MD-QMS ISO 13485:2016 Lead Auditor Course (Medical Device)

• Any new or existing auditors that wish to be able to conduct 1st party (internal), 2nd party (supplier) and 3rd party (external/certification) audits of a quality management system (MD-QMS) that conforms to ISO 13485:2016 for medical devices.
• Anyone planning, managing or implementing an ISO 13485:2016 medical devices quality management system.
• Staff/managers who need to identify gaps in the effectiveness of an ISO 13485:2016 quality management system to help ensure the organisation remains compliant.
• Individuals involved in medical devices quality management, regulatory compliance, manufacturing, engineering or device lifecycle management.
• This course satisfies the training requirement for anyone registering as an Auditor with IRCA (International Register of Certified Auditors).

Anyone attending this CQI and IRCA-certified ISO 13485 Lead Auditor course must have existing knowledge of ISO 13485:2016 – please take our ISO 13485 quiz to check your level of understanding.

It is highly recommended that delegates first attend an MD-QMS ISO 13485 Foundation course to secure prior knowledge.  As part of our COURSE BUNDLE offer, a £50 discount will be applied to the online shopping basket when booking both a Foundation and Lead Auditor course.

During this Lead Auditor training course, delegates will be taught the following –

• The purpose, structure and intent of a Medical Device Quality Management System based on ISO 13485:2016
• MD-QMS requirements, including risk-based processes and regulatory alignment
• Audit types, audit programme design and risk-based audit planning
• Plan, prepare and manage effective audits, including: audit scope, criteria and objectives, audit plans and working documents, opening/closing meetings
• Conduct process-based audits using ISO 19011 best practice
• Collect, verify and record objective evidence
• Lead audit teams and apply interview techniques
• Identify, grade and write traceable and compliant nonconformities
• Produce concise, credible and value-adding audit reports
• Follow up audits, verify corrective actions and evaluate effectiveness.

Delegates will also gain insight into auditing areas specific to medical devices, such as: design and development controls, risk management (ISO 14971), software lifecycle controls (IEC 62304), sterilisation and cleanroom controls, post-market surveillance and complaints, global regulatory expectations and MDSAP considerations.

 
MD-QMS ISO 13485:2016 specifically requires personnel to be competent – this course provides essential skills and knowledge to help delegates become fully competent auditors.