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ISO 9001:2015 Strategic Approach to Risk-Based Thinking

  • Overview
  • Course Outline
  • For Whom
  • Other Details
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ISO 9001 is the most widely used standard in the world.  This Quality Management System standard forms the foundation for defining a system of processes required to achieve customer satisfaction which is the fundamental reason of existence for all organizations. 

ISO 9001:2015 is the fifth edition of the Quality Management System (QMS) standard and deemed to be the most significant change since year 2000. Context of the organization is one of the new concepts introduced in this version. It requires the organization to determine the issues and requirements that can impact on the planning of the quality management system.  The implementation of QMS should be the strategic decision of the organization and is influenced by the context of the organisation and the changes in that context.

The standard also requires an organization to consider the following:
  • alignment of the QMS with the strategic direction of the organization;
  • determining the processes needed to achieve the intended outcomes; and
  • addressing risks and opportunities arising from the context of the organization.
This training course is specially designed to provide sufficient knowledge, understanding and practical application of these concepts in order to plan a QMS that meets the intended outcomes of the organization and addresses its context.

This programme aims to provide delegates with knowledge and understanding of the following:
  • the organizational context in the planning and implementation of the QMS
  • application of risk-based thnking in the QMS
  • structured method in development of an effective QMS relevant to the organization’s context
Note: Delegates are advised to bring notebook to work on e-templates

Upon completion of the training, delegates will :-
  • Have a good understanding of the organizational context, risk-based thinking and process approach concepts necessary for establishment of a Quality Management System relevant to the organization’s strategy
  • Be able to use the management tools and techniques to develop the system in a structured approach 

The Foundation and Structure of the Standard
  • The quality management principles; the PDCA cycle; process approach; risk-based thinking, get the facts right on risk-based thinking, high level structure of Annex SL
Overview of Strategic Planning in QMS
  • Strategic planning process
  • Vision, mission & strategy
  • How systems support the strategy
  • Strategic planning of the QMS in detail and understanding the ISO requirements related to it
Determination of External Issues
  • Business environment - macro and micro
  • PESTLE – examples of issues
Determination of Internal Issues
  • Internal issues – resource and capabilities
  • Examples of internal issues
Needs and Expectations of Interested Parties
  • Relevant interested parties and their relevant requirements
  • Register of compliance obligations
Establishing Strategies for the QMS
  • Strategic management framework
  • The organizational context storyboard
  • Deployment of policy and objectives
  • Alignment of the QMS with the organization’s strategy and process approach
  • The scope of the QMS
A Proactive QMS
  • Risk and opportunities
  • Swiss Cheese Model
  • Chain effect
  • Defining risks and opportunities
  • Risk identification, analysis and evaluation
  • Risk treatment - actions to address risks and opportunities
Effective Strategic Control and Monitoring
  • The process approach and business process map
  • The organizational process management plan based on SIPOC
  • Process KPI, control and monitoring
  • Action plans
  • Management of change
Application of the Context into the Management Review
  • Review of changes to the context & actions on risk & opportunities
This programme is designed for the management level of organizations that are currently certified or yet to be certified to ISO 9001:2015.

Note: Delegates are advised to bring notebook to work on e-templates
Prior Knowledge
It is recommended that delegates have knowledge of the ISO 9001 standard prior to attending this training.

All Neville Clarke tutors are full time consultants, auditors and trainers. The tutor assigned is a professional who has years of experience working with organisations to help them set-up and successfully maintain their quality management system. They are able to share their experiences, provide practical advice and solutions, and share common pitfalls faced by real-life organisations in their quest towards ISO 9001 certification.


This is a two-day course running from 9.00 am to 5.00 pm

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