Health Arx Technologies Pvt. Ltd. completed the initial audit for IAS-accredited ISO 9001:2015 Certification for Quality Management System (QMS).
The scope of the certification includes the Design and Development (Hardware and Software), Sales and Marketing and Post Sales Support of Blood Glucose Meter (Capillary Based Blood).
Along with this, Health Arx Technologies Pvt. Ltd. can also apply for ISO 13485:2016 Certification for Medical Devices – Quality Management System (MD-QMS) to deliver safe and quality medical devices to customers. The organization can obtain Good Manufacturing Practices (GMP) and ISO 41001:2018 Certification Facility Management – Management System.
What is ISO 9001:2015 Certification?
ISO 9001:2015 is a universal quality standard that enables organizations to implement an effective Quality Management System (QMS). Moreover, it is a process-oriented certification rather than a product-oriented one that allows an organization to manage shortcomings and inefficiencies at the root level. The certification helps to minimize risks and maximize profits by assisting organizations in implementing and maintaining the highest quality standards to meet customers’ needs and requirements.
Benefits of ISO 9001:2015 Certification for Health Arx Technologies Pvt. Ltd.
The following are the benefits of ISO 9001:2015 certification for Health Arx Technologies Pvt. Ltd. These are :-
- ISO 9001:2015 enables Health Arx Technologies Pvt. Ltd. to adopt an appropriate risk management strategy to ensure the delivery of safe and quality medical devices to ensure patients’ safety and well-being.
- The standard aims to improve the overall process efficiency of Health Arx Technologies Pvt. Ltd. by identifying and eliminating potential risks and inefficiencies.
- ISO 9001 assists Health Arx Technologies Pvt. Ltd. in maintaining compliance with all national and international medical device requirements. Hence, it helps the organization avoid regulatory fines and penalties and creates a positive brand image in the market.
Conclusion
Health Arx Technologies Pvt. Ltd. achieved IAS-accredited ISO 9001:2015 certification to streamline various internal business processes and manufacture safe and quality medical devices. However, implementing the quality requirements mentioned in ISO 9001 enables the organization to identify and eliminate processes that might cause errors and duplication of efforts.
