Internal Auditing of Risk Management: Emphasis on effectiveness and compliance to QSR, ISO 13485 and ISO 14971

Internal auditors are being asked to assess Risk Management for effectiveness. This includes assessment of the risk management process as a whole together with auditing key ISO 14971 outputs such as the RM Plan, DFMEA’s, PFMEA’s and completeness the RM File. The audit must also address risk mangement in post-design transfer areas such as Purchasing / Supplier Management, Environmental Montitoring & Control, Process Validation, Production control, Calibration, etc. Finally, the internal audit is to assess key feedback to/from other key processes such as Complaints and Post-market Feedback, CAPA, Recalls and Advisory Notices, Regulatory Reporting, etc.

Topics covered will include:

• Internal audit requirements according to QSR and ISO 13485: What every internal auditor should know.
• Risk Management and Risk Assessment requirements according to QSR, ISO 13485 and ISO 14971
• Basic implementation of audits and an audit program according to ISO 19011
• Top-down approach to auditing Risk Management as a ’key process’.
• Auditing against ISO 14971: Roles & Responsibilities, Planning, Analysis, Evaluation, Control, Residual Risk Acceptability, RM Report, Production and Post-Production Information
• Auditing against ISO 13485: Examples taken from Purchasing, Environmental Control, Control of NC Product, Calibration.
• Auditing production and post-production feedback: Complaint Handling and CAPA
• Adding value to the organization when performing internal audits of Risk Management or other processes

Who will benefit?:

This webinar will provide valuable assistance to internal auditors, audit managers and personnel dealing with risk management within medical device or IVD companies regulated by the FDA and/or certified to ISO 13485. The employees who will benefit include:

• RA/QA Managers and related personnel
• Audit Managers, Internal Auditors
• Risk Management personnel
• Internal process owners who will be audited to the requirements of risk mangement
• Company Executives
• Consultants

Instructor Profile:

Phil Smart is a founding member and Regulatory Consultant with RA/QA International LLC. He serves the US, Asian and European medical device communities as Consultant, Facilitator and Instructor to 21 CFR Part 820, CMDR/CMDCAS, MDD, ISO 13485:2003, ISO 9001:2000, ISO 14971:2000 (Risk Management), ISO 14644, ISO 14698 as well as MHLW/PMDA/Japanese PAL (Ordinances 2, 139, 169, 179)

He has been a European Notified Body Lead Assessor and Monitoring Auditor for over 15 years with auditing experience in a wide range of active and non-active medical device families, risk management for medical devices, electrical safety testing, terminal EtO and Gamma sterilization, sterile packaging, hygiene, environmental controls, calibration and clinical diagnostic laboratories as well as EAC codes 40, 4, 12, 14, 17, 18, 19, 21, 25, 26, 33, 34 and 35.

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