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What Documentation Should a Medical CNC Supplier Provide?

Created on 10.19

A medical CNC supplier should provide documentation showing that the correct material was used, the machined parts meet the approved drawing requirements, and each batch can be traced. Common documents include material certificates, a Certificate of Conformity (CoC), dimensional inspection reports, and first article inspection (FAI) reports when required. The exact documentation package should be agreed before production begins.

For medical device manufacturers, documentation is an important part of supplier quality control. It helps purchasing, engineering, and quality teams verify incoming parts and maintain the records required for their products.

1. Material Certificates or Material Test Reports

Material documentation helps confirm that the raw material matches the specification on the engineering drawing.

Depending on the material and project requirements, a supplier may provide a Certificate of Analysis (COA), Material Test Report (MTR), or another accepted material certificate.

These documents may identify the material grade, batch or heat number, chemical composition, mechanical properties, and applicable material standard.

For example, if a drawing specifies Ti-6Al-4V ELI to ASTM F136, the buyer should confirm that the supplied material documentation corresponds to that exact grade and specification. A generic statement that the part is made from titanium is not enough to establish compliance with the specified material grade.

Buyers should also check whether the material batch information can be linked to the finished parts.

2. Certificate of Conformity or Compliance (CoC)

A Certificate of Conformity, sometimes called a Certificate of Compliance, is a document in which the supplier declares that the delivered parts meet the agreed requirements.

A useful CoC should identify the relevant part number, order or batch, drawing revision when applicable, and the applicable specifications. It should also identify the supplier issuing the certificate.

The CoC is not a substitute for inspection data or material records. Instead, it summarizes the supplier's statement that the order conforms to the agreed requirements.

Before placing an order, confirm whether a CoC is required with every shipment and what information the customer's quality system expects it to contain.

3. Dimensional Inspection Report

A dimensional inspection report records measurements taken from the manufactured parts and compares them with the specified dimensions and tolerances.

For CNC-machined medical components, this report may cover hole diameters, overall dimensions, positions, flatness, profiles, threads, and other critical features identified on the drawing.

Buyers should confirm whether the report needs to include:

l Actual measured values, nominal dimensions, and allowed tolerances.

l Results for all drawing dimensions or only selected critical features.

l The inspection method or equipment, where required.

l Part numbers, drawing revision, batch identification, and acceptance status.

The inspection scope should be agreed before production. A report that checks only a few dimensions may not meet the buyer's needs if full dimensional inspection has been specified.

At Marigold Rapid, our published Quality Management System describes dimensional inspection, first article inspection, material traceability, and inspection reports for delivered batches.

4. First Article Inspection (FAI) Report

A First Article Inspection report documents the inspection of an initial part to verify that the manufacturing process can produce a component meeting the approved requirements.

FAI is particularly useful when starting a new part, introducing a new production setup, or making a change that requires renewed verification.

The report may include measured dimensions, drawing references, material information, and other checks specified by the customer.

FAI is not automatically required for every CNC order. Buyers should define when it is needed, what dimensions must be reported, and whether customer approval is required before the remaining batch is produced.

It is also important to distinguish an FAI report from routine final inspection records. They serve related but different purposes.

5. Material and Production Traceability Records

Traceability connects a finished part or batch to the records associated with its manufacture.

For a medical CNC project, relevant information may include the raw material batch, work order, inspection records, production batch, and applicable finishing records.

Traceability can help a manufacturer investigate a quality issue, identify affected batches, and determine which records are relevant to a particular shipment.

Before ordering, ask how the supplier identifies batches and whether the delivered parts can be linked to material and inspection documentation.

The required level of traceability depends on the product, customer requirements, and applicable quality procedures. Buyers should define it clearly rather than assume every supplier uses the same system.

6. Certificates for Surface Finishing and Other Special Processes

Some CNC parts require additional operations after machining, such as anodizing, passivation, heat treatment, coating, or another specified finishing process.

When these operations are part of the order, supporting documentation may be required to show that the work was completed according to the agreed specification.

Depending on the process, this could include a process certificate, test report, or record identifying the applicable batch and specification.

Not every part needs every type of certificate. For example, a coating report is relevant only when the coating is part of the specified process. The buyer should identify which finishing requirements need documented evidence before the supplier starts production.

If a supplier uses an approved subcontractor for a finishing operation, clarify who is responsible for obtaining, reviewing, and delivering the related records.

7. Quality System Certificates

A supplier's quality management system certificate is different from documentation for an individual batch of parts.

ISO 13485:2016 is a quality management system standard specifically intended for medical devices and related services. It helps buyers assess whether a supplier operates within a quality management system designed for medical device requirements.

However, an ISO 13485 certificate alone does not prove that a particular shipment meets its drawing, material, inspection, or regulatory requirements. Buyers should check the certificate's validity, scope, and issuing body, as well as the part-specific documentation.

For U.S. medical devices, the FDA's Quality Management System Regulation (QMSR) took effect on February 2, 2026. It applies to finished device manufacturers intending to commercially distribute medical devices. Supplier documentation requirements still need to be determined according to the applicable requirements, the customer's quality system, and the agreed purchasing or quality terms.

Official references: ISO 13485:2016 and FDA Quality Management System Regulation (QMSR).

Which Documents Should You Request Before Placing a CNC Order?

Do not wait until shipment to discuss documentation requirements. Agree on them during quotation or order review, when the supplier can plan the required inspections and records.

Start by providing the supplier with the latest 2D drawing, 3D CAD file, material specification, quantity, and any required finishing specifications.

Then confirm:

l Which material certificate or test report is required.

l Whether a CoC must accompany every shipment.

l Which dimensions must appear in the inspection report.

l Whether FAI and customer approval are required before batch production.

l What batch or material traceability information must be maintained.

l Whether special-process certificates or other quality records are needed.

l How drawing revisions and changes will be confirmed.

Some quality records, such as calibration records or detailed internal process records, may be available for review or audit rather than automatically supplied with each shipment. Clarify access and retention requirements in advance if these records are important to your project.

A clear documentation agreement helps avoid missing records, shipment delays, and disagreements during incoming inspection.

What Documentation Does Marigold Rapid Provide?

Marigold Rapid provides CNC machining and custom manufacturing services for prototypes and low-volume production. Our published quality management information identifies the following documents for orders:

l Certificate of Compliance (CoC): Documents conformity with the agreed requirements.

l Raw material Certificate of Analysis (COA): Supports material verification and batch traceability.

l Dimensional inspection report: Records inspection results for the delivered batch.

Our quality information also describes first article inspection, incoming material checks, and traceability throughout production. Additional documents, inspection scope, and any special-process records should be confirmed for each project according to the drawing and customer requirements.

To help us review your request, please provide the part drawing, material grade, order quantity, inspection requirements, and any required documentation list.

Visit our CNC Machining Service or contact Marigold Rapid to discuss your project and request a quote.

Frequently Asked Questions

What documents should come with a medical CNC shipment?

Common documents include a material certificate or COA, a Certificate of Conformity, and a dimensional inspection report. FAI reports, traceability records, and special-process certificates may also be required, depending on the order.

Is an ISO 13485 certificate enough for a medical CNC supplier?

No. It helps demonstrate that the supplier operates a medical device quality management system, but it does not replace material certificates, part inspection results, or shipment-specific records.

Does every medical CNC part require a First Article Inspection report?

Not necessarily. FAI requirements depend on the customer, product, production circumstances, and agreed quality procedures. Confirm the requirement and approval process before production begins.

Should a CNC supplier provide material traceability?

Material traceability should be defined for the project, especially when material identity and batch history are important to product quality. Buyers should confirm what information is recorded and how it links to the delivered parts.

Should all quality records be delivered with every shipment?

No. Some documents are normally agreed as shipment deliverables, while others may be retained by the supplier and made available for review or audit. The required document list, format, and retention period should be agreed before production.