This case concerns our work reviewing quality documents following amendments to the QMS Ordinance and preparations for a third-party audit. In addition to creating and revising procedures, we identified document issuance and record creation required of the client and provided support through the audit.
Client: Medical device company
Support provided: Creating and revising QMS documents and preparing for an audit
Outcome: Audit response completed
Reviewing Documents With the Audit Date in Mind
The client commissioned the revision of quality documents and the preparations required for the audit with the audit date already set. The main work was to review existing procedures and create or revise the documents needed.
We prepared and provided required documents and forms, including a revision to the corrective action procedure. Rather than replacing everything uniformly, we determined which documents required revision and which current versions could remain in use.
Dividing Responsibilities for Document Issuance and Record Creation
After delivery of the revised versions, the client needed to issue the documents and forms and create the required records. During meetings, we checked progress on document revisions and the remaining work, sharing concrete tasks to be carried out by the client.
This support distinguished our document drafting from the client's work and clarified what each party needed to do before the audit.
Completing the Audit Response
The third-party audit concluded, completing the work commissioned for this case. The client expressed appreciation for our support with the preparation and audit response under a short timetable.
Related Services
・QMS and business licensing support
Discuss QMS Document Revision and Audit Preparation
Contact us if reviewing existing documents or preparing for an audit is difficult to progress internally. Taking account of the state of documentation and the deadline, we will identify priorities and our scope of work.
Company and audit-body names are withheld. This case describes support for revising quality documents and preparing for an audit and does not guarantee audit outcomes in other cases.
Prepared by: MK Consulting K.K.