- Scope of Application
This policy applies to the designing of product development plans, product development, and implementation (referred to as the development operations), as well as client support and contract-related activities with clients (referred to as the support operations).
- Quality Policy
Our quality policy shall be as follows:
To satisfy the requirements that apply to the quality of product development and to continually make improvements to pursue the maximization of the quality in product development, providing products and services with high client satisfaction.
- Action Guidelines for Quality
The following shall be the action guidelines for enforcing our quality policy:
- Create a quality management system that incorporates proven development processes and standards (referred to as the QMS), and define quality standards and quality practices.
- Document the QMS and always keep it up to date.
- Appropriately maintain the QMS, and monitor and review the internal and external achievement of the defined quality standards and quality practices.
- Regularly monitor, analyze, correct deviations, and report to the stakeholders.
- Revise the QMS and regularly provide training and disseminate information to employees to continually improve the QMS.
- Use IT to perform the QMS to efficiently manage it and to leave electronic records using PDF files.
- Provide products and support that lead to client benefits.
- Accurately identify client requirements for appropriate action.
- Quickly notify clients of information regarding product repair.
- Clearly present clients with the scope of support to prevent problems.
- Build a support system that enables quick action.
- Assign personnel with appropriate knowledge and experience to product development and support.
- Accumulate client inquiries to improve support quality.
- Report progress as appropriate for support requests from clients.
- Refrain from support activities that may ruin client trust.
- Designing, Enforcement, Implementation, Maintenance, and Enforcement Verification of the Quality Policy
The President, who is ultimately responsible for quality, shall design our quality policy and ensure its full enforcement by all employees.
The President shall implement this policy to improve both the quality of our products and services and client satisfaction, while verifying that all employees are maintaining the quality defined in this policy.
The President shall use management reviews to revise this policy and the QMS, as needed.
Certifications of Standard
ISO 9001: 2015; JIS Q 9001: 2015
- Scope of Certification
Development and support of the company’s own software system relating to the filing for the approval of pharmaceutical products and medical devices.
- Date of Certification
December 14, 2017
- Certification Number