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Transitions for New ISO 9001:2015, 13485:2016, & AS9100:2016

The newly revised standards are here.

Many things have changed from the prior revisions. They include an increased emphasis on strategic planning elements and risk-based thinking, as well as a dramatically “Osterized” structure – with 10 clauses rather than 8.

There are things you can begin doing now to smooth the transition for your organization and suppliers.

Come learn insider’s perspectives from Ray Hanson, an Axeon Sr. Instructor and member of the Technical Committee (TC176 SC2) tasked with the evolution of ISO 9001. In this 1-day class you will receive detailed insights into the implications of the changes and a transition road map to guide your efforts.

 

1-Day Transition for ISO 9001:2015, ISO 13485:2016, AS9100:2016 Course $950

9001:2015 , 13485:2016, & AS9100:2016 Transition

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

  • Understand the key changes to ISO 901:2015, AS9100 Rev D (2016), and ISO 13485:2016
  • Understand the development and implications of Annex SL
  • Learn how the new format and structure of 2015 sub-clauses compares to those of 2008
  • Provide tools, techniques and tips to address the new requirements for strategic planning, risk management, the context of the organization, etc.
  • Become aware of new requirements in documentation

Agenda

 

Day One

 

  • New Requirements of ISO 9001:2015, ISO 13485:2016, and AS9100:2016
  • 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
  • Differences in Documentation and Other Requirements
  • Timetable for Transition of Certification to ISO 9001:2015 and AS9100:2016
  • Individualized Transition Road Map