Compliance & Regulatory Framework

Precision Manufacturing maintains a comprehensive compliance posture across export control, quality standards, environmental regulations, and supply chain requirements — so your approved vendor list stays clean.

Regulatory Coverage at a Glance

Key frameworks that govern how we manufacture and document

ITAR / Export Control

We maintain awareness of ITAR (International Traffic in Arms Regulations) and EAR (Export Administration Regulations) for defense and aerospace work. Controlled technical data and export-controlled items are handled under applicable requirements.

ISO 9001:2015

ISO 9001 certified quality management system covering design, development, production, and delivery. Annual third-party audits maintain certification status and continuous improvement cycles.

AS9100 Alignment

Our processes align with AS9100 Rev D requirements for aerospace manufacturing: configuration management, risk-based thinking, product/service realization controls, and traceability requirements.

FDA QSR Awareness

For medical device equipment components, we maintain awareness of FDA Quality System Regulations (21 CFR Part 820) including design controls, corrective and preventive action (CAPA), and device history records.

DFARS Compliance

Defense Federal Acquisition Regulation Supplement (DFARS) requirements addressed for government contract work, including domestic sourcing requirements (Berry Amendment / specialty metals) and cybersecurity controls.

RoHS / REACH

We can provide documentation supporting RoHS (Restriction of Hazardous Substances) and REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) compliance for customers in EU and global regulated markets.

Export Control & ITAR

Responsible handling of controlled technology and defense-related work

ITAR Awareness Program

Precision Manufacturing recognizes that many of the components we manufacture for aerospace and defense customers may be subject to International Traffic in Arms Regulations (ITAR) or Export Administration Regulations (EAR). We maintain awareness of these requirements and work with customers to ensure controlled technical data is handled appropriately.

Key aspects of our export control awareness program include:

Technical data handling protocols for controlled drawings and specifications
Screening of foreign national access to controlled information
Identification of USML (United States Munitions List) and CCL (Commerce Control List) items
Customer-directed export control requirements incorporated into work orders

ITAR Considerations for Customers

When submitting controlled technical data to D&J for quotation or production:

Clearly mark all controlled drawings and documents with applicable ITAR/EAR designations
Specify any DSP-5 export license requirements or exemptions applicable to your program
Contact us directly to discuss ITAR-sensitive programs before submitting documents electronically
We can accept controlled data via secure transmission methods upon request

Discuss Your Program Requirements

Aerospace & Defense Compliance

Supporting AS9100 supply chains and government contract requirements

AS9100 Process Alignment

Our quality system is built on ISO 9001 and extends to address AS9100 Rev D aerospace-specific requirements. Customers who require AS9100-compliant suppliers will find our processes well-aligned with those expectations.

Configuration Management: Engineering change control and revision tracking on all production documentation
Risk Management: Risk identification and mitigation in production planning for critical features
First Article Inspection (FAI): AS9102 FAIR documentation available including balloon drawings, measurement data, and material certs
Special Processes: Approved supplier control for heat treating, surface finishing, and non-destructive testing
Traceability: Full material heat/lot traceability from raw stock through finished part delivery

DFARS & Government Work

For customers involved in U.S. defense procurement, we understand the requirements of the Defense Federal Acquisition Regulation Supplement and support compliance in the following areas:

Specialty Metals (Berry Amendment): Material sourcing and documentation for DFARS-compliant specialty metals when required by contract flow-down
Cybersecurity (CMMC/NIST 800-171): Awareness of Cybersecurity Maturity Model Certification requirements for handling Controlled Unclassified Information (CUI)
Counterfeit Parts Prevention: Approved supplier list management and traceability practices to mitigate counterfeit component risk
Documentation Flow-Down: Customer contract requirements are reviewed and flowed to production floor documentation

Medical Device Manufacturing Compliance

FDA QSR awareness for equipment and device component manufacturing

Important Scope Clarification

Precision Manufacturing manufactures medical device equipment frames, housings, and Class I/II device components. We do not manufacture Class III implantable devices.

21 CFR Part 820 Awareness

For medical device OEM customers, our quality system incorporates awareness of FDA Quality System Regulations including:

Design history file (DHF) support documentation
Device history record (DHR) material and production traceability
Corrective and Preventive Action (CAPA) system
Nonconforming material controls and disposition documentation
Calibrated measurement equipment with current calibration records

Medical Documentation Package

Standard documentation available for medical device customers:

Certificate of Conformance (CoC) per customer specification
Material certifications with heat/lot numbers
Dimensional inspection reports (100% or sampling per AQL)
Special process certifications (plating, heat treat, surface finish)
First Article Inspection reports
Nonconformance reports and dispositions (if applicable)

Request Documentation Sample

Environmental & Materials Compliance

Supporting global supply chain environmental requirements

RoHS Compliance Support

We can provide material documentation supporting Restriction of Hazardous Substances (RoHS) Directive compliance for customers selling into EU markets. Our material suppliers provide RoHS-compliant certifications upon request.

REACH Documentation

REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) declarations can be provided for materials and surface treatments to support customers' substance of very high concern (SVHC) reporting requirements.

Conflict Minerals Awareness

For customers subject to SEC conflict minerals reporting (3TG: tin, tungsten, tantalum, gold), we support the due diligence process through our supply chain and can assist with CMRT completion.

Supply Chain Compliance

Approved suppliers, traceability, and documented controls throughout our supply base

Approved Supplier List (ASL)

Precision Manufacturing maintains a controlled Approved Supplier List for critical sub-tier suppliers and special process providers. Our ASL includes qualification criteria and periodic performance monitoring.

Qualification criteria based on quality system, capability, and past performance
Periodic re-qualification reviews for critical suppliers
Documented approval status for heat treating, plating, and NDT providers
Flow-down of customer quality requirements to sub-tier suppliers

Material Traceability

Every material that enters our facility is traceable to its mill certificate and heat/lot number. This traceability is maintained throughout the production process and delivered with the finished part.

Mill test reports (MTR) for all structural metals
Heat/lot number tracking from raw stock to finished part
Certified Material Test Reports available upon request
Segregation and identification of materials throughout the production flow

Compliance Documentation Available

Standard documentation we provide with every shipment or upon request

Standard Shipment Documents

Certificate of Conformance (CoC) — certifying parts meet drawing and specification requirements
Material certifications with heat/lot numbers
Packing list with part number, revision, quantity, and purchase order references

Available Upon Request

First Article Inspection (FAI) report — AS9102 format available
Dimensional inspection reports
Special process certifications (heat treat, plating, NDT)
RoHS / REACH declarations
CMRT (Conflict Minerals Reporting Template)
ITAR/export control program documentation

Need Supplier Qualification Documentation?

We're accustomed to working through supplier qualification processes for aerospace, defense, and medical OEMs. Contact us to discuss your specific compliance requirements and we'll provide the documentation you need.

Request a Quote Call 817-536-0718