Control conformance
✓ Rigorous self-assessment
✓ Inspection readiness
✓ Suppliers conformance control
Where is PREMIS used?
Our customers use PREMIS for assurance cases, technology qualification
and conformance control in industries such as:
Automotive
PREMIS is used for standards such as:
- ISO 26262 Road vehicles – Functional safety
- SS 7740 Road vehicles - Functional Safety Process Assessment Model
- Automotive SPICE version 4.0
- ISO 21448 Road vehicles - Safety of the intended functionality (SOTIF)
Air traffic
PREMIS is used for regulations such as:
- EU 2017/373 – Requirements for providers of air traffic management/air navigation services
- CAP 670 Air Traffic Services Safety Requirements
- EU 2018/1139 – Common rules in the field of civil aviation
Process industry,
Oil & Gas
PREMIS is used for standards such as:
- EN/IEC 61511: Functional safety – Safety instrumented systems for the process industry sector
- NORSOK Z-016: Regularity Management & Reliability Technology
Technology
qualification
PREMIS is used for standards such as:
- ISO/IEC 17065 Conformity assessment — Requirements for bodies certifying products, processes and services
- IEC 60300: Dependability management
Cybersecurity
PREMIS is used for standards such as:
- IEC 62443 Security for industrial automation and control systems
- ISO 27001 Information Security Management
Medical devices
PREMIS is used for standards such as:
- IEC TR 60601-4-5: Medical electrical equipment - Safety-related technical security specifications
- IEC 80001-1: Application of risk management for IT-networks incorporating medical devices
- ISO 81001-1: Health software and health IT systems safety, effectiveness and security
Why PREMIS?
Online collaboration
- Shared workspace for all involved parties
- Online access to the integrated assurance case, evidence and the assessment
- Role-based access management for each assurance module
Traceability and auditability
- Explicit tracking of goals to requirements, evidence and assessments
- Complete change history and audit log
- Baselines, past state revisions and restoring any past version
Efficiency
- Controlled integration with AI tools
- Early involvement of interested parties
- Strong communication and early feedback
- Verification steps integrated in the process
Scalability and adaptability
- Modular approach and templates for complex systems and product lines
- Easy integration with other systems with API
- Use of live data for continuous assurance
- Automation in CI/CD pipeline
PREMIS User Group
News
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Assurance case architecture for space systems
Space systems are developed using rigorous processes. In Europe, these are most often in accordance with ECSS (European Cooperation for Space Standardization) standards. These standards describe processes that ensure a high level of safety and reliability in the execution of missions. While the use of assurance cases is not explicitly required by ECSS standards, they […]
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Inspection readiness managed with assurance cases
Regulations and standards in some industries require an organization to maintain readiness for control, audit, or inspection. Examples include GMP (Good Manufacturing Practices) in the pharmaceutical industry, MDR (Medical Device Regulation) for medical devices, and more recently the AI Act for high-risk AI systems. Maintaining inspection readiness requires coordinated cooperation between the relevant units, and […]
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Verification of AI-generated work products with assurance cases
The accuracy and thoroughness of documentation are crucial for system certification. While the use of AI can accelerate the preparation of such documentation, it can also impact its quality. How can such documentation be effectively reviewed when it is extensive? It is important that information is presented in a way that makes it easy for […]
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Best Practices for Assurance Case Development
25.08.2026
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for selected standards