ISO 13485:2016 Medical Device QMS Internal Auditor Training Course
Medical devices are critical to healthcare delivery, and for that reason they are closely regulated. In India, the Medical Devices Rules 2017 were notified by the Central Government and came into effect in 2018, harmonising Indian practice with international regulatory expectations. ISO 13485:2016 is the quality management system standard that sits behind that compliance.
This two-day course teaches participants how to audit the processes of an ISO 13485:2016 Quality Management System, so that the system stays both effective and conformant. It covers the standard from an auditor's point of view, the principles of auditing under ISO 19011, and the planning, execution, reporting and CAPA activities that make up a real internal audit.
What You Will Learn
Why Attend This Course
The Audit Cycle
How the Programme Unfolds
Course Content
What Sits Behind the Audit
ISO 13485:2016 Requirements
The standard read the way an auditor has to read it.
ISO 19011 Guidelines
The auditing principles the whole discipline rests on.
EU Directives
Directives 93/42/EEC and 98/79/EC and their relationship to the QMS.
Risk-Based Thinking
Where risk drives audit attention in a medical device system.
CAPA
Corrective and preventive action, planned and then verified.
Practical Audit Technique
Observation, questioning and sampling applied in audit-based sessions.
Who Should Attend
Is This Training Right for You?
Before You Begin
Recommended Prior Knowledge
Note: participants without any grounding in ISO 13485 are recommended to complete a requirements or awareness programme before attending, since this course is about auditing the system rather than introducing it.
Course Details
How the Course Is Delivered
Duration and Delivery
A two-day programme available as a virtual session, a public classroom batch or an in-house delivery at your own site.
Audit-Based Learning
Delivered through practical audit-based learning sessions, so that participants practise planning, questioning and reporting rather than only reading the clauses.
Why Choose Us
Why Choose Quality Austria Central Asia
A Recognised Notified Body
Quality Austria Central Asia is recognised as a Notified Body under the Medical Devices Rules 2017 for Class A and Class B devices.
Medical Device Specialism
ISO 13485 taught by people who work inside the regulatory system, not alongside it.
Trusted by Industry
Chosen by manufacturers, consultants and quality teams across the sector.
Audit-Based Learning
Practical sessions built around how audits actually run.
Globally Connected
Part of the Quality Austria group network with international reach.
Notified Body recognition: under Notification related to MD-2, Quality Austria Central Asia is approved to grant licences for the manufacture, sale, storage, distribution and exhibition of Class A and Class B medical devices under the Medical Devices Rules 2017.
FAQ
Frequently Asked Questions
The ISO 13485:2016 Internal Auditor Training Course is designed to help participants understand and audit Medical Device Quality Management Systems (MDQMS) in accordance with ISO 13485:2016 requirements and applicable regulatory standards for medical devices.
This course is ideal for internal auditors, quality managers, medical device professionals, consultants, management representatives and individuals involved in maintaining or auditing quality management systems within the medical device industry.
ISO 13485 helps medical device manufacturers establish consistent quality processes, improve product safety, meet regulatory requirements, reduce risks and enhance customer confidence in medical devices and related services.
The training covers ISO 13485:2016 requirements, audit planning, audit execution, CAPA processes, risk-based thinking, ISO 19011 auditing guidelines, audit reporting and practical internal auditing techniques for medical device quality systems.
Participants should have a basic understanding of the Plan-Do-Check-Act (PDCA) cycle and quality management principles. Familiarity with medical device regulations and ISO 13485 concepts can be beneficial.
The ISO 13485 Internal Auditor course is typically conducted over two days and is available in online training mode with practical audit-based learning sessions.
ISO 13485 Internal Auditor certification helps professionals build expertise in medical device quality systems, improve auditing skills, support regulatory compliance activities and pursue career opportunities in medical device manufacturing, healthcare and compliance management.
Ready to Audit Your Medical Device QMS with Confidence?
Talk to our team about the next available batch or in-house delivery for your organisation.
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