Document House Group — JAPAN

Standards Compliance Support

Compliance Consulting

We perform risk assessments on products and evaluate conformance to safety regulations. We clear the risks in each process of the product — in its life cycle and then propose specific measures. We can evaluate the conformance to safety regulations and risk assessments when and as required.

Risk Assessment on Products
From the User Point of View

We propose manual improvements, changes required for warning labels, product designs, and support systems based on the results of usability checks such as product risk assessments and effectiveness assessments which clarify risks and problems related to the product from the user's point of view.

Analyzing Information from Call Centers

A call center is a place where user's opinions, questions, and complaints are given. By analyzing the Call Center's database, we can produce a list of product risks and measurements of usage.

Effectiveness Assessments

We have various assessment techniques that can be utilized to check your communication content — like written documents and video publications. We can even run an assessment of content that is not developed by us.

Usability Assessments

We run various analysis to evaluate if the contents can be used easily and without stress by its users. We can also evaluate user interfaces of the product based on our element analysis, not only for documents but also for requests to outsource usability assessment.

Operation Assessments

By actually using product manuals and online help libraries, we can evaluate if they contain any incorrect information or inappropriate expressions related to the product or the software.

Product Risk Assessment Consulting

We perform risk assessments and consultation for lowering the risks according to international standard safety regulations such as ISO12100-1 and ISO14971 by evaluating the types of potential risk in each product.

Product Life Cycle

Product life cycle refers to the term that spans the time from purchase to disposal.

Purchase > Set > Preparation before use > Unexpected usage > Normal usage > Maintenance > Actions taken in abnormality > Restrictions on storage > How to dispose of the product

Types of Risks

Below are types of risks which some products may have.

Mechanical risks (includes risks from human ergonomics point of view) - Electrical risks - Heating risks - Chemical risks - Noise risks - Vibration risks - Radiation risks - Combination risks - Power cut off, mechanical parts failure, and other risks from machine failure - Risks from no safety measures or misset.

Legislation/Standard Conformance Assessment and Consulting

We will evaluate the conformance to product manual safety standards (JIS, ISO, IEC, ANSI, EN, SEMI, ASTM, GB, and others) and propose measures to conform. We will also evaluate conformance to various legislation and safety standards for existing product manuals.

Reflecting Assessment Reports from Test Certification Body

A conformance assessment report is given when requested for the safety authentication of your product when applying to a test certification body, listing the conformance of various manuals, and warning labels to legislation and standards. Based on this report, we apply any changes required for authentication.

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