The objective of the ISO 13485:2016 internal auditor training course is to help you 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 while maintaining the effectiveness and conformity of an ISO 13485:2016 compliant QMS. In the course, we will cover the general principles of ISO 13485:2016 auditing and walk through all the clauses in this standard, to provide a holistic picture of how audits can be performed.

What You Will Learn?

The ISO 13485:2016 Internal Auditor Training will help you:

• •  Know ISO 13485:2016's structure and scope, as well as how it pertains to organizations seeking regulatory compliance.
• •  Recognize essential auditing principles and auditor responsibilities.
• •  Plan for an internal audit.
• •  Know about general concepts and principles of auditing.
• •  Post-audit activities and CAPA planning.

What You Will Gain Through This Course?

• •  Know the ISO 13485:2016 requirements and the quality system requirements of Directives 93/42/EEC and 98/79/EC.
• •  Have a good understanding of how to conduct internal quality system audits.
• •  Plan and prepare for an internal audit by understanding the function of internal audits in the maintenance and enhancement of management systems.
• •  Collecting information through observation, questioning and sampling.
• •  Conduct a thorough audit based on identifying, sampling, and questioning processes.
• •  Check to see if corrective action has been taken effectively.

Who Can Attend the ISO 13485:2016 Internal Auditor Training course?

• •  Internal auditors
• •  Consultants
• •  Individuals interested in performing first-party or second-party audits
• •  Management representatives
• •  Medical device quality professionals with expertise in quality management systems and ISO 13485:2016

Course Pre-requisites

You should have an understanding of the Plan-Do-Check-Act cycle and the process used in the quality cycle management..

The objective of the ISO 9000:2015 Quality Management System (QMS) CQI Lead Auditor course is
to help you gain the skills and competence required to plan, conduct and report a QMS audit. This course will help you undertake and lead a successful management systems audit in line with the
audit principles, procedures, and techniques. The course offers guidance on the fundamental
principles and practices of effective QMS audits. The ISO 9001:2015-Quality Management System-
the course has been set up to develop your existing auditor skills in compliance with best practices. You
will understand the aim of an ISO 9001:2015 QMS audit and satisfy third-party certification. The
course helps you build your expertise to enhance your and your organization's productivity.

What You Will Learn?

• • Concepts and principles of ISO 9001:2005
• • Purpose and benefits of a QMS.
• • Planning and creating a report in accordance with ISO 9001:2015.
• • Implementation practices of QMS as per ISO 9001:2015.
• • Plan, perform and report QMS Audits.
• • Building expertise in management systems standards.

What You Will Gain Through This Course?

This QMS course will help you:

• • Gain clarity about the purpose of the ISO 9000 series.
• • Get information about the QMS definitions, concepts, and guidelines.
• • Gain an understanding of the requirements of the ISO 9001:2015 standard.
• • Understanding the scope and criteria in the audit process.
• • Gain knowledge about best audit practices, and techniques and identify appropriate use.
• • Understand lead auditor responsibilities.
• • Prepare audit conclusions.
• • Create audit results report as per best standards.
• • On successful completion of the course, you will be awarded an IRCA certified training course certificate.

Who Can Attend ISO 9001:2005 Course?

• • Quality engineers
• • QA/QC specialists
• • Quality managers
• • Quality Auditors
• • Consultants for management systems
• • QMS internal auditors
• • Individuals looking to build their skills from ISO 9001:2008 to ISO 9001:2015
• • Anyone interested in QMS
• • Quality analysts

Course Pre-requisites

Individuals attending the ISO 9001:2005 course should have prior knowledge of the ISO 9001 standard. You also possess knowledge of ISO 9001:2008 and the key principles of a QMS. If not, you can enrol in our ISO 9001:2015 requirements course, which will help you gain clarity of the concepts used in this course.