Avantor Performance Materials India Pvt. Ltd. has completed the Surveillance – I audit and has received a favourable recommendation for the continuation of their IOAS-accredited ISO 13485:2016 (Medical Devices — Quality Management System). Moreover, the scope of the certification includes the Design & development, manufacturing, packaging, labelling and supply of in-vitro diagnostics kits and reagents for Immunochemistry (Rapid Card & ELISA), Clinical Biochemistry, Serology and Hematology; Labelling and Packaging of in-vitro diagnostic instruments (Hematology, clinical chemistry and immunochemistry analyzers) intended for Immunochemistry, Clinical Biochemistry and Hematology analysis.
Apart from this, Avantor Performance Materials India Pvt. Ltd. can also apply for ISO 41001:2018 Certification for Facility Management – Management System to efficiently deliver facility services to support the organization’s vision and mission. Moreover, the organization can apply for ISO 22301:2019 certification for Business Continuity Management System (BCMS) and ISO 37001:2016 Certification for Anti-Bribery Management System (ABMS) to adopt ethical and just business practices to ensure long-term growth organizational growth.
What is ISO 13485:2016 Certification?
ISO 13485:2016 Certification is an international standard for quality management system specifically designed for Medical Device manufacturers. It is also known as Medical Devices – Quality Management System (MD-QMS). The standard ensures that companies creating, producing, assembling, and maintaining medical equipment meet customer needs and legal requirements to assure users’ safety and well-being.
ISO 13485 certification concentrates on risk management to ensure product traceability and maintaining procedures to manufacture reliable and safe medical equipment. It closely adheres to other quality management standards like ISO 9001. However, it has additional requirements specific to the Medical Device Industry.
Benefits of ISO 13485:2016 for Avantor Performance Materials India Pvt. Ltd.
Avantor Performance Materials India Pvt. Ltd. can implement ISO 13485:2016 for Medical Devices – Quality Management System to ensure the devices manufactured by the organization are safe for use. The certification offers the following benefits for the organization:
- ISO 13485:2016 will help Avantor Performance Materials India Pvt. Ltd. readily access and compete in worldwide markets. The certification ensures the organization’s compliance with international regulatory standards and reduces the risk of non-compliance.
- ISO 13485 consistently ensures the safety and efficacy of medical devices by emphasizing risk management and stringent quality control. Additionally, the certification requirements strengthen the reputation of Avantor Performance Materials India Pvt. Ltd. by improving customer satisfaction and decreasing the frequency of product errors and defaults.
Conclusion
Avantor Performance Materials India Pvt. Ltd. received ISO 13485:2016 certification to streamline various manufacturing practices to ensure the supply of quality medical devices. It is a significant milestone for medical device manufacturers that maintain compliance with global regulatory standards to facilitate access to the worldwide market. ISO 13485:2016 validates the organization’s commitment to producing safe medical devices while contributing to long-term business success and sustainability in the healthcare industry.
