ISO 13485 Internal Audit
An ISO 13485 audit helps determine the actual status and health of your current QMS and processes. The purpose of quality audits is to verify that manufacturing, development, and related control facilities meet current good manufacturing processes (GMP), as well as conform to the commitments of ISO 13485.
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An ISO 13485 audit includes:
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An off-site review of your current quality and regulatory documentation before your on-site ISO 13485 audit by a Notified Body or Registrar.
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A systematic and independent process audit to determine conformity or nonconformity of your QMS to ISO 13485:2016 requirements
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A review of your internal and external documentation to verify requirements have been addressed.
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An actual verification of ISO 13485 audit requirements through a review of the objective evidence.
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A physical verification of compliance via interviews and fact-based observations to confirm the quality system requirements are met.
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An evaluation of current special controls and validated processes. Our consultants are knowledgeable in various processes such as sterilization, clean rooms, or software systems.