Contact us
Illustration for ISO management-system services

ISO 22163

ISO 22163 railway quality management consulting

ISO 22163 quality management consulting helps suppliers of railway products or services connect projects, supply chains and quality evidence with delivery responsibilities. Vosurein starts with the scope, existing processes and evidence to plan responsibilities, implementation and internal reviews.

Discuss ISO 22163 consulting needs

For Your Business

Who this service is for and when to start

For suppliers of railway products or services. Start by identifying gaps if project requirements are not passed on fully, or changes, configurations and supplier records are difficult to trace.

The Challenge

Common challenges faced by businesses

Rail products have a long lifecycle; part discontinuations, configuration changes, and long-lead-time supplies may span multiple projects. If requirements are only kept in contracts and not transmitted to design, procurement, and delivery evidence, subsequent maintenance will find it difficult to verify the actual installed version and replaceable parts.

Our Approach

Methods and applicable requirements

The applicable edition is ISO 22163:2023 with Amd 1:2024. It is the first edition published as an International Standard, replacing ISO/TS 22163:2017.

This standard combines ISO 9001:2015 with rail industry-specific requirements. The scope of application must correspond to actual supply roles and projects. If the customer requires IRIS certification, the evaluation and qualification arrangements of that program must also be verified; the standard and the program cannot be confused.

The following consulting tasks can be arranged to suit your needs.

Current-state and gap analysis

Review products, supply roles, sites, customers and management system gaps.

Requirements and project management

Organize requirements review, milestones, resources, risks, deliverables, and changes.

Design, configuration and change

Organize design review, verification, validation, and product version traceability according to roles.

Suppliers and obsolescence risks

Review supplier evaluation, outsourcing, quality agreements, long lead times, and part obsolescence responses.

Production and delivery control

Review operations, inspections, equipment, measurement, release, and delivery records.

Quality and product safety coordination

Linking defects, risks, and safety-related responsibilities does not replace professional engineering safety assessments.

Performance and improvement

Organize project, delivery, quality, customer feedback, and improvement tracking.

Training and internal review

Support pilot operation, internal audits, management review and certification preparation.

Process

Consulting scope and process

  1. Review supply roles and projects

    Review products, projects and supply roles against customer requirements and the existing quality system. Confirm the sites covered and delivery responsibilities.

  2. Review requirements, configurations and supply risks

    Integrate requirements, configurations, and design changes into project milestones while organizing long lead time and obsolescence risks, confirming the evidence suppliers should provide.

  3. Trial manufacturing, delivery and version controls

    Verify manufacturing, inspection, and delivery versions against the actual product, ensuring that alternatives and changes can be traced back to approval records.

  4. Project performance and defect improvement

    Review project delivery, defects, and customer feedback, track the impact of improvements on subsequent projects, and organize quality evidence according to assessment needs.

Preparation

What documents do companies need to prepare?

  • Project scope: Products, supplier roles, customers, and milestones.
  • Technical data: Requirements, configuration, design, and change records.
  • Supply and production processes: Suppliers, obsolescence risks, inspection, and release.
  • Performance feedback: Delivery, defects, customer complaints, and improvements.

For the initial discussion, you can provide a summary. Handle customer, personal and confidential business information within the necessary scope and agreed access permissions.

Project Planning

Estimating time and cost

Evaluate according to product complexity, number of projects, suppliers, and configuration data. Long lifecycle products require time to trace historical changes and supply information.

Consulting on the standard, product safety engineering, specialist testing and assessments under schemes such as IRIS are agreed separately. Confirm eligibility and acceptance conditions with the customer and the scheme.

FAQ

Frequently asked questions

Is ISO 22163 the same as IRIS certification?

Standard requirements and certification schemes are not at the same level. Scheme rules, scoring, organizations, and customer acceptance conditions must be verified separately; you cannot claim qualification by just organizing standard documents.

Can existing systems and records be reused?

You can first review existing product projects, customer requirements, configuration changes, suppliers, and quality records to confirm applicable period, scope, and evidence quality, then fill gaps; rewriting all documents is not a prerequisite for implementation.

How to handle different versions of delivery documents?

First confirm product configuration and approved changes, then check whether inspection and delivery documents correspond to the same version; historical versions must also retain necessary traceability.

How are consulting and third-party certification responsibilities divided?

Vosurein supports system implementation and preparation but does not issue third-party certificates. Confirm the applicable certification scheme, accreditation scope, fees and schedule separately. A certificate does not constitute product approval or proof of compliance with every regulation.

Do discontinued parts also require quality management?

They need to be included in project and supply risk considerations, confirming the need for substitute parts, change reviews, and traceability arrangements; seemingly identical parts cannot be used directly without confirmation.

Which version should be confirmed before implementation?

The applicable edition is ISO 22163:2023 with Amd 1:2024. It is the first edition published as an International Standard, replacing ISO/TS 22163:2017. Confirm the edition and transition arrangements required by customers and the assessment scheme. A standard’s publication date is separate from an organisation’s transition deadline.

Related

Related services and enquiries

Please provide the industry, activities, locations, main requirements, and expected completion time.Contact Vosurein

Content checked: . Applicable versions and requirements depend on the company’s circumstances.

Let's Talk

Start a conversation about your needs.

Tell us how the work is done today and when you hope to finish,
so we can agree the scope and way of working together.

Discuss your service needsBack to ISO management-system contents