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ISO 9001|ISO 13485
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01Quality Systems

Quality built in.Not bolted on.

ISO 9001 and ISO 13485 certified. PPAP, APQP, and AS9102B documentation standard on every production program. Audited annually.

CertificationsISO 9001 / 13485
SamplingMIL-STD-105E II
Critical AQL0 (zero tolerance)

, ISO 9001 + 13485 certified

Quality control inspection of injection molded parts
Certifications02 active

Audited annually.
Documented every time.

Standards we hold across both facilities. Certificates available on request.

ISO 9001

All facilities

General Quality Management

Documented processes for consistent product quality and continuous improvement. The foundation we run every program on.

ISO 13485

Medical programs

Medical Device QMS

Design controls, risk management, and traceability for medical device manufacturing. Audited annually.

Documentation05 entries

Paperwork that follows
the program.

Full production part approval and quality planning built into every production program. Level set by your team.

  1. 1Pre-Production

    Drawing review

    Critical features, tolerances, and inspection callouts reviewed against print before tool start.

  2. 2Pre-Production

    Test requirements & special measurement

    Custom check fixtures, CMM programs, and special-process callouts defined and approved.

  3. 3Production

    PPAP submission

    Production Part Approval Process package submitted with each new program at the level your team requires.

  4. 4Production

    ISIR / FAI

    First-article inspection report with dimensional, material, and process data on every part number.

  5. 5Aerospace

    AS9102B documentation

    Forms 1, 2, and 3 completed for aerospace programs. Material certs, special-process certs, and ballooned drawings.

InspectionAQL Spec

Zero tolerance
on critical defects.

MIL-STD-105E II sampling, Level II single normal. The AQL bands we hold to on every shipment.

CategoryStandard
Sampling PlanMIL-STD-105E II, Level II single normal sampling
Critical DefectsAQL 0 (zero tolerance)
Major DefectsAQL 0.65
Minor DefectsAQL 1.0

Sections Covered

Inspection RequirementsAppearance StandardsStructural / DimensionalReliability StandardsPackaging Standards

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Quality built into the process, not bolted on after.

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