International Standards Information Section

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International Standards Information Section

At the International Standards Information Section, we provide consulting for manual regulations.
Not just for Japan, we can provide your desired services to match the countries and regions around the world.

Regulations

As with the regulations for products, there are international rules for usage instructions and they are determined in the IEC 82079-1 (Preparation of instructions for use) international standard. Each country adapts their own national standards according to their national characteristics after taking into consideration the knowledge level of consumers and social norms. In addition, international standards are revised and changed.

Usage instructions

Usage instructions include not just user guides and service manuals, they also include catalogs, carton boxes, product labeling, and all information that explains usage at all stages of the product life cycle from initial purchase to disposal.

1. Support and consulting for investigating the usage instruction regulations according to the product and the country of sale.

Confirm the required laws, bylaws, and regulations applicable to the product, and then extract the related items to be written in the manual.

2. Consulting for safety and precaution text based on the product risk analysis performed by the product manufacturer

Propose safety and precaution text based on the results of the product risk analysis.

3. Total support for complying with the CE marking

In order to distribute or use Japanese products in the EU market, the products must comply with the CE marking.
Before products are placed on the market, the CE marking requires that a conformity assessment is carried out according to the directives of the European Commission. Products that satisfy the directives, as well as the packaging, owner's manual, and other related materials, must display the CE marking.
Specifically, the manufacturer must select the directives and standards that apply to the product, create and translate the related conformity assessments, technical documents, owner's manuals, and service manuals, etc.

Consulting Service for Declarations of Conformity

Service for Creating Technical Documents and Owner's Manuals

Determining which directives are applied to a product is the responsibility of the manufacturer. Which directives are applied is determined by checking the product's intended use, structure, etc. against the scope of each directive. Although there are cases where multiple directives are applied to a single product, only one CE mark is applied to the product.

4. Authorized representatives for Europe

The authorized representative works on behalf of manufacturers located outside the EU. The representative in the EU serves as the contact point for the CE marking to comply with the market monitoring activities of the applicable competent authorities. Clients who do not have an office located in the EU can use our International Standards Information Section authorized representative service to respond quickly to inquiries from the competent authorities by concluding an authorized representative agreement with our European office.

Technical File Management

Support after Products Are Placed on the Market