FMEA ISO 14971

FMEA vs ISO 14971

FMEA vs ISO 14971

Product safety always remains a priority for any industry, especially those within the manufacturing, healthcare and engineering industries. 

FMEA and ISO 14971 are widely recognized methods for assessing and managing risks. The two methodologies provide remarkable frameworks for identifying potential hazards, evaluating threats, and implementing suitable measures to minimize or remove them. 

In this article, we have a closer look at the key differences, advantages, and applications of FMEA ISO 14971

What is FMEA?

FMEA’s complete form is Failure Modes and Effects Analysis. It is a system reliability tool that involves a structured approach to identify, evaluate and control potential failures associated with a process or a product and their potential impacts.

FMEA examines the potential causes, effects, and likelihood of failures occurring, enabling proactive risk management.It involves analyzing and documenting activities that can reduce or eliminate these potential failures from happening. 

Types of FMEA 

Typically, there are three primary types of Failure Modes and Effects Analysis: 

  • Design FMEA (DFMEA): It seeks solutions to prevent or mitigate possible system or product failures. DFMEA is used to find potential failures, the degree of their effects, and the preventive measures. This process helps engineers identify failures early so they can be resolved, saving money. 
  • Process FMEA (PFMEA): This approach centers around recognizing prospective hazards in the process. PFMEA aids in identifying the functions, failure modes, and consequences of each process step, enabling organizations to grasp potential risks at the earliest stages.
  • Functional FMEA (FFMEA): The main aim of FMEA is to prevent failures by proactively identifying and prioritizing potential functional failure modes, ensuring timely corrective actions.

What is ISO 14971?

ISO 14971 is an international standard designed by the International Organization for Standardization (ISO) to specify terminology and principles for medical devices. It provides a risk management framework encompassing the entire lifecycle of a medical device, from its conception to disposal.

The ISO 14971 does not apply to: 

  • Decision-making on the use of a medical device for any particular clinical procedure
  • business risk management

It primarily focuses on identifying hazards, evaluating threats and implementing threat control measures, ensuring the safety and efficacy of medical devices.

The Key Differences Between FMEA & ISO 14971

Scope and Application
While FMEA is a versatile methodology and can be applied to various industries, ISO 14971 is specific to the medical device industry. FMEA can be used to analyze and manage risks associated with products or manufacturing processes in different sectors.

On the other hand, ISO 14971 provides a comprehensive framework to satisfy the unique challenges and requirements of the medical industry.
Main Risk Analysis Components
Under ISO 14971, the key components of risk analysis include identifying hazards (potential sources of harm), evaluating hazardous situations (conditions exposing people or the environment to threats), understanding the series of events causing dangerous problems and assessing the resulting harm (injury or damage to people, property, or the environment).

In contrast, the following are the components of FMEA risk analysis:

       1. a cause (set of circumstances causing failure)
       2. a failure mode (how failure happens)
       3. an effect (the consequence of a loss)

Harm-based Severity 

Both methodologies rate severity in different ways. FMEA assesses severity based on the impact on system performance, while ISO 14971 examines the seriousness of harm to individuals as a measure of severity.

Applications of FMEA & ISO 14971

Uses of FMEA
Industries such as aerospace, aviation, automobiles and nuclear power use FMEA widely, enabling them to find errors before they occur. Of late, healthcare sectors have also adopted FMEA to evaluate risks and identify areas requiring improvement.

Automakers were pioneers in embracing FMEA to enhance safety and minimize the likelihood of large-scale product recalls.
Uses of ISO 14971
Although ISO 14971 standards mainly focus on medical device manufacturers and help them ensure the safety and effectiveness of their products, the principles outlined in ISO 14971 can also be applied to other industries where risk management is critical.

ISO 1471 can be applied to other industries such as aerospace, automotive, pharmaceuticals, food, chemical and consumer electronics.

Benefits of FMEA & ISO 14971

Advantages of Using FMEA

FMEA benefits various organizations in the following ways:

It provides them with an early method to recognize and reduce potential failure.

Addressing potential problems in advance helps reduce the need for last-minute project modifications by addressing potential issues in advance.

It reduces the risk of a problem happening more than once.

It guides employees on what to do when they encounter a failure.

It encourages increased teamwork among the design, production, quality assurance, testing, and sales departments.

Identifying and resolving issues early on helps save money by avoiding expensive fixes during development.

Advantages of Using ISO 14971 

ISO 14971 enhances the safety of patients.

It provides a systematic framework for assessing risks associated with medical devices.

It includes risk management at every stage of a medical device’s life, from the initial idea to its eventual disposal.


In conclusion, FMEA ISO 14971 are valuable methodologies for identifying and managing risks. 

While FMEA provides a proactive approach to prevent failures and early risk detection in various industries, ISO 14971 specifically focuses on the medical device industry. 


1. Is FMEA a lean or Six Sigma tool?
FMEA is an essential tool in Six Sigma that reduces errors and boosts customer happiness.

2. What type of controls are there in FMEA?
There are types of controls in FMEA: Preventive and detection type controls.

3. When was ISO 14971 first published?
The first ISO 14971 was released in 2000, and a newer version, widely adopted in standards, was published in 2007.

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