safe and effective for patient use.
- ISO 13485 implementation within WELDON BIOTECH (INDIA) PRIVATE LIMITED streamlines quality management processes. Hence, it promotes better documentation, risk management, and operational consistency.
Conclusion
WELDON BIOTECH (INDIA) PRIVATE LIMITED received ISO 13485:2016 certification to highlight its commitment to quality and regulatory compliance in the medical device industry. Moreover, ISO 13485 certification strengthens the organization’s position in the global market and ensures the safety and effectiveness of its products.
 PRIVATE LIMITED for obtaining IOAS-accredited ISO 13485:2016 Certification.){kind=link}