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ISO 13485 Foundation Training Course

Medical Device Quality Management | 1 Day

Prices are in US dollars. Customers with a billing address in India are charged in Indian rupees (INR) plus 18% GST. India prices

Course Overview

This Foundation-level training course provides a comprehensive introduction to the ISO 13485 Medical Device Quality Management standard. Participants will gain a clear understanding of the standard's structure, key concepts, principles, and requirements. The course is ideal for individuals new to the standard or those seeking to broaden their knowledge of MD-QMS.

Learning Objectives

  • Understand the purpose and benefits of ISO 13485
  • Explain the key clauses and requirements of ISO 13485
  • Describe the relationship between MD-QMS and organisational performance
  • Understand the Plan-Do-Check-Act (PDCA) improvement cycle
  • Identify the roles and responsibilities within a MD-QMS

Topics Covered

  • ›Introduction to ISO 13485 and MD-QMS
  • ›Historical development and purpose of the standard
  • ›Key terms and definitions
  • ›Structure of ISO 13485 using the High Level Structure (HLS)
  • ›Clauses 4–10 overview and key requirements
  • ›Relationship between MD-QMS and business performance
  • ›Benefits of ISO 13485 certification

Who Should Attend

  • Managers and executives new to management systems
  • Quality, environmental, health & safety professionals
  • Staff involved in implementing or maintaining a management system
  • Anyone seeking an introduction to the standard

Learning Outcomes

  • Explain the structure and key requirements of the standard
  • Contribute to management system discussions and initiatives
  • Support the implementation and maintenance of the system
  • Prepare for further training such as Internal Auditor or Implementer

Course Details

DURATION1 Day
LEVELFoundation
FORMATOnline (live, interactive sessions)
CERTIFICATECertificate of Achievement after passing the course examination
EXAMINATION30 multiple-choice items, 45 minutes, online, pass mark 70 %. One free retake after 7 days; further retakes US $25. Reasonable adjustments on request before the attempt.
IDENTITY AND INVIGILATIONIdentity attestation with automated controls; 10 % of attempts followed by a live identity check. Examination specification: QA-CB-EXM-001.
CERTIFICATIONCompleting this course meets the training requirement of the QA Assessor certification grades for this scheme (Associate Auditor); it is not a certification. Certification is a separate application assessed against a published rubric on verified audit experience, a work sample and, for the higher grades, a structured interview, by an assessor who did not teach you; the course gives no advantage in that assessment.
MATERIALSFull course materials included
LANGUAGEEnglish
PRICE$99.00 per participant, in US dollars, all materials and the course examination included

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ISO 13485 Training

Other ISO 13485 Courses

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Plan, conduct, and report internal management system audits.

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Implementer Training

Implement and maintain a management system from scratch.

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Lead Auditor Training

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FAQ

Frequently Asked Questions

Internal Auditor training focuses on planning and conducting audits within your own organisation. Lead Auditor training prepares you to lead audit teams and conduct external audits.

No. QA Assessor courses are designed in line with ISO 19011 and the relevant management system standard. Course certificates are issued by QA Assessor and are not accredited by any accreditation body. Completing a course is not required for QA Assessor personnel certification and gives no advantage in the assessment of a certification application.

Yes. We offer live online training through interactive video-conferencing platforms.