Quality & Certifications

Quality System & Certifications

This page states only what current source documents show, including where a document leaves an open question — see the notes under each item below.

Quality system

Every job carries first-article inspection, in-process checks at defined intervals, and final inspection before shipment. Documentation packages — material certifications, lot traceability, and inspection records — are available and scaled to what your program requires. See Quality Inspection & Documentation for process detail.

ISO 9001:2015

Registered entity: WREX Products, Inc.
Scope: The production of precision injection molding, tooling and die casting.
Registrar: P&Y Quality System
Auditor: Lewis P. Yasenchak
Certificate number: PY0126WP
Original certification date: July 22, 1997
Current certificate issued: January 13, 2026
Expires: January 30, 2027

ISO 13485:2016

Registered entity: WREX Products, Inc.
Scope: The production of precision injection molding, tooling and die casting.
Registrar: P&Y Quality System
Auditor: Lewis P. Yasenchak
Certificate number: PY0126WP
Original certification date: May 27, 2005
Current certificate issued: January 13, 2026
Expires: January 30, 2027

Internal note: both certificates above are titled “Certificate of Recognition... in recognition of cooperative and active participation in [standard] Compliance,” issued by “P&Y Quality System.” This phrasing differs from a typical accredited third-party ISO registration certificate. Before this page states “ISO 9001/13485 certified” as an unqualified fact, confirm whether P&Y Quality System is an IAF/ANAB-accredited (or equivalent) certification body, and adjust the wording above to “certified” vs. “recognized” accordingly. Also confirm the identical certificate number (PY0126WP) on both the ISO 9001 and ISO 13485 certificates isn't a documentation error. See docs/factual-verification.md.

FDA establishment registration

Owner/Operator number: 10049354
Registration number: 3002589861
Initial registration: May 15, 2015
Current registration valid through: December 31, 2026

Wrex Products is FDA-registered as a device establishment and lists activity as a contract manufacturer and repackager/relabeler for powered and non-powered breast pump devices under the following listings:

Listing	Device	Activity	Premarket submission
D320624	Pump, Breast, Powered	Contract Manufacturer	K172772
D247483	Pump, Breast, Powered	Repackager/Relabeler	K093145
D247484	Pump, Breast, Non-Powered	Repackager/Relabeler	510(k) exempt
D242794	Pump, Breast, Powered	Contract Manufacturer	K130349

Registering a facility and listing devices with the FDA does not, in any way, constitute FDA approval of the facility or its devices. We do not describe this registration as “FDA approved” or “FDA certified.”

California Medical Device Manufacturing License

License: Medical Device Manufacturing License
Issued by: State of California, Department of Public Health, Food and Drug Branch
Licensee: Wrex Products, Inc.
License number: 52444
Expiration date: October 6, 2026

Per the license: the licensee is licensed to manufacture devices through the expiration date of this license, issued in accordance with the California Health and Safety Code.

Requesting documentation

Customers and prospective customers may request current certificates and quality documentation directly — contact us or note the request on your RFQ submission.

Calibration program

Measuring equipment is calibrated on two tracks — what we do ourselves each month, and what goes to a third party or the manufacturer on its own schedule. Records are retained for both and are available on request.

Calibrated in-house, monthly

Monthly

Gages and measuring equipment are calibrated in-house on a monthly schedule using GageTrak calibration management software, with the results recorded and retained.

Gages
Gage pins
Gage blocks
Height gages
Measuring equipment

Calibrated by third party or manufacturer, on schedule

On a scheduled interval

Equipment that requires accredited or manufacturer calibration is sent out or serviced on its scheduled interval. Certificates and records are retained and available on request.

Scales
Surface plates
CMMs
Test equipment
Special gages
Powder coating guns
Curing ovens

Records we maintain

Tool history	Build, sampling, maintenance, repair, and modification history for each tool, retained for the life of the tool.
Production records	Run data for each production order, captured from the machines rather than transcribed by hand.
Lot history	Material lot and production lot records supporting traceability where a program requires it.
Machine maintenance	Preventive and corrective maintenance history for presses, casting cells, and support equipment.
Calibration	In-house monthly calibration results plus third-party and manufacturer calibration certificates.
Training	Employee training records, including cross-functional training across departments.
Employee training matrix	A matrix of which employees are qualified for which parts and which processes — so qualification is verifiable per part and per operation, not recorded as a single blanket status.
Health and safety	Health and safety training records and related documentation.

Business continuity and supply risk

Wrex maintains a documented Business Continuity Plan (BCP) and qualified backup vendors for critical supply.

Documented BCP

A written business continuity plan covering how production is protected and recovered through a disruption. Available for review as part of a supplier assessment.

Backup vendors

Qualified alternate vendors are maintained for critical supply, so a single vendor failure does not stop your parts. This matters most on material and outside processing, where a sole source is the usual hidden risk.

Capability concentrated on one site

Tooling, molding, casting, machining, finishing, coating, assembly, and inspection all run across roughly 100,000 square feet in Chico. Fewer external handoffs means fewer places a supply chain can break.

Manufacturing system of record

IQMS DELMIAWORKS

A single ERP, MES, document control, and quality management system, connected to the machines on the floor in real time.

Wrex runs IQMS DELMIAWORKS as its manufacturing system of record — ERP, MES, document control, and QMS in one database, wired to the production equipment in real time. Practically, that means production data comes off the machines directly instead of being written down and keyed in later, and that tool history, lot traceability, maintenance, and quality records all live in the same system rather than in separate spreadsheets.

ERP — orders, scheduling, inventory, and purchasing
MES — real-time machine monitoring and production data capture
Document control — controlled documents and revisions
QMS — quality records, non-conformance, and corrective action

Ready to talk about your project?

Send your drawings or describe your part — an engineer will follow up, not a sales queue.

Request a Quote Call (530) 895-3838