GIGALAB® completed the Re-Certification audit for IOAS-accredited ISO 13485:2016 Certification for Medical Devices – Quality Management System (MD – QMS). Moreover, the scope of the management system includes the IVD Products (Rapid Tests, Culture Media Ready to use, Immumoanalyse Reagents) and Laboratory Equipment’s Assembling (Microscopes, hematology and Biochemistry Analysers).
Apart from this, GIGALAB® can also apply for ISO 14001:2015 Certification for Environmental Management System (EMS) to adopt eco-friendly practices and achieve sustainable growth. The organization can also apply for ISO 41001:2018 Certification for Facility Management—Management System and Good Manufacturing Practices (GMP) Certification 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 systems (QMS) designed specifically for medical device design, production, installation, servicing, and manufacturing. The certification is a global benchmark for quality within the medical device sector. ISO 13485:2016 certification boosts an organization’s credibility with regulators, stakeholders, and potential clients by streamlining the pathway for products to reach the market.
ISO 13485 standard provides a robust framework for risk management and enables organizations to identify and mitigate potential threats effectively. It also ensures companies can maintain thorough documentation and traceability across the entire product lifecycle. ISO 13485 aligns with regulatory requirements by facilitating compliance with international laws and regulations.
Benefits of ISO 13485:2016 standard for GIGALAB®
ISO 13485:2016 certification offers the following benefits for GIGALAB®. These are as follows:
- ISO 13485 aligns with global regulatory requirements and supports GIGALAB® in meeting the strict medical device standards required in international markets.
- The standard ensures that GIGALAB® complies with legal and quality regulations by reducing the risk of legal issues. It enables the organization to adhere to standard requirements to minimize product defects and ensure that medical devices are safe and effective for patients.
- ISO 13485 helps GIGALAB® optimize quality management processes by improving documentation, strengthening risk management, and achieving greater operational consistency.
Conclusion
GIGALAB® obtained ISO 13485:2016 certification to showcase its dedication to quality and regulatory compliance in the medical device industry. This certification enhances the organization’s standing in the global market by ensuring the safety and effectiveness of its products.
