PAS 2050 pilot ToR



Pilot Assessment Programme Terms of ReferenceISO/IEC 17021-1 Accreditation of Certification Bodies certificating compliance with BS ISO 19443:2018 QMS- 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 (ITNS) UKAS Project Number 301066The United Kingdom Accreditation Service is the sole national accreditation body recognised by government to assess, against internationally agreed standards, organisations that provide certification, testing, and inspection and calibration services.Accreditation by UKAS demonstrates the competence, impartiality and performance capability of these organisations.Revisions(Changes to the text of the latest issue are highlighted) IssueDateRevised SectionsSummary of revisions105/03/2020AllNew document1.0 INTRODUCTIONBS ISO 19443 ‘QMS - 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 (ITNS)’ was published in May 2018 having followed the ISO development process for Standards, by Committee ISO TC 85 (WG4). Since publication, work has continued to develop two ‘supporting documents’;ISO/TR 4450 (Technical Report) ‘Guidelines for the application of ISO 19443’ (by ISO TC 85 WG 4), andISO TS 23406 (Technical Specification) ‘Nuclear sector requirements for bodies providing audit and certification of MS for organisations supplying products and services’ - by a joint working group of ISO CASCO and ISO TC 85 WG4.The ‘Guidelines’ document is undergoing final voting prior to publication. PD ISO/TS 23406:2020 is now published and it should be noted that it contains ‘requirements’ and therefore has a mandatory (normative) application to ISO/IEC 17021-1. Attention of Certification Bodies is drawn to these additional requirements when reviewing their arrangements to deliver audit and certification to ISO 19443. The key additional requirements concern ‘competence’ - Annex A (Normative) of ISO/TS 23406 has introduced additional and specific nuclear industry related requirements which also extend to the planning and reporting of audits.The UK’s Office for Nuclear Regulation (ONR) publish assessment guides specifically for their inspectors to ensure consistency of approach when assessing Licensees and others. In support of the publication of ISO 19443, ONR Assessment guide NS-TAST-GD-077 Revision 5, Supply Chain Management Arrangements for the Procurement of Nuclear Safety was issued in August 2019. This states in Section 6.4 ‘Supply Chain Organisation and Technical Capability’: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.In January 2018, UKAS issued a call for expressions of interest from those UKAS accredited quality management systems certification bodies interested in extending their ISO 9001 scope of accreditation to include ISO 19443 for suppliers of ‘important to nuclear safety’ (ITNS) items to the nuclear energy sector. A UKAS Technical Bulletin in January 2019 provided information on progress by the above ISO working groups and identified key considerations for certification bodies. Now PD ISO/TS 23406:2020 is published, UKAS can launch the pilot assessment programme as part of the project to extend accreditation activity. This document describes the terms of reference (see Section 4 below) and the predicted milestones (see Section 5 below) under which the pilot assessment programme will be conducted and to which any certification body wishing to participate in the programme will need to commit to in writing (see Appendix 1 below). 2.0 AIM OF THE PILOT PROGRAMME To develop a credible ISO/IEC 17021-1 plus PD ISO/TS 23406:2020 accreditation programme for certification to ISO 19443. 3.0 OBJECTIVES OF THE PILOT PROGRAMME There are a number of objectives for the pilot assessment programme, these include:To confirm that the assessment approach is appropriate and fit for purpose thus providing the necessary confidence in accredited certification To define scopes of accreditation as applicable to the nuclear sector. To accredit certification bodies meeting the requirements for accreditation ISO/IEC 17021-1 and ISO/TS 23406To make available accreditation for certification to ISO 19443 as a routine UKAS accreditation activity 4.0 TERMS & CONDITIONS OF THE PILOT ASSESSMENT PROGRAMME 4.1 Important please note: To cover some of the development costs associated with this project, all applicants will be charged a development fee of ?2000 in addition to the cost of UKAS assessment. This development fee is non-refundable along with any other advance payments if an applicant withdraws from the pilot programme.4.2 The pilot programme is only available to applicants already accredited to ISO/IEC 17021-1 for QMS certification. Additionally, to progress through the pilot, applicants will need a minimum of two clients available for witnessed assessments to allow for UKAS to assess the competence, impartiality and capability for consistent delivery of the ISO 19443:2018 certification activity.4.3 The UKAS Agreement and the terms and conditions published on are applicable to applicants. In addition, the following terms and conditions apply to the applicant committing to this pilot programme:4.3.1 Applicants are required to complete an application for extension to scope (in addition to Appendix 1 below) using the AC 1 application form on the UKAS website and submit to DevelopmentEnquiries@ (by 1st May 2020) together with the supporting information identified thereon and the development fee of ?2000. Additionally, applicants are required to submit:Information demonstrating how the specific requirements of PD ISO/TS 23406:2020 Annex A.3 have been addressed including details of the training programme and the training material (by 26th June 2020)Identification of personnel authorised for the various certification functions regarding BS ISO 19443:2018 activity (by 26th June 2020)4.3.2 Applicants will be requested to send a representative(s) to pilot programme initiation and/or review meetings that may be held at UKAS and/or elsewhere by agreement. The purpose of these meetings is to discuss the detail for the implementation of the pilot programme and/or review progress/lessons learned during the pilot programme.4.3.2.1 A pilot programme initiation meeting is planned for 6 May 2020 to discuss the pilot and the requirements ISO 19443 and ISO/TS 23406 including; the expectations regarding demonstration of competenceman-day calculationthe overall audit strategyISO 19443 requirements and depth/visibility of auditrequired documentation for the UKAS document review phasethe office assessment and witnessing requirementsscope of accreditation4.3.3 Dependent upon the number of applicants who satisfy and agree to comply with these Pilot Assessment Programme Terms of Reference, UKAS may need to restrict the number of applicants participating in the pilot to enable achievement of the pilot programme objectives in the published timescales. Should this be necessary, this decision will be based upon:Prioritising those who submitted expressions of interest in accordance with the expression of interest notice published in January 2018Demonstrable preparedness to satisfy the timescales as published4.3.4 The names of the applicants participating in the pilot programme may be made public.4.3.5 Following application, UKAS will conduct a desk-top document review, an office assessment (including interviews of a sample of selected auditors across applicable scopes) and witness two ISO19443 audits for each applicant. It is acknowledged that a certified ISO 9001 client may also seek ISO 19443 certification, and this will be considered suitable for a UKAS witnessed audit but not when in conjunction with a combined audit or an audit of an integrated management system. UKAS reserves the right to select the organisations at which witnessed assessments are performed to ensure that a variety of services (across the QMS scope applicable to the nuclear supply chain) are included for witnessing. Additional information may be requested after the assessment visits as a result of a review of all pilot assessments in the programme. Preassessment visits may be arranged on request.4.3.6UKAS will provide a quotation for each element of the pilot assessment programme in line with standard practice. It should be noted however that due to the nature of a pilot assessment programme (e.g. the identification of unexpected issues) it may be necessary to undertake additional assessment effort. Should this be necessary, UKAS will provide justification of the need together with the quotation for the additional assessment effort.4.3.7 If during the assessment activities UKAS identifies nonconformities against ISO/IEC 17021-1 and/or the applicant’s systems/procedures ‘Improvement Actions’ will be raised as per the normal assessment process.4.3.8 UKAS reserves the right to vary the category assigned to Improvement Actions reported (IAR) at pilot assessments from ‘R’ (Recommended) to ‘M’ (Mandatory) at any time during the pilot phase where appropriate justification exists.4.3.9Applicants will be given 3 calendar months from the date of issuing any IAR (M category) to submit evidence of completed improvement actions to UKAS.4.3.10Those applicants who meet the requirements for accreditation and the terms and conditions of the pilot programme documented in this document will be accredited at the end of the pilot programme once the programme’s aim and objectives have been satisfied. UKAS will not delay announcing accreditation of successful applicants if some applicants are not able to meet the requirements of the pilot programme.4.3.11Those applicants who have been accepted on to the pilot programme but then do not meet the timescales can continue through the process on the understanding that the priority for UKAS assessment resource will be given to the remaining applicants who do meet the timescales. Consequently, those not meeting the timescales will be granted accreditation when all requirements have been satisfied but not before those applicants who have satisfactorily met the requirements and the timescales for the pilot programme.5.0 MILESTONES The following are the predicted milestones for the pilot and will be reviewed and confirmed following a review of applications:Deadline for Applications, Signed ToR and Application Fee1st May 2020 Launch meeting 6th May 2020Submission of all specified documents 26th June 2020UKAS document reviews July 2020UKAS head office visits Jul – Aug 2020UKAS witnessing assessmentsAug – Oct 2020UKAS review (inc Stakeholders) and decisions Jul – Nov 2020Announce accreditations End November 20206.0 UKAS CONTACTSProject Manager: Ian RonksleyUnited Kingdom Accreditation Service2 Pine Trees, Chertsey Lane, Staines-upon-Thames TW18 3HRTel. 01784 428871email: ian.ronksley@Development Coordinator: Emily RobinsonUnited Kingdom Accreditation Service2 Pine Trees, Chertsey Lane, Staines-upon-Thames TW18 3HR.Tel: 01784 428963 email: emily.robinson@Appendix 1ISO/IEC 17021-1 Accreditation of Certification Bodies certificating compliance with BS ISO 19443:2018 QMS - 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 (ITNS)UKAS Pilot Assessment Programme DeclarationThe organisation named below undertakes to commit fully to the UKAS Pilot Assessment Programme Terms of Reference detailed in this document.For and behalf of the organisationSigned ___________________________Name (please print)_____________________________Organisation444510477500Position held within the organisation_________________________________Date _____________________ Please note that the return of this declaration alone does not constitute an application for accreditation. An extension to scope form AC 1 together with the documents identified thereon are required (submission by 1st May 2020). ................
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