ICS 11.040.01; 03.120.10                         MHD 14

NATIONAL FOREWORD

This Indian Standard (First Revision) which is identical with ISO 13485 : 2016 ‘Medical devices - Quality management systems - Requirements for regulatory purposes’ issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Hospital Planning Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council.

This standard was first published in 2009 as is ISO 13485 : 2003. The first revision of this standard has been undertaken to harmonize it with the latest version of ISO 13485 : 2016 in order to align with the latest international practice.

The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions and terminologies are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as ‘Indian Standard’.

b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker.