ISO 13485:2016 Medical Devices Quality Management Internal Auditor Training Course

Course Aim

Learn how to audit the processes of an ISO 13485:2016 Quality Management System (QMS). This course provides guidance and practical experience in planning, executing, reporting and audit follow-up of an internal audit when monitoring the effectiveness and conformity of a ISO 13485:2016 compliant QMS.

Course Description

An ineffective audit can mean severe consequences; resulting in process failure, patient dissatisfaction and regulatory noncompliance. Optimize your auditing skills with the internationally recognized ISO I3485:2016 and boost your internal audit capabilities. Gain confidence in planning and performing an effective audit, as well as reporting and taking corrective action where necessary.

This course is intended for medical device quality professionals wishing to build on their current knowledge of ISO 13485:2016 and evaluate the effectiveness of their QMS. It teaches the principles and practices of effective audits in accordance with ISO 13485:2016 and ISO 19011:2011.


Who should attend?

Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016, as well as individuals interested in conducting first-party or second-party audits, management representatives, internal auditors and consultants.

What will you learn?

On completion, you should gain the knowledge and skills to:

  • Explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance
  • Identify the key principles of auditing and auditor responsibilities
  • Plan an internal audit
  • Conduct an effective audit based on process identification, sampling and questioning
  • Determine if corrective action has been effectively implemented

How will you benefit?

This course will help you:

  • Maintain compliance with ISO 13485:2016
  • Improve a global benchmark in quality standards
  • Be confident that your organization can rely on competent auditors
  • Motivate colleagues through CPD and ensure rigorous regulatory internal processes
  • Write factual audit reports and suggest corrective actions

Prerequisites

You should have a good knowledge of ISO 13485:2016 and the key principles of a QMS. If not, we strongly recommend you attend our ISO 13485:2016 Introduction or Clause by Clause course.

What's included?

  • Refreshments & Lunch
  • Delegate Training Course Folder, Pen & Notepad
  • Case Studies
  • On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
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Mode of Payment

You can make payment through Cheque, NEFT transfer, e-payment or UPI payment.

Below are the details

BSI Group India Private Limited
Current Account No.: 166045294001
HSBC Bank, 25, Barakhamba Road, New Delhi-110 001
IFSC/RTGS Code: HSBC0110002
Swift Code: HSBCINBB
UPI Code: bsiindia@hsbc

Please note: Service tax will be charged extra as per prevailing Government rates.

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Client Testimonials

"The training is extremely interesting and useful. Many of the staffs remarked how helpful it was. The trainer is able to explain in simple terms on the difficult areas of the standard requirements. He has conducted with appropriate speed, well communication and interaction. The trainer made everyone, feeling very comfortable and able to contribute all the participants with full attention. Excellent."

-- R. Sundaram on ISO 13485:2016 Internal Auditor Course


 

"Excellent facilitation by Sunder. He had ways to connect to practical examples and relate back to the standard which enables participants to grasp concepts better."

-- Safeer Ibrahimkutty from Beckman Coulter