Industry-Specific Standards Standards - ISO Library

Overview

Industry-specific standards build upon foundational standards like ISO 9001 to address unique requirements of particular sectors. These standards incorporate industry best practices, regulatory requirements, and sector-specific risks.

Examples include IATF 16949 for automotive, AS9100 for aerospace, ISO 13485 for medical devices, and ISO 22163 for railways.

Benefits

Sector-specific requirements addressed
Supply chain recognition
Enhanced product safety and quality
Regulatory compliance
Industry best practices
Market access
Customer requirements met

Standards in this Category

ISO IATF-16949:2016 Automotive Quality Management Systems Automotive sector quality management system requirements, applied together with ISO 9001; published by the IATF, not by ISO Certifiable ISO 17025:2017 Testing and Calibration Laboratories - Competence Requirements The international standard against which testing and calibration laboratories are accredited. The third edition, ISO/IEC 17025:2017, was reviewed and confirmed in 2023 and remains current. Certifiable ISO 14971:2019 Medical Device Risk Management The risk management standard for medical devices, specifying the process manufacturers use to identify hazards, estimate and evaluate risks, control them and monitor the effectiveness of controls across the device life cycle. Third edition, published 2019. ISO 20022:2026 Financial Services - Universal Financial Industry Message Scheme Multi-part standard defining a common modelling methodology, repository and message scheme for financial industry messaging; Part 1 (metamodel) third edition published 2026 ISO 10993:2025 Biological Evaluation of Medical Devices The multi-part series governing biological evaluation (biocompatibility) of medical devices. Part 1, the framework document, was revised in 2025 as its sixth edition, reorganised to align with ISO 14971 and replacing ISO 10993-1:2018. ISO 26262:2018 Automotive Functional Safety The automotive functional safety standard for electrical and electronic systems in road vehicles. The 2018 second edition is a multi-part series covering the whole safety lifecycle and extends the scope beyond passenger cars to trucks, buses, trailers, semi-trailers and motorcycles. ISO 15189:2022 Medical Laboratories - Quality and Competence Requirements The accreditation standard for medical laboratories. The fourth edition, ISO 15189:2022, replaces ISO 15189:2012 and also replaces ISO 22870:2016, bringing point-of-care testing into the main standard and aligning its structure with ISO/IEC 17025:2017. Certifiable ISO 62304:2015 Medical Device Software - Software Life Cycle Processes The software life cycle standard for medical device software. It defines development, maintenance, risk management, configuration management and problem resolution processes, scaled by software safety class A, B or C. A second edition is in development. ISO 62366:2020 Medical Devices - Usability Engineering / Human Factors The usability engineering standard for medical devices. It specifies a process for analysing, specifying, developing and evaluating the usability of a device as it relates to safety, addressing use errors and use-related hazards. Current text is the 2015 edition with Amendment 1:2020. ISO 21434:2021 Automotive Cybersecurity Engineering Joint ISO/SAE standard specifying cybersecurity engineering requirements for road vehicle electrical and electronic systems across the whole vehicle lifecycle Certifiable ISO 21448:2022 Road Vehicles - Safety of the Intended Functionality (SOTIF) Defines safety of the intended functionality (SOTIF) and gives an argument framework and design, verification, validation and operation measures for hazards arising from functional insufficiencies rather than component failures. ISO 22005:2007 Traceability in the Feed and Food Chain General principles and basic requirements for designing and implementing a feed and food traceability system, applicable to organizations operating at any step of the feed and food chain. Reviewed and confirmed in 2022. ISO 22002-1:2025 Prerequisite Programmes on Food Safety - Food Manufacturing Specifies, in conjunction with ISO 22002-100, requirements for establishing, implementing and maintaining prerequisite programmes to control food safety hazards in food manufacturing. Replaces ISO/TS 22002-1:2009. ISO 15223:2021 Medical Devices - Symbols to be Used with Information Supplied by the Manufacturer Specifies the symbols used to convey information supplied with medical devices, on the device, its packaging or accompanying documentation. The fourth edition (2021) is amended by Amendment 1:2025. ISO 14155:2026 Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practice Specifies good clinical practice for the design, conduct, recording and reporting of clinical investigations of medical devices in human subjects. The 2026 edition supersedes ISO 14155:2020. ISO 9362:2022 Banking - Business Identifier Code (BIC) Specifies the elements and structure of the business identifier code (BIC), a universal identifier for financial and non-financial institutions used to address messages, route transactions and identify business parties.