Our Accomplishments
ISO 22609:2004
ISO 22609:2004 describes a laboratory test method for measuring the resistance of medical face masks to penetration by a splash of synthetic blood.
ISO 13485:2016
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
ISO 9001:2015
It is often referred to as the certification against the ISO 9001:2015 standard. The “ISO” certificate is awarded to the organization for showing the compliance at the times of certification audits against the said standard.
The organization has to Establish, Document, Implement and Maintain and Monitor the management system before proceeding for the certification audit. The certification audit is conducted by the selected Certification Body or the Conformity Assessment Body. However, it is not mandatory to opt for the certification audit to implement the said standard.