Requirement Management in ISO 22163:2023 - IRIS Certification - Railway Quality Management System

We are trying to focuses on critical aspects of the ISO 22163:2023 IRIS Certification - Requirements Management Process, an area that has witnessed evolutionary strides in the latest iteration of the standard.

Annex B of the ISO 22163:2023 figured the Subordinate concept of requirements for products and services

The Foundation of Requirements Management

1. The Essence of Requirement At the core, a 'Requirement' is the nucleus of expectations within a business framework—whether stated, implied, or obligatory. It is the origin from which the entire management process proliferates, ensuring that the product or service aligns with customer and regulatory expectations.

2. Technical and Non-Technical Requirements The bifurcation of requirements into 'Technical' and 'Non-Technical' aspects reflects a holistic approach. While the former delineates the product or service features, the latter encompasses elements that influence delivery. This distinction is pivotal for addressing the multi-faceted nature of product development and service provision in the railway industry.

3. Functional and Non-Functional Requirements Delving deeper, 'Functional Requirements' articulate specific functionalities or operations that the product or service must fulfill. In contrast, 'Non-Functional Requirements' establish the operational backdrop that ensures usability and efficiency without impinging on core functionalities. These components are essential in creating products that not only work but work well under various constraints and use cases.

4. Performance and Integration Requirements 'Performance Requirements' stipulate the performance benchmarks or results that products or services should achieve. 'Integration Requirements' then address the cohesive interplay between subsystems or components, ensuring that the product functions as an integrated whole rather than a disjointed assemblage.

5. Addressing Other Non-Functional Requirements Safety, obsolescence, usability, color, and labeling are encapsulated under 'Other Non-Functional Requirements.' These are critical in assuring that the product not only functions as intended but also adheres to safety standards, has a well-planned lifecycle, and possesses the necessary attributes for optimal user interaction and marketability.

Requirements Management Process in ISO 22163

1. Determination of Product and Service Requirements ISO 22163 emphasizes the precise definition of product and service requirements, including legal, regulatory, and internally mandated stipulations. It mandates a clear understanding of the organization's capacity to fulfill these requirements to avoid overcommitment and under-delivery.

2. Considerations for Requirement Determination Functional, non-functional, RAMS (Reliability, Availability, Maintainability, and Safety)/LCC (Life Cycle Cost), and obsolescence requirements are among the elements that must be contemplated. Additionally, the organization must consider market inputs, historical data from similar endeavors, and end-of-life implications like disposal and recycling.

3. Documentation and Review of Requirements Documented information concerning the determination and consideration of requirements is not just a procedural formality but a cornerstone of traceability and accountability. Reviews prior to customer commitments are exhaustive, encompassing all customer, legal, and implicit requirements.

4. Managing Changes in Requirements Dynamic adjustments to requirements are an inevitable reality. ISO 22163 requires that any amendments are methodically integrated into existing documentation and communicated effectively to all relevant stakeholders.

Establishing the Requirements Management Process

The IRIS mandates the establishment of a robust requirement management process. This process is multifaceted, integrating steps such as determination, review, verification, and validation. It also ensures the involvement of multidisciplinary teams, encapsulating both internal and external parties' inputs.

a) Inclusion of Requirements

• The process must encompass the customer communication, determination of requirements related to products and services, review of requirements related to the products and services etc

b) Applicability Across Various Stages

• Design and Development: Applicable to the design and development stages for new products and services to meet market expectations before the tender stage, which may include platforms or product families.
• Tender Management: It applies to the management of tenders, encompassing the submission of tenders and acceptance of contracts or orders.
• Project Execution: Relevant during the project execution phase, especially concerning the acceptance of changes to contracts or orders.
• Change Control: Pertinent to the control of changes, as detailed in various processes of ISO 22163:2023 (Ex: Configuration management, change management, design and development changes, process changes etc). This process is often integrated within the project management process.

c) Multidisciplinary Involvement

• A multidisciplinary approach is mandated, incorporating both internal and external interested parties, as relevant to the project.

d) Mandatory Steps

• Determination of Requirements related to products and services
• Review of Requirements related to products and services
• Verification: This is a separate process step where the products or services are checked against the specified requirements to ensure accuracy.
• Validation: Ensures the product or service fulfills its intended purpose.

e) Assurance of Requirement Integrity

• Requirements must be individually checked for adherence to each conformity clause.
• All requirements should be evaluated and considered within the context of the overall project.
• There must be an assessment in relation to risks and opportunities
• Requirements should be properly transferred, understood, acknowledged, cascaded down, and committed to by all involved stakeholders.
• They must be complete, unequivocal, verifiable, and feasible.
• They should be documented in a technical specification, which includes both functional and non-functional requirements. The technical specification may be provided by the customer or developed by the organization.
• Finally, the requirements must be updated in the event of any change

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