Conducting Risk Analysis for Business Processes for ISO 9001:2015 Quality Management Systems

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Note:Pricing is dependent on location and may vary.

Course Duration: 2 Days - 8 Hours/day

This two or three day workshop addresses, in a hands on workshop, the Process Review approach to analyzing and managing risk in business processes as part of a management system. The workshop will enable a process team to define, analyze, control and document key processes in a management system.


Part of the intent of this seminar is to enable an organization to effectively apply risk-based thinking and to analyze and control risks in business and service processes. This approach includes the effective use of Process Flows and Process FMEAs in business, service and support processes.



  • Overview of Enterprise Risk Assessment
  • Risk and ISO 9001:2015
  • Risk Assessment
  • Planning and Control of Risk Responses


  • Overview of the Process Review Approach
  • Developing the Process Approach
  • Alignment of Objectives, KPIs and Processes


  • Conducting a Process Review
  • Developing a Process Definition
  • Characteristics and Requirements
  • C-O-P-I-S and Turtle Analysis
  • Defining a Process
  • Breakout Exercise 1: Developing Turtle Diagram


  • Developing a Process FMEA
  • Preparing for PFMEA: Process Flow Diagram
  • Breakout Exercise 2: Developing a Process Flow Diagram
  • Process FMEA for a Business or Service Process
  • Breakout Exercise 3: Developing a Process FMEA


  • Process Control Methods
  • Process Documentation & Standardization
  • Technical Process Control Plan
  • Breakout Exercise 4: Developing a Technical Process Control Plan



  • Summary


This seminar is designed for managers responsible for Quality, Environmental or Health &Safety Management Systems, process owners, implementation teams, and management systems auditors, both internal and 3rd party.

Each participant will receive a course manual and related exercise materials.


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