ISO 19443 Quality management system for supply chain of the nuclear energy sector Hanna Kuivalainen 1 Hanna Kuivalainen 12.3.2019 Content • Status of standard ISO 19443 • YVL A.3 renewal and scope • ISO 19443 requirements • ISO guidance and conformity assessment progress The status of standard • The formal publication of ISO 19443 was in June 2018. • The document was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies, and radiological protection.The International Standard ISO 19443:2018 has the status of a Finnish national standard • WG (members from nine countries) has performed review of the draft of the ISO 19443 guidance material. • Guidance will be issued by the WG as an ISO Technical Report • Conformity assessment - ISO/Casco conformity assessment committee knowledge ja ISO/TC 85 Nuclear Activities => ISO/TS (Technical specification) 23406 Nuclear sector -- Requirements for bodies providing audit and certification of Quality management systems for organizations supplying products and services important to nuclear safety (ITNS) - Under development 3 Hanna Kuivalainen 12.3.2019 YVL A.3 Background Standards IAEA and ISO 9000 • Renewal of YVL A.3 was supposed to be minor updating for Management System for a nuclear facility (2014) • Many changes in backgroud standars: – GS-R-3 Management Systems for Facilities and Activities, IAEA 2006 => GS-R Part 2 (2016) • The vocabulary was taken mainly from ISO9000:2005 Quality management systems. Fundamentals and vocabulary =>ISO 9001:2015 . • New version will be published in March. • Most changes in wording and clarification of requirements. • Some requirements moved from YVL A.5 4 12.3.2019 YVL A.3 Management and Leadership for Safety • YVL A.3 guide presents the general requirements of safety and quality management that affect the contents, implementation, maintenance, assessment, and improvement of the management system of an organisation applying for a construction or operating licence for a nuclear facility or one constructing or operating a nuclear facility. • The requirements of guide YVL A.3 apply, to the appropriate extent, to the plant supplier, suppliers contributing to nuclear fuel fabrication, safety-significant design and expert organisations, testing and inspection organisations, component and material manufacturers, and other safety-significant suppliers. If a requirement only concerns the licensee or the nuclear facility, it is specifically mentioned. • Other YVL-guides (YVL A.4, YVL A.5, YVL A.6, YVL A.7, YVL A.11, YVL A.12, YVL B.1, and several YVL guides in E-series) give more detailed ’how-to’ guidance 5 Hanna Kuivalainen 12.3.2019 YVL A.3 Supply chain management system reguirements • 629. Suppliers of safety-significant products and related services shall have in place a management system that is appropriate certified (for example, ISO 9001 or ISO 19443) or independently evaluated by an expert third party. Requirements for the management system of manufacturers of serially manufactured products are presented in the E series Guides. • 629a. With regard to deliveries of products in safety class 1 and 2 and related services, the management system of the supplier shall comply with the management system requirements set forth in this guide and be compatible with the other standards used in the operation. The management system can be supplemented in the quality plan for justified reasons by applying the procedure presented in paragraph 630. 6 Hanna Kuivalainen 12.3.2019 Appropriate certification in YVL -guides Hyväksytty sertifiointi (appropriate certification) • Hyväksytyllä sertifioinnilla tarkoitetaan laatujärjestelmän sertifiointia, jossa sertifiointielimen akkreditointi on tehty standardin EN ISO/IEC 17021 vaatimuksia vasten ja akkreditointi kuuluu FINASin solmimien monenkeskisten tunnustamissopimusten (MLA) piiriin. Appropriate certification • Appropriate certification shall refer to a certification of quality management system in which the certification body is accredited against the requirements of standard EN ISO/IEC 17021 and accreditation is covered by the multilateral recognition arrangements (MLA) signed by Finnish FINAS. 7 Hanna Kuivalainen 12.3.2019 ISO 19443 Quality management systems 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) • Laadunhallintajärjestelmät. Erikoisvaatimukset ISO 9001:2015:n soveltamiseen ydinenergiateollisuutta palvelevissa toimitusketjuissa toimiville organisaatioille ydinenergiaturvallisuuden kannalta tärkeiden tuotteiden ja palveluidentoimittamisessa • ISO collaborated with the International Atomic Energy Agency (IAEA). IAEA has it’s own standards for Nuclear Safety. ISO standards are complementary technical documents. • The text reproduced from ISO 9001:2015 is placed in boxes 8 Hanna Kuivalainen 12.3.2019 Principles and scope Principles also apply the following : – nuclear safety culture; – determination of ITNS items and activites; – graded approach to the application of quality requirements. • Requirements specific to security management, and nuclear material accounting and control don’t belong to this standard • applies to organizations supplying ITNS products or services • activities on a licensed nuclear site prior agreement by the Licensee • complementary (not alternative) to customer and applicable statutory and regulatory requirements 9 Hanna Kuivalainen 12.3.2019 Terms, definitions, policy – Quality Manager • Some new terms and definitios: Activity, commercial grade item or activity, Counterfeit/fraudulent/suspect (CFS) item (refer IAEA NPT-3.21), graded approach, important to nuclear safety ITNS, item and nuclear safety (IAEA). • Organisation and its context -External and internal issues shall include nuclear safety considerations. • Policy (5.2) and quality objectives (6.2.1) – include nuclear safety and commitment to nuclear safety • Quality Manager – member of the organization's management – a) the organizational independence and authority to manage nuclear safety and quality issues, and – b) unrestricted access to top management. 10 Hanna Kuivalainen 12.3.2019 Nuclear Safety Management System Integrated Management System Nuclear Safety Management System Quality Management Quality planning, assurance, control and improvement Occupational Health and Safety Management (ISO 45001:2018) Environmental Management (ISO 14001:2015) Leadership for Safety, Nuclear Safety Culture, ITNS, CFSI, Safety Classification, Graded Approach, Project Control Competences, Processes, Supply Chain Management, Product and services, Independet review 11 Hanna Kuivalainen 12.3.2019 Leadership and nuclear safety culture • Requirements for top management not to compromise nuclear safety in decision making (5.1.1) and Nuclear Safety Culture (5.1.3) • Commitment to nuclear safety, • Encouraging a questioning attitude • Open communication • Use of needed documented information • Reporting HOF issues • Lesson learned • Challenging unsafe acts, behaviours and conditions • Analyze and evaluate nuclear safety culture aspects (9.1) Environment (7.1.4) Psychological factors include non-blaming ITNS - persons shall understand the importance of their work and consequences of errors in their activities 12 Hanna Kuivalainen 12.3.2019 ITSN and Graded Approach • Quality manual or quality plan (4.4.3), risk management (planning 6.1.1, 6.1.2) • ITNS (6.1.3) – break down products and activities to items and acitvies • Safety Classification specified by customer in line with Licensee’s classification • Graded Approach (6.1.4) – grade the application of requirement taking into account: – ITNS specified by customer – Complexity of items – Organizational aspects • Measuremnet traceability (7.1.5.2) outputs and actions taken 13 Hanna Kuivalainen 12.3.2019 Nuclear safety is not compromise • Changes – communication of changes • Changes to quality management system so that safety is not compromise • Not include – organizational changes directly like YL A.3 • Determination and provisions of resources (7.1.1) • Management review – receive the attention by its significance 14 Hanna Kuivalainen 12.3.2019 Support • • • • Resources so that safety in not compromised (7.1.1) Suitability of the monitoring and measurement resources (7.1.5.1) Competence and qualification of persons – shall maintained Persons shall be trained to understand the importance of their tasks (7.3) • Translations needs to be correct (7.5.2) • Documentation: Independent review, traceable, authenticated • Documented information: change communication, prevent misuse of old documentation 15 Hanna Kuivalainen 12.3.2019 Operation – products and services • • • • • • Project and configuration management (8.1) Schedule and interface management Managing the interfaces with exernal parts (8.2.1) Managing the changes of requirements Design and development has many new requirements (8.3) Verification and validation test shall be planned, performed, controlled, reviewd and documented • Organisation shall spesify when commersial grade items can be used • Documented information from design and development changes • Many requirements for control of externally provided processes, products and services (8.4) 16 Hanna Kuivalainen 12.3.2019 CFS – counterfit, fraudulent or suspect items Prevention has to go through the whole organisation - Selection of suppliers - Specific information from CFS and requirements for control sub tier provides - Control of externally provided processes - Monitoring and measurement activities - Handling detected CFS - Customer information IAEA documentation 17 Hanna Kuivalainen 12.3.2019 Production and service provision • Control of production and service provision - addings – Customer and statuory and regulatory requirements related to monitoring and measurement • Control of production equipment - new chapter • Monitoring and measurement activities – new chapter – Independent inspections • Identification and traceavility – addings • Preservation – Prevention of ITNS product deterioration • Control of nonconforming outputs – addings 18 Hanna Kuivalainen 12.3.2019 Performance evaluation • Conformity to products needs to consider when thinking performance and effeciveness of the quality management. (9.1) • Customer requirements in internal audits (9.2) • Auditors independence – not audit own work • Management review – nuclear safety (9.3) • Lessons learned from nuclear field • Not exist: regular self-assessment • YVL A.3: The management and all organisational levels shall carry out regular self-assessment of their own work performances against pre-defined criteria. Experts in the topic shall be utilised in self-assessment of safety culture and leadership. 19 Hanna Kuivalainen 12.3.2019 Improvement • Lessons learned from experience • Risk evaluation • Can apply: – Technical R&D – Identify good practices • Resources for improvements plans, share to its supply chain relevant OE • Nonconformaties and corrective actions are managed and reported without undue delay to management and customer. • Impact analysis and root cause analysis for nonconformity. • Safety culture continual improvement 20 Hanna Kuivalainen 12.3.2019 The ISO guidance planned activities The ISO guidance activities have been agreed to meet the following sequence (see N061): 1. Early February 2019 (and for 2 months duration): review/ballot of the ISO Technical Report outside of the Working Group; 2. Early April 2019 (and for 2 months duration): a. compilation and distribution of comments by the ISO Secretariat; b. subsequent National Committee assessment of the reported comments; 3. July 2019: Working Group meeting to upgrade the Technical Report as appropriate; 4. September 2019: review and approval of the Technical Report by the ISO TC 85 Chairman; 5. October 2019: release of the Technical Report. 21 Hanna Kuivalainen 12.3.2019 Planning the conformity assessment The review of ISO TS WD 23406 has being performed during the meeting with a particular focus on discussions addressing the: • knowledge and skills of the certification functions; • definition of the technological sectors. As a fast track project, ISO TS 23406 roadmap is confirmed as follows: 2019 – Q1: working draft completion 2019 – Q2: CD ballot 2019 – Q4: ballot analysis and standard update as needed 2020 – Q1: publication of ISO TS 23406 Next meeting is planned April 9th 2019 to review the Working Draft with a particular focus on the: competence section; ISO 19443 knowledge. 22 Hanna Kuivalainen 12.3.2019 https://www.stuk.fi