ISO 19443:2018 Lead Implementer training is designed to equip professionals with the knowledge and skills required to lead the implementation of a Quality Management System (QMS) within their organization based on the ISO 19443:2018 standard. This comprehensive training program covers the principles, processes, and best practices for establishing and maintaining a QMS that complies with ISO 19443 requirements, particularly in the context of organizations within the nuclear energy sector supplying products and services important to nuclear safety (ITNS).
The target audience for ISO 19443:2018 Lead Implementer training typically includes:
- Quality Professionals: Quality managers, officers, and professionals responsible for overseeing QMS implementation.
- Nuclear Industry Professionals: Individuals working in the nuclear energy sector or organizations supplying products and services important to nuclear safety.
- Project Managers: Project managers involved in implementing QMS within their projects or organizations.
- Compliance Officers: Professionals responsible for ensuring that the organization complies with ISO 19443 and relevant industry standards.
- Management Representatives: Individuals designated as management representatives responsible for QMS implementation and maintenance.
- Auditors: Auditors looking to gain a deep understanding of QMS implementation to improve their audit capabilities.
The primary reference standard for ISO 19443:2018 Lead Implementer training is ISO 19443:2018 itself, titled “Quality management systems – Specific requirements for organizations in the nuclear energy sector supplying products and services important to nuclear safety.” This standard provides specific requirements for implementing a QMS in the nuclear sector.
- Comprehensive Understanding: Ensure participants have a thorough understanding of ISO 19443:2018 and its significance in the nuclear energy sector.
- Implementation Planning: Educate participants on how to develop an effective plan for implementing a QMS based on ISO 19443.
- Documentation and Procedures: Provide guidance on developing and maintaining the required documentation and procedures for QMS compliance.
- Risk Assessment: Equip participants with the skills to identify, assess, and manage risks related to nuclear safety in the context of QMS.
- Internal Auditing: Prepare participants to conduct internal audits to ensure QMS effectiveness and compliance.
- Management Review: Teach participants how to facilitate management reviews of the QMS and drive continuous improvement.
- Supplier and Contractor Management: Address the management of suppliers and contractors to ensure they meet QMS requirements.
The training content should cover a wide range of topics to meet the specified objectives. Here’s a breakdown of the content:
Module 1: Introduction to ISO 19443:2018
- Overview of ISO standards and their importance
- Introduction to ISO 19443:2018 and its scope
- Applicability to the nuclear energy sector
Module 2: ISO 19443 Requirements
- Detailed exploration of ISO 19443:2018 clauses and requirements
- How ISO 19443 supplements ISO 9001:2015
- Key concepts and terminology
Module 3: Implementation Planning
- Developing an implementation plan for ISO 19443:2018
- Setting objectives and defining roles and responsibilities
- Resource allocation and budgeting
Module 4: Documentation and Procedures
- Developing and maintaining documentation and procedures
- Document control and record keeping
- Ensuring document consistency with ISO 19443
Module 5: Risk Assessment and Management
- Risk assessment methodologies (e.g., HAZOP)
- Risk prioritization and mitigation strategies
- Risk reduction measures and controls in nuclear safety
Module 6: Internal Auditing
- Planning and conducting internal audits
- Reporting and follow-up on audit findings
- Auditor roles and responsibilities
Module 7: Management Review
- Facilitating management reviews of the QMS
- Using management review to drive continuous improvement
- Addressing corrective and preventive actions
Module 8: Supplier and Contractor Management
- Establishing and maintaining supplier and contractor relationships
- Ensuring supplier and contractor compliance with QMS requirements
Module 9: Case Studies and Best Practices
- Real-world examples of successful ISO 19443 implementations
- Best practices from industry leaders
Module 10: Action Plan and Implementation
- Developing an action plan for ISO 19443 implementation within participants’ organizations
- Steps to initiate and sustain an effective QMS
Module 11: Q&A and Course Evaluation
- Opportunity for participants to ask questions and seek clarification
- Course evaluation and feedback collection
- Case Study
- Individual Exercises
- Role Play
- Group Exercises
- Group Presentation
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