Supporting document creation based on the know-how cultivated as a third-party organization for safety certification!
Since September 2015, "IEC 82079-1:2012" has been implemented in the EU region as "EN 82079-1:2012." "IEC/EN 82079-1:2012 Preparation of instructions for use – Structure, content, and presentation – Part 1" specifies various information communication contents related to manuals, nameplates, labels, and packaging that accompany products. By conforming to IEC/EN 82079-1, the requirements for instructions for use mandated by EU directives can be indirectly fulfilled. 【Leave it to us in these situations】 ○ Want to comply with CE marking ○ Lack confidence in existing manuals ○ No time or budget to redo them ○ Want to know just the key points for in-house creation Please contact us for more details.
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【Service Contents】 ○Want to comply with CE marking →Conduct diagnosis and creation of user instructions based on relevant standards of EU directives for products, such as IEC 82079-1, EMC Directive, Machinery Directive, and Low Voltage Directive. ○Not confident in existing manuals →Evaluate the structure of existing manuals, compliance with standards, and even the nuances of the text. →The evaluation results will be submitted as a report along with improvement proposals. ○No time or budget to redo →Extract only the necessary items from existing user instructions that need to comply with safety standards. →Create as a separate "Safety Manual." ○Want to create in-house but only need key points →Seminars or consulting services regarding manuals are also available. →Focus on explaining the essential points regarding manuals for products and target destinations. ●For more details, please contact us.
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Company information
In 1992, our company was established by engineers engaged in safety management and quality control of nuclear power plants as a company that conducts safety and quality inspections of industrial machinery. In the following year, 1993, we began our business in SEMI guideline compliance evaluation. Since then, based on our experience in the SEMI business and the know-how cultivated in the engineering and semiconductor field, we provide total support related to the safety of semiconductor manufacturing equipment, including: 1. Safety evaluation services as a third-party organization (SEMI S2/S8, CE marking, etc.) 2. Creation and translation of product documentation 3. Creation and sales of warning labels Our company tests and evaluates product safety from the design stage and responds to our customers' diverse safety requirements with a "One Stop" solution. The testing items cover a wide range, including mechanical, electrical, EMC (electromagnetic compatibility), F47/F42 evaluation tests, chemical (tracer gas tests, etc.), pressure, and environmental aspects. Additionally, for hazardous energy that cannot be eliminated from the product, we provide follow-up with warning labels and documentation. We offer a consistent service that includes safety reviews, warning labels, and product manuals.
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