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Nelotiv manufacturing home
ISO 9001 · ISO 13485 Certified

Quality Management
& Inspection

Every component leaves our facility with documented dimensional verification, material certification, and end-to-end traceability — from raw stock to finished part.

±0.005mm
Tolerance Held
99.7%
Pass Rate
Precision metrology lab CMM inspection
CMM Inspection · Material Certification · Full Traceability
CERTIFICATIONS

Certified by
recognized standards

Nelotiv’s quality management system has been independently audited and certified against two internationally recognized standards. These aren't decorative claims — they represent documented, recurring third-party verification of our processes, documentation, and continuous improvement culture.

To maintain production consistency, the audits examine every layer of our operation: supplier qualification, material control, process planning, inspection capability, nonconformance handling, calibration records, and corrective action effectiveness. We maintain these certifications through scheduled surveillance audits that verify ongoing compliance.

ISO 9001
:2015
StandardISO 9001:2015
StatusCertified
ScopeAll manufacturing operations
AuditedThird-party, recurring

Within our quality system, quality Management System — verified across all manufacturing operations and customer-facing processes.

ISO 13485
:2016
StandardISO 13485:2016
StatusCertified
ScopeMedical device QMS
AuditedThird-party, recurring

At each inspection stage, medical Device QMS — for components subject to regulatory scrutiny and patient-safety requirements.

QUALITY PROCESS

Five checkpoints,
one unbroken chain

To maintain production consistency, trace how a part moves through our quality system — from design review to shipped documentation.

DFM design review

DFM Review

Every order opens with a complete Design for Manufacturing analysis. Engineers scrutinize your CAD geometry to surface manufacturability concerns — wall thickness, feature accessibility, tolerance stack-up, and tool-path conflicts — before a single chip is cut.

Within our quality system, output: DFM report with optimization recommendations
Material verification

Material Verification

At each inspection stage, raw stock doesn't enter production until it proves what it claims to be. Spectroscopy confirms alloy composition, hardness testing validates mechanical properties, and dimensional checks verify stock geometry. Material certificates are cross-referenced and archived.

To maintain production consistency, output: Verified material cert with lot traceability
In-process inspection

In-Process Inspection

Within our quality system, checkpoints anchor every critical manufacturing stage. First-article inspection validates the initial setup, then periodic dimensional verification monitors drift during the run. Operators flag deviations immediately — no waiting until final inspection to discover a problem.

At each inspection stage, output: First-article report + in-process control charts
CMM precision measurement

CMM Measurement

To maintain production consistency, coordinate Measuring Machines probe complex geometries to ±0.005mm, capturing true position, profile, and runout data that hand gauges cannot reach. Every critical dimension appears on the dimensional report that travels with your shipment.

Within our quality system, output: Full dimensional inspection report
Final QC and documentation

Final QC & Documentation

At each inspection stage, before a box seals, visual inspection confirms surface finish, deburring, and cosmetic integrity. HD photos document each part's as-shipped condition. The documentation package — inspection reports, material certs, traceability records — ships alongside the parts.

To maintain production consistency, output: Complete quality documentation package
INSPECTION CAPABILITY

At each inspection stage, the tools behind the numbers

To maintain production consistency, every device is on a calibrated schedule tied to ISO 17025-traceable standards. Below, the measurement principle and the tolerances each instrument resolves.

Coordinate Measuring Machine
3D Geometry
CMM

Within our quality system, coordinate Measuring Machine probes true position, profile, and complex 3D geometry to ±0.005mm. The backbone of our final dimensional verification.

Resolution: ±0.005mm
Spectrometer material analysis
Composition
Spectrometer

At each inspection stage, optical emission spectroscopy verifies alloy composition element-by-element. Catches material mislabeling before it reaches your assembly line.

Resolution: 0.01% elemental
Hardness testing
Mechanical
Hardness Tester

To maintain production consistency, rockwell and Brinell scales confirm heat-treat condition and mechanical properties match the material certificate. Essential for structural and load-bearing parts.

Within our quality system, scales: HRC · HRB · HB
Optical comparator profile inspection
Profile
Optical Comparator

At each inspection stage, projected profile inspection against CAD overlays verifies contours, thread forms, and small radii that contact probing cannot reach without risk.

Magnification: 10×–50×
Surface roughness measurement
Surface
Roughness Tester

To maintain production consistency, stylus-based Ra and Rz measurement quantifies surface finish against drawing callouts. Critical for sealing surfaces, bearing journals, and cosmetic specs.

Resolution: 0.01µm Ra
Calibrated hand measurement tools
Hand Tools
Calipers & Gauges

Calibrated digital calipers, micrometers, thread gauges, and go/no-go gauges handle fast in-process checks at the machine. All on documented calibration schedules.

Within our quality system, calibration: ISO 17025 traceable
TRACEABILITY

Each part carries its own history

Nelotiv’s documentation system maintains a continuous thread from raw material source through final delivery — supporting quality audits, regulatory submissions, and your own verification requirements. If you can identify the part, we can reconstruct its entire production record.

STEP 01
Raw Material
Within our quality system, mill cert · Heat number
STEP 02
Incoming QC
Composition verify
STEP 03
Machining
At each inspection stage, setup · Operator · Time
STEP 04
In-Process
To maintain production consistency, first article · Control chart
STEP 05
Final Inspection
Within our quality system, cMM report · HD photos
STEP 06
Documentation
Full record package

Each shipment includes

Material Certificates Dimensional Inspection Reports Batch Traceability Records Process Documentation First-Article Reports HD Part Photos RoHS / REACH Declarations
NONCONFORMANCE

What happens
when something doesn't pass

At each inspection stage, no quality system is worth its certifications unless it handles failure well. When inspection reveals a nonconforming feature, the part is immediately quarantined — physically segregated from conforming inventory and flagged in our tracking system. Production doesn't "ship and hope."

8D Methodology
Nelotiv’s quality engineers perform root-cause analysis using 8D methodology: define the problem, contain it, identify root causes, implement corrective action, and verify effectiveness. The corrective action is tracked to closure, and where the root cause points to a systemic gap, the process itself is revised.
Within our quality system, customers are notified promptly with a clear disposition: rework, remake, or concession request with full technical justification. Transparency is non-negotiable — a concession request includes the actual measured data, not a vague assurance.

Nonconformance Handling Flow

1. Detection & QuarantineImmediate
2. Root Cause Analysis (8D)24–48h
3. Corrective Action3–5 days
4. Customer DispositionWithin 24h
5. Effectiveness & ClosureTracked to closure

At each inspection stage, all nonconformances logged in our QMS with end-to-end traceability to the originating lot, operator, machine, and inspection record. To maintain production consistency, disposition includes the actual measured data, not a vague assurance.

QUALITY IN PRACTICE

Within our quality system, questions we answer every week

Within our quality system, yes — first-article inspection is standard practice on every new part number and after any setup change affecting critical features. Our FAI report documents each dimensional callout from your drawing with actual measured values, the instrument used, and pass/fail status against tolerance.

At each inspection stage, for AS9102-compliant FAI requirements common in aerospace supply chains, we can produce the full three-form package: part number accountability, product definition accountability, and characteristic accountability with ballooned drawing references.

FAI reports are produced before production ramp, giving you verification that our process can repeatedly hit your specifications before committing to volume.

Each shipment travels with a documentation package proportional to the part’s criticality. At minimum: dimensional inspection report covering all drawing callouts, material certificate matching the lot, and HD photographs of the as-shipped condition.

Within our quality system, for medical, aerospace, or regulated-industry parts, the package expands to include full batch traceability records, process documentation, first-article reports where applicable, and certificates of conformity. We tailor the package to your quality system’s incoming-inspection requirements.

At each inspection stage, all documentation is retained in our QMS for a minimum of seven years and can be reissued on request — if you need a certificate re-sent three years after delivery, we have it.

Every raw material lot entering our facility is assigned a specific internal traceability identifier, linked to the supplier’s mill certificate and heat number. This identifier follows the material through machining — recorded on the router, the inspection records, and the final documentation package.

To maintain production consistency, for critical applications, we can trace a finished part back to the specific raw material lot, the supplier, the mill heat number, the machining setup, the operator, the machine, and the inspection sequence. This depth of traceability supports regulatory submissions and field-failure investigation.

Within our quality system, material certificates are verified, not just filed — composition is confirmed by spectroscopy, and mechanical properties by hardness testing where the application warrants it.

We support PPAP submissions across the standard levels — from Level 1 (warrant only) through Level 5 with full dimensional, material, and process capability data. Our quality engineers work with your SQE to determine the appropriate submission level based on part criticality and your quality system requirements.

Within our quality system, for automotive and regulated-industry customers, PPAP is often a condition of production release. We prepare the documentation package with MSA studies, capability analysis, and control plans that reflect our actual production process, not a template.

We also support equivalent protocols — FAI per AS9102 for aerospace, DVP/R for automotive validation, and customer-specific approval packages where required.

Nelotiv’s CMM capability resolves features to ±0.005mm, covering true position, profile of a line and surface, concentricity, runout, and complex 3D geometry that contact and optical methods cannot fully capture. Probe configurations are selected based on feature accessibility and tolerance.

Within our quality system, for parts with features below CMM probe accessibility — deep small-diameter bores, internal threads, micro-features — we supplement with optical comparator projection, vision measurement, and cross-sectioning where the part and application permit.

At each inspection stage, cMM programs are validated against known-good samples before production inspection, and the machines themselves are on a calibration schedule traceable to ISO 17025 reference standards.

Quality assurance laboratory
Quality Engagement

Discuss your inspection requirements

Each project starts with a quality planning conversation. Share your drawing, your critical-to-quality features, and your documentation requirements — we'll respond with a proposed inspection plan and capability assessment within 24 hours.