Does your EMS provider offer compliance? — What you should know about ISO 9001 & ISO 13485 compliance.
Are you planning your next project for 2026?
When you partner with an Electronics Manufacturing Services (EMS) provider, compliance isn’t a “nice to have.” It’s a critical component of quality assurance, regulatory readiness, and product safety, especially if your end product goes into regulated industries such as medical devices, aerospace, defence or safety-critical equipment.
Compliance matters and Duet Electronics delivers it, with a focus on the two most relevant standards for B2B customers, ISO 9001 and ISO 13485.
Why ISO standards matter for EMS providers
Guarantee of quality, repeatability and reliability
ISO 9001 is the internationally recognised standard for quality management systems (QMS). It defines requirements for consistent processes, documented procedures, quality controls, and continual review to ensure products meet customer and stakeholder expectations. Organisations certified under ISO 9001 are committed to process discipline, defect prevention, and customer satisfaction.
If an EMS provider holds ISO 9001 certification, it should provide you with the confidence that procurement, assembly, testing, traceability and delivery is all provided in a structured, controlled manner, reducing the risks of defects and delays.
Regulatory compliance and medical device readiness via ISO 13485
If your electronics manufacturing project involves medical equipment or other highly regulated electronic devices or if you anticipate future certification, regulatory submission or export ISO 13485 is essential. While ISO 9001 is a generic QMS standard, ISO 13485 is specifically tailored for medical devices. Focusing on stringent requirements for safety, traceability, documentation, supplier control, risk management, and regulatory compliance.
Certification to ISO 13485 signals that the EMS provider understands and implements the rigorous quality and compliance regime that regulators and healthcare customers expect.
Competitive advantage, supply-chain integrity, and customer trust
For B2B customers — especially those in medical, defence, aerospace, or regulated industrial sectors — working with an EMS with ISO certifications can be a decisive differentiator. It reduces risk, ensures consistent quality, and supports regulatory or tender requirements (many contracts or regulatory approvals demand ISO-certified suppliers).
Moreover, certification tends to improve internal efficiency, reduce waste, provide better documentation and traceability, and establish accountability — all of which translate into reduced liability, fewer recalls or failures, and more reliable supply-chain partnerships.
How Duet Electronics delivers compliance and value
Duet is accredited for both ISO 9001 and ISO 13485.
Our 12,000 sq ft Brunswick manufacturing facility supports a full range of EMS services: surface-mount (SMT) assembly, through-hole assembly, selective soldering, PCB assembly (single- and double-sided), global purchasing, supply-chain/logistics management, cable assemblies, over-moulding, encapsulation, conformal coating, testing, and full turnkey production.
Our SMT capability is modern and robust with high-speed pick-and-place (up to 120,000 placements/hour), ability to handle components down to 0201, large QFPs/BGAs (up to 55 × 55 mm), multi-zone reflow ovens, automatic screen printing, 3D AOI (automatic optical inspection), X-ray inspection, and strict RoHS compliance through nitrogen selective soldering.
Quality control is taken seriously with production tracking, traceability of all components and assemblies, linking manufacturing data to operators and processes, and internal audits to ensure compliance with ISO standards.
When you engage Duet Electronics, you’re not just outsourcing assembly — you’re partnering with an EMS provider that embeds compliance, quality, traceability, and regulatory readiness into every step.
Contact Duet Electronics for more information Ph: +61 3 9380 6454