ISO 13485 Audit Services

Comprehensive QMS audits against ISO 13485:2016 — covering document control, management responsibility, training, infrastructure, risk-based processes, purchasing, production controls, identification and traceability, monitoring and measurement, complaint handling, and CAPA effectiveness.

Objective internal audits performed as an independent third party to verify implementation, identify nonconformities, and prepare your site for certification, surveillance, or recertification audits. Particularly valuable when an organization needs an independent view of recurring weaknesses or wants to strengthen its internal audit program.

→ Learn more about our ISO 13485 Internal Audit Services

Independent supplier audits for medical device manufacturers — covering machining, molding, electronics, packaging, sterilization, assembly, labeling, and other outsourced operations. We assess process control, documentation integrity, traceability, change management, and supplier capability under ISO 13485:2016 clause 7.4 (purchasing controls).

→ Learn more about our ISO 13485 Supplier Audit Services

Gap assessments and pre-certification audits to measure your current QMS against certification expectations — covering procedures, records, process interactions, risk controls, CAPA effectiveness, and audit-trail consistency before the certification body visit.

Focused reviews of production and special processes — process validation logic, cleanliness controls, environmental monitoring, line clearance, equipment qualification, maintenance discipline, and batch/lot traceability — where quality cannot rely solely on final inspection.

Detailed assessment of how deviations, complaints, audit findings, rejects, and customer issues are captured, investigated, corrected, and trended. We verify that root cause analysis is robust, corrective actions are effective, and recurrence risk is being controlled.

This depends on company size, scope (full QMS vs. focused process), and the number of locations or critical suppliers in scope. Pre-certification gap assessments often take two to three man-days; supplier audits typically take one to two man-days per site.

An internal audit (often performed by Pro QC as an independent second party) is conducted by your organization to verify implementation and identify gaps. A certification audit is conducted by an accredited certification body (notified body) to grant or maintain ISO 13485 certification. Pro QC’s internal and pre-certification audits prepare you for the certification body visit but do not replace it.

Yes, but only partially. Document review, procedure walk-throughs, and management interviews can be conducted remotely. However, ISO 13485 requires verification of real implementation on the shop floor, in cleanrooms, and at supplier sites — so most engagements use a hybrid model combining remote document review with on-site process observation. Most of Pro QC’s client prefers full onsite audits for better audit effectiveness.

Pricing depends on audit scope, site size, number of suppliers in scope, and certification stage. Pro QC provides a fixed quote after a brief 15-minute scoping call. Contact us with your company size, audit type, and timeline for a tailored proposal.

Pro QC audit reports clearly classify findings as major, or minor, Opportunity For Improvement (OFI) with a CAPA worksheet for the vendors to work on root-cause indicators and recommended corrective actions. For major findings ahead of certification, you typically have 30 to 90 days to implement corrections before the certification body’s follow-up. We provide post-audit support to help your team prioritize and close gaps effectively.

Pro QC operates in 16+ countries across Asia, Europe, and the Americas, including China, India, Vietnam, Taiwan, Malaysia, Thailand, Turkey, Germany, France, Italy, Spain, Poland, Switzerland, the United Kingdom, the USA, and Mexico. Local auditor placement reduces travel cost and shortens scheduling lead time.

Pro QC operates as an independent second-party auditor — not a certification body, so we don’t issue ISO 13485 certificates. Because we have no certification stake in the outcome, there’s no conflict of interest in supporting the work that follows an audit. Beyond objective, evidence-based auditing, we offer facilitation on QMS implementation and validation of corrective actions through follow-up audits. You get the independence certification bodies and customers expect, plus practical support to close gaps without engaging a separate consultant.

You receive a detailed audit report within 48 to 72 hours, including findings, severity ratings, and recommended priorities. Pro QC offers a free Corrective Action Worksheet for you to follow up with your suppliers or your own team and track your progress. We also offer post-audit follow-up sessions to clarify findings, support corrective action planning, and conduct verification audits once corrections are implemented.

Yes. Supplier and subcontractor audits are a core service, covering all kinds of subcontracted processes, for example, machining, molding, electronics, packaging, sterilization, assembly, and labeling partners. We audit suppliers on behalf of medical device manufacturers (buyer-driven audits) and also help suppliers prepare for upcoming customer or regulatory audits. See our dedicated ISO 13485 Supplier Audit Services page for details.

ISO 13485:2016 is the foundation for both EU MDR / IVDR technical documentation and the FDA’s QMSR (effective February 2, 2026). Our audits include readiness modules that map your QMS against MDR-specific requirements (technical documentation, post-market surveillance, vigilance) and QMSR expectations (supplier verification, design controls, complaint handling).