How to effectively manage supplier audits in global medical supply chains

This article was originally published in LabMate.

The challenges associated with supplier audits and verification of supplier compliance are increasing alongside the growing complexity of global supply chains in the medical device sector. Supplier controls are no longer solely about meeting regulatory obligations—they are now a critical component in safeguarding product quality and ensuring that safe and effective devices reach the market. Many recalls, warning letters, and incidents like the 2012 breast implant scandal, which prompted changes to EU legislation, highlight the consequences of inadequate supplier qualification and insufficient controls. After all, supplier management is a fundamental aspect of any quality management system (QMS), such as ISO 9001, ISO 13485, or QSR

In general, the risks associated with inadequate supplier oversight are increasing as the industry becomes more global, with suppliers dispersed across multiple countries and subject to varying regulations. To maintain compliance on a global scale, manufacturers must implement a strategic and proactive supplier management process within their QMS to oversee supplier audits effectively.

Global supply chain management through a business lens

Compliance for supply chain actors - medical device manufacturers, distributors, and importers - is not just important; it is critical for ensuring device safety and achieving business success. Failure to meet these requirements can result in serious consequences, including device recalls, financial penalties, and lasting damage to a brand’s reputation. A strategic approach involves ensuring the supply chain operates efficiently while adhering to the required regulatory framework.

Medical device manufacturers often depend on a diverse and geographically dispersed network of suppliers for essential components, raw materials, and services. These suppliers, operating across multiple countries, add complexity due to varying regional regulations and quality standards. This complexity extends to border regulations for delivering parts, components, pre-finished devices, and associated labelling. The challenge is further heightened by subtier suppliers - those supplying goods or services to the primary suppliers. These subtier suppliers are often less visible to manufacturers, and their failure to meet regulatory requirements can trigger compliance issues throughout the supply chain. Each tier in the chain introduces potential risks, particularly when suppliers operate under less rigorous quality management systems (QMS) or lack familiarity with medical device manufacturing regulations.

For instance, compliance with directives such as WEEE (Waste Electrical and Electronic Equipment), RoHS (Restriction of Hazardous Substances), and REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) is often mandatory for manufacturing medical devices, depending on the materials or components involved. These regulations address environmental safety, chemical usage, and recyclability. Failure to comply can halt production, delay shipments at borders, or lead to legal actions by authorities. The complexity increases with regional variations in these regulations, which global businesses must navigate and adhere to.
Additionally, processes like sterilisation - critical for ensuring the safety and hygiene of medical devices - often involve subcontractors or third-party service providers. These critical subcontractors are a key focus of supplier audits and require detailed supplier controls and thorough documentation to verify compliance with regulatory requirements.

The challenges grow more significant with niche materials or components critical to the functionality and safety of medical devices. Manufacturers often rely on a limited pool of highly specialised suppliers for these components, many of whom lack the infrastructure, quality management systems (QMS), or regulatory expertise to meet international standards. For instance, a supplier might provide a rare biocompatible material essential for a device but lack the traceability documentation required to demonstrate regulatory compliance. In such cases, the supplier may not be qualified to produce materials or components for medical device manufacturers.

The golden rule remains: a medical device is only as safe as its parts. Relying on underqualified suppliers introduces significant business risks, including regulatory scrutiny, operational delays, and potential product recalls. This underscores the critical importance of thorough, risk-based supplier qualification and oversight to safeguard the supply chain and protect the business.

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