TUV Rheinland issued a new ISO 13485:2012 certificateFrom: 2017-07-18
has established and applies a quality management system for medical devices
according to the requirements specified in EN ISO 13485:2012. From the year of
2004, our quality management system has been subject to yearly surveillance by
TUV Rheinland. We attained and retained ISO 13485:2012 certificates for all
these 13 years.
Due to the expiration of our previous ISO 13485:2012 certificate, at the end of Apr., TUV Rheinland auditors conducted an annual audit on our ISO 13485:2012 Quality Management, which shows that our quality management conforms to ISO 13485:2012 Standard as ever.
Therefore, TUV Rheinland issued a new ISO 13485:2012 certificate to our company for the following scope:
Design and development, manufacture and distribution of in-vitro diagnostic analyzers, in-vitro diagnostic test kits used in the detection of cancer, cardiac markers, disease status, drug of abuse, fertility testing, pregnancy testing including home use in-vitro diagnostic devices.
As always, we are dedicated to providing more accurate, reliable and cost effective products to our customers.
Our Values on Quality:
•Delivers customer value in all projects, services and processes;
• Gives quality at least as much consideration as schedules and budgets when day-to-day choices need to be made;
• Drives QMS results to the bottom line in terms of defect reduction and financial benefits;
• Allocates resources to achieve quality execution.