This website uses cookies

Kiwa uses three types of cookies on its website. We do this to make your website visit as pleasant as possible. Read more about our cookie policy.

You can indicate below what kind of cookies we may use.

Please indicate your preferences
Necessary cookies
Analytical cookies
Marketing cookies
I agree
  • +31 (0)88 998 44 00
  • Media
  • Stories
  • Careers
  • Contact us
EN - Global

Choose your country and language

  • Global
    Global English
  • Belgium
    Belgium Nederlands Français
  • China
    China 中文
  • Denmark
    Denmark Dansk
  • Estonia
    Estonia Eesti keel
  • Finland
    Finland Suomi
  • France
    France Français
  • Germany
    Germany Deutsch English
  • Italy
    Italy Italiano English
  • Korea
    Korea 한국어 English
  • Latin America
    Latin America Español Português
  • Latvia
    Latvia Latviešu Pусский
  • Lithuania
    Lithuania Lietuviškai
  • The Netherlands
    The Netherlands Nederlands English
  • Norway
    Norway Norsk
  • Poland
    Poland Polski
  • Portugal
    Portugal Português
  • Spain
    Spain Español
  • Sweden
    Sweden Svenska
  • Turkey
    Turkey Türkçe English
  • United Kingdom
    United Kingdom English
  • Services
    • Testing
    • Inspection
    • Certification
    • Training
    • Consultancy
    • References
    • Explore services
  • Markets
    • All markets
    • Agri, Feed and Food
    • Automotive and Aviation
    • Building materials
    • Construction and infrastructure
    • Consumer products
    • Education and Training
    • Energy and Power Generation
    • Fire, Safety and Security
    • Hazardous materials
    • Management Systems
    • Manufacturing industry
    • Medical and Pharma
    • Mining
    • Oil, Gas and Chemicals
    • Process industry
    • Real Estate services
    • Renewable Energy
    • Retail
    • Tourism and Leisure
    • Transport and Mobility
    • Utilities
    • Water
  • About Kiwa
    • About Kiwa
    • Mission and vision
    • Corporate Social Responsiblity
    • Kiwa Code of Conduct and Compliance
    • Management
    • Key figures
    • Make a career at Kiwa
    • The Kiwa beaver
    • Quality labels
    • Accreditations and notifications
    • Terms, conditions and regulations
    • Head office locations
    • Kiwa proud sponsor of Dutch Women’s Eight rowing team
  • Media
  • Stories
  • Careers
  • Contact us
  • EN - Global
    • Global
      Global English
    • Belgium
      Belgium Nederlands Français
    • China
      China 中文
    • Denmark
      Denmark Dansk
    • Estonia
      Estonia Eesti keel
    • Finland
      Finland Suomi
    • France
      France Français
    • Germany
      Germany Deutsch English
    • Italy
      Italy Italiano English
    • Korea
      Korea 한국어 English
    • Latin America
      Latin America Español Português
    • Latvia
      Latvia Latviešu Pусский
    • Lithuania
      Lithuania Lietuviškai
    • The Netherlands
      The Netherlands Nederlands English
    • Norway
      Norway Norsk
    • Poland
      Poland Polski
    • Portugal
      Portugal Português
    • Spain
      Spain Español
    • Sweden
      Sweden Svenska
    • Turkey
      Turkey Türkçe English
    • United Kingdom
      United Kingdom English
  • Services
  • Markets
  • About Kiwa
Request quote
Services

  • Testing
  • Inspection
  • Certification
  • Training
  • Consultancy
  • References
  • Explore services
Markets

  • All markets
  • Agri, Feed and Food
  • Automotive and Aviation
  • Building materials
  • Construction and infrastructure
  • Consumer products
  • Education and Training
  • Energy and Power Generation
  • Fire, Safety and Security
  • Hazardous materials
  • Management Systems
  • Manufacturing industry
  • Medical and Pharma
  • Mining
  • Oil, Gas and Chemicals
  • Process industry
  • Real Estate services
  • Renewable Energy
  • Retail
  • Tourism and Leisure
  • Transport and Mobility
  • Utilities
  • Water
About Kiwa

  • About Kiwa
  • Mission and vision
  • Corporate Social Responsiblity
  • Kiwa Code of Conduct and Compliance
  • Management
  • Key figures
  • Make a career at Kiwa
  • The Kiwa beaver
  • Quality labels
  • Accreditations and notifications
  • Terms, conditions and regulations
  • Head office locations
  • Kiwa proud sponsor of Dutch Women’s Eight rowing team
  1. Service
  2. ISO 13485 Medical Devices QMS Training

ISO 13485 Medical Devices QMS Training

The aim of the training is to inform the participants about EN ISO 13485: 2016 Medical Devices Quality Management Systems and to train competent auditors who can take an active role in the audit cycle which is required by the standard. The participants who can successfully complete this training will be the auditors (internal-external) who can contribute to the development of EN ISO 13485 standards and quality management system systematically and objectively.

Request quote Download PDF
  • Experienced Training Staff
  • Sectoral knowledge
  • Training information
  • Practical information

Management systems provide a continuous improvement mechanism and discipline to your organization in addition to the market advantage. In addition, the quality consciousness of the employees and increase customer satisfaction, provides an important step towards institutionalization.

ISO 13485: 2016 Medical Devices QMS Training Background & Description

The Management System Standards are one of the most important internationally proven references to establish an effective management system.  In the rapidly developing production and service sector; One of the most important criteria that ensures continuous growth and customer satisfaction on national and international grounds is the understanding of "Quality Competition". This is achieved through the "Management System" within the company.

EN ISO 13485: An international standard, which is based on the 2016 standard process approach model, with special requirements for medical devices.This standard sets out a quality management system that can be used by an organization for the development and improvement of processes related to the design and development, production, installation and service of medical devices.


Targets

ISO 13485: 2016 Medical Devices With QMS training, is aimed to refresh the knowledge of participants about EN ISO 13485: 2016, to provide an understanding of the standard from an auditor point of view, to review the accepted criteria related to auditing and to take the first steps of the auditors experience with practical applications.

Interested?

Kiwa N.V.
Request quote +31 (0)88 998 44 00
Kiwa Inspecta Finland
Request quote +358 (0)10 521 600

Related Products

  • ISO 13485 Medical Devices

    ISO 13485 Medical Devices Certification with Kiwa: ensure quality, build trust and comply with regulations in the medical devices sector.
    Show
Kiwa: We create trust

We are Kiwa. With our certification, inspection, testing, training and consultancy services, we create trust in our customers' products, services, processes, (management) systems and employees.

Services
  • Certification
  • Inspection
  • Training
  • Consultancy
Contact us
  • Send us your message

Follow us:

  •  
  •  
  •  
  • Disclaimer
  • Cookie policy
  • Responsible disclosure policy
  • Beware of fake Kiwa certificates in China
  • Privacy Policy
  • Kiwa Stories