Master Quality
Training, Consulting, & Auditing
Awesome-Colorful-Backgrounds-001.jpg

ISO 13485:2016

ISO Certified Training is our business. 

ISO 13485:2016 Implementation Training
3-5 Day Training/Consulting 

Good businesses understand quality, but great businesses implement it. An ineffective Medical Devise Management System (MDQMS) can cost you time, money and customers. That's why it's important to get it right from the start. Implementing a framework based on ISO 13485:2016 helps your business consistently deliver and drive continual improvement in your products and services.

Gain the required skills to conduct a base-line review of your organization's current position and implement the key principles of ISO 13485:2016. By using a step-by- step approach, you'll learn how to develop an implementation plan, create necessary documentation, monitor your MDQMS, and achieve continual quality improvement.

ISO 13485:2016 Transition Training                                                                         

1-DAY  COURSE

Discover more about the changes from ISO 13485:2008 to ISO 13485:2016 and how they will affect your organization so you can put transition arrangements in place. This course is particularly valuable for individuals directly involved in the planning, implementing, maintaining or auditing of an ISO 13485 QMS

This course is particularly valuable for individuals directly involved in the planning, implementing, maintaining or auditing of an ISO 13485 Quality Management System (QMS). By attending you will transform your existing knowledge to ISO 13485:2016. This course will help you find out what you need to know about transitioning to the new ISO 13485:2016 Quality Management Systems (QMS) standard. You will discover more about the changes from ISO 13485:2008 to ISO 13485:2016 and how these will affect your organization so you can start putting transition arrangements in place. Grasp the latest concepts and requirements defined in ISO 13485:2016 and how they differ from ISO 13485:2008. 

Building on your knowledge of ISO 13485, and through our understanding of the new requirements, you will now develop the skills and road map to landscape the change from ISO 13485:2008 to ISO 13485:2016 Quality Management System (QMS).

You’ll gain the practical knowledge needed to build your auditing skills.

ISO 13485:2016 INTERNAL AUDITOR (TPECS FORMAT)
3 DAY COURSE

This course provides extensive knowledge of ISO 13485 medical devise definitions, concepts, guidelines and requirements. It provides in-depth coverage of an auditor’s roles and responsibilities, the principles, practices and types of audits. This course provides you with the tools you need to conduct all phases of an internal audit, including preparing and presenting effective audit reports.

ISO 13485:2016 LEAD AUDITOR (TPECS FORMAT)
4 DAY COURSE

This course is for individuals interested in conducting first-party, second-party and third-party audits, management representatives, quality directors, managers, engineers and consultants. This course is for those interested in seeing there QMS system like a registration auditor. You will also learn how to lead a team of auditors, and receive certification showing completion of Lead Auditor training. 

Always do things right. This will gratify some people and astonish the rest – Mark Twain

Course Learning Objectives:

  • Identify key changes between ISO 13485:2008 and ISO 13485:2016
  • Understand what needs to be revised in your current QMS
  • Appreciate the significance of organizational context and adopting a risk-based approach
  • Grasp the application of risk-based thinking, leadership and process management
  • Explain new requirements in Annex SL (Appendix 2) relating to organizational context, planning and support
  • Explain the QMGlobal certification transition arrangements
  • Prepare, conduct and develop the required skills for an ISO 13485:2016 audit
  • Build stakeholder confidence by leading and managing teams and processes in line with the latest requirements
  • Grasp the application of risk-based thinking, leadership and process management
  • Understand transition arrangements for QMGlobal certification
  • Build stakeholder confidence by updating teams and processes in line with the latest requirements

Who Should Attend:

  • Operations managers and consultants
  • Organizations that are currently certified to ISO 13485:2008
  • Organizations currently developing systems for certification to ISO 13485
  • Management system practitioners who will be converting to ISO 13485:2016
  • Internal and external management system auditors who will be auditing to ISO 13485:2016
  • Anyone interested in finding out how ISO 13485:2016 differs from its 2008 version
  • ISO 13485:2008 Lead Auditors who will be auditing to ISO 13485:2016

Materials:

Students receive comprehensive course manuals with reference materials.


Get in touch

We at Master Quality know that finding the right partner for your ISO training, auditing, and consulting needs is a choice that shouldn't be taken lightly. That’s why we offer free consultations to walk you through your needs, the scope of your goals, and your budget.

REQUEST INFORMATION ▸