Certifications
Zero Defects: Achieving Excellence in Quality Management.
ISO 9001:2015
for Quality Management Systems
Our ISO 9001:2015 shows our commitment to having robust quality assurance systems in our company. This international standard seeks to promote standardization and quality in all our products, services, processes, customer satisfaction, efficiency, and risk management in all our operations. It guides various improvement processes that help the company meet changing market needs and customers’ expectations.
ISO 14001:2015
for Environment Management Systems
As an ISO 14001:2015 certified company, our objective is to minimize any adverse effect on the surroundings. This supports the fact that we understand the need to do something about the environment, conserve resources, and provide legal compliance with environmental factors. It is an environmentally friendly process as well as self-promoting and may be inviting greater cost efficiency due to the efficiency grant.
IATF 16949:2016
for Automotive Quality Management Systems
Our IATF 16949:2016 certification shows our determination to comply with the high-quality standards set by the automotive sector. This certification emphasizes the development of a process-oriented quality management system that provides for continual improvement, defect prevention and reduction of variation and waste in the supply chain. They offer our automotive clients the assurance that our products conform to the industry’s highest standard of quality, reliability, and performance.
ISO 13485:2016
for Medical Quality Management Systems
Certified to ISO 13485:2016, it will ensure that quality management for medical devices is international, for the highest standard is expected. This certification proves our interest in patient safety and guarantees compliance with the known regulatory standards of our medical devices. It also offers a guide to risk management, improvement, and standardization of products to instill confidence in our customers in the use of our medical devices.
China Food and Drug Administration (CFDA) Approval
Our CFDA approval demonstrates our commitment to meeting the regulatory requirements for the sale and distribution of our products in China. This approval allows us to access the Chinese market and provides our customers in China with the assurance that our products meet the required safety and quality standards.
Council Directive 93/42/EEC
Compliance with Council Directive 93/42/EEC guarantees that the medical devices supplied by our company meet the essential requirements for the safety and health of medical devices in the European Union. This compliance allows us to market our medical devices in Europe and reassures our European consumers that our products are safe to use.
UKCA Certification
The UKCA (UK Conformity Assessed) mark is a conformity mark that was introduced after Brexit. It indicates that our products comply with British regulations. It allows us to market our products in UK and reassures our UK consumers that our products are safe to use.
