ISO, Risk and Reliability Initiative

Can Failure Mode and Effects Analysis (FMEA) be part of your answer to ISO 9001:2015?

risk and complex systems

“[Quality is] the totality of features and characteristics of a product or service that bear on its ability to satisfy a given need.”
– ISO 9000 Series

One of the significant changes in ISO 9001:2015 concerns a focus on risk management. While the concepts of risk management are not new to ISO 9001, previous versions dealt more with “after the fact” elements of risk management such as finding root causes of problems, fixing them, and preventing recurrence. The updated version puts much more emphasis on considering risks up front and having a solid approach to address risk in planning, managing, and driving actions

The table below lists the relevant clauses concerning risk in ISO 9001:2015:

ISO 9001:2015 clauses Comments

4.4 Quality Management

The overall quality management system (QMS) must consider both risks and opportunities as part of its core planning process.
5.1.1 Organizational Leadership Those who lead the organization must go beyond merely supporting risk-based approaches and become strong advocates of the practice.
5.1.2 Serving Customers Risks and opportunities must become the core of serving an organization’s customer base, including not only maintaining quality, but to improve customer perceptions as well.
6.1.2 Risk-Driven Planning In the main planning clause, risk becomes a central focus in determining actions, including deciding how to use risk to the organization’s advantage including both risk avoidance, purposeful risk-taking, sharing risk and factoring it into ongoing operation.
9.1.3 Measuring Performance The effectiveness of risk-based activities must be evaluated in terms of meeting overall organizational goals.
10.2.1 Making Corrections

If non-compliance is determined, then it must be factored back into the planned risk management approach, and a new risk profile determined.


So, is there a risk management approach that is known and proven to be effective that many Quality and Reliability practitioners are already aware of?

The answer is yes, Failure Mode and Effects Analysis (FMEA). FMEA is a team approach to identifying and addressing potential failure modes and their effects on product or process performance before they occur.

FMEA helps you:

  • Identify and address failure modes or potential failure modes early on
  • Initiate, drive, and track actions
  • Design out problems from the start
  • Manage and flow necessary risk information throughout the organization and operations
  • Retain what is learned to fold back into future efforts

Do you want to know more about FMEA and how to effectively use it to address the risk management requirements of ISO 9001:2015?  Check out the introductory video by a recognized expert in FMEA, Carl Carlson.