Monthly Roundup: Manufacturing Standards from September 2025

Looking back at September 2025, the Manufacturing Engineering sector witnessed the publication of five influential standards shaping key aspects of manufacturing operations and compliance. Spanning batch control, intelligent device management, welding qualifications, and additive manufacturing for medical implants, these documents reflect ongoing trends in digitalization, process standardization, and safety within the ICS 25 domain. This monthly overview provides industry professionals with a comprehensive synthesis, highlighting not only technical specifics but also broader patterns and compliance implications—essential for those seeking to stay at the forefront of industry advancements.

Monthly Overview: September 2025

September’s standardization activity in the Manufacturing Engineering sector was marked by a strong focus on process clarity, advanced digital integration, and heightened safety requirements. The month saw the publication of five standards issued by leading organizations such as CLC, IEC, ISO, and CEN, touching on critical themes like batch process modeling, intelligent asset management, advanced welding procedures, and the growing influence of additive manufacturing in medical applications.

Compared to typical months, September 2025 stood out for its balanced attention to both traditional manufacturing issues (notably welding) and emergent fields such as intelligent device management and additive-made medical implants. The breadth of coverage illustrates a sector striving to harmonize established best practices with new technological opportunities, setting the pace for digital transformation, quality assurance, and risk-based thinking in manufacturing.

These publications suggest an industry moving intentionally toward greater interconnectivity, harmonized process vocabularies, and rigorous qualification paths—particularly in product segments sensitive to performance and safety, such as medical device manufacturing.

Standards Published This Month

FprEN IEC 61512-1:2025 - Batch Control – Part 1: Models and Terminology

Batch control - Part 1: Models and terminology

FprEN IEC 61512-1:2025 sets out the foundational language and model structures for batch control within manufacturing engineering. Its scope encompasses terminology, hierarchical batch process models, equipment control, recipe management, and compliance approaches—creating a universal reference point for communication and system integration in batch-oriented industries (e.g., pharmaceuticals, food & beverage, chemicals).

Key requirements include the definition of batch process and equipment models, process cell classifications, hierarchical recipe types, and state management for procedural operations. The standard maps activities and functions required for coherent batch control, addressing both control engineering and plant management. Conformance, compliance, and completeness sections guide system integrators and auditors.

Stakeholders such as process engineers, automation architects, digital transformation leads, and system vendors benefit from this harmonized framework, which also serves as a baseline for international project alignment and regulatory acceptance. With expanded models and clarified definitions in this edition, organizations can better establish end-to-end traceability and consistency across multivendor environments.

Key highlights:

• Standardized terminology and models for batch control processes
• Guidance on hierarchical process structure and equipment classifications
• Enhanced coverage of recipe management and procedural state transitions

Access the full standard:View FprEN IEC 61512-1:2025 on iTeh Standards

IEC 63082-1:2025 - Intelligent Device Management – Part 1: Concepts and Terminology

Intelligent device management - Part 1: Concepts and terminology

IEC 63082-1:2025 provides the conceptual and linguistic foundation for intelligent device management (IDM) within modern manufacturing environments. Its scope includes definitions of IDM, relationships to asset management, and the principles underlying IDM systems—spanning organizational, functional, and programmatic domains. Notably, this edition aligns with updated structures established in IEC 63082-2 and expands on technical changes since the 2020 technical report.

The standard establishes key requirements for management functions (such as risk, lifecycle, and cybersecurity), IDM program structure—including coordination of stakeholders—and alignment with existing asset management frameworks. It addresses enterprise-level policy, supplier coordination, IDM work process templates, and the integration of continuous improvement principles.

Targeted toward digitalization program managers, plant asset managers, and systems integrators, IEC 63082-1 bridges the gap between technological opportunity and governance, helping organizations develop coherent IDM programs that enhance device longevity, security, and data quality. Emphasizing lifecycle thinking and change management, it provides actionable guidance for both new and existing facility deployments.

Key highlights:

• Comprehensive IDM terminology and conceptual structure
• Integration with risk, supplier, and lifecycle management
• Emphasis on programmatic coordination and continuous improvement

Access the full standard:View IEC 63082-1:2025 on iTeh Standards

EN ISO 15613:2025 - Welding Procedure Qualification via Pre-Production Test

Specification and qualification of welding procedures for metallic materials – Qualification based on a pre-production welding test (ISO 15613:2025)

EN ISO 15613:2025 details the qualification of welding procedures for metallic materials, using a pre-production welding test as the primary evaluation method. This standard addresses various techniques—arc, gas, beam, resistance, stud, and friction welding—for industries where assurance of weld quality, traceability, and compliance is mandatory: pressure equipment, structural steel, shipbuilding, and beyond.

Central requirements include the creation and qualification of a preliminary welding procedure specification (pWPS), performance assessments via sample welds, and the documentation needed for welding procedure qualification records (WPQR). The standard’s linkage to the EU Pressure Equipment Directive (PED) provides a basis for regulatory conformity in safety-critical contexts.

Welding engineers, quality managers, and fabricators must comply to ensure safe, repeatable, and regulatory-approved welds. This edition reinforces harmonization of qualification processes across borders and supports the withdrawal of superseded national standards.

Key highlights:

• Focus on pre-production test as qualification route
• Applicable to multiple welding processes and industry segments
• Supports presumption of conformity with EU Pressure Equipment Directive (PED)

Access the full standard:View EN ISO 15613:2025 on iTeh Standards

EN ISO 15614-2:2025 - Arc Welding of Aluminium and Its Alloys

Specification and qualification of welding procedures for metallic materials – Welding procedure test – Part 2: Arc welding of aluminium and its alloys (ISO 15614-2:2025)

EN ISO 15614-2:2025 focuses on the qualification of welding procedures specifically for arc welding of wrought and cast aluminium and its alloys, covering production, repair, and build-up applications. It provides detailed instructions for conducting welding procedure tests, defines the range of qualification, and clarifies exclusions (such as finishing welding, which falls under ISO 15614-4).

Requirements specify conditions for test samples (butt, T-joints, branches, etc.), welding processes (MIG, TIG, plasma arc), and subsequent testing—visual, non-destructive, and destructive. As with other standards in this series, compliance is crucial for manufacturers supplying pressure vessels, transport infrastructure, and any sector demanding traceable welding quality of aluminium components. The inclusion of normative references ensures harmonized procedures and validates the global supply chain.

Aluminium fabricators, certification authorities, and quality assurance personnel must implement this standard to demonstrate compliance with EU directives and international procurement specifications.

Key highlights:

• Applies to all arc welding of aluminium and its alloys in manufactured products
• Defines testing, sample preparation, and validation methods
• Essential for suppliers working with pressure equipment and regulated sectors

Access the full standard:View EN ISO 15614-2:2025 on iTeh Standards

ISO 5092:2025 – Additive Manufacturing for Medical: Non-Active Implants

Additive manufacturing for medical – General principles – Additive manufacturing of non-active implants

ISO 5092:2025 identifies safety and performance factors affecting non-active surgical implants manufactured using additive techniques (AM), including custom-made and patient-matched devices. Its scope covers additive manufacturing’s unique attributes, associated risk assessment, material/feedstock management, process and post-process controls, cleanliness, and sterilization for implants and instruments.

Key requirements involve comprehensive risk analysis specific to AM implants, qualification and validation of processes, material selection, feedstock reuse, and design criteria tailored for lattice structures, supports, and complex geometries. While primarily oriented toward non-active devices, several provisions are applicable (optionally) to active implants can be leveraged for cross-standard harmonization.

This standard is essential for medical device manufacturers, regulatory affairs professionals, and engineers involved in the design, production, and validation of additively manufactured surgical implants. It responds to the sector’s push for mass customization, precision, and dependable patient safety amid increasingly complex AM manufacturing chains.

Key highlights:

• Applies to both standard and custom-made additively manufactured non-active implants
• Emphasizes risk management, materials verification, and post-process safety
• Complements implant-specific and AM process-focused standards for global market access

Access the full standard:View ISO 5092:2025 on iTeh Standards

Common Themes and Industry Trends

The five standards from September 2025 collectively signal a few consistent themes emerging within Manufacturing Engineering:

• Digitalization and Data Consistency: The expansion of standardized terminology and models for both batch processing and intelligent device management highlights the push toward interoperable and digitally-integrated factories.

• Quality and Qualification in Special Processes: The prominence of two welding qualification standards underlines the sector’s emphasis on repeatable, documented, and regulatory-aligned special processes—particularly where public safety and cross-border commerce are at stake.

• Safety and Risk-Based Engineering: Standards for both welding and additive manufacturing for medical emphasize structured risk assessment, from pre-production evaluation of welding procedures to life cycle risk analysis of implants.

• Customization and Advanced Manufacturing: Additive manufacturing’s rise is reflected in new guidance addressing custom and patient-matched devices, responding to a market moving toward individualized solutions without compromising regulatory rigor.

• Process and Lifecycle Integration: Both IDM and batch control standards illustrate the sector’s maturing focus on complete lifecycle—from design and commissioning through operations, maintenance, and decommissioning.

Notably, the month’s standards cut across industries including pharmaceuticals, metals fabrication, and medical device manufacturing, underlining the horizontal influence of these best practices.

Compliance and Implementation Considerations

Organizations affected by these September 2025 standards should:

• Prioritize Gap Assessments: Review existing processes against the updated requirements, particularly where digital models or lifecycle documentation are newly emphasized.
• Integrate Updated Terminology and Models: Ensure all documentation, training, and controls mirror the latest definitions, supporting smoother audits and cross-team communication.
• Align with EU and International Directives: For those involved with pressure equipment or medical implants, integrate references to applicable directives (e.g., PED, SPVD) and use these standards to demonstrate presumption of compliance.
• Update Supplier and Asset Management Programs: Extend IDM and welding qualification requirements into supply chain expectations, ensuring all tiers maintain the same rigor.
• Leverage Training and Certification Resources: Provide education not only to technical teams, but also to compliance, procurement, and IT specialists responsible for supporting manufacturing operations.

Timeline:

• For EU-centric standards (EN ISO designations), anticipate enforcement or expected compliance within 6–12 months of national adoption.
• For new product development or contract manufacturing, immediate reference and adoption are advisable to avoid delays in certification or market access.

Resources:

• Access the standards via iTeh Standards for authoritative content and guidance.
• Consult related harmonized standards referenced within each document.
• Engage with sector-relevant trade associations and standards user groups for practical implementation case studies.

Conclusion: Key Takeaways from September 2025

Reflecting on September 2025, the Manufacturing Engineering sector made significant strides in standardizing complex industrial processes—balancing digital innovation, quality assurance, and regulatory alignment. The five standards covered in this overview highlight:

• The growing necessity for structured models and terminology in process control and device management
• Continual advancement in welding qualification, safeguarding structural integrity in safety-critical applications
• The progression of additive manufacturing standards for precise, patient-focused medical solutions

For industry professionals, staying current with these standards is essential—not only for maintaining compliance, but also for leveraging process improvements, expanding into new markets, and future-proofing manufacturing operations against rapid technological change.

Explore the full content of these standards on iTeh Standards and ensure your teams, processes, and documentation reflect the latest in Manufacturing Engineering best practices.