Industrial manufacturing
Development of electronics, semiconductor products and production systems, from concept to series production
Electronic products, semiconductors and production systems are created in companies in which development, manufacturing, quality and testing have to work closely together. Procedures have grown over the years, and new requirements for safety, cybersecurity and traceability meet existing structures.
Fixed requirements apply. IEC 61508 governs the functional safety of electronic systems and components, and the Cyber Resilience Act the cybersecurity of products with digital elements. Semiconductors for vehicles also follow ISO 26262, part 11.
Which requirements apply in industry and manufacturing
Standards and regulations to be met for electronics, semiconductors and production systems.
Functional safety
IEC 61508 classifies safety functions in SIL 1 to 4 and governs hardware and software of systems and components. ISO 26262, part 11, applies this to semiconductors for vehicles.
More on functional safety →Cybersecurity in the development process
Connected products and production systems need cybersecurity from the first requirement: threat analysis, security requirements and the handling of vulnerabilities in the field.
More on cybersecurity →Products with digital elements
The Cyber Resilience Act requires manufacturers to consider cybersecurity across the entire life cycle of a product, including the handling of vulnerabilities.
More on cybersecurity →Processes and interfaces
Development, manufacturing and quality work together across interfaces. Defined handovers, change management and traceability are the prerequisite for reliable evidence.
More on process maturity and interfaces →When support makes sense
Typical triggers in industry and manufacturing.
SIL required for a component
A customer requires a SIL rating to IEC 61508 for a component or module, and analyses and evidence are not available.
Product is connected
A product is given a network connection, and the requirements from the Cyber Resilience Act have not been assessed.
Semiconductors for vehicles
A semiconductor product is to be used in vehicles, and customers ask for evidence on ISO 26262.
Departments work at cross purposes
Development, manufacturing and quality work with different versions, and changes do not reach everywhere.
What we take on in industry and manufacturing
Three service areas that can be combined as the task requires.
Engineering
Product requirements, architecture and safety concepts for electronics and production systems, plus a feasibility assessment before the decision.
More →Management
Project and process management across development, manufacturing and quality, with defined interfaces and change management.
More →Development and testing
Development of hardware and software, safety analyses such as FMEDA and FTA, verification and validation, and cybersecurity testing.
More →Approach and work products
The work follows four steps.
Define product and use
Function, operating environment and system boundaries are defined, together with the applicable standards and the role in the project.
Assess risks and threats
The hazard analysis determines the SIL rating, the threat analysis the cybersecurity goals. Assumptions are documented.
Derive requirements and architecture
The goals lead to safety and cybersecurity requirements and the architecture, traceable through to testing.
Show the evidence
Analyses and verification and validation reports are prepared so that customers and assessors can follow them.
This produces, among other things, the hazard analysis and risk assessment, the SIL rating, the safety concept, the threat analysis and risk assessment, safety analyses such as FMEDA and FTA, traceability from requirements to testing, and verification and validation reports. An independent assessment or certification is not part of it.
Frequently asked questions
What is the difference between IEC 61508 and ISO 26262?
IEC 61508 is the cross-industry basic standard with SIL 1 to 4. ISO 26262 is derived from it for road vehicles and works with ASIL A to D.
What does SIL mean?
SIL (Safety Integrity Level) is the safety integrity level from 1 to 4, where 4 has the highest requirements. It results from the hazard analysis and determines the effort and depth of development, testing and evidence.
Does IEC 61508 also apply to software?
Yes. Part 2 of the standard deals with hardware, part 3 with software. The required measures depend on the SIL.
How are functional safety and cybersecurity related?
A connected product can also fail in a safety-relevant way through an attack. This is why the hazard analysis and the threat analysis are aligned, so that measures are not duplicated or contradictory.
Who is affected by the Cyber Resilience Act?
Manufacturers, importers and distributors of products with digital elements. Products covered by their own regulations are partly excluded. Whether a product is affected is clarified case by case.
Do semiconductor products for vehicles need evidence to ISO 26262?
Customers from the automotive industry often ask for it. ISO 26262, part 11, describes how the standard can be applied to semiconductors.
Clarify your project in a call
In the call we clarify the trigger, which standard applies and which deadline has to be met.