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ISO 13485:2016 Lead Auditor

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This ISO 13485:2016 Lead Auditor training course is a 5 Day public programme, designed to provide attendees with the knowledge and skills required to assess the conformance and performance of an organization’s medical device management system.  The course presents the most up-to-date approaches to auditing and utilises case studies, workshops and accelerated learning to allow learners to apply and practise their knowledge and skills throughout all the main phases of the audit process.

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Course Content:

  • Introduction & Course Objectives
  • Introduce the purpose and benefits of a Medical Device Management System, MDMS and evolution of the ISO 9000 series of standards on which ISO 13485 is based, the continuing development process of these standards and key concepts and terminology.
  • The 8 Quality Management Principles, their applications and potential benefits.
  • Explain the structures, purpose, content and interrelationship of ISO 16485, ISO 14971:2012 and ISO 19011:2002 and the difference between auditable standards and guidance documents.
  • Discuss and explain the requirements of the ISO 13485:2016, use ISO / TR 14969:2009 and the 8 Quality Management Principles, where appropriate, for illustration and to enhance understanding.
  • Explain the benefits and approaches of documentation, circumstances of exclusion of the ISO 13485:2016 requirements and the Process-based Quality Management system model.
  • Describe the certification/registration and accreditation processes, types of audits (1st, 2nd and 3rd party) and the differences between legal compliance and conformance with ISO 17021:2006.
  • How to plan and prepare MDMS audits based on the “Process Approach” including the ability to develop and use Checklists and Process-based Audit Plans, using appropriate information gathered during the document review and/or stage-1 audit.
  • How to Conduct, Report and Follow-up MDMS audits based on the “Process Approach” including various Audit Methodology, Questioning Techniques, Roles and Responsibility in order to collect and analyse evidence, exercise objectivity and make decisions on the significance of observation made in accordance to relevant audit criteria.
  • Q&A
  • Conclude & Follow Up Process

This ISO 13485:2016 Lead Auditor training programme may be beneficial to people with responsibility for leading quality audits of Medical Device Management Systems, MDMS, against the requirements of ISO 13485:2016 and associated standards and guides.  Participants should have a familiarity with medical device manufacturing and hold a secondary school qualification with 5 years’ experience in the manufacturing and quality management areas.

Classroom based, instructor lead, practical hands on course.

Product Description

This ISO 13485:2016 Lead Auditor training course is a 5 Day public programme, designed to provide attendees with the knowledge and skills required to assess the conformance and performance of an organization’s medical device management system.  The course presents the most up-to-date approaches to auditing and utilises case studies, workshops and accelerated learning to allow learners to apply and practise their knowledge and skills throughout all the main phases of the audit process.

Awarding Body: Optima Training & Consulting Ltd

National Framework of Qualifications Level: N/a

Certification: Optima Training & Consulting Ltd Certificate of Completion

Renewal: N/a

Entry Requirements:
Minimum age- 18 years old

Minimum English requirements: Leaners must be able to understand and convey the concepts contained in the programme content.

Assessment Details: Class Interaction

Cost Per Person:
The fee is inclusive of all training courseware materials, certificate of completion and 3 months after training support.

Progression Opportunities: Please see related courses

Protection for Enrolled Students: N/A

Should a course not proceed, any payment received will be refunded within 48 hours