Regulatory, Quality and Information Security Audits

Management systems such as a Quality Management Systems (QMS) or Information Security Management System (ISMS) continue to be subject to both medical device internal audit and external audits after the initial certification has been granted by a certification body or Regulatory Authority.

Information Security Management Systems per ISO/IEC 27001 and NEN 7510-1 require the organization to execute internal audits on a periodic basis to assess the effectiveness of the management system, and the implemented information security technical and organizational controls.

Quality Management Systems per ISO 13485, ISO 9001, QSR or QMSR, MDSAP and ISO/IEC 42001 similarly require the organization to execute internal audits on a periodic and planned basis to assess the compliance of the QMS, the implemented quality controls, procedures and changes implemented over time.

In addition, organizations may wish to exercise control over suppliers and subcontractors (supplier audits) or execute due diligence audits to understand the level of regulatory compliance to applicable regulations from an external party prior to entering into an acquisition.

At MedQAIR, our team of qualified auditors is ready to support with Quality, Regulatory, Information Security and Privacy audits. Together with our expert auditors, we help draft an audit plan, plan for the relevant dates, execute the (hybrid) audits, and provide a detailed report with the relevant findings from the audit.