Supplier Qualification Audit

Ensuring that your suppliers consistently meet defined quality and regulatory requirements is a critical part of an effective Quality Management System. A structured supplier qualification audit helps manufacturers verify supplier controls, identify gaps, and demonstrate due diligence to regulatory authorities.

For who?

Sobel supports companies with structured supplier qualification audit services, combining supplier auditing and qualification activities to strengthen supplier oversight and support compliance with applicable quality standards.

Why do you need this service?

A structured supplier qualification audit helps demonstrate that your suppliers meet defined quality requirements and that your QMS includes effective supplier control.

Without documented audit and qualification evidence, supplier-related gaps can lead to nonconformities, delays, and increased risk during inspections or customer audits.

Conducting structured supplier audits and qualification activities strengthens compliance and helps reduce supply chain risk.

Supplier Qualification Audit: From Planning to Reporting

A well-executed supplier qualification audit helps reduce supply chain risks, supports regulatory inspections, and provides clear evidence of supplier oversight within your quality system.

Qualification and audit that strengthen supplier oversight.

Scope definition

You define the suppliers and scope to be assessed. We align the audit or qualification activities with your quality standards and internal requirements.

Planning

Audit activities and documentation requirements are planned based on the selected service and supplier profile.

Execution and assessment

The supplier audit or qualification is conducted remotely, focusing on documented procedures and their implementation.

Documentation and reporting

Findings are summarized in structured reports that can be incorporated into your Quality Management System.

Which service applies to your supplier management?

Depending on your needs, you may request a structured supplier audit, a focused supplier qualification activity, or both as part of a broader supplier control strategy.

Supplier Audit

This supplier audit evaluates whether defined quality requirements are properly implemented across key supplier processes. Ideal for manufacturers that need documented evidence of supplier compliance and effective supplier oversight within their Quality Management System.

Supplier Qualification

Supplier qualification focuses on formally documenting that a supplier meets the quality criteria established by the contracting company. Recommended for organizations onboarding new suppliers or maintaining controlled and approved supplier lists.

Audit + Qualification

By combining audit and qualification activities, this approach provides a comprehensive view of supplier compliance and performance. Best suited for manufacturers seeking an integrated solution to strengthen supplier oversight and reduce supply chain risk.

Not sure how to register your medical device product with Anvisa?

Sobel’s experts can help you determine whether a supplier audit, supplier qualification, or a combined approach best supports your quality and regulatory objectives.

Related
Services

Supplier control is part of a broader quality and regulatory framework. You may also rely on Sobel for:

Quality Management Services

Quality management support, aligned with EU MDR and ISO 13485 requirements.

Internal Audits

Internal audits supporting ISO 13485 compliance and notified body readiness in Europe.

Regulatory Affairs Training

Expert-led courses on CE Marking, EU MDR, UK MDR, and more.

Build confidence in your supplier qualification process

Sobel helps manufacturers implement structured, well-documented supplier audit and qualification activities that align with quality system expectations. Get expert support for your supplier qualification audit!

Still have questions? Checkout our FAQ

1. Are supplier qualification audits required under EU MDR and ISO 13485?

Yes. Both the EU MDR and ISO 13485 require manufacturers to demonstrate control over suppliers and outsourced processes. Supplier qualification audits are a key tool to verify compliance and document supplier oversight within the Quality Management System.

2. What is the difference between supplier audit and supplier qualification?

A supplier audit evaluates whether a supplier’s processes and controls comply with defined quality requirements. Supplier qualification focuses on documenting whether a supplier meets the manufacturer’s approval criteria and can be added to or maintained on the approved supplier list.

3. Do all suppliers need to be audited?

Not necessarily. Supplier control is risk-based. Critical suppliers and those providing products or services that impact device safety and performance typically require audits, while lower-risk suppliers may be qualified using alternative evaluation methods.

4. Can supplier audits be conducted remotely?

Yes. Remote supplier audits are commonly accepted, especially when supported by documented procedures, records, and objective evidence. On-site audits may still be required depending on supplier risk and regulatory expectations.

5. Does Sobel approve suppliers on behalf of the manufacturer?

No. Sobel provides audit and qualification support, but final supplier approval decisions and accountability remain with the manufacturer.

6. Is supplier qualification required for existing suppliers?

Yes. Existing suppliers should be periodically re-evaluated based on risk, performance, and changes in regulatory or quality requirements to ensure ongoing compliance.