United Registrar of Systems Ltd  login  member join  contact us  sitemap
SERVICE APPLICATION URS COMMUNITY ABOUT URS
 
ISO 9000
ISO 14000
ISO/TS 16949
ISO/IEC 20000
HACCP/ISO 22000
OHSAS 18000
ISO 13485
ISO 27001
ISO 28000
ISO/TS 29001
AS 9100
TL 9000
Do you want the Best?
We'll do it!
SERVICE Home > SERVICE > System Certifications > ISO 13485
Why URS?Assessment ProcessSystem CertificationsTraining Service
Government-Support Business
ISO 13485


Medical Device Regulatory Quality Standards - Importance of ISO13485


ISO13458 is becoming widely accepted as the quality management systems standard for Medical Device manufacturers throughout the world. This international standard specifies requirements for regulatory purposes for medical device manufacturers. The main goal of ISO13458 is to provide a unified model for quality management system requirements in the international market since different countries might have different standards.

The standard is based on the ISO9001 process model (plan-do-check-act) and provides a good base model for compliance with global regulatory requirements. In addition to that ISO13458 contains the requirement applied for medical devices. The additional requirements are: 4.2.1 Technical File (DMR), 4.4 Clinical Data, 4.4.1 Risk Analysis, 4.4.4 Safety Requirements.

Medical device is used for human especially for patient, and it has direct effect to human life and health. With these characteristics, regulation for medical device requires higher level of safety standard than general devices. Therefore attention is focused on how such companies will manage risk related to their products and services.

Under the revised Pharmaceutical Affairs Law, manufacturers and distributors of controlled medical devices and in vitro diagnostics (ClassⅡ) specified by the Ministry of Health, Labor and Welfare will be required throughout Japan to establish a system that companies with ISO13485 based on third party certification, which will apply as of April 2005. A company will no longer be able to trade in the domestic market without third party certification of a corporate quality management system which gives priority to risk management in the provision of its products rather than the its own assessment. For manufacturers and distributors of medical devices and in vitro diagnostics, risk management, which essentially means the introduction of ISO13485, will be watershed in deciding whether those companies will continue to exist in the future.

 



Contact Person : Tran Vinh Khang
Tel : +84 (08) 3930 1376 (Ext: 106) /  Fax : +84 (08) 3930 1349
Email : vinhkhang@urs.vn

Contact Person : Choi, Chun Seoung
Tel : +82 (02) 2636 9003 /  Mobile : +84 (0122) 809 3480 / +82 (10) 3709 9001
Email : cschoi112@gmail.com
 
Why URS? Contact us Global Network Vietnamese Korean English
6th floor, Estar Building, 147-149 Vo Van Tan, Ward 6, District 3, Ho Chi Minh City, Vietnam
Tel : 84(08) 3930-1376   |   Fax : 84(08) 3930-1349   |    Mail to : vietnam@urs.vn
COPYRIGHT(C) 2004 URS VIETNAM. ALL RIGHT RESERVED.