ISO/TR 4450:2020 品質マネジメントシステム— ISO 19443：2018の適用に関するガイダンス | ページ 2

Foreword

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This document was prepared by the Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies, and radiological protection WG 4, Management systems and conformity assessment.

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Introduction

As general consideration, this guideline document:

• has been developed to assist users to apply the quality management system requirements of ISO 19443:2018 by organizations in the supply chain of the nuclear energy sector supplying products and services important to nuclear safety (ITNS)^[1],
• does not add to, subtract from, or in any way modify those requirements,
• does not prescribe mandatory approaches to implementation, or provide any preferred method of interpretation of ISO 19443:2018 requirements supplementing those of ISO 9001:2015 ^[2], but only provide examples of possible solutions an organization can implement to meet the requirements,
• proposes also good practices for some clauses of ISO 9001 when applied to ISO 19443.

Where there is no supplementary text to ISO 9001 ^[2] (refer also to Annex A which gives a global picture of additional requirements of ISO 19443:2018 versus ISO 9001:2015), the sentence “noISO 19443additional requirement toISO 9001” has been included. In this case, for guidance on the initial text of ISO 9001, refer to:

• • ISO 9001:2015 ^[2], Annex A,
• • ISO/TS 9002 ^[3], and
• • ISO/IAF Auditing Practices Group^[4].

Where it is considered that the added text is self-explanatory and thus no guidance has been added, the sentence “No supplementary guidance provided “ has been included.

This guidance follows the layout of ISO 19443 and thus, users need to clearly understand the vocabulary of ISO 9000 and ISO 9001, which underlie it, before addressing the added text in ISO 19443.

The delivery of all products or services will involve tiers (See Figure 1) to which the Licensee requirements will be cascaded through Contractor(s) using technical specifications, procedures, management system (including Quality Assurance and Quality Control) requirements, and other contractual documents.

At each level, the external provider (called hereby “contractor”, “supplier” or “sub-supplier”) will be potentially in position to be “the organization” considered by ISO 19443.

0.1General

noISO 19443additional requirement toISO 9001.

0.2Quality management principles

No supplementary guidance provided.

0/3Process approach

noISO 19443additional requirement toISO 9001.

0.4Relationship with other management system standards

No supplementary guidance provided.

1 Scope

This document provides guidance on the implementation of the ISO 19443 requirements, with examples of possible steps an organization can take to meet the requirements.

It does not add to, subtract from, or in any way modify those requirements.

This document does not prescribe mandatory approaches to implementation, or provide any preferred method of interpretation.

2 Normative references

There are no normative references in this document.

noISO 19443additional requirement toISO 9001 .

3 Terms and definitions

No terms and definitions are listed in this document.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

Bibliography