This case concerns our end-to-end work for a Japanese medical device manufacturer's initial ISO 13485 certification, from preparing required documents through additional responses requested during the audit.
Client: Japanese medical device manufacturer
Support provided: Document preparation and audit support for ISO 13485 certification
Outcome: ISO 13485 certification obtained
Preparing Required Documents for the Audit
MK Consulting prepared the documents required for certification in this case. In addition to advising on document preparation, we worked with the client to prepare the documents that would actually be presented during the audit.
Responding to Additional Document Requests Within the Deadline
During the audit, additional requested materials had to be prepared within a short deadline. We also prepared written responses and explanatory materials for matters that required presentation by the next day, helping the client submit them on time.
Obtaining Certification After the Initial Audit
The initial audit identified no major or minor nonconformities. Following the audit team's recommendation, ISO 13485 certification was obtained, completing our support for this case.
Related Services
・QMS and business licensing support
Discuss ISO 13485 Certification
Contact us if you would like to commission the preparation of required documents or clarify what to prepare for an audit. We will review your existing documentation and state of preparation, then explain the scope we can undertake and how to proceed.
Company and product names are withheld. The audit outcome described is specific to this case and does not guarantee the same outcome in other cases.
Prepared by: MK Consulting K.K.