ISO/TS 22163

ISO/TS 22163 adds requirements beyond ISO 9001 that address railway industry characteristics and challenges. Understanding these additions enables practitioners to implement compliant systems.

Project Management requirements establish systematic approaches for managing complex railway projects. Requirements address project planning, execution monitoring, and risk management throughout project lifecycles. Railway projects often span years and involve significant complexity.

Configuration Management ensures that railway products and their documentation remain controlled and traceable throughout extended lifecycles. Requirements address configuration identification, change control, status accounting, and verification. Configuration integrity is essential for safety and maintenance.

Tender and Contract Management addresses the complex commercial processes typical in railway procurement. Requirements cover bid preparation, contract review, and contract management. Railway contracts often involve complex technical and commercial terms.

Design and Development requirements expand ISO 9001 provisions with railway-specific considerations. RAMS integration, safety requirements, and interface management receive particular attention. Railway design must address extreme reliability and safety requirements.

Obsolescence Management addresses the challenge of supporting products with lifecycles measured in decades. Requirements ensure that component obsolescence is anticipated and managed proactively. Railway equipment may operate for 30+ years requiring ongoing support.

Supply Chain Management requirements recognize the importance of supplier capability in railway quality. Requirements address supplier selection, development, and monitoring with railway-specific considerations.

First Article Inspection requirements ensure that initial production outputs meet design intent. FAI verification provides confidence before serial production. Railway first articles require thorough verification given product complexity and safety criticality.

RAMS (Reliability, Availability, Maintainability, Safety) considerations are fundamental to railway applications and integrated throughout ISO/TS 22163 requirements. Understanding RAMS enables effective quality system implementation.

Reliability addresses product ability to perform required functions under stated conditions for specified periods. Railway reliability requirements often specify metrics like Mean Time Between Failures (MTBF). Design, manufacturing, and maintenance all affect achieved reliability.

Availability measures the proportion of time that systems are operational and ready for use. Railway availability requirements reflect service commitments and economic impacts of unavailability. System design must balance reliability, maintainability, and maintenance strategy.

Maintainability addresses ease of maintaining and restoring products to operational condition. Design for maintainability reduces maintenance time and cost. Railway maintainability requirements consider fleet maintenance constraints.

Safety encompasses systematic approaches to identifying and controlling hazards. Railway safety requirements derive from standards like EN 50126, 50128, and 50129. Safety assurance activities must demonstrate that safety requirements are met.

RAMS Analysis techniques identify and quantify RAMS characteristics. FMEA, fault tree analysis, and reliability modeling support RAMS assessment. Analysis results inform design decisions and validate achieved performance.

RAMS Verification confirms that products meet specified RAMS requirements. Testing, analysis, and operational data demonstrate RAMS achievement. Verification evidence supports customer acceptance and regulatory approval.

RAMS in QMS integration ensures that quality management supports RAMS achievement. Process controls, measurement, and improvement activities must consider RAMS impacts. Quality systems enable RAMS performance, not just quality conformance.

ISO/TS 22163 certification involves assessment by accredited certification bodies using the IRIS certification scheme. Understanding certification requirements enables successful certification achievement.

Certification Scheme establishes rules for ISO/TS 22163 certification that ensure consistent, rigorous assessment worldwide. The scheme specifies auditor qualifications, audit processes, and certification rules. Scheme administration ensures integrity across certification bodies.

Assessment Scoring distinguishes ISO/TS 22163 from typical ISO certification. Auditors score requirements on scales that measure implementation maturity. Scoring enables quantified comparison and improvement tracking.

Mandatory Questions must be satisfied for certification. Certain requirements are designated mandatory, meaning organizations must demonstrate compliance to achieve certification. Mandatory requirements address the most critical quality system elements.

Certification Levels reflect assessment scores achieved. Higher scores indicate more mature quality system implementation. Levels provide differentiation for customers evaluating supplier capability.

IRIS Portal provides the database of certified organizations and their scores. The portal enables customers to verify certification status and compare suppliers. Public scoring creates transparency and incentive for improvement.

Certification Body Selection requires choosing IRIS-approved certification bodies. Not all ISO registrars are approved for IRIS certification. Approved bodies meet scheme requirements for competence and independence.

Surveillance and Recertification maintain certification through periodic assessment. Annual surveillance audits verify continued compliance. Three-year recertification audits comprehensively reassess system effectiveness.

Implementing ISO/TS 22163 requires approaches that address railway-specific requirements while building on ISO 9001 foundations. Systematic implementation enables effective quality systems.

Gap Analysis identifies differences between current systems and ISO/TS 22163 requirements. Analysis should address both railway-specific additions and ISO 9001 elements. Understanding gaps enables focused implementation planning.

Project Management System Development creates capabilities often not present in generic quality systems. Project management methods, tools, and competencies require development. Railway projects justify substantial project management investment.

Configuration Management Implementation establishes systems for controlling product and documentation configuration. Configuration management requires databases, procedures, and disciplines that may be new. Early implementation supports design and development activities.

RAMS Capability Development builds technical competencies for RAMS analysis and verification. RAMS methods require specialized knowledge. Training and possibly external expertise may be needed.

Supply Chain Enhancement develops supplier management capabilities meeting railway requirements. Supplier qualification, development, and monitoring activities may require expansion. Railway suppliers often require their own ISO/TS 22163 certification.

Documentation Development creates the documented information required by the standard. Railway documentation requirements are extensive. Balance thoroughness with practical usability.

Training and Culture Development prepares organization members for quality system operation. Training should address both requirements and underlying rationale. Culture change may be needed for effective implementation.