ISO Standards
Introduction
Since ISO 9001 was first published it has been said by IAEA and NII/ONR that compliance with it, which focussed on enhancing customer satisfaction, was insufficient to address all matters which address nuclear safety. ISO 9001:2015 is written so that any organization can use it to develop their own management system reflecting the sector(s) in which they operate. However, ISO has recognised that individual sectors may find it appropriate to develop ISO 9001 into sector specific standards.
Around the world many nations have published their own standards applicable to nuclear e.g:
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US NQA-1 etc,
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CSA CAN3-Z299series,
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China HAF 003/ 601/ 604 and HAD 003 series,
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Finland YVL A.3 and .5,
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France AFCEN RCC-M and RCC-E,
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Russian Federation OPB-88/97 NP-001-97 (PNAE G-01 011-97), General Regulations on Ensuring Safety of Nuclear Power Plants.
ISO 19443 Supply Chain Quality management systems
ISO 19443:2018 - 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) copies ISO9001:2015 and then section by section adds nuclear specific requirements. It was officially published by ISO on 01/06/2018 and is now available from BSI as BS ISO 19443:2018.
The following is a partial extract from ONR Nuclear Safety Technical Assessment Guide NS-TAST-GD-077 Revision 5 – July 2019 “Supply Chain Management Arrangements for the Procurement of Nuclear Safety Related Items or Services”:
“6.4.3 Purchasers are expected to ensure that supply organisations have the organisational and technical capabilities to deliver items or services, including site construction, in line with their requirements. Suppliers’ organisational arrangements should include documented management system arrangements appropriate to the items or services being supplied. These systems should be implemented and be able to meet the requirements of a relevant national or international management system standard for quality, environment and safety management, an example is, BS ISO 19443: 2018 “Quality Management Systems – Specific requirements for the application of ISO 9001: 2015 by organisations in the supply chain of the nuclear energy sector supplying products and services important to nuclear safety” An evaluation of a potential supplier should include the potential supplier’s nuclear safety culture, ensuring that the organisation and its leaders understand, or have the potential to understand, the importance of nuclear safety and the contribution of any high risk item or service they would supply to achieving the safety case requirements of the purchaser.”
“6.4.4 As part of the supplier selection process, the purchaser should confirm that suppliers have adequate oversight and assurance arrangements for their own suppliers (see section 6.7 for more detail on supply chain oversight and assurance requirements). The purchaser and suppliers should hold certification to recognised management system requirements, issued by a UKAS or international equivalent accredited organisation, to ensure that appropriate quality management arrangements are in place and are being applied throughout the supply chain. This approach should not preclude purchasers from directly evaluating any level of the supply chain or carrying out oversight and assurance when work is in progress. All contracts should detail this right of access by the purchaser.”
ISO TR 4450:ISO 19443 Guidance
ISO TR 4450:2020 - “Recommendations for the application of ISO 19443:2018” was published in September 2020."
This Technical Report (TR) was written by the ISO 194443 authors and sits alongside ISO 194it, reflecting ISO TS 9002 guidance on ISO 9001.
ISO/IEC TS 23406: Certification on ISO 19443
ISO TS 23406 “Requirements for bodies providing audit and certification of Quality management systems for organizations supplying products and services important to nuclear safety (ITNS)” was published 01/2020.
UKAS has developed a pilot assessment programme for accreditation and was originally seeking applications from interested Certification Bodies by 1 May 2020. This date was extended as a result of the Covid 19 pandemic. Other international Accreditation Societies are also looking to establishing parallel schemes.
One area of interest to NucSIG members, and potential difficulty, is the need in Note A3 (2). That requires auditors to pass a written exam on completion of a 3-day (minimum) training course. This “course is to be delivered by organisations recognised by the nuclear industry at National or International level”. UKAS is investigating how this arrangement will be enacted.
Status of the WG
The work of ISO TC85 WG 4, responsible for all three standard documents, is completed until the five yearly review kicks in – around 2022 for ISO 19443.
Iain McNair and Neil Ivinson who were NucSIG and UK representatives on WG4 have resigned, recommending to BSi that if future work arises then NucSIG and the Safety Directors forum (SDF) should be asked again to provide the UK representatives.
Updated - 12/05/2020