Regulation
Standards, regulations, directives, conformity marks, and frameworks — the normative envelope around PLM. Grouped by type: ISO / industry standards first, then governmental regulations, EU directives, conformity marks, and methodology frameworks.
24 concepts. Generated by scripts/generate_mocs.py — do not hand-edit.
Standards (ISO / IEEE / OMG / Industry Consortium)
| # | Title | Type | Definition |
|---|---|---|---|
| 1 | ISO 10007 (Configuration Management) | standard | ISO 10007 is the international standard providing guidelines for configuration management as part of a quality management system. |
| 2 | ISO 9001 (QMS Requirements) | standard | ISO 9001 is the international standard specifying requirements for a quality management system. |
| 3 | OMG SysML v2 | standard | OMG SysML v2 is the next-generation Systems Modeling Language standardized by the Object Management Group. |
| 4 | ISO 13485 (Medical Device QMS) | standard | ISO 13485 is the international standard for quality management systems specific to medical devices. |
| 5 | ISO 14971 (Medical Device Risk Management) | standard | ISO 14971 is the international standard for the application of risk management to medical devices. |
| 6 | AS9100 (Aerospace QMS) | standard | AS9100 (current revision: AS9100D) is the QMS standard for the aviation, space, and defense industries — the sector specialization of ISO 9001 stewarded by the International Ae. |
| 7 | EXPRESS (ISO 10303-11) | standard | EXPRESS is the formal data-modeling language defined in ISO 10303-11 — the language used to write every Application Protocol (AP) schema in the STEP family (10303-203, -214, -2. |
| 8 | ISO 13399 (Cutting Tool Data Representation) | standard | ISO 13399 is the ISO standard for representing cutting-tool data — geometry, materials, performance characteristics, identifiers — in a vendor-neutral, machine-readable form so. |
| 9 | 21 CFR Part 820 (FDA Quality System Regulation) | standard | 21 CFR Part 820 is the United States Food and Drug Administration’s Quality System Regulation (QSR) governing the methods used in, and facilities and controls used for, the des. |
| 10 | 21 CFR Part 11 (Electronic Records and Signatures) | standard | 21 CFR Part 11 is the FDA regulation establishing the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to . |
| 11 | QIF (Quality Information Framework, ISO 23952) | standard | Quality Information Framework (QIF) is the open metrology data standard, published as ISO 23952 (and ANSI QIF), that defines an end-to-end XML schema for digital-thread quality. |
| 12 | IFC (Industry Foundation Classes, ISO 16739) | standard | IFC is the ISO 16739 open Building Information Modeling (BIM) data standard for the architecture, engineering, construction, and facilities-management (AEC/FM) sector — the AEC. |
| 13 | REACH (EU Chemicals Regulation) | standard | REACH — Registration, Evaluation, Authorisation and Restriction of Chemicals — is European Union Regulation (EC) No 1907/2006 governing the production and use of chemical subst. |
| 14 | RoHS (EU Hazardous Substances Directive) | standard | RoHS — Restriction of Hazardous Substances Directive — is European Union Directive 2011/65/EU (the “RoHS recast” or RoHS 2; further amended by 2015/863, sometimes called RoHS 3. |
| 15 | WEEE (EU Electronic Waste Directive) | standard | WEEE — Waste Electrical and Electronic Equipment Directive — is European Union Directive 2012/19/EU establishing producer-responsibility obligations for the collection, recycli. |
| 16 | CE Mark (EU Conformity Marking) | standard | CE marking (Conformité Européenne) is the manufacturer’s declaration that a product meets the applicable EU New Approach directives or regulations and may be placed on the Euro. |
| 17 | ITAR (US Defense Articles Export Regulation) | standard | ITAR — International Traffic in Arms Regulations, codified at 22 CFR 120-130 — is the United States regulation controlling the export and import of defense articles, defense se. |
| 18 | EAR (US Export Administration Regulations) | standard | EAR — Export Administration Regulations, codified at 15 CFR 730-774 — is the United States regulation controlling the export and reexport of commercial and dual-use items, incl. |
| 19 | EU MDR (Regulation 2017/745) | standard | EU MDR — Regulation (EU) 2017/745 on medical devices — is the European Union regulation that, since May 26, 2021, governs the placing of medical devices on the EU market. |
| 20 | EU IVDR (Regulation 2017/746) | standard | EU IVDR — Regulation (EU) 2017/746 on in vitro diagnostic medical devices — is the European Union regulation governing the placing of IVDs on the EU market. |
| 21 | CMMC (US DoD Cybersecurity Maturity Model Certification) | standard | CMMC — Cybersecurity Maturity Model Certification — is the United States Department of Defense framework requiring contractors and subcontractors handling Federal Contract Info. |
| 22 | CMII (Configuration Management II) | standard | CMII is the configuration-management methodology and certification developed by Vincent Watts and the Institute of Configuration Management (ICM), widely cited in CIMdata mater. |
| 23 | ISO 9000 (Quality Management Systems — Fundamentals and Vocabulary) | standard | ISO 9000 is the foundational vocabulary and principles standard of the ISO 9000 family — distinct from ISO 9001 (the certifiable requirements) and ISO 90. |
| 24 | ISO 10303 (STEP — Standard for Exchange of Product Data) | standard | ISO 10303 — informally “STEP” (STandard for Exchange of Product model data) — is the umbrella ISO standard family for representing and exchanging product data over the entire p. |