Quality is key success factor to us, thus, we have implemented the ISO13485:2016, ISO 9001:2007, ISO 14001:2004 & Qhsas 18001:2007
What is the ISO 13485:2016 certificate?
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.
What is the ISO 9001:2007 certificate?
- The ISO 9001:2007family of quality management systems standards is designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product. ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles upon which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill.
We have taken a further step we have also implemented the ISO 14001:2001 and QHSAS 18001:2008. This step came as reason from our social responsibility social and environmental responsibility.
What the ISO 14001 and Qhsas certificates are?
- ISO 14001:2004 sets out the criteria for an environmental management system and can be certified to. It does not state requirements for environmental performance, but maps out a framework that a company or organization can follow to set up an effective environmental management system. It can be used by any organization regardless of its activity or sector. Using ISO 14001:2004 can provide assurance to company management and employees as well as external stakeholders that environmental impact is being measured and improved.
- OHSAS 18001:2007 is an internationally applied British Standardfor occupational health and safety management systems. It exists to help all kinds of organizations put in place demonstrably sound occupational health and safety performance. It is a widely recognized and popular occupational health and safety management system.
