Functional Safety: What is it and Why Does it Matter?

Modern products, such as cars, medical devices, and airplanes, rely heavily on electronic devices and software. Even a single fault in system software can put human lives at risk and lead to legal actions.

In June 2025, Air India flight 171 crashed at Ahmedabad, India, and 241 passengers died. This incident occurred due to a malfunction in the airplane’s system.

This is why product teams place a strong focus on functional safety. It is not about stopping every failure. It is about making sure that when failures occur, the system responds in a controlled way and shifts to a safe condition.

This blog clearly explains to you what functional safety is, its importance, and the functional safety standards to follow in different industries.

What is Functional Safety?

Functional safety is a core component of system safety that ensures systems or products operate correctly in faulty conditions. It applies to the system controlled by electrical, electronic, or software-based components and ensures that the system automatically prevents hazardous situations and reduces risks to the acceptance level.

Let’s understand with this example: In many industries, robotic arms are used. If a position sensor fails and stops sending accurate data, the robot might not perform normally and damage machinery. In such cases, if functional safety is implemented correctly, the robot system directly detects failures, limits its motion, and prevents any kind of unusual accident.

Furthermore, functional safety can’t be achieved by just performing a single test. Instead, it is a structured process outlined by regulatory standards, such as ISO 26262 for automotive, IEC 62304 for medical devices, etc., that need to be followed during product development.

In short, functional safety answers one key question. If a failure happens, will the system fail safely?

Why Functional Safety Matters Across Highly Regulated Industries

The global functional safety market was valued at $5.5 billion in 2023, which is expected to reach $11.2 billion in 2032. This clearly shows the increasing importance of functional safety across every industry.

Here are the reasons why functional safety is important across highly regulated industries:

• Protects human life: A single fault in safety-critical systems like cars, aviation, medical equipment, etc., can directly affect human lives and public infrastructure. The main purpose of functional safety is to ensure human lives are at no risk.
• Helps with regulatory approvals: By following functional safety requirements during product development, teams can prove that the system is safe to use. This helps in quickly getting regulatory approvals.
• Increased trust: Beyond compliance, clear evidence of functional safety increases trust among regulators and end-customers.
• Lowers liabilities: Functional safety prevents expensive recalls and legal actions. This saves costs and reduces the burden on product development teams.

Functional Safety Standards for Businesses

After looking at the importance of functional safety, let’s look at which specific standards to follow in different industries for implementing functional safety. Below standards cover a step-by-step process for how the system should be built and how risks should be identified and documented to implement functional safety in the product.

• ISO 26262 for automotive systems: The ISO 26262 functional safety standard applies to all electrical and software-based systems in road vehicles. It defines how to identify and classify risks in vehicle systems and how to write and test safety requirements. Its main goal is to reduce the risk of accidents caused by system failures.
• IEC 62304 for medical software: In healthcare, software development teams must follow the IEC 62304 standard regardless of whether they are developing standalone healthcare software or embedding it into the medical device. This standard expects strict control over the change process. Even minor updates must be assessed for their impact on patient safety. Its main focus is to ensure that software-related failures do not lead to any risks to patients.
• IEC 61508 for industrial equipment: This is the foundational functional safety standard, which is used across multiple industries, and many standards, such as IEC 62304, are derived from this one. It applies to systems where safety functions are carried out by electrical, electronic, or programmable components.
• EN 50128 and EN 50129 for railway systems: These 2 standards are followed while developing software for railway system control, signals, and locomotives. It defines different techniques to safely gather requirements, risk analysis, design, coding, and testing based on safety integrity levels.
• DO-178C for aerospace software: It defines a step-by-step process from requirements gathering to releasing product and managing changes for developing aviation software. The standard assigns Design Assurance Levels (DAL A to E) based on the severity of potential failure conditions. This standard helps in achieving aircraft certifications from aviation authorities.
• DO-254 for aerospace hardware: DO-254 is followed while developing the complex electronic hardware used in airborne systems. The standard covers the development lifecycle that must be followed to avoid safety risks. 

Challenges While Managing Functional Safety Requirements Effectively

Managing functional safety requirements during product development is not straightforward and comes with challenges, as explained below:

• Interpreting complex standards: Functional safety standards are often written in technical language. If different team members interpret any clause in a different way, it might lead to safety gaps.
• Scattered requirements sources: When requirements are scattered across different documents, emails, tools, and teams, it becomes difficult to maintain consistency.
• Maintaining traceability: All functional safety standards expect teams to maintain traceability between compliance, requirements, and test cases. Maintaining these links in a spreadsheet or manually is time-consuming.
• Audit preparation pressure: To get approvals from regulatory authorities, teams need clear evidence of how functional safety is implemented. Without proper version history and change management processes in place, it is next to impossible.

Other than these, teams also face challenges related to cross-functional collaboration, scaling functional safety across multiple programs, and managing frequent changes.

Best Practices for Functional Safety Requirements Management

To overcome the challenges given in the previous section, teams are required to follow the best practices given below:

• Centralize requirements: The first thing you need to fix is to centralize all your requirements. If you are using multiple tools, emails, spreadsheets, or documents to manage requirements, stop doing that and start using tools like Azure DevOps that allow you to manage all requirements in one place.
• Define each requirement properly: Make sure to write each safety requirement in such a way that it is easy to understand and doesn’t contain any vague terms. For this, you can use AI tools like Copilot4DevOps that work directly within Azure DevOps and allow teams to draft requirements based on functional safety standards. So, teams don’t miss any important requirements. It also analyzes requirements using AI and clearly identifies vague requirements.
• Regularly review requirements: Keep reviewing requirements collaboratively with multiple team members, including safety engineers, developers, QAs, etc., and identify safety gaps before they become bigger problems.

Use a requirements management tool: In whatever industry you are working, you must use a requirements management tool like Modern Requirements4DevOps, which allows users to create traceability matrices in seconds, review requirements collaboratively, and maintain version history. This helps audit teams in preparing reports in no time. It also allows writing live-in documents, which automatically update when requirements change, and performing change impact assessment directly within your Azure DevOps workspace.