Industry-Specific Standards
Standards tailored to specific industry requirements including automotive, aerospace, healthcare, banking, and more, addressing unique sector challenges and regulations.
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
✓ CertifiableAutomotive Quality Management Systems
Automotive sector quality management system requirements, applied together with ISO 9001; published by the IATF, not by ISO
ISO 17025
✓ CertifiableTesting 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.
ISO 14971
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
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
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
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
✓ CertifiableMedical 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.
ISO 62304
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
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
✓ CertifiableAutomotive Cybersecurity Engineering
Joint ISO/SAE standard specifying cybersecurity engineering requirements for road vehicle electrical and electronic systems across the whole vehicle lifecycle
ISO 21448
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
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
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
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
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
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.