As a third-party organization in international safety standards, TOKIONE has amassed a wealth of expertise on evaluation and documentation of conformity to standards for semiconductor manufacturing equipment and general industrial machinery. Based on this knowledge, TOKIONE offers compliance services focusing on customers’ user manuals and various documents and labels. We offer a comprehensive suite of services from consulting to information gathering, writing and printing related to responses to standards that directly affect product exports. These standards particularly include CE-compliant manuals for Europe-bound products, semi-compliant manuals for semiconductor manufacturing equipment and compliance with ANSI Z535 for products bound for North America.
Manual Diagnostics
TOKIONE checks user manuals and related documents prepared by customers to ensure that they conform to the standards of the destination country or region, do not infringe public liability laws and so on. We report on conformity and improvements thereto using easy-to-understand radar charts and lists.
Diagnostic methods are based on the international standard IEC 82079-1, requirements in EU standards, and industry guidelines. The methods used depend on the requirements of the products’ destination country or region.
The following is a list of our main diagnostic services.
- Checking flexibility based on the IEC 82079-1 international standard
- Checking flexibility based on EU directives (Machinery Directive, Low Voltage Directive, EMC Directive, etc.)
- Checking flexibility based on the SEMI S1 and S13 standards for semiconductor manufacturing equipment
In addition, we can conduct surveys and diagnosis for other, individual standards as necessary, such as ISO 10218-1 (Safety Requirements for Industrial Robots) for industrial robots.
Manual Preparation
Manuals are sets of instructions provided by equipment suppliers to equipment users. They cover all phases of equipment use, from steps before purchasing the product to final disposal of it. In other words, manuals must encompass all the information users need to use the product safely and without problems.
At TOKIONE, we can prepare manuals from scratch, gathering information on the machines in question according to customer needs.
For customers who desire manuals for safety certification, we can extract the necessary health and safety requirements to create safety manuals. By creating safety manuals, we can satisfy the requirements of safety standards without greatly modifying existing user manuals. When we undertake projects for safety certification and testing, we can reflect the technical standards information directly into the manuals, dramatically reducing both delivery time and cost.
Files can be edited not only in Word and Excel but also in desktop publishing applications such as Illustrator and InDesign. For customers who require printing, we responsibly handle all steps from cover design to delivery of printed manuals.
Agency for Preparation of Conformity Declaration Documents for Technical Files
TOKIONE prepares a wide range of technical files. These include conformity declaration documents and other technical documents required for EU conformity declarations as well as application documents for certification in each country.
Custody of Technical Files
Technical files must be prepared and kept on file for 10 years after a product’s most recent market release, either as paper files or as electronic data. Manufacturers must be able to submit them promptly (normally within two weeks) if the authorities request them.
For customers who are unable to appoint an agency in the EU or an agent who is an EU national, TOKIONE’s affiliate in the EU can keep technical files on file as a proxy and respond to requests from EU authorities as necessary.
Label Preparation and Sale
TOKIONE sells warning labels in standard use for industrial equipment. We can also produce custom products for hazards associated with customers’ individual products.
Technical Translation
We provide technical translation, native-speaker checking and proofreading of manuals, specifications and other technical documents.