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Incorporating Risk-Based Thinking into Internal Quality Audits for ISO 9001 and Other QMS Standards (MFG851M)

Presented By : Duke Okes , FASQ, CMQ/OE
(*) Single User Price. For multiple users please call 1-800-223-8720
Pre Recorded Webinar
60 minutes
  •  Thu, August 13, 2015
Event Description
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How to employ risk-based thinking within a QMS process

The upcoming release of ISO 9001:2015 will require risk-based thinking (RBT) related to how the quality management system (QMS) impacts the ability to achieve organizational objectives. While each organization might emphasize risk management in some QMS processes more than others, one where all will need to incorporate RBT is the internal audit process. Doing so will help ensure that audit resources are more focused on the processes having higher potential impact on organizational performance. This will not only increase the value of quality audits but also help link them to the enterprise risk management (ERM) process.

Financial auditors have been conducting risk-based audits for more than a decade. Given the visibility of organizational failures in today's world, as well as the need to more efficiently utilize resources (auditors, process owners), it's time for the same concepts to be applied to quality (and other) management system audits. In effect, applying risk management concepts and tools to the audit process will result in better alignment of the QMS and organizational priorities and risks.

This webinar by Duke Okes will explain how to use risk-based thinking in the quality management system. You will get simple tools for assessing risks within a QMS process. Further, you will understand how to report audit nonconformities from a risk-based perspective.

In this program, you will learn

  • What are some options for using RBT in the audit process
  • The business case for risk-based quality audits
  • How risk can be assessed for as well as in QMS processes
  • Using change to drive the audit process
  • How an organization's ERM process can inform the quality audit process, and vice versa

Benefits of the session

  • The basic concepts of RBT
  • Communicating the organization's risk appetite
  • Simple tools for assessing risk of each QMS process and the use of RBT within a QMS process
  • Reporting audit nonconformities (NCs) from a risk-based perspective

Who should attend

  • Audit managers and coordinators
  • Director of quality
  • Quality managers
  • Quality auditors
  • Quality supervisors
  • Management system representatives
  • Vice-president administration
  • Managers process technology
  • COOs
  • And anyone involved in planning, conducting or acting on the results of internal quality management system audits under ISO 9001, ISO/TS 16949, ISO 13485, TL 9000 and AS 9100

Industries: Pharmaceuticals, Rubber Industry, Heavy machinery manufacturers, Logistics and Bio-technology

About Our Speaker(s)

Duke Okes, Manufacturing Regulations ExpertDuke Okes FASQ, CMQ/OE
Duke Okes (FASQ, CMQ/OE) has been in private practice for 29 years, helping organizations implement processes for better control and improvement of their operations. He has worked with a wide range of organizations, including manufacturing and healthcare industries as well as financial and government services. He has c... More info

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    Event Title: Incorporating Risk-Based Thinking into Internal Quality Audits for ISO 9001 and Other QMS Standards
    Presenter(s): Duke Okes , FASQ, CMQ/OE Protection Status