ISO 13485 Audits for Medical Device Companies


  • What are the benefits of a third-party internal ISO 13485 audit?
  • What are the key elements of an internal audit?
  • How can our quality team learn to conduct regular ISO 13485 audits?

Medical device manufacturers are required to perform regular audits of their ISO 13485 compliant Quality Management System (QMS). Internal audits support the safety and effectiveness objectives of the products they sell and ensure that an adequate, effective quality system is established and maintained. Your quality staff can perform these audits, but a professional, third-party auditor is more objective when assessing the status of your QMS and processes.

Emergo conducts fully independent quality system reviews for companies with ISO 13485 certification, and for firms approaching their initial ISO 13485 certification audits by a Notified Body or Registrar.

Emergo provides the following ISO 13485 auditor services:

An ISO 13485 audit helps determine the actual status and health of your current QMS and processes. The purpose of quality audits is to ensure that manufacturing, development, and related control facilities meet current good manufacturing processes (GMP), as well as conform to the commitments of ISO 13485.

An ISO 13485 audit includes:

  • An off-site review of your current quality and regulatory documentation before your on-site ISO 13485 audit by a Notified Body or Registrar.
  • A systematic and independent process audit to determine conformity or nonconformity of your QMS to ISO 13485:2016 requirements
  • A review of your internal and external documentation to verify requirements have been addressed.
  • An actual verification of ISO 13485 audit requirements through a review of the objective evidence.
  • A physical verification of compliance via interviews and fact-based observations to confirm the quality system requirements are met.
  • An evaluation of current special controls and validated processes. Emergo consultants are knowledgeable in various processes such as sterilization, clean rooms, or software systems.

Additional ISO 13485 audit services

Emergo conducts targeted ISO 13485 process audits in which we focus on specific areas where noncompliance issues have occurred, as well as areas that your internal auditors cannot audit due to conflicts of interest.

Emergo also provides on-site ISO 13485 auditor training to help clients learn how to effectively audit their own quality systems. Our training is classroom-based and teaches your employees how to measure your compliance with ISO 13485 and ensure proper functioning of your QMS. Key topics of the training include:

  • why ISO audits are required,
  • planning an internal audit,
  • and performance/conduct issues related to ISO 13485 internal audits.

Emergo’s QMS Consultants bring practical, real-world experience to each ISO 13485 audit. We can help you pass your Notified Body audit and comply with quality regulations worldwide.

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