Quality Management & Compliance

Certification Scope & Quality Alignment

Shine operates an accredited ISO 9001:2015 quality management system covering precision CNC machining and mechanical assembly, complemented by Cyber Essentials Mark data security, bizSAFE Level 3 workplace safety compliance, and ISO 14644-1:2015 cleanroom verification. We work transparently with OEM quality teams to align with sector-specific requirements:

• Medical device programs: We operate as a precision component and sub-assembly manufacturer under our accredited ISO 9001:2015 QMS. Formal Supplier Quality Agreements (SQAs), First Article Inspection (FAI), 100% mill test certificates, and lot traceability records feed directly into your Device History Record (DHR). Learn more about our medical device manufacturing capabilities.
• Semiconductor, optics, automotive, and energy programs: Customers qualify Shine via comprehensive audits against ISO 9001:2015 and customer-specific quality requirements, including cleanroom validation data, custom inspection plans, and PPAP-style submission packages.
• Sector focus: Our manufacturing is dedicated to semiconductor, medical, optics, automotive, and energy equipment; Shine does not hold AS9100 certification and does not undertake aerospace flight-hardware programs.
• Digital transformation award: In 2020, Shine was awarded the SwissCham Digital Transformation Award (Overall Winner and Advanced Manufacturing Winner, evaluated in collaboration with Deloitte) in recognition of shop-floor OEE telemetry, automated machine tending, and digital lot traceability. Read the case study.

For a detailed overview of how quality standards apply across contract manufacturing, read our guide on ISO 9001, AS9100, and ISO 13485 in precision machining.

Metrology Equipment & Inspection Capabilities

Our temperature-controlled quality assurance laboratory is equipped with precision measurement systems calibrated on cycles traceable to the Singapore National Metrology Centre:

• Zeiss Coordinate Measuring Machines (CMM) - High-accuracy contact probing for complex 3D profiles, GD&T verification, and multi-axis feature positions
• SmartScope Optical Vision Systems - Multi-sensor non-contact optical measurement for micro-features, delicate edges, and thin-walled parts
• Surface Roughness Testers (Profilometers) - Calibrated stylus testing verifying Ra, Rz, and Rmax values down to Ra 0.1 µm
• Digital Height Gauges & Bore Micrometers - Calibrated benchtop metrology for immediate in-process machining checks
• Thread & Pin Gauging - Comprehensive inventory of metric and imperial go/no-go plug and ring gauges

Controlled Cleanroom Facilities

Positive-pressure cleanroom suites tested to ISO 14644-1:2015 by a NEBB-certified testing firm, dedicated to contamination-sensitive cleaning, assembly, and packaging:

• Assembly Room 1 (ISO Class 6 / Fed Std 209E Class 1,000) - HEPA-filtered clean environment for semiconductor tooling assembly, medical sub-assemblies, and high-purity vacuum integration
• Assembly Room 2 (ISO Class 7 / Fed Std 209E Class 10,000) - Controlled environment for optomechanical integration, laser optics packaging, and precision sub-assemblies
• Material Transfer Room (ISO Class 8) - Ultrasonic cleaning, DI water rinsing, filtered dry air blow-off, and staged component ingress
• Change Room (ISO Class 8) - Gowning and personnel airlock maintaining the pressure cascade

Cleaning, assembly, verification, and packaging controls are detailed under cleanroom assembly & packaging.

Quality Control Workflow

1. Incoming material verification - Raw stock inspected against purchase orders, mill test certificates (MTC), and alloy composition limits
2. First piece inspection (FAI) - Machine setup approval verified on Zeiss CMM before authorizing production runs
3. In-process statistical control - Operator checks and scheduled metrology audits across critical control dimensions
4. Final inspection & documentation - 100% or sampling inspection with full dimensional reports, Certificate of Conformance (CoC), and lot tracking records

Frequently Asked Questions