JIS Q 13485:2005
Medical devices -- Quality management systems -- Requirements for regulatory purposes

Standard No.

JIS Q 13485:2005

Release Date

2005

Published By

Japanese Industrial Standards Committee (JISC)

Status

Withdraw

Replace By

JIS Q 13485:2018

Latest

JIS Q 13485:2018

Replace

JIS Q 13485:1998 JIS Q 13488:1998

Scope

This International Standard applies to situations where an organization needs to demonstrate its ability to provide medical devices that meet customer requirements and regulatory requirements applicable to medical devices and related services. , which specifies the requirements for a quality management system.

JIS Q 13485:2005 Referenced Document

• JIS Q 9000:2000 Quality management systems -- Fundamentals and vocabulary

JIS Q 13485:2005 history

• 0000 JIS Q 13485:2018
• 2005 JIS Q 13485:2005 Medical devices -- Quality management systems -- Requirements for regulatory purposes
• 1998 JIS Q 13485:1998 Quality systems -- Medical devices -- Particular requirements for the application of JIS Z 9901