Metrology & Quality Management

Quality and Certifications

At TK Mold, quality is engineered into every stage of toolmaking. From certified mold steels and sub-micron Zeiss coordinate measuring machines to ISO 13485 cleanroom validation and IATF 16949 automotive compliance, discover how our testing infrastructure guarantees absolute dimensional certainty.

ISO 9001 / 13485 • IATF 16949
Zeiss CMM 0.9 μm Accuracy
Reviewed by Brandon Henderson, CPSP

Direct Sourcing Summary: Quality Standards & Verification

TK Mold maintains international quality certifications encompassing ISO 9001 for precision tooling, ISO 13485 for medical device molds, and IATF 16949 for automotive components. Every mold program incorporates optical emission spectrometry to confirm steel alloy chemistry, Zeiss multi-axis CMM inspection with 0.9-micron accuracy, industrial CT scan porosity verification, and DIN EN 10204 3.1 mill certifications to ensure flawless production longevity.

Accredited Systems

International Quality Certifications & Accreditations

TK Mold tooling operations adhere to rigorous global quality frameworks. Each plant undergoes periodic third-party surveillance audits to verify compliance across tool design, CNC machining, EDM processing, cleanroom molding, and supply chain integrity.

Medical Device
ISO 13485 Certified
Governs medical device tooling, Class 100k cleanroom molding, risk management, and rigorous documentation for diagnostic consumables, surgical handles, and fluidic cartridges.
Automotive Tier 1
IATF 16949 Certified
Automotive quality standard covering defect prevention, variation reduction, APQP processes, and full Level 3 PPAP qualification packages for exterior and interior components.
Core Management
ISO 9001 Certified
Baseline foundation for all tooling facilities, defining continuous process improvement, customer requirement validation, and corrective action workflows.
Environmental & Customs
ISO 14001 & AEO Tier-Advanced
Demonstrating ecological responsibility in solvent recycling and coolant filtration, paired with Authorized Economic Operator accreditation for expedited North American customs release.
Quality certifications wall displaying ISO 13485, IATF 16949, and ISO 9001 credentials at TK Mold
Figure 1: Quality management system credentials including ISO 13485, IATF 16949, and ISO 9001 accredited facilities.
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Dimensional Verification

Inspection Fleet: Sub-Micron Zeiss CMM & Optical Scanners

Dimensional control is maintained within dedicated climate-controlled inspection laboratories maintained strictly at 20 degrees Celsius plus or minus 0.5 degrees. Our inspection team utilizes metrology systems recognized by the National Institute of Standards and Technology (NIST) for traceability.

  • Zeiss Prismo & Accura CMMs: Equipped with VAST XT active scanning heads capable of holding volumetric measurement uncertainty to 0.9 μm + L/350. Every electrode, cavity insert, and mold base bore is checked prior to assembly.
  • GOM ATOS 3D Optical Surface Scanners: Triple-scan blue light optical scanning captures full 3D point clouds of molded components, generating color-coded deviation heat maps directly against customer native 3D CAD files.
  • Mitutoyo Contracer & Surftest: High-resolution stylus instruments measure thread profiles, seal radius geometry, and surface finishes down to Ra 0.02 μm.
Zeiss coordinate measuring machine inspecting complex injection mold cavity insert
Figure 2: Climate-controlled metrology lab with Zeiss CMM scanning an intricate multi-cavity tooling insert.
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Non-Destructive Testing

Industrial CT Scanning & Internal Defect Mapping

For complex medical fluidic housings, conformal cooling channels, and fiber-filled automotive components, conventional optical or touch probe methods cannot verify internal geometries. TK Mold deploys industrial computed tomography (CT) X-ray scanning to examine internal structures non-destructively.

CT scanning reveals micro-voids, internal weld line consolidation, fiber orientation distributions, and internal channel blockages without destroying test parts. This capability proves invaluable for verifying the clean flow integrity of 3D printed maraging steel conformal cooling channels before mold assembly.

Industrial CT X-ray scanning visualization of internal injection molded part geometry
Figure 3: Computed tomography false-color scan displaying internal wall thickness uniformity and core cooling circuits.
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Material Authentication

Steel Authenticity & Full Mill Traceability

Premature tool failure, cracking, or surface pitting during polishing almost always stems from inferior, uncertified tool steels. TK Mold maintains an uncompromising material procurement protocol:

  • Direct European Steel Sourcing: Mold cavities and cores are sourced exclusively from verified steelmakers including Uddeholm (Sweden), Finkl (USA), Bohler (Austria), and Daido (Japan).
  • DIN EN 10204 3.1 Mill Certificates: Every incoming steel forging is accompanied by authenticated mill inspection documents detailing chemical composition, melt batch numbers, and ultrasonic cleanliness ratings.
  • On-Site Spectrometric Confirmation: Our metallurgy laboratory performs on-site optical emission spectrometry to cross-verify chromium, vanadium, and molybdenum concentrations before releasing material to rough machining.
  • Vacuum Heat Treatment Logs: Hardening cycles include thermocouple strip charts documenting preheat stages, austenitizing soak times, cryogenic treatments, and triple tempering for dimensional stability.
Steel mill inspection certificates and certified tool steel test blocks
Figure 4: DIN EN 10204 3.1 mill certificates and authenticated Uddeholm steel blocks with heat-lot serial stamps.
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Process Flow

Six-Gate Quality Assurance Workflow

Every mold tooling program passes through six sequential quality verification gates. A tool cannot proceed to the subsequent manufacturing stage without full sign-off from the quality engineering team:

GATE 1 DFM & CAD Moldflow Review Draft & Steel Plan GATE 2 Material Inflow Spectrometry Test Mill 3.1 Cert Check GATE 3 In-Process CNC Electrode Inspection On-Machine Touch GATE 4 Zeiss CMM Lab Insert 100% Audit Hardness Verification GATE 5 T1 Press Trials 3D Point Cloud Scan CPK > 1.67 Study GATE 6 Final Sign-Off Dry Cycle 4-Hour Export Packaging
Equipment Specifications

Metrology & Inspection Equipment Standards

Inspection System Make & Model Measurement Uncertainty Primary Application
Bridge CMM Zeiss Prismo Ultra VAST XT 0.9 μm + L/350 mm High-cavity cores, precision shutoffs, guide pin bores
Production CMM Hexagon Global S Chrome 1.3 μm + L/300 mm Fast in-process electrode and cavity plate verification
3D Optical Scanner GOM ATOS Q Triple Scan ±0.005 mm Full 3D contour color map scanning of molded parts
Industrial CT Scanner Nikon XT H 225 Industrial Voxel resolution down to 3 μm Internal channel flow checks, micro-porosity, wall variance
Optical Comparator Mitutoyo PH-A14 Quadra-Chek 3.0 μm Gate diameters, ejector pin steps, micro-radius checks
Interactive Verification Matrix

Industry Quality Protocol & Metrology Selector

Select your application sector to review corresponding international quality standards, mandatory metrology equipment, required inspection deliverables, and target CPK thresholds:

Primary Certifications
ISO 13485 / ISO 9001
Class 100k Cleanroom Validated
Mandatory Metrology
Zeiss CMM + CT Scan
0.9 μm Touch + Void Mapping
Target Capability (CPK)
≥ 1.67 (4 μm spread)
100% Critical Dimension Coverage
Documentation Package
IQ / OQ / PQ Validation
Mill 3.1 Certs + Full FAI
Common Questions

Frequently Asked Questions: Quality & Certifications

Which quality management systems does TK Mold maintain? +
TK Mold operates certified quality facilities conforming to ISO 9001 for general manufacturing, ISO 13485 for medical device tooling, IATF 16949 for automotive components, and ISO 14001 for environmental management.
How is mold steel authenticity verified? +
Every steel block arrives accompanied by DIN EN 10204 3.1 mill inspection certificates from certified producers like Uddeholm and Finkl. We conduct on-site optical emission spectrometry to verify chemical composition before machining.
What level of dimensional inspection is included with export molds? +
Each export mold includes complete Zeiss multi-axis CMM dimensional inspection reports, full 3D optical surface scan color-deviation maps, core-to-cavity concentricity verification, and sample part CPK statistical analyses.
Can TK Mold accommodate on-site customer audits? +
Yes, our technical broker Brandon Henderson coordinates direct facility visits, cleanroom walk-throughs, and quality documentation reviews for North American engineering teams.

Require Certified Quality Documentation for Your Program?

Connect with Brandon Henderson in North Carolina to review metrology protocols, required validation packets, and steel certification standards for your next high-cavitation tooling project.

Request Quality Audit Packet Call Brandon: (336) 953-9664