Risk Analysis and Risk Management Workshop

Saturday, SEP 26, 2015 from 08:00 AM – 12:00 PM Central

Chris Anderson,, Management Coach, Bizmanualz, Inc.

Chris Anderson,, Management Coach, Bizmanualz, Inc.

What does ISO 9001:2015 require for risk analysis and risk management?

Learn what Risk Based Thinking is and how to apply it to your QMS.

While a formal process of risk analysis or risk management is not required in the ISO 9001:2015 standard, the concept of risk is included in eight areas of the current draft of the new standard.

1. Determining risks and opportunities that affect the quality management system.
2. Planning changes to the quality management system.
3. Evaluating processes, as part of the process approach.
4. Establishing appropriate controls of external providers (such as suppliers)
5. Identifying risks that can affect the company’s products, services, and overall customer satisfaction.
6. New product design and development risks.
7. Determining post-delivery support risks (e.g. warranty, maintenance, and other services).
8. Establishing monitoring and measurement of risks.

The inclusion of risk throughout the standard is referred to as “risk based thinking”. The standard does not require specific processes or procedures for risk analysis, like Failure Modes and Effects Analysis (FMEA), but using FMEAs and Control Plans will provide a basis for risk analysis and management. In this fast paced class we will review some of the core tools used to identify, quantify, and control risks including: Process diagram, FMEA, and Control Plan.

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