Product compliance & functional safety: product compliance and functional safety standards and frameworks

This family is about the product and the evidence behind it. A manufacturer placing devices on the EU market under Regulation (EU) 2017/745, a machine builder working to ISO 12100 and the EU Machinery Regulation, a fabricator supplying structural steel under EN 1090, a workshop working to ISO 3834 for fusion welding, a supplier of safety-related electrical and electronic systems claiming IEC 61508, or a process plant running safety instrumented systems under IEC 61511 all face the same question from customers, distributors and authorities: can you show that this product, or this system, meets the requirements that apply to it? CE marking and UKCA marking are the visible answer for the EU and Great Britain; ISO/IEC 17050 sets out how a supplier’s declaration of conformity and its supporting documentation are structured; REACH, RoHS and WEEE add the substance and end-of-life duties that sit alongside.

Here the manufacturer carries the responsibility. The manufacturer draws up the technical documentation, signs the declaration and affixes the mark; a notified body in the EU, or an approved body in Great Britain, takes part only where the applicable procedure requires it, as it does for medical devices above plain class I. IEC 61511 is the process sector implementation of IEC 61508, so the two share a lifecycle and a vocabulary, and the EU MDR quality system is normally built on EN ISO 13485. Sterling’s part is the system and the file: the quality and functional safety management processes, the structure of the risk assessment and technical documentation, the evidence behind the declaration, internal audits and readiness for the body’s review. Sterling never affixes a mark, never signs your declaration and never acts as a notified or approved body; laboratories carry out the testing. You choose Design™, where we develop and your team implements under our advice and supervision, or Drive™, where we design and build under your approval; the two are alternatives. Effivity is included at no additional cost to hold documents, risk files, changes and corrective actions.

• ISO 26262ISO 26262 Functional Safety certification consulting for vehicle E/E systems: an ASIL-scaled safety lifecycle and safety case ready for independent assessment.
• CE markingCE marking compliance support for manufacturers: EU rules, technical files, declaration of conformity and quality systems. Sterling is not a notified body.
• UKCAUKCA marking support for products sold in Great Britain: UKCA or CE route, technical files, declaration of conformity. Sterling is not an approved body.
• IEC 61508IEC 61508 compliance support for E/E/PE safety-related systems: functional safety management, lifecycle records, SIL evidence and assessment readiness.
• IEC 61511IEC 61511 compliance for process plants: the safety instrumented system lifecycle, functional safety management and the evidence your assessors expect.
• ISO 12100 / Machinery RegulationISO 12100 and Machinery Regulation compliance: machinery risk assessment and risk reduction, technical records and the evidence the EU framework requires.
• ISO 3834ISO 3834 certification for welding manufacturers: requirement levels, welding coordination, procedures and records, with support until certification.
• EN 1090EN 1090 certification for steel and aluminium fabricators: factory production control, welding, execution records and support through the notified body's audit.
• ISO 10377 / 10393ISO 10377 and ISO 10393 consumer product safety and recall guidance put into practice: hazard and risk work, warnings, recall plans and ISO 9001 alignment.
• ISO/IEC 17050ISO/IEC 17050 supplier's declaration of conformity: the general requirements, supporting documentation and a declaration process your customers can rely on.
• 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.
• REACH / RoHSREACH, RoHS and WEEE compliance for products sold in the EU: what each law covers, who it affects and how Sterling builds your compliance programme.
• EU MDR (CE for devices)EU MDR compliance consulting for CE marking: QMS, technical documentation, traceability and post-market surveillance prepared for your notified body.

REACH, RoHS and WEEE share one page. If you are unsure which route applies to your product, the Select the Standard™ tool and the readiness check are the quickest place to start.