February 12, 2012 — JTECH Medical, a medical device company developing therapeutic and evaluation products, recently announced the renewal of their ISO 9001:2008 and ISO 13485:2003 with Canadian Medical Devices Conformity Assessment System (CMDCAS) certifications for its manufacturing facility.
Passing the recertification audit is a commitment to quality, which benefits JTECH’s customers and the company. This demonstrates the hard work and team effort on behalf of all of JTECH employees in maintaining and improving the quality of their products, manufacturing processes, and communications with their customers. JTECH has developed a culture of regulatory compliance, which is reflected in the audit results.
“With this renewal of our certification, JTECH Medical customers can be confident in our commitment to our ultimate goal of guaranteed client satisfaction,” says JTECH Medical President Len Smith.
The ISO 9001:2008 and ISO 13485:2003 with CMDCAS standards specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements. It also aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
The ISO standards provide a tried and tested framework for taking a systematic approach to managing an organization’s processes so that it consistently turns out products that satisfy customer expectations and can assure regulatory authorities that JTECH Medical is manufacturing products using a quality management system in its facility.
The companies’ compliance to ISO standards are certified by third-party audit and registration organizations, such as Intertek. For more information, visit intertek.com.
Source: JTECH Medical, jtechmedical.com