The Complexity of Compliance

The future of industrial compliance consulting is transforming rapidly. As regulations grow more complex, compliance will become a strategic driver of global market access, risk reduction, and sustainable growth, says Naithik Brahmakshtriya, Manager–Engg. & Consulting at Schmersal India. In an exclusive interview with Engineering Review, Naithik explains how crucial is the need for Indian manufacturers to align with the global quality standards. Excerpts:

Q1. How do you perceive India’s evolution as a global export hub for industrial machinery and automation systems
India is steadily emerging as a significant global hub for the export of industrial machinery and automation systems, driven by a combination of policy initiatives, skilled manpower, cost advantages, and a growing focus on innovation and quality.

Over the past decade, India has seen a substantial transformation in its manufacturing landscape. Government initiatives such as ‘Make in India’, PLI (Production-Linked Incentive) schemes, and infrastructure development have encouraged domestic manufacturing and positioned India as a reliable alternative to traditional manufacturing powerhouses. These initiatives have also catalyzed investments in smart factories, robotics, and digital automation solutions.

Indian manufacturers are increasingly aligning with global quality standards, including CE marking, ISO certifications, and safety compliance as per IEC and ISO norms, which has boosted their credibility in international markets. Additionally, India’s strong IT and software engineering capabilities provide a unique edge in integrating Industry 4.0 technologies—like IoT, AI, and cloud-based automation—into machinery exports.

The cost competitiveness, robust supplier ecosystem, and improving logistics infrastructure further enhance India’s appeal as an export destination. Moreover, Indian companies are becoming more proactive in building global service networks, ensuring after-sales support and customization as per regional compliance requirements.
As global companies seek to diversify supply chains and reduce overdependence on a single country, India is increasingly being viewed as a strategic manufacturing and export partner, particularly for sectors such as pharmaceuticals, food processing, automotive, textiles, and renewable energy machinery.

Q2. What strategic role does tec.nicum play in facilitating export readiness for machine manufacturers in India?
tec.nicum, the consulting and services division of the Schmersal Group, plays a pivotal strategic role in preparing Indian machine manufacturers for global markets by helping them navigate the complex landscape of international safety, compliance, and export regulations.

As global machinery exports require strict adherence to compliances such as CE marking (EU), UKCA (UK), UL/OSHA (USA), CSA(CANADA) , NR12(Brazil)
and various IEC/ISO safety standards,
tec.nicum provides comprehensive support to Indian OEMs through:

Safety Consulting & Risk Assessments: tec.nicum guides manufacturers through ISO 12100-based risk assessments and helps implement functional safety as per ISO 13849-1 / IEC 62061, ensuring machines meet international expectations for operator safety and design integrity.

Technical Documentation & Compliance Support: tec.nicum assists in the creation of Technical Files, Declarations of Conformity, and compliance reports necessary for exports. This is critical for CE marking and market entry into Europe and other regulated regions.

Training & Knowledge Transfer: Through workshops and certified training programs, tec.nicum builds internal competency within Indian companies, empowering engineering teams with up-to-date knowledge on machinery directives, risk mitigation, and international regulations.

Gap Analysis & Retrofitting Recommendations: For existing machines or brownfield projects,
tec.nicum conducts compliance gap analysis and recommends cost-effective retrofitting solutions to align with destination country standards.

Global Integration & Local Expertise: With a deep understanding of both local manufacturing practices and global regulatory frameworks, tec.nicum serves as a strategic partner—bridging Indian manufacturers with international buyers by ensuring machines are export-ready and legally compliant.

tec.nicum enhances the export competitiveness of Indian machine manufacturers by embedding compliance, safety, and global best practices into product development—ultimately reducing time-to-market and increasing trust among global customers.

Q3. What are the key international certifications and safety regulations that Indian exporters need to comply with and how does tec.nicum support this?
Indian exporters of industrial machinery must comply with various international safety regulations and certifications to access global markets. Each region has its own mandatory requirements to ensure machinery safety, performance, and environmental compatibility. Compliance with these is essential not only for legal market entry, but also to build trust with overseas buyers.

CE Marking (European Union): Mandatory for machinery sold in the EU under the Machinery Regulation (EU) 2023/1230 (replacing Directive 2006/42/EC).

UKCA Marking (United Kingdom):
Post-Brexit equivalent of CE marking, with similar technical requirements.

UL Certification / OSHA Compliance (United States): Focuses on electrical safety and machine construction standards as per NFPA 79, ANSI B11, and UL standards. OSHA also mandates compliance with safe working practices.

CSA Certification (Canada): Like UL, focusing on safety of electrical and industrial control equipment.

IECEx / ATEX (For Hazardous Areas): Required for machines or components used in explosive atmospheres. ATEX (Europe) and IECEx (International) ensure explosion protection
compliance.

NR-12 (Brazil): Brazilian industrial machinery safety regulation that establishes mandatory safety requirements for machinery & equipment used in workplaces throughout Brazil.

SASO ( Saudi Arabia ): For most industrial products, especially machinery, electrical/electronic equipment, and appliances, SASO compliance is required for customs clearance and legal sale in the Saudi Arabia.

EAC/TRCU (Eurasian Conformity – EAEU) : Industrial machinery intended for sale or use in any EAEU country (Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan) must carry the EAC mark and be certified according to relevant Technical Regulations of the Customs Union (TR CU).tec.nicum plays a vital role in supporting Indian machine manufacturers to comply with these certifications through the services Compliance Assessment & Gap Analysis; Detailed evaluation of machinery against international directives and standards; Identification of design, documentation, or safety control gaps; Risk Assessment & Functional Safety Design; Performing ISO 12100-based risk assessments; Designing and validating safety-related control systems as per ISO 13849-1 or IEC 62061; Technical File Preparation & CE/UKCA Support; Assisting in compiling all necessary documents: risk assessment, circuit diagrams, component specs, EC Declaration of Conformity, etc.; ATEX/IECEx Advisory for Hazardous Area Machinery; Guidance on equipment categorization, explosion protection techniques, and compliance route; Global Market Access Strategy, Supporting manufacturers in aligning with region-specific regulations (CE, UL, CSA, UKCA) and facilitating smooth certification processes; Training & Knowledge Transfer, Conducting training programs for manufacturers’ teams on global machine safety compliance, helping them become self-sufficient in long-term compliance management.

Q4. Could you explain how tec.nicum assists manufacturers in managing the CE conformity process – from risk assessment to Declaration of Conformity?
tec.nicum provides end-to-end support to manufacturers in achieving CE conformity for their machinery and automation systems. The CE marking is essential for selling products within the European Economic Area (EEA) and demonstrates compliance with all relevant EU directives and regulations, especially the Machinery Regulation (EU) 2023/1230 (replacing Directive 2006/42/EC)

i. Identification of Applicable EU Directives & Harmonised Standards
Analyzing the machine’s function and structure
Determining which EU directives apply (e.g. Machinery, EMC, LVD, RoHS)
Identifying relevant harmonised EN standards for safety, EMC, and performance

ii. Defining the conformity assessment procedure
Analyzing the technical specification of the machine
Select an appropriate conformity assessment procedure from 2006/42/EC to show the machine CE compliance

iii. Risk assessment (EN ISO 12100)
Conducts a systematic risk assessment to identify hazards during all machine lifecycle phases (transport, installation, operation, maintenance, etc.)
Evaluates the risk level and helps define risk reduction measures
Delivers a full Risk Assessment Report with Hazard Rating Number (HRN), forming the basis of CE compliance

iv. Functional Safety Design (EN ISO 13849-1 & EN IEC 62061)
Defining the Safety requirement Specification (SRS)
Evaluates or helps design safety-related control systems (PLr or SIL based)
Ensures proper safety logic, redundancy, diagnostics, and fail-safe operation
Validates the system using SISTEMA or equivalent tools

v. Identification of test & conducting test
Low voltage directive 2014/35/EU test like Protective bonding, earth leakage, GB, HV test as per EN 60204-1
EMC test as per EN 61000-6-2 & EN 61000-6-4

vi. Technical File Compilation and Storage under European Authorised Service (EAR)
Assists in compiling a complete Technical Documentation (Annex VII) required by the Machinery directive, including:
Risk Assessment
Machine design drawings, Circuit diagrams, component specifications
Safety calculations and software descriptions
Test results and verification reports
Machine Installation and operating instructions

vii. Declaration of Conformity (DoC)
Drafting the Declaration of conformity or verifying the content of the Declaration of conformity, which declares that the machine meets all relevant directives and standards.
Ensures the correct CE marking is affixed on the machine.
Signing EU DoC (under EAR)
For non-EU manufacturers, tec.nicum can advise or help arrange an EU-based Authorized Representative (tec.nicum – Solutions & Services GmbH), who legally holds the technical file and signs the DoC.

Q5. What are your other support services from the Consulting & Certification Division?

Apart from the Consulting & Certification services, tec.nicum has the academy, engineering, integration, digitalization and outsourcing. Our services are designed to support clients through every stage of the machine lifecycle — from concept and design to certification and post-installation. Key Support Services include:

Academy: The tec.nicum academy offers a comprehensive range of seminars and training on machine and plant safety worldwide. From basic introductory courses to customer-specific topics, training content is carefully matched to the requirements of tec.nicum customers. Training subjects include: Basic Machinery safety risk assessment, Advance Machinery Safety Training, Practical workshop – working with SISTEMA, Qualification program – Machinery CE Expert® (MCEExpert) & Function Safety Engineer (FSE) certified by TÜV Rheinland®.

Engineering : Machinery Safety Engineering Projects – Machine Retrofit & Compliance Upgrade Support project for the existing machine in plant, designing and engineering of the machine safety guarding solution and selecting and appropriate machine safety component & guarding solution, Support for engineering drawing CAD/CAM & Bill of material.
Installation and commissioning of the machine safety guarding, safety fence, Installation & integration of safety component.

Digitallization: Digital Lock Out – Tag Out (LOTO), Energy Monitoring System, Artificial Intelligence for Accident reduction, and Behavioral and interaction analysis system.

Q6. With safety and functional compliance becoming more digitized, how is tec.nicum leveraging technologies like IIoT, AI, and cloud platforms to enhance its certification services?

As the landscape of industrial safety and functional compliance rapidly evolves with the advent of digital transformation, tec.nicum is at the forefront of integrating Industry 4.0 technologies—such as IIoT (Industrial Internet of Things), AI (Artificial Intelligence), and cloud platforms—to provide smarter, faster, and more reliable certification and consulting services to its clients.
tec.nicum supports the integration of IIoT sensors and smart safety devices into machinery to enable real-time monitoring of safety-critical parameters (e.g., emergency stop usage, door interlock status, machine operating conditions).This allows predictive diagnostics and maintenance planning based on live data, reducing downtime and improving compliance with functional safety standards like ISO 13849-1 & IEC 62061.

Also tec.nicum secure cloud platforms for storing and sharing technical files, risk assessments reports, and compliance reports, Enabling real-time collaboration between manufacturers, certifying bodies, and engineering teams. Clients can access CE documentation, conformity status, and audit reports from anywhere, streamlining global project management.

tec.nicum is increasingly using e-learning platforms, AR/VR training modules, and AI-driven learning systems to train machine safety aspirants on safety compliance topics—creating a more scalable and digital-savvy workforce.

Q7. What is your outlook on the future of industrial compliance consulting, especially for emerging economies like India aiming at global competitiveness?
The future of industrial compliance consulting is transforming rapidly, especially in emerging economies like India. As regulations grow more complex, compliance will become a strategic driver of global market access, risk reduction, and sustainable growth. In this shift, digital, integrated consulting solutions will be key enablers of India’s rise as a global manufacturing leader.

Those firms that adopt a forward-thinking, technology-integrated, and globally-aligned approach will be crucial in making Indian manufacturing not only compliant—but globally competitive.

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