テュフズードジャパン List of News Articles

In November 2025, the revised "Good Manufacturing Practice (GMP) for Medical Devices" in China will be announced, with implementation scheduled for November 2026. Local experts will provide a clear explanation of the key points for compliance. < Seminar Topics > - Overview of China's new GMP - Differences from ISO 13485:2016 - New requirements that require particularly careful measures - Anticipated inspection styles

This is a core human resource development program in the field of industrial systems cybersecurity developed by the German certification organization TÜV SÜD. Participants will understand the basic concepts of a secure development lifecycle based on IEC 62443 and acquire the necessary elements for implementing and maintaining security throughout the entire development process. By passing the exam on the final day of training, participants can obtain an individual certificate for the IEC 62443 Foundation qualification. <Seminar Topics> - Overview of Industrial Automation - Basics of Information Security - IEC 62443 and Industrial Cybersecurity - Laws and Regulations (EU, International) - Threats and Risk Assessment - Secure Product Development Lifecycle - Operations and Maintenance

With the rapid development of AI technology, countries around the world are advancing the establishment of AI-related laws and regulations. Among them, the "EU AI Act," which is the world's first comprehensive AI regulation adopting a "risk-based approach" to set regulations according to AI risks, is gaining attention. In this seminar, we will add the content of the "Digital Omnibus" amendment, which was approved by the EU Council on June 29, 2026, to the previously well-received EU AI Act seminar and explain the latest trends. This seminar is recommended not only for companies providing AI-enabled products and services to the EU but also for those who want to systematically understand the overall picture of AI regulations. < Seminar Topics > - Basic information and scope of the EU AI Act - Classification of risk categories for AI systems - Conformity Assessment (CA) - Overview of obligations imposed on providers - Relationship with other regulations - Changes due to the Digital Omnibus amendment - Regulations concerning General Purpose AI (GPAI)

This seminar, which is the first hosted by TÜV SÜD Japan, is recommended for those considering transitioning to ISO/IEC 27001:2022 or reviewing their ISMS operations. Against the backdrop of the proliferation of generative AI and the sophistication of cyberattacks, the environment surrounding information security is undergoing significant changes. In this seminar, experts from TÜV SÜD Japan will systematically explain the requirements and key points of ISO/IEC 27001:2022, allowing participants to acquire practical knowledge beneficial for ISMS operations in just half a day. < Seminar Topics > - Latest trends and industry developments surrounding information security - What is ISMS (ISO/IEC 27001) - Organizational situation analysis and stakeholder management - Risks and opportunities in information security - Risk response planning and ISMS operations - Performance evaluation and nonconformity response - Practical points of ISO/IEC 27001:2022 management measures

With the spread of IoT products and the increasing security risks, Japan has launched the IoT product security labeling system "JC-STAR," operated by the IPA. This seminar will clearly explain the overview of JC-STAR in harmony with international standards, the application procedures for obtaining ★1, and key points regarding technical requirements and evaluation methods. TÜV SÜD Japan, a registered organization certified by the Ministry of Internal Affairs and Communications and a JC-STAR verification provider, will provide useful knowledge from application preparation to acquisition based on its experience in third-party evaluations. <Seminar Topics> - Overview and objectives of the JC-STAR system - Steps and necessary documents from application to label issuance - Details of technical requirements and the underlying concepts - Specific processes and key points of the evaluation method - Common application mistakes and how to avoid them

In the internal audits and second-party audits of IATF 16949:2016, in addition to confirming compliance with the standard, practical auditing skills are required to grasp the actual state of processes and identify risks and opportunities for improvement. In this seminar, we welcome Katsuhisa Mizumoto, a former official instructor of IATF 16949 with over 25 years of teaching experience in the automotive industry, to review the key points of IATF 16949:2016 and related requirements, as well as to learn through exercises about the judgment and description of nonconformities and the evaluation of corrective actions. < Seminar Topics > - Latest trends in IATF 16949:2016 and related requirements - Reconfirmation of the competencies required for internal auditors and second-party auditors - Process approach and risk-based thinking in the automotive industry - Key points of auditing considering customer-specific requirements (CSR) - Process analysis and auditing using the turtle diagram - Basics of auditing and practical auditing skills based on ISO 19011 - Discovery and classification of nonconformities as major/general nonconformities - Methods for describing nonconformities based on objective evidence - Evaluation of corrective actions, root cause analysis, and effectiveness verification - Acquisition of practical auditing skills through group exercises

The EU Machinery Regulation (EU Machinery Regulation 2023/1230) is a comprehensive legal framework aimed at ensuring the safety, reliability, and compliance of machinery placed on the EU market. Established in June 2023, it will fully apply from January 20, 2027, as a new regulation replacing the previous EU Machinery Directive (2006/42/EC). This seminar will clearly explain important topics faced in practice, including key amendments in the new regulation, digitalization and cybersecurity (such as Annex III 1.1.9), and safety requirements for AI and autonomous systems. < Seminar Topics > - Part 1: Overview of the EU Machinery Regulation (2023/1230) and key changes from the old directive (2006/42/EC) - Part 2: Safety requirements and responses to cybersecurity and new technologies - Part 3: Practical aspects of conformity assessment procedures and technical documentation (TCF) - Part 4: Practical roadmap and case studies for entering the European market