How do I note regulated scope on an RFQ?

Write the industry and the documents you need in the quote notes. Add inspection and material identity next to that line. Do not replace the list with a certification slogan.

Can I write unapproved certification labels on the quote form?

Do not ask the quote page to display those labels. ISO 9001 is the approved quality-system mention. Send detailed compliance questions to sales.

What if I only know the industry, not the document list?

Write the industry and say which documents will follow. Add the inspection list as soon as you have it. Industry alone is not a ballooned plan.

Where do detailed compliance questions go?

They go to sales. The RFQ keeps industry, inspection, material identity, and the matching drawing revision. Marketing copy on this page stays with ISO 9001.

What if my customer asks for a certification this site does not list?

Write that requirement in the note and route the certificate-level question to sales. The RFQ itself should carry industry, intended use, FAI scope, and material identity. The quote form does not display unheld certification labels.

Can I just write medical and let review figure out the rest?

No. Medical alone is not a ballooned plan. Add high-level use, which features are critical, and what documents incoming will file, such as FAI, material cert, or lot traceability. Review can then scope the program instead of guessing it is a generic cover.

Does a regulated note change how the mold is owned or supported?

No. Ownership and same-tool continuity follow the same rules. After the tooling charge is paid, the customer owns the steel. Continuity means the same tool keeps running on reorders and the tooling charge is not billed again. Regulated scope adds documentation requirements, not a different title path.

How to Note Regulated Scope on an RFQ

Q: Does NetProto mold medical or dental parts?

Yes. NetProto runs medical, dental, and other regulated molding programs when the requirements are written on the RFQ. Put those requirements in the note.

A Regulated Note Is a Scope Flag, Not a Badge

A regulated-scope note tells review the part sits in a medical, dental, or validation-driven program and lists the documents you will file. Write the industry, high-level use, inspection package, and material identity. Do not paste certification badges the site does not claim. ISO 9001 is the only approved system mention. Detailed compliance goes to sales.

Read quality assurance overview for that system mention. This page is the RFQ note, not a brochure.

Medical and dental is in scope when requirements are written

NetProto runs medical, dental, and other regulated molding programs when the requirements are written on the RFQ. Do not write that the work is out of scope. Engineers bounce when the quote form has no badge. The form is not a brochure. Write the industry and the documents. Review can scope the program.

Certification slogan is not a document list

Regulated work is written, not implied. A badge in the title bar is not a scope. Industry names the program. Documents scope it. A slogan does neither. Sourcing often pastes a certificate name into the project title because the customer used it. That paste does not create a quality system on the quote. It also does not create a document list.

ISO 9001 is the only marketing-claimable system mention

ISO 9001 is the system mention. It is not a medical-device certificate, and we do not pretend it is. Marketing copy on this site may only claim ISO 9001. Do not ask the quote page to display unapproved certification labels.

A worked example: a dental-handpiece housing needs a ballooned FAI and material identity to the named resin. The note says dental program, FAI on Balloons 4, 5, and 12, material identity to named resin, ISO 9001. It does not say a certification the site does not claim. That note can be reviewed.

What to tell sourcing: regulated work is written, not implied. Upload CAD through the instant quote platform with the note attached. If two teams disagree on the vertical, write the stricter industry and let sales narrow it.

What to Write in the RFQ Note

Industry word: medical, dental, or other validation-driven

Step one is the industry word. If you cannot name it, you do not have a regulated note yet. Medical in the filename only is not a note.

Intended use at high level (external housing, non-implant)

Intended use stays high level. Dental handpiece housing is enough. External housing, non-implant is enough. A long clinical story is not required on the first upload. High-level use prevents review from assuming implant rules from a housing.

Inspection docs: FAI balloons + material identity

Read specify inspection requirements on an RFQ for FAI, visual, or a dimensional list. Read first article inspection for molded parts when incoming will file a ballooned report. Material identity sits beside the note when incoming will check the named grade.

Drawing revision must still match CAD

Regulated or not, the print and the solid must match. Read what information a quote needs for the rest of the package: CAD, resin, quantity, finish. This page only adds the regulated line.

A worked note: industry dental. Use: external housing, non-implant. Inspection: FAI on three balloons. Material identity: named resin. Quality-system mention: ISO 9001. That block is complete enough to review.

Common mistakes: writing medical in the filename only; copying a customer badge list into the title; leaving inspection blank because the industry felt like enough. Industry is not a balloon.

What to tell sourcing: use the sister articles for fields. Use this page for the industry line. If they only know the vertical, write that and say documents to follow. Do not invent a badge.

What Review Will Ask Next

Which features are critical

Review does not invent a validation plan from the word medical. They will ask which mates you will measure. Answer those on the same record.

Which revision wins (CAD vs drawing)

They will ask whether drawing Rev C or CAD Rev D is the acceptance source. Attach the pair. A report against current is not scoped.

Who receives the report

They will ask who files the report. Name the recipient. A blank incoming box is another TBD.

Beyond-ISO-9001 paperwork goes to sales, not the quote form

If the customer later asks for paperwork beyond ISO 9001, that thread goes to sales. This page will not fill those claims. It will not refuse the industry either. The split is: RFQ gets industry plus documents you can name. Sales gets the rest.

TBD on inspection is a flag to fill, not a validation plan. A worked follow-up: note said dental and FAI TBD. Review asks for balloons and the revision pair. The buyer attaches drawing Rev C and three balloons. The program can move. TBD alone cannot.

What to tell sourcing: expect three questions after the note. Features, revision, recipient. Have the print ready. Have sales ready if the customer wants claims this page does not make.

RFQ Checklist

Use this list so the vertical is a note, not a badge hunt.

Write the regulated industry in notes.
List the inspection or validation documents you need.
Attach the drawing revision that matches CAD.
Leave unapproved certification labels off the form.
Upload CAD through the instant quote platform.

Step 1 is the industry word: medical, dental, or another validation-driven program.

Step 2 is the document list. FAI, material identity, or a list your quality plan already uses.

Step 3 is the revision pair. Regulated or not, the print and the solid must match.

Step 4 keeps unapproved labels off the form. ISO 9001 is the mention you may write. Detailed claims go to sales.

Step 5 writes the note onto the quote. A slide deck is not the RFQ.

A worked submit block: CAD Rev C, drawing Rev C, dental housing, FAI on three balloons, material identity to named resin, ISO 9001. That block is usable.

Common mistakes at submit:

Title bar full of certificate names.
Industry in the filename only.
Inspection left blank.
Asking the page to display a badge.
Sending a quality manual instead of the document list you will file.

What to tell sourcing: send this checklist with the CAD. Hold the quote as regulated-scoped only after industry and documents are both written.

Ownership and same-tool continuity on reorders do not change because the note is regulated. Read who owns the injection mold. Continuity means the same tool keeps running and the tooling charge is not billed again. See same-tool continuity on reorders. Regulated scope adds documentation, not a different title path.