IEC 61508 · Functional safety of E/E/PE safety-related systems
IEC 61508 compliance consulting for electrical, electronic and programmable safety systems.
IEC 61508 is the IEC basic safety publication for functional safety of electrical, electronic and programmable electronic safety-related systems. Sterling's expert and experienced consultants help your engineering team build the functional safety management, lifecycle records and evidence that assessors and customers expect. We help our clients put it into practice and prove it.
- One all-inclusive proposal: consulting, Effivity software, Sterling Academy access and internal auditor training, as applicable to your standard
- Expert and experienced consultants who have built management systems for engineering and manufacturing businesses since 2003
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. Sterling does not certify or assess conformity; independent bodies do
8,100+ client engagements in 60+ countries.
Engineering client experience
What it is
What is IEC 61508?
IEC 61508 is the International Electrotechnical Commission series on functional safety of electrical/electronic/programmable electronic (E/E/PE) safety-related systems. It has two jobs: it is the basis on which committees write sector and product standards, and it applies directly where no sector standard exists. It holds basic safety publication status under IEC Guide 104.
Safety requirements are expressed as safety integrity levels, one of four, with SIL 4 the highest and SIL 1 the lowest. Sector standards derived from it include IEC 61511 for the process industry, IEC 62061 for machinery, IEC 61513 for nuclear and IEC 61800-5-2 for power drives.
Current edition. IEC 61508-1:2010, Part 1 General requirements, is edition 2.0, published 30 April 2010, replacing the 1998 first edition. The series runs to seven parts, and IEC shows a stability date of 2027.
Who it is for
Who needs IEC 61508?
Engineering organisations usually come to IEC 61508 from one of four starting points:
- A customer asks for a SIL claim. System integrators and plant operators want evidence behind the SIL of your device or subsystem.
- Your product has no sector standard. IEC 61508 applies directly where no sector standard covers it.
- You supply into process plants, machinery or nuclear. Sector standards built on IEC 61508 expect components developed to it.
- Your development process is informal. Safety lifecycle records are scattered, and an assessment would find gaps.
The value lies in a disciplined safety lifecycle; the assessment report records it.
Requirements
What are the main IEC 61508 requirements?
IEC 61508 is published in seven parts, with Part 1 setting general requirements. The titles of the remaining parts are not summarised here, so the list describes what a Sterling IEC 61508 programme covers; your engineering team works from the parts themselves, held under licence.
- Gap assessment: your current development and management practice compared with the applicable parts
- Functional safety management: roles, competence, planning and procedures for the safety lifecycle
- Safety lifecycle records: hazard and risk analysis, safety requirements and SIL targets documented and traced
- Verification and validation: reviews, tests and records planned and kept
- Change and configuration control: modifications assessed for their safety impact before release
- Assessment readiness: evidence organised for an independent functional safety assessment
What does useful IEC 61508 evidence look like?
A functional safety plan, competence records, hazard and risk analyses, a safety requirements specification traced to design and test, verification reports, change records and a safety manual. Held in Effivity, the evidence stays linked as the design changes.
Your engagement
What your IEC 61508 engagement includes
Your agreed scope brings together what your engineering team needs to work to IEC 61508 and show it, from one team under one all-inclusive proposal.
Scope, gap assessment and plan
Products, parts and SIL targets agreed, with owners and dates.
Functional safety management
Procedures and roles built with your engineers, on Sterling's template sets.
Effivity ISO & GRC software
Records, changes and actions in one workspace, included at no additional cost.
Training for everyone
Preferential Sterling Academy access, including complimentary awareness training for your people.
Internal audit
Your functional safety management audited, with findings closed with evidence.
Assessment readiness
Preparation for independent assessment and support until the report is issued.
Sterling does not certify or carry out the independent functional safety assessment. That decision rests with the assessor or certification body you appoint.
Often combined with
Standards organisations pair with IEC 61508
- CE markingCE marking compliance support for manufacturers: EU rules, technical files, declaration of conformity and quality systems.
- EN 1090EN 1090 certification for steel and aluminium fabricators: factory production control, welding, execution records and support through the notified body's audit.
- EN 71 / ASTM F963EN 71 and ASTM F963 toy safety compliance for manufacturers: product and market mapping, material control, test planning and records that keep lots conforming.
- EU Cyber Resilience ActCyber Resilience Act compliance and requirements for products with digital elements: categories, reporting since September 2026 and CE marking by December 2027.
- EU MDR 2017/745EU MDR compliance consulting for CE marking: QMS, technical documentation, traceability and post-market surveillance prepared for your notified body.
- IEC 61511IEC 61511 compliance for process plants: the safety instrumented system lifecycle, functional safety management and the evidence your assessors expect.
Effivity · ISO and GRC software, included in every engagement
How Effivity helps you fulfil, automate and simplify the requirements of IEC 61508.
Every Sterling IEC 61508 engagement includes Effivity, the ISO and GRC automation platform built by the Sterling group and used in 50+ countries. Your consultant configures the workspace within the agreed scope, so safety plans, competence records, hazard analyses, verification records, changes and corrective actions live in one place, the system runs in daily work and the functional safety assessor reviews a live system rather than a binder. Sterling consulting clients get their Effivity subscription included with the engagement, at no additional cost.
Scope and interested parties
The scope, the internal and external issues and the interested parties are kept in one register and reviewed on a schedule, so they stay current as the business changes instead of being rewritten before each assessment.
Policies, roles and objectives
Policies, responsibilities and objectives with their measures, owners and dates live where the people who own them work; progress is reported from the system, not from a separate spreadsheet.
Risks and opportunities
A risk register with owners, actions and review dates; treatments tracked to closure and brought to management review automatically.
Competence, awareness and documented information
Training and competence records for every person, linked to Sterling Academy; documents with versions, approvals and distribution, so the current version is the only one in use.
Safety lifecycle, verification and change
Lifecycle work products, reviews, test records and change requests, each with its record created as the work is done.
Monitoring, internal audit and management review
Audit programmes, findings and follow-up; KPIs on live dashboards; a management review that records its inputs, decisions and actions.
Nonconformity, complaints and corrective action
Raised, investigated and closed with root cause and the evidence that the action worked; recurring issues visible to management before they become a finding.
Your own processes, forms and reports
Forms, fields, workflows and reports adapted to how you work, without code; legal and customer requirements tracked to the processes they affect.
What this means at the functional safety assessment
The assessor asks for the safety plan, competence records, hazard analysis, traceability and verification reports. In Effivity each is a screen with dates, owners and evidence attached. After assessment, Sustain™ keeps the records current as the product evolves.
In your engagement
- Subscription included with the engagement, at no additional cost
- Configured by your Sterling consultant within the agreed scope
- Your documents, records and registers migrated, not retyped
- Admin and user training for your team
- Modules for QMS, EMS, OHSMS, ISMS and more when you integrate other standards
Sterling Academy · IEC 61508 e-learning
Train your whole engineering team, not just the safety lead.
Sterling Academy delivers e-learning for the whole workforce and for the people who run the system: video lessons with practice checkpoints, a final exam and a numbered Certificate of Completion for each learner, verifiable online. Sterling consulting clients benefit from preferential course access and special pricing through their Sterling consultant, including complimentary awareness training for their people as part of the engagement.
- Awareness for every employee on why functional safety matters
- Courses for engineers, testers and the functional safety manager
- Internal auditor training for your management system, as applicable, as part of the engagement
- Learner progress by team and a training status report for the assessor
- New hires trained as they arrive
- A Sterling consultant reachable when a learner needs one
Keep exploring
Explore more about IEC 61508
Why Sterling
Want IEC 61508 done right? Come to Sterling.
Whether you develop one safety device or a family of products, Sterling helps you set a functional safety management system your engineers can work with, linked to the quality system you already run.
Management systems in 60+ countries since 2003
Programmes delivered for organisations across sectors and every region we serve, with one engagement team accountable across every country you operate in.
All-inclusive proposal
Consulting, Effivity, training and Academy access in one proposal, with any third-party fees identified separately. No surprises, ever.
A system your people can use
Less documentation and maximum effectiveness: documents, training and software connected to day-to-day work, so your people adopt the system rather than tolerate it.
Expert and experienced consultants
Consultants who have advised on management systems for engineering and manufacturing businesses across sectors and countries, and who build it properly the first time, so the assessment confirms what already works.
The Sterling Promise
What our IEC 61508 support guarantee means
We stay with you until your agreed IEC 61508 readiness outcome is achieved, supporting implementation, preparation and the resolution of assessment findings. Clear explanations, practical delivery, included software and employee learning turn the investment into lasting capability.
The engagement identifies the products, parts, outcome and responsibilities. Your organisation supplies accurate design data and puts the agreed practices into use. The independent assessor or certification body retains its decision. Our commitment concerns the agreed support, not the SIL your design achieves.
FAQs
Frequently asked questions about IEC 61508
Is there an IEC 61508 certificate?
The standard itself does not issue certificates. Organisations usually show compliance through an independent functional safety assessment, and some choose third-party certification from a body that offers it. Sterling does neither; we prepare you for both.
What is a SIL in IEC 61508?
A safety integrity level is one of four discrete levels for specifying the safety integrity requirements of safety functions. SIL 4 is the highest and SIL 1 the lowest.
Should we use IEC 61508 or a sector standard?
Use the sector standard where one exists, such as IEC 61511 for the process industry or IEC 62061 for machinery. IEC 61508 applies directly where no sector standard covers your product and underpins those that do.
Keep exploring
More on IEC 61508 and related standards
More in Product compliance & functional safety
Talk to a consultant
Plan your IEC 61508 compliance with confidence.
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