QMS construction business menu
Updated: July 2025, 10
At Support Administrative Scrivener Corporation, one of our specialized fields is application for permits and licenses related to medical devices and operational support for business operators.
We are not just experts in creating documents. We are experts in helping businesses starting new businesses smoothly, and businesses that have already received permission to operate businesses based on legal compliance.
For medical device business operators, we will introduce the QMS construction menu along with examples that we have been in charge of implementation.
Our dedicated staff handles cases nationwide.
For new businesses/companies entering the market
Example: I want to start a medical device business with no experience
① I don't have anyone with experience, and I don't know what I need to prepare before starting my business...
② I'm worried about the on-site inspection...
I solved it like this
☑ Providing procedure manuals
☑ Actually see the site and advise on layout etc.
☑ Mock field survey
☑ Lecture on what you need to do in your work
For companies that already have a medical device permit
Example (1): I'm worried about whether I'll be able to survive the on-site inspection when it's time to update...
① It's time for an update every five years, but I haven't kept any records...
② Insufficient procedure manual…
3) Up until now, we have not been operating with a view to complying with laws and regulations…
④ There is no one in the company who is knowledgeable...
I solved it like this
☑ Supports efficient record-keeping by determining record priorities and making clear distinctions
☑ Providing a procedure manual that covers all legal compliance matters
☑ Explanations and lectures by consultants
☑ Mock field survey
The update procedure was completed successfully without any issues.
Case (2): My predecessor retired and there is no one who knows about QMS.
① Documents are scattered and disorganized…
② It does not correspond to the change in the law…
3) No records were left behind…
I solved it like this
☑ Systematic document organization using unique tools
☑ Advice and document proposals to comply with the latest laws
☑ Proposal for record keeping methods suited to the company's business style
Internal audit support ~ Effective and meaningful internal audit ~
Example: Internal audit records are created in a hurry every time it is updated.
① Regular internal audits are not conducted...
② I don't know what to check for the audit...
③ I don't have the luxury of conducting internal audits myself...
I solved it like this
☑ Support internal audits by visiting the site
☑ Propose an internal audit checklist
☑ Record and provide the results of the audit
After the internal audit, we supported the management review.
Consulting menu
| Menu | Outline |
| Creation of QMS procedure manual when applying for a new permit | When making a new application, we will create a QMS procedure manual tailored to your company. |
| Review of QMS procedure manual during operation | We will thoroughly review the procedures currently in use at your company and make revisions and improvements. We will also revise the procedures manuals from a legal compliance perspective. |
| Application of revised law for QMS procedure manuals | There are many cases where QMS has been operated without applying the 26 legal amendments, and this has been pointed out during an investigation when applying for renewal. |
| Regular document creation support | We regularly check documents and records, such as once every three months, and continuously support appropriate QMS operations. |
| internal audit support | We not only create internal audit check sheets and provide actual internal audit support, but also provide post-internal audit results reports and management reviews. |
| Educational training support | We support sustainable education and training by proposing annual education and training plans and supporting the creation of records. |
| Sales of QMS templates | Provides the basic type of QMS procedure manual. |
We provide consulting services to meet a variety of needs.
I want to obtain permission with minimum effort...
I want to understand and operate QMS...
Would you like to outsource QMS operations that take a lot of effort and time?
The first consultation is free.
Detailed case study introduction
Company A: The person in charge of QMS has decided to retire, and there is no one in the company who understands QMS.We received a request from Support Administrative Scrivener Corporation.
Since it was just time for renewal and there was also an on-site inspection by the PMDA, it was decided that concentrating the work on the newly appointed person in charge of QMS alone would be too much of a burden, so the responsibilities were divided among the team.
The team consists of four people, two from Company A and two from our company.
First, let's sort out the current situation.
I started by sorting out which documents are where.
Using our tools, we systematically organized the disparate documents and grasped the overall picture.
We then explained the importance of the records and helped them organize them in a clear and concise manner.
We also check the documents to see if they comply with the laws and regulations.
We supplemented the documents with parts that did not correspond to the legal changes, and we also revised the product standard manual to include items that were based on the old law.
New staff members also start with little knowledge of QMS and gradually deepen their understanding.
I was able to organize it.
