Internal Auditor Training ISO 13485:2016

Objectives

This CQI & IRCA Certified Blended ISO 13485:2016 Internal Auditor Course is ideal for anyone that has a good understanding of Quality Management Systems (QMS) and the requirements of ISO 13485:2016 and wants to gain an in-depth understanding of the process for performing internal audits of part of their QMS.

Content includes

Three learning objectives/outcomes:
At the end of this course, participants will be able to:
1. With reference to the PDCA cycle, explain the process-based quality management system model for ISO 13485 and the role of an internal audit in the maintenance and improvement of quality management systems.
2. Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up an internal quality management system audit, in accordance with ISO 19011.
3. Plan, conduct, report and follow-up an internal audit of part of a quality management system based on ISO 13485, and in accordance with ISO 19011.

Delivery:

It is 1 virtual classroom day from 9am – 5pm

Entry Criteria (Prior Learning Requirements)

In registering for this course, each Learner must have the following prior knowledge before completing this course:

Management Systems
• The Plan, Do, Check, Act (PDCA) Cycle
• The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review and continual improvement.
ISO 13485
• Knowledge of the requirements of ISO 13485 and the commonly used quality management terms and definitions
• Knowledge of the requirements is a key pre-requisite in attending this course as without a good understanding, the course may be very challenging.

If any Learner does not meet the above entry criteria, successful completion of Comply Guru’s 10hr ISO 13485:2016 Requirements eLearning Course will ensure that they meet the above prior learning requirements.

For Quality Professionals or Engineers, Internal Auditors, Regulatory Professionals.

Qualification

Successful completion of this course will entitle each Participant to a CQI & IRCA Recognised ISO 13485:2016 Internal Auditor Certificate of Achievement.
Course accreditation held by Comply Guru (Course No. 2286)