1
Certify your quality management system for medical devices with ISO 13485 www.tuv-sud.com/medicaldevice 2015 © TÜV SÜD AG 167 0.7% Top 10 countries for ISO 13485 growth in 2014 ▲1,229 CHINA ▲571 ITALY ▲319 SWITZERLAND ▲430 SOUTH KOREA ▲241 JAPAN ▲218 CANADA ▲109 SPAIN ▲78 UK ▲103 MALAYSIA ▲140 USA The changing ISO 13485 in numbers 2010 2011 2012 2013 2014 ISO 13485 certification over the past 5 years More than 27,000 ISO 13485 certificates were issued in 2014. This continues the moderate growth of ISO 13485 certification, and is a 8% growth from 2013 certification numbers. Breakdown of ISO 13485 certifications by regions in 2014 On trend from last year, Europe claims nearly 60% of the total number of certificates issued due to stringent regulations that mandate certification to the standard in some countries. The growth of ISO 13485 certification in China where its certification output was almost doubled, was also a strong contributor to the growth of ISO 13485 certification in the East Asia and Pacific region. 18,834 ▲ 15% 19,849 ▲ 5% 22,317 ▲ 12% 25,655 ▲ 15% 27,791 ▲ 8% ISO 13485 (Medical) ISO 13485 certification in numbers The International Organization for Standardization (ISO) performs an annual survey of ISO management system certifications. The following sections in this infographic illustrate some of the key statistics about ISO 13485 certification from the 2014 survey.* Revision-in-progress The most important change is the application of a risk-based approach in the development of most aspects of a quality management system. Implement new requirements Once the revised version is published, organisations currently certified have up to three years to meet the revised requirements. 2012 New edition A new edition is expected to be published in 2016. 2016 2019 ISO 13485 is undergoing revision ISO 13485 addresses the development, implementation and maintenance of a quality management system intended for use by medical device manufacturers and suppliers. Work to revise ISO 13485:2003 began in 2012 and a new edition is expected to be published in 2016. Top 10 countries for ISO 13485 certificates in 2014 2,890 GERMANY 1,076 JAPAN 2,559 CHINA 2,695 ITALY 1,059 FRANCE 1,169 S. KOREA 1,890 UK 1,304 SWITZERLAND 764 TAIWAN 5,175 USA ▲ Year on year growth in percentage ▲ Increase in number of certificates issued between 2013 and 2014 MIDDLE EAST EAST ASIA AND PACIFIC NORTH AMERICA CENTRAL AND SOUTH AMERICA EUROPE AFRICA CENTRAL AND SOUTH ASIA 316 1.4% 902 4.0% 6,637 29.7% 760 3.4% 6,026 27.0% 12,983 58.2% Regional share in percentage * All statistics illustrated in this infographic are from ISO and available at www.iso.org/iso/iso-survey.
