Quality PolicyPrint

  1. The best quality in the world (target)
    Achieve world's best quality (quality, cost, delivery) to meet the needs and expectations of customers.
    We believe this is the quickest way to gaining acceptance worldwide.
  2. Quality assurance activities that all employees participate in (duty)
    All employees should ensure quality in their assigned area of duty.
    We believe this ensures MANI quality.
  3. Creation of original technology (policies)
    Pursue original and unique technologies with passion and commitment from a scientific approach.
    We believe this realizes the best quality in the world.
  4. Observance of laws and regulations (means)
    Observe laws and regulations to realize manufacturing and distribution of the most trusted quality in the world.

MANI has independently established high standards of quality and production. We plan to establish world-class management technology to maintain our production and information environment while further developing our original technology.
We acquire certification under external schemes such as ISO 13485 and maintain them through periodic audits.

ISO 13485
(Medical devices, Quality management system)

MDD 93/42/EEC Annex II. Article 3
(CE Marking)(EC Medical Device Directive)

ISO 13485 under CMDCAS
(Canadian Medical Device Conformity Assessment System)

Action Guidelines

  1. Observe regulations and the agreed rules of our industry in a law-abiding spirit.
  2. Sustain and improve the quality management system with the participation of all employees.
  3. Ensure familiarity and understanding of the Quality Policy at all levels of the organization.
  4. Work for continuous improvement through appropriate management review.
  5. Set quality targets at each level based on quantitative analysis of quality status, customer satisfaction, and market share in order to implement the Quality Policy.
  6. Satisfy customer needs throughout all processes from R&D and manufacturing to sales and service.