Quality Management System

The Full Name Of Iso13485:2003 Standard Is "Medical Devices - Quality Management Systems - Regulatory Requirements"

This Standard Was Developed By The Sca/Tc221 Medical Device Quality Management Standardization Technical Committee And Is An Independent Standard Based On Iso9001:2000. This Standard Specifies The Quality Management System Requirements Of Relevant Organizations, But It Is Not A Guide For The Implementation Of Iso9001 Standards In The Medical Device Industry.

Since Its Release In 1996, This Standard Has Been Widely Implemented And Applied Worldwide. On July 3, 2003, A New Version Of The Iso13485 Standard Was Officially Released. Unlike The Iso 9001:2000 Standard, Iso 13485:2003 Is Applicable To The Regulatory Environment Of Management Standards: It Specifies The Regulations Used For Quality Management System Requirements By Name. In The International Market, Medical Devices Are Not Only General Listed Products Operated In A Commercial Environment, But Also Subject To Supervision And Management By National And Regional Laws And Regulations, Such As The Us Fda, Eu Mdd (Medical Device Directive), And China's Medical Device Supervision And Administration Regulations.

Therefore, This Standard Must Be Legally Binding And Operate In A Regulatory Environment. Meanwhile, In The Entire Process Of Implementing Medical Device Products, It Is Necessary To Fully Consider The Risks Of Medical Device Products And Carry Out Risk Management. So, Except For Special Requirements, It Can Be Said That Iso13485 Is Actually Iso9001 In The Medical Device Regulatory Environment.

The United States, Canada, And Europe Generally Adopt Iso 9001, En 46001, Or Iso 13485 As Quality Assurance System Requirements, And The Establishment Of Medical Device Quality Assurance Systems Is Based On These Standards. Medical Devices Should Comply With Corresponding Regulatory Requirements Before Entering Markets In Different Countries In North America, Europe, Or Asia.