ISO 13485 is a quality management system standard for the design, development, production, installation and service of medical devices.
Medical devices - Quality management systems - Requirements for regulatory purposes.
On March 1, the newly revised ISO 13485: 2016 was announced, along with EN ISO 13485: 2016.
The revised edition permits the application of the requirements more flexibly than the previous version.
For example, in the case of the old version, only clause 7 can be excluded, whereas the revised edition permits the exclusion of clauses 6, 7 and 8 if the organization can demonstrate justification based on its activities and the nature of the product.
And we are strengthening the application of the law.
The GIC supports certification audits for the ISO 13485: 2016 standard.