JQA became a registered certification body under the Ministry of Health, Labor and Welfare on April 1, 2005 and conducts certification pursuant to PMDL (RCB ID: AH).
As an RCB, JQA is able to issue certificates for the above medical devices. To determine compliance, JQA conducts conformity assessments for product requirements and QMS* audits (desktop audit or on-site audit) for factories.
* QMS: Quality Management System
ISO 13485 management system audits can be conducted at the same time as QMS audits for PMD Act certification.
The PMD Act QMS Ordinance was developed with consideration of ISO 13485. If you have ISO 13485 certification from JQA, it is possible to avoid an additional on-site audit for the PMD Act QMS Ordinance.
* Contact us if you wish to utilize ISO 13485 certification issued by another certification body.
ISO Certification Page