Compliance Document Translation Services for Manufacturing
Accurate, industry-specific translations of regulatory and technical compliance documents for factories and manufacturers worldwide.
Regulatory Document Translation for Global Manufacturing
Stepes provides specialized compliance document translation services tailored for the global manufacturing industry. From ISO 9001 quality manuals and CE declarations of conformity to MSDS sheets and technical construction files, we translate a full range of regulatory documents required for product certification, factory audits, and international market access.
Unlike general compliance translation services, this page addresses the unique documentation and regulatory standards specific to manufacturing environments. Our solutions support industrial companies in meeting regional and global compliance requirements across the EU, North America, Asia, and other major markets.
If you are looking for broader regulatory translation services beyond the manufacturing sector, please visit our Compliance Translation Services page.
Types of Compliance Documents We Translate for Manufacturers
Stepes provides expert translation of compliance documents essential for regulatory approval, quality management, and market entry in global manufacturing. Our linguists combine subject-matter expertise with in-depth knowledge of international standards to deliver accurate, audit-ready translations across all major languages.
We support a wide range of compliance-related content, including:
Required for products sold in the European Union, these documents must be accurately translated to demonstrate conformity with EU directives and regulations.
Comprehensive translation of quality management system documentation to support internal audits, external assessments, and multi-site compliance.
Technical documentation related to the restriction of hazardous substances and chemical safety, required for EU market access.
Critical safety documents for handling, storage, and transport of chemical substances, often mandated in multiple languages under GHS guidelines.
Detailed files including design drawings, product specifications, and test reports that support CE marking and other regulatory submissions.
Certifications issued by notified bodies that must be translated accurately for legal equivalency across EU member states.
Translation of electronic records and signature compliance documentation for manufacturers subject to U.S. FDA regulations, particularly in life sciences.
Documentation of internal compliance processes and operational guidelines used during inspections and audits.
Risk analysis reports and CAPA records translated with precision to ensure alignment with regulatory expectations and quality assurance practices.
Multilingual translation of packaging labels, inserts, and product information to meet country-specific legal and regulatory requirements.
Each document is translated with strict attention to terminology consistency, regional regulatory language, and formatting to support regulatory submission or inspection-readiness.
Supported Standards and Regulations
Stepes delivers professional compliance translation services aligned with international and regional manufacturing standards. Our translators have in-depth knowledge of regulatory terminology and documentation formats required for factory audits, certification, and product approvals worldwide.
We support the full range of ISO documentation required for manufacturing compliance:
- ISO 9001 – Quality Management Systems
Translation of policies, quality manuals, and audit procedures for global QMS alignment.
- ISO 13485 – Medical Devices
Accurate translation of documentation related to medical device quality systems, especially for contract manufacturers and OEM suppliers.
- ISO 14001 – Environmental Management
Support for environmental documentation related to factory operations, sustainability reporting, and emissions compliance.
Our team specializes in translating regulatory content for European Union market entry and post-market surveillance:
- CE Marking
Translation of declarations of conformity, TCFs, and user-facing materials to comply with EU directives.
- RoHS – Restriction of Hazardous Substances
Technical translations for documentation proving the absence of restricted materials in electrical and electronic equipment.
- REACH – Registration, Evaluation, Authorisation, and Restriction of Chemicals
Accurate rendering of safety and chemical data for compliance with EU chemical registration.
- EU MDR – Medical Device Regulation
Specialized support for manufacturing clients producing medical components or devices that fall under MDR scrutiny.
We support U.S. FDA requirements and major regulatory bodies across Asia and other global markets:
- FDA Regulations
Translation of 21 CFR Part 11 records, labeling, and documentation for FDA-regulated manufacturing operations.
- OSHA Standards
Workplace safety procedures, hazard communication plans, and training materials translated to support U.S. Occupational Safety and Health Administration compliance.
- CCC – China Compulsory Certification
Translation of compliance documents and technical specifications required for product approval in the Chinese market.
- METI and PAL – Japan Regulatory Bodies
Support for documentation related to Japan’s Ministry of Economy, Trade and Industry and Pharmaceuticals and Medical Devices Act, especially for exported goods.
- UKCA – United Kingdom Conformity Assessment
Post-Brexit translation support for UK product certifications replacing CE marking for the British market.
Languages We Support for Manufacturing Compliance
Stepes provides professional compliance document translation services in over 100 languages to support global manufacturing operations. Whether you are preparing CE declarations for the European market or submitting ISO documentation for factories in Asia, our native linguists ensure regulatory accuracy across all major languages and regions.
We specialize in key compliance languages, including:
- German – Required for CE marking, technical files, and conformity documentation in the DACH region
- French – Used for EU submissions and Canadian manufacturing compliance, including Quebec regulatory filings
- Chinese (Simplified) – Essential for product approvals, safety documents, and CCC submissions in Mainland China
- Japanese – Used for translations submitted to Japan’s METI and PAL authorities
- Korean – Supports KOSHA and KFDA compliance for industrial and life sciences manufacturing
- Spanish – Covers both EU Spanish for CE-related documents and Latin American Spanish for regional certifications
- Portuguese – Translation services for both European Portuguese (Portugal) and Brazilian Portuguese (ANVISA and INMETRO documentation)
We also support Dutch, Italian, Polish, Turkish, Russian, Thai, Arabic, Vietnamese, and many other languages across Europe, Asia, the Americas, and the Middle East. All translations are performed by professional native linguists with experience in regulatory and technical documentation.
Why Stepes for Manufacturing Compliance Translation
Stepes delivers high-quality compliance document translation services tailored to the complex needs of global manufacturers. Our solutions combine linguistic expertise, regulatory knowledge, and advanced technology to ensure your documentation meets international standards with precision and efficiency.
Our translators are native speakers with specialized experience in manufacturing and regulatory compliance. They understand sector-specific terminology used in ISO manuals, CE declarations, MSDS, and other technical files.
We leverage advanced translation memory tools and custom terminology databases to maintain consistency across all documents, reduce turnaround times, and lower costs for repeat content.
Stepes works with in-market linguists who are familiar with local regulatory language and formatting requirements. This ensures compliance with regional standards across Europe, Asia, and the Americas.
Our translation platform is hosted on AWS, providing enterprise-grade security and encryption to protect your intellectual property and sensitive compliance materials.
Stepes integrates with your existing document control systems and QA workflows, allowing for streamlined handoffs and improved collaboration with your compliance and regulatory teams.
We offer full DTP services to format translated compliance manuals, product labels, and packaging inserts in accordance with target-language layout and regulatory design specifications.
Whether you are preparing for a factory inspection, international certification, or product launch in new markets, Stepes provides the language solutions you need to stay compliant and competitive.
Use Cases in Manufacturing Compliance Translation
Stepes supports leading manufacturers across industries with fast, accurate, and regulator-ready translation services. Below are examples of how we help clients meet global compliance requirements through high-quality multilingual documentation:
Translated technical documentation, CE declarations of conformity, and RoHS compliance reports into 20 European languages. Stepes enabled localized submissions to notified bodies and streamlined EU market entry for consumer electronics products.
Delivered bilingual translations of quality manuals, internal audit reports, and SOPs for multi-site ISO 9001 certification. Our linguists ensured consistent terminology across Mandarin and German, supporting the client’s internal QMS review and external audit readiness.
Localized material safety data sheets, risk assessments, and CAPA documentation to meet U.S. FDA and European EMA regulatory requirements. The translated files were formatted for submission and integrated into the client’s document control system for traceability.
These examples highlight Stepes’ ability to deliver scalable, compliance-focused translation solutions that align with local regulations and global quality expectations.
Technology-Driven Translation Workflows for Regulatory Compliance
Stepes delivers accurate, consistent, and regulator-ready translations through an advanced translation workflow built specifically for manufacturing compliance. Our process integrates professional linguists with cloud-based tools and structured quality control to ensure technical precision and fast turnaround across all project types.
We use:
- Computer-Assisted Translation (CAT) Tools to maintain consistency across multilingual documents
- Translation Memory (TM) Leverage to reduce costs and turnaround time by reusing previously approved content
- Cloud-Based Quality Assurance to enable real-time collaboration, version control, and multi-step linguistic review
Our 5-Step Manufacturing Compliance Translation Workflow
Clients upload files securely through our encrypted web portal or integrated system.
Our team prepares source files, extracting translatable content and ensuring format compatibility for regulatory documents.
Native linguists with industry expertise translate the content using approved terminology and TM assets.
All translations undergo a second-layer review for accuracy, formatting, and compliance with target regulations.
Completed translations are formatted to match original layouts or regulatory templates, then delivered in print-ready or submission-ready formats.
This workflow ensures your CE documentation, ISO manuals, MSDS sheets, and other compliance files are translated with the accuracy, consistency, and speed required for global manufacturing success.
Related Manufacturing Translation Services
Stepes provides a complete suite of language solutions to support manufacturers with global regulatory compliance, product localization, and multilingual technical communication. Explore our related services to enhance your end-to-end translation workflows and maintain consistency across all documentation.
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End-to-end language support for product manuals, quality documentation, and global factory operations. Ideal for manufacturers targeting international markets.
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Professional translation of installation guides, user manuals, service handbooks, and product instructions with precise terminology and formatting for global use.
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Centralized termbase creation and maintenance to ensure linguistic accuracy and consistency across all regulatory and technical materials.
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Multilingual translation and desktop publishing for medical device packaging, safety labels, and compliance inserts that meet regional regulatory requirements.
These services are fully integrated with Stepes’ compliance translation solutions to help you maintain quality, reduce risk, and accelerate time to market across all target regions.
Frequently Asked Questions (FAQ)
Yes. Many notified bodies require certified translations of CE-related documentation such as declarations of conformity, technical construction files, and product manuals. Stepes provides certified translations that meet EU regulatory standards for legal and technical equivalency across member states.
We support a wide range of file formats including Microsoft Word, Excel, PowerPoint, PDF, InDesign (INDD), FrameMaker (FM), XML, XLIFF, and more. Our engineering team can also process custom formats for structured content and regulatory publishing systems.
Stepes uses subject-matter expert linguists and terminology management tools to ensure accuracy across all compliance documentation. We build client-specific glossaries and translation memories to maintain consistency, reduce errors, and align with regional regulatory language.
Trusted by Global Manufacturers
Stepes is a certified language service provider with a proven track record of supporting global manufacturers with compliance-focused translation solutions.
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ISO 17100 and ISO 9001 Certified
Our quality management systems and translation processes meet internationally recognized standards for language service providers.
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Trusted by Fortune 500 Manufacturers
We support leading companies across electronics, automotive, life sciences, and industrial manufacturing with scalable translation solutions for compliance and regulatory documentation.
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Client Testimonials and Case Studies Available
Upon request, we can share anonymized case studies or testimonials that highlight our experience delivering fast, accurate, and regulator-ready translations for complex manufacturing projects.
Get a Free Quote for Your Compliance Document Translations
Ready to translate your ISO manuals, CE declarations, MSDS sheets, or other regulatory materials? Stepes provides fast, accurate, and fully compliant translations by expert linguists with manufacturing and regulatory experience. Upload your files today to receive a free quote and timeline estimate.
