Quality Systems & ISO Standards

Part of SGH Technical Resource Centre

Quality at SGH is governed by structured systems, external certification and disciplined process control. ISO 9001 accreditation has underpinned our operations for over two decades, with ISO 14001 now achieved and further standards targeted as our capability expands. This guide explains how our process-based approach protects your supply chain and reduces risk.

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Structured Quality Management at SGH

Quality at SGH is governed by formal systems rather than informal practice. Our quality framework integrates design review, validation, production control and lifecycle monitoring to protect dimensional integrity and supply stability.

We have maintained ISO 9001 certification for over 20 years, embedding process discipline across all manufacturing and administrative functions. In January 2026, we achieved ISO 14001 accreditation, extending structured governance into environmental management.

ISO 13485 certification is targeted for FY27 to further strengthen our capability within regulated sectors.

Quality is therefore embedded within how we operate, not layered on after production begins.

ISO 9001 – Process-Based Control

ISO 9001 provides a framework for process-driven quality management.

Within SGH, this includes:

  • Documented procedures
  • Controlled work instructions
  • Defined validation protocols
  • Non-conformance reporting
  • Corrective action processes
  • Internal auditing

These systems govern:

  • Design for Manufacture
  • Tool validation
  • Dimensional inspection
  • Batch release
  • Customer communication

Process-based control reduces variability and protects long-term consistency.

ISO 14001 – Environmental Governance

ISO 14001 accreditation formalises our environmental management system.

This includes:

  • Structured energy monitoring
  • Environmental objective setting
  • Waste management control
  • Continuous improvement planning

Environmental governance supports both regulatory compliance and customer ESG expectations.

Energy efficiency improvements of 9%, alongside a targeted further 20% reduction over five years and a 100 kWp solar installation, align operational performance with environmental responsibility.

ISO 13485 – Regulated Sector Alignment

ISO 13485 certification, targeted for FY27, will extend our quality management framework specifically for medical device manufacturing environments.

Preparation for ISO 13485 aligns with our existing cleanroom assembly capability and structured validation processes.

This progression reflects a deliberate expansion of capability rather than a reactive accreditation.

Validation and PPAP Integration

Quality systems integrate directly with tool validation and production release.

At SGH, validation includes:

  • Controlled tool trials
  • CMM dimensional verification
  • First-off sample inspection
  • Level 3 and Level 5 PPAP documentation where required
  • ISIR reporting
  • Material certification

Validation is documented and retained in accordance with ISO-controlled procedures.

Dimensional Control and Inspection

Dimensional integrity is central to quality performance.

Inspection methods include:

  • CMM measurement
  • Manual precision inspection
  • Batch-level verification prior to dispatch

Inspection frequency is aligned to component criticality and production volume.

For high-runner components, on-line vision systems are being integrated from 2026 to enhance automated dimensional oversight.

Tool Lifecycle Documentation

Quality does not end at initial validation.

Tool lifecycle management includes:

  • Documented servicing intervals
  • Tool card records
  • Maintenance tracking
  • Modification history

Service frequency is aligned to annual cycle volume:

  • Under 50,000 cycles – annual servicing
  • Over 50,000 cycles – six-monthly servicing
  • Over 100,000 cycles – quarterly inspection

Maintaining dimensional stability over time is a core element of our quality system.

High-Mix Manufacturing and Quality Discipline

Operating with approximately 1,000 active SKUs annually requires structured quality control across varied batch sizes.

Batch-level inspection and controlled release procedures protect:

  • Dimensional consistency
  • Cosmetic standards
  • Assembly compatibility

Quality systems operate consistently across both low-volume and high-runner programmes.

Digital Traceability and Transparency

Insight123 integration, completing March 2026, strengthens production traceability through barcode-driven tracking.

From H2 2026, the SGH Client Portal will provide clients with:

  • Batch-level QC documentation
  • Tool service history
  • Delivery performance metrics
  • Scope 3 emissions estimates

This transparency enhances audit readiness and procurement governance.

Continuous Improvement and Audit Culture

ISO certification is not static.

SGH conducts:

  • Internal audits
  • Management review cycles
  • Corrective action tracking
  • Continuous improvement initiatives

This structured audit culture reinforces accountability across production, tooling and logistics functions.

Quality is therefore monitored, reviewed and improved continuously.

Protecting Supply Chain Confidence

Formal quality systems protect against:

  • Dimensional drift
  • Uncontrolled process change
  • Documentation gaps
  • Validation weakness
  • Supply instability

By integrating DFM, tool validation, preventative maintenance and structured inspection within ISO-governed processes, SGH provides a stable and audit-ready manufacturing environment.

Related Technical Guides:

If your programme requires structured validation, regulatory alignment or audit-ready documentation, we can outline how our ISO-governed systems integrate with tooling, production and lifecycle management.

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