We are pleased to inform you that our company has successfully passed the ISO 9001:2008 -of quality management system- and ISO 13485 -specific quality norm for medical devices- certification audit.
The audit was conducted by the Argentinian Institute for Standardization and Certification (IRAM) under the scope “Manufacturing and sale of ethylene oxide cartridges and ampoules, sterilization indicator inks, chemical indicators for sterilization in strips, tapes and adhesive labels and sterilization packaging”.
This certification is accredited by OAA (Argentine Accreditation Agency) and IQNet (the largest international network of certification bodies worldwide).
Achieving these certifications demonstrates that the organization complies with internationally recognized standards and their application involves systematizing processes and continuous improvement, especially oriented to customer satisfaction and to achieving safe and effective products.
We want to share the satisfaction of this achievement, result of the work of our staff in all areas, as it has been the target aim in order to be closer to our customers by providing quality products. Thus it reaffirms our commitment to quality since we are now the first and only company in the Argentinean market which has achieved ISO 13485 certification for the manufacturing of ethylene oxide cartridges and ampoules and sterilization packaging.
EFELAB privileges customer satisfaction, for it has been proposed that products and services provided by the company meet the expectations and requirements of its clients, in that direction is oriented quality management assuming the next principles:
– Secure commitment from all staff in a process of continual improvement of products and services offered to customers, and the processes that result in these products and services.
– Striving for excellence on an ongoing basis by identifying opportunities for improvement in both internal management and in product development and customer relations.
– Maximize productivity and optimize resources. Continuously improving the quality and safety of its products and business management.
– Develop new products based on customer needs.
The human factor is an essential component in the implementation of quality management, this can only be achieved through communication, involvement, training and teamwork at all levels of the company.
As a basic tool for the fulfillment of this policy, EFELAB has implemented and maintains a system of quality management based on the guidelines of ISO 9001:2008 and the provisions of ANMAT.