テンダーラビングケアサービス 海外認証PRO　グローバルアクセス部（東京本社） Official site

In the previous issue (Vol. 3), we organized the impact of the transition to machine regulations on the practical aspects of instruction manual creation. This time, we will take a further step and focus on the practical aspects of the design process regarding "when, who, and how should instruction manuals be created." In response to the question of "when should we start writing the instruction manual," the standard provides a clear answer. ISO 12100 requires that the results of risk assessment be reflected in three stages: design, protective measures, and information provision, positioning the instruction manual as the final output of the design process under "information provision." Practically speaking, it is ideal to start creating the instruction manual simultaneously from the stage of defining requirements and initiating the initial risk assessment. In this issue, we will clarify the relationship between the ISO 12100 three-step method and instruction manuals, outline specific instruction manual tasks and internal role distribution for each design phase, and present four checkpoints that should be incorporated into the design review.

In the previous issue (Vol. 2), we organized the common deficiencies pointed out in the instruction manuals. In this article, as a continuation, we will specifically explain the changes in the instruction manuals resulting from the transition from the Machinery Directive to the Machinery Regulation. As of January 20, 2027, the regulations applicable to machinery exports to the EU market will switch from "Machinery Directive 2006/42/EC" to "Machinery Regulation EU 2023/1230." The change from "Directive" to "Regulation" is not just a matter of terminology. There are several changes that require direct attention from those responsible for technical documentation and instruction manuals. In this issue, we will outline the impact of the transition to the Machinery Regulation on practical instruction manual work and highlight the points that should be addressed starting now.

CRA: The reporting obligations under the European Cyber Resilience Act will begin in September 2026. In preparation for Article 14, which mandates the reporting of vulnerabilities and significant incidents, companies such as industrial machinery manufacturers and electronics manufacturers are working to establish internal systems. Did you know that "Our products do not connect to the internet" and "We have previously declared CE marking for products, but we are not currently selling them" could also fall under the scope of the CRA? In this "free assessment," you can clarify what you should do first under the CRA by simply answering five questions.

Tender Loving Care Service Co., Ltd. will hold a free online seminar titled "What You Should Know by Your Fifth Year of Employment! Understanding Overseas Export and CE Marking" To launch industrial machinery in Europe, it is essential to understand CE marking, machine safety, and EMC. The basics of overseas export, including CE marking, that you should know by your fifth year of employment. This seminar will help you understand the overall picture of CE marking and assist you in smoothly progressing with CE marking at your company.

We will hold a free WEB seminar titled "Key Points Explanation for Compliance with the EU Cyber Resilience Act (CRA) | Overseas Certification PRO × BVJ." This seminar will clearly explain the new regulations directly related to CE marking. The newly established "Cyber Resilience Act (CRA)" is an essential regulation that companies wishing to market products in Europe cannot afford to overlook. In this seminar, we will invite engineers from BVJ (Bureau Veritas Japan) to explain the basics of the CRA and practical response points, including its relationship with CE marking, in an easy-to-understand manner. We hope this will be useful for understanding the initial steps towards CRA compliance and for internal discussions.