| Axeon Corporation » Live Online Courses » 1-Day Transition for ISO 9001:2015, ISO 13485:2016 & AS9100:2016

Price: $950.00
Fri, Apr 1, 2016 7:30 AM – 6:30 PM MDT

*******Live- Instructor Lead Virtual Class*******

Who Should Attend:

Those responsible for planning and executing the transition from ISO 9001:2008 to ISO 9001:2015, including Management Representatives and Quality Managers, or anyone desiring an up-to-date awareness of the changes that will be impacting new or existing ISO 9001:2008-based Quality Management Systems, including ISO 13485 and AS9100.

Course Objectives:

  • Fully understand and interpret the relevant appendices of Annex SL, with their implications
  • Receive tools, techniques and tips to address the strategic planning elements of Annex SL
  • Become aware of changes to Preventive Action, and basic risk-management concepts and tools
  • See how the new format and structure of the 2015 sub-clauses compares to those of 2008
  • Become aware of potential changes in documentation and other requirements
  • Understand key changes for ISO 13485:2016 and ISO 9001:2015
  • Understand key changes proposed for AS9100
  • Plan and schedule needed internal changes on a Transition Road Map
  • Provide critical knowledge for your management and staff regarding the evolution of ISO 9001 and ISO 13485


Day One

  • New Requirement of ISO 9001:2015, ISO 13485:2016, and AS9100:2016
  • Highpoints of the new requirements proposed for AS9100
  • Major Milestones completed to date
  • Schedule Leading to Final Publication of AS9100 Rev D
  • Introduction to Annex SL, 2012
  • Implications of Appendix 2
  • Comparison of the Structure and Sequence of ISO 9001:2015 to ISO 9001:2008
  • Implications of Appendix 4
  • Strategic Planning Elements of 4.1, 4.2, 6.1, and 9.3
  • Risk-based Elements of 6.1, 7.5.1, and 8.1
  • Action Plan Elements of 6.2
  • Likely Differences in Documentation and Other Requirements
  • Timetable for Transition of Certification to ISO 9001:2015, ISO 13485:2015, and AS9100:2016
  • Individualized Transition Road Map
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