Planet Pharma Solutions

Quality Policy

Scope of Application

This policy applies to product development planning, product development, and implementation (hereinafter referred to as “development operations”) at our company, as well as support operations such as customer support and contract negotiations.

Quality Policy

We define the following as our quality policy.

"To maximize quality in product development by meeting applicable requirements for quality in product development and continuous improvement to provide products and support with the highest level of customer satisfaction.”

Quality-related Code of Conduct

In order to achieve our quality policy, we set forth the following action guidelines.

  1. Creating a Quality Management System ("QMS") that incorporates proven development processes and standards, and defining quality standards and quality practice criteria.
  2. The QMS shall be documented and kept up to date.
  3. Maintain the QMS appropriately and monitor and review internal and external performance against defined quality standards and standards of practice.
  4. Monitoring, analyzing, responding to deviations, and reporting results to stakeholders at all times.
  5. Continuously improve the QMS through revision, periodic education and dissemination of the QMS.
  6. QMS practices shall utilize IT for efficient QMS management and electronic record keeping using PDF files, etc.
  7. Provide products and support that benefit customers.
  8. To accurately identify customer requirements and take appropriate actions.
  9. Promptly disseminate information to customers regarding product refurbishment.
  10. Clearly present the scope of support to the customer to avoid problems.
  11. Establish a system capable of providing prompt support.
  12. Assign appropriate personnel to product development and support, commensurate with their knowledge and experience.
  13. To accumulate customer inquiries and use them to improve support.
  14. Provide progress reports on customer support requests as appropriate.
  15. Refrain from responding in a manner that will cause customers to lose confidence in you.

Ensure that the quality policy is developed, thoroughly implemented, implemented, maintained, and thoroughly enforced

The TMS General Manager, as the person ultimately responsible for quality, shall formulate the Company's quality policy and ensure its thorough implementation by all employees.

The TMS General Manager will personally implement this policy to improve quality and customer satisfaction,
and ensure that all employees are maintaining quality in accordance with this policy.

The TMS General Manager shall revise this policy and the QMS as necessary through management reviews and other means.

Certifications Standards

ISO 9001: 2015; JIS Q 9001: 2015

Scope of CertificationDevelopment and support of software products developed in-house and related to the registration application of medicines and medical devices.
Certification NumberJP024128
Date of Initial CertificationApril 23, 2015
Date of RecertificationOctober 17, 2023
Expiration Date of CertificationApril 22, 2027

Established: July 19, 2012
Last revised: February 01, 2025
Planet Pharma Solutions, Inc.
Representative Director: Masayuki Ueno

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