The changing ISO 13485 in numbers - TÜV SÜD … · 22,317 12% 25,655 15% 27,791 8% ISO 13485 ......
Transcript of The changing ISO 13485 in numbers - TÜV SÜD … · 22,317 12% 25,655 15% 27,791 8% ISO 13485 ......
Certify your quality management system for medical devices with ISO 13485www.tuv-sud.com/medicaldevice
2015 © TÜV SÜD AG
167 0.7%
Top 10 countries for ISO 13485 growth in 2014
▲1,229CHINA
▲571ITALY
▲319SWITZERLAND
▲430SOUTH KOREA
▲241JAPAN
▲218CANADA
▲109SPAIN ▲78
UK
▲103MALAYSIA▲140
USA
The changing ISO 13485 in numbers
2010 2011 2012 2013 2014
ISO 13485 certification over the past 5 yearsMore 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 2014On 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 numbersThe 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-progressThe most important change is the application of a risk-based approach in the development of most aspects of a quality management system.
Implement new requirementsOnce the revised version is published, organisations currently certified have up to three years to meet the revised requirements.
2012
New editionA new edition is expected to be published in 2016.
2016 2019
ISO 13485 is undergoing revisionISO 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
CHINA2,695
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 EASTEAST ASIAAND PACIFIC
NORTH AMERICACENTRAL AND SOUTH AMERICA
EUROPEAFRICA CENTRAL ANDSOUTH 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.