ISA is a service that evaluates if the system or product adheres to the specified safety requirements and decides, through a judgement, if it's suitable for its intended purpose concerning safety. It relies on evidence and aims to assess if both the design authority and the validator have successfully achieved a product that fulfils the set criteria.
We perform ISA according to the requirements of international standards on railway safety, as ISO/IEC EN 17065:2012 (Certification of products) and ISO/IEC 17020:2012 (Type A inspection). The service consists of a third-part assessment of the safety aspects of complex systems or products. The process, performed by RINA as ISA body, involves the following steps:
- ISA plan: the design stage, it's grounded in the system description and the requirements specification for the system/subsystems.
- Documental analysis, in factory and on-site inspection supported by expert review, field tests, test witnessing, safety audits and inspections, during all lifecycle phases.
- Intermediate ISA Reports to provide the display progress and facilitate the management of observations/findings on Customer side.
- Progress meetings on regular basis.
- Final ISA Report with a record of results and a conclusion with possible recommendations.
The key benefits to obtain ISA assessment are:
- Increasing confidence of final customer in the system/product safety thanks to the independent expert opinion based on competence and impartiality.
- Receiving a comprehensive double-check of the system/product safety due to the independent expert opinion of the ISA Body and its wide portfolio of reference.
The assessment can also provide a competitive advantage for a company in the railway sector, as it can showcase its commitment to safety and quality and improve its reputation and credibility in the market. This can facilitate the acceptance and recognition of the system or product by different stakeholders, such as regulators, customers, operators, and users, and lower the risks of liability or non-compliance.
ISA is a specific type of safety assessment that involves an independent and accredited third party, called the ISA Body, to review and evaluate the evidence of safety provided by the system or product developer. Other types of safety assessment may be performed internally by the developer or externally by a non-independent assessment company or a customer, but they do not have the same level of independence as an ISA Body.
The duration of ISA depends on several factors, such as the complexity and criticality of the system or product, the scope of the ISA and the availability and quality of the evidence of safety. If performed in pipeline with the project lifecycle phases, it follows the project and its milestones with a typical delay of three or four weeks.
Submitting a product or system for ISA has several benefits. An independent, competent, and impartial ISA body accredited by an internationally recognised accreditation body will evaluate the safety of the product or system. This will increase the trust and confidence of the final customers and make their acceptance process easier and faster. As a result, the total time and cost of the whole project will be reduced.