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..

ISO 50001:2018 is a global standard certification whose primary goal is to provide the efficient use of an Energy Management System. Like some other common ISO standards, the standard is based on a management system model of continuous improvement.

The certification requires a company to develop an energy policy, set goals to meet the policy, use data to meet the goals, measure policy effectiveness, and continuously improve the policy.

Adopting ISO 50001 is critical for establishing a more systematic and sustainable approach to energy management within a facility. When you comply with the standard, it demonstrates that your organization has implemented a sustainable energy management system.

Who Should Apply for ISO 50001:2018?

The standard provides organizations, ranging from large retailers to smaller manufacturers and small businesses, with the opportunity to become more resilient to energy costs and availability.

The Benefits of ISO 50001:2018

• • Enhanced tender opportunities by demonstrating your environmental credentials.
• • Helping organizations gain external credibility for their energy-saving efforts.
• • Provides a better understanding of the relationship between predictable energy demand and supply
• • Increasing profitability while minimising energy costs
• • Recognizing and managing the risks associated with your future energy supply.
• • Measure and monitor energy consumption to determine where efficiency can be improved.
• • Enhancing overall performance by reducing energy consumption and costs.
• • Reducing carbon emissions while meeting government desired goals.

How Can QACA Help You?

A Quality Austria Central Asia certificate verifies that internal corporate processes have been checked and are in compliance with the relevant standard for ISO 50001:2018. In addition, our certified certification body conducts audits that follow the ISO 50001:2018.

You can request a certificate from us to evaluate your organization's performance based on ISO 50001:2018.