Amol Pharmaceuticals Pvt. Ltd. has successfully completed the Surveillance – 01 audit and has received a favourable recommendation for the continuation of their UAF-accredited ISO 13485:2016 (Medical Devices – Quality Management System). Moreover, the scope of the certification includes the Design, Development, Manufacturing and Supply of Nasal Wash Kit.
Apart from this, Amol Pharmaceuticals Pvt. Ltd. can also apply for 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, customers and stakeholders with a more hassle-free and smooth facility system.
What is ISO 13485:2016 Certification?
ISO 13485 is an internationally recognized standard for Quality Management System (QMS) tailored for industries involved in the design, production, installation, servicing, and manufacturing of medical devices. The certification is a global benchmark for quality in the medical device industry. Achieving ISO 13485 certification enhances an organization’s credibility with regulators, stakeholders, and potential customers. As a result, the standard accelerates the organization’s product’s path to market.
ISO 13485 provides an organization with an appropriate risk management system to identify and eliminate potential threats. It also helps companies maintain documentation and traceability throughout the product lifecycle. It is aligned with regulatory requirements and supports compliance with international laws and regulations.
Benefits of ISO 13485 standard for Amol Pharmaceuticals Pvt. Ltd.
Amol Pharmaceuticals Pvt. Ltd. can obtain the following benefits by implementing ISO 13485:2016 certification. These are as follows:
- ISO 13485 aligns closely with global regulatory requirements and helps Amol Pharmaceuticals Pvt. Ltd. meet stringent medical device standards of international markets.
- The standard requires Amol Pharmaceuticals Pvt. Ltd. to adhere to legal and standard quality regulations to avoid legal complications. As a result, it reduces the risk of product defects to ensure that medical devices are safe and effective for patient use.
- Implementing ISO 13485 within Amol Pharmaceuticals Pvt. Ltd. streamlines quality management processes. Hence, it leads to better documentation, risk management, and operational consistency.
Conclusion
Amol Pharmaceuticals Pvt. Ltd. received ISO 13485:2016 certification to demonstrate its commitment to quality and regulatory compliance in the medical device industry. Moreover, this certification not only strengthens the organization’s position in the global market but also ensures the safety and effectiveness of its products.
