The 80000sqm Jiangxi Risun Technology Industrial Park, which cost 300 million to build, successfully applied ISO13485:2016 Medical Devices Quality System and ISO9001:2015 Quality Management System in January 2020.
What is ISO13485
Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485.
Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.
What is ISO9001:2015
ISO 9001:2015 specifies requirements for a quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
An oral/dental health care product manufacturer having such a strict system certification of ISO13485:2016, it significantly set up a new, high and strict standard for the industry. It will promote the development of oral care products, such as electric toothbrush and water flosser in the direction of health and safety. It is a new era Chinese enterprise style of strict self-discipline and honest operation based on the concept of high attention and responsibility to products, customers and consumers. At the same time, it is also to implement the enterprise spirit of "Integrity & Reliable. Proficient & Excellent", and practice the enterprise mission of "Continuously to provide innovation oral/dental health products for families".
Risun Technology will constantly provide customers with more perfect and aggressive market products in trending appearance, better function and higher quality!