TS EN ISO 19443
Quality management systems - Specific requirements for the application of ISO 9001:2015 by organizations in the supply chain of the nuclear energy sector supplying products and services important to nuclear safety (ITNS)
This International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. This International Standard applies to organizations supplying ITNS products or services. Application of this standard to organizations performing activities on a licensed nuclear site is subject to prior agreement by the Licensee. Requirements specified in this International Standard are complementary (not alternative) to customer and applicable statutory and regulatory requirements.
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About This Item
TS EN ISO 19443 addresses the specific requirements for applying ISO 9001:2015 within the nuclear energy sector supply chain for organizations that provide products and services important to nuclear safety. Its focus is the integration of the generic quality management system model with additional expectations shaped by the nuclear safety context. In practical terms, it supports organizations in consistently meeting customer needs as well as applicable statutory and regulatory requirements.
Quality management in the ITNS context
The ITNS concept places emphasis on disciplined processes across the supply chain, not only on final inspection of the end product. In nuclear-related activities, items and services important to safety often depend on strong control of design, procurement, manufacturing, maintenance, verification, and documentation. From a general technical perspective, a quality management system in this environment is meant to reduce the risk of error, strengthen traceability, and ensure that critical work is performed under controlled conditions with reliable records.
What this standard does and does not cover
- It specifies quality management system requirements; it is not a product design specification or a technical performance standard for equipment.
- It applies to organizations supplying ITNS products or services in the nuclear energy sector.
- Application to organizations performing activities on a licensed nuclear site is subject to prior agreement by the Licensee.
- Its requirements are complementary to customer and applicable statutory and regulatory requirements, not a substitute for them.
- Publication Date: 30.09.2022
- Standard Status: U (Yürürlükteki Standard/Standard)
- Publisher: TSE
- Document Language: en
- ICS Classification: 03.120.10 Kalite Yönetimi ve Kalite Güvencesi; 27.120.01 Nükleer Enerji (Genel)
- Pages: 63
- Source Standard: EN ISO 19443:2022
- International Equivalents: EN ISO 19443-EQV; ISO 19443-EQV
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