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ISO 13485 Certification
Meet medical industry and customer requirements
Download the service sheet in PDF  
   Business Challenge

Meeting legislative regulations and customer requirements for the manufacture and sale of medical devices in a global marketplace can be confusing. With so many regulations, differing from country to country, an organization must address a complex array of quality, process, and management issues in order to compete internationally.



ISO 13485 defines the requirements that medical device manufacturers must incorporate into their management systems in order to achieve compliance in the medical device industry. Based on ISO 9001, the emphasis on continu- al improvement is replaced with an emphasis on meeting regulatory and customer requirements, risk management, and maintaining effective processes, namely the safe design, manufacture, and distribution of medical devices.
It is important to note that being certified to ISO 13485 does not fulfill the requirements of either the FDA or foreign regulators; however, the certification provides a solid framework on which to build compliance to various regulatory and customer requirements.


We perform a systematic, independent audit of the management system to identify strengths and areas for improvement.

We use a planned audit schedule to ensure the management system meets objectives and provides continual improvement in key areas.
Certification from Bureau Veritas is recognized and well-respected globally.
We can certify your management system to ISO 9001 in conjunction with ISO 13485, bringing further benefits to your organization.
   Why Choose Bureau Veritas


6,500 skilled auditors operating in more than 100 countries offer a unique combination of international and local expertise providing consistent services wherever our clients are.


Our auditors have extensive knowledge of specific industry sectors, local regulations, markets and language that enables them to provide solutions adapted to your needs.


Bureau Veritas Certification is recognized by more than 60 national and international accreditation bodies across the world.

Mark of global recognition

The Bureau Veritas Certification mark is a globally recognized symbol of your organization’s ongoing commitment to excellence, sustainability and reliability.

Experienced Instructors

Our training courses are delivered by lead auditors with years of industry experience and insight, who have been trained in interpersonal communication, intercultural issues and adult learning concepts.

   Details of Service
ISO 9001 Cerification Boosting quality to differentiate yourself from the competition  
ISO 13485 Certification Meet medical industry and customer requirements  
ISO 21001 Certification 現代教育及培訓機構需要有一個專門針對教育及培訓機構的管理體系的標準。  
ISO 27001 Certification Protecting your information assets  
AS/EN/JISQ 9100 Certification Demonstrating your company's commitment to quality in the aeronautics industry  
ISO/TS 16949 Certification Helping position your company as a reliable partner to the Automotive and Motorcycle Industry  
ISO 20000 Certification Building a competitive edge through higher quality IT Services  
11th Jun 2019
Sustainable Tourism & GSTC (Global Sustainable Tourism Council)
31st May 2019
食品安全管理系統 ISO22000: 2018 新版標準研討會
25th Apr 2018
FSC™ 商標新版標準研討會
IRCA Registered ISO45001:2018 Annex SL (Module 1) Training Course
IRCA Registered ISO45001:2018 Modular Auditor Migration (Module 2) Tra ...
IRCA Registered ISO 45001:2018 Auditor Conversion training course
4th Jul 2018
8th Aug 2016
Bureau Veritas Certification assists enterprise well understanding of ...
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