During this ISO 13485 Internal Auditor training course, the tutor will lead informative sessions alongside interactive exercises, which help to facilitate a fun and engaging learning environment.
DurationThis course teaches delegates the knowledge and skills required to conduct an internal audit of part of a Quality Management System (QMS) against ISO 13485:2016.
During this ISO 13485 Internal Auditor training course, the tutor will lead informative sessions alongside interactive exercises, which help to facilitate a fun and engaging learning environment.
We offer ISO 13485 Internal Auditor training online in a virtual classroom or you can attend a course at one of our UK venues. Alternatively, we can visit your workplace to deliver ISO 13485 team training.
Who should attend this ISO 13485 Internal Auditor Course?
New or existing auditors who want to conduct internal audits of a quality management system (QMS) that conforms to ISO 13485:2016
Anyone involved in planning or managing an ISO 13485:2016 quality management system.
People who are implementing an ISO 13485 QMS.
Anyone who needs to identify potential gaps in an ISO 13485:2016 quality management system – which in turn will help the organisation remain compliant.
This course satisfies the training requirement for those who wish to register as an Auditor with the IRCA (International Register of Certified Auditors)
Anyone new to ISO 13485:2016 would benefit from gaining knowledge of the Standard before attending this Internal Auditor course. This prior knowledge can be achieved via our ISO 13485 Foundation course. Both courses are in our COURSE BUNDLE offer, whereby a £50 discount will automatically be applied to the online shopping basket when the courses are added.
What will delegates learn on this ISO 13485 Internal Auditor Course?
On this CQI and IRCA-certified ISO 13485 course, delegates will learn the following knowledge and skills –
The purpose of a Quality Management System based on ISO 13485:2016 medical devices
Audit scope, criteria and objectives
The role and responsibilities of an ISO 13485 Internal Auditor
How to plan and prepare for an audit
How to develop a checklist
How to conduct a process audit
How to report on audit findings
Developing interviewing skills and techniques
ISO 13485:2016 specifically requires personnel to be competent – this course provides essential skills and knowledge to help delegates become fully competent auditors.
Organisations with certification to multiple ISO Standards may benefit from running an Integrated Management System; in this instance, an IMS Internal Auditor Course may be more suitable.
Batalas and its productivity training division John Evans were formed in the same year, 1962. As early entrants to their specialist fields both organisations have played their part in assisting both governments and organisations to adopt new policies and practices which have impacted the public and private sector environments.
Batalas has over 50 years experience in assisting organisations in improving their performance. In excess of 250,000 people have attended our training courses covering management systems, performance improvement and management development.
We have assisted more than 4,500 organisations to achieve registration to international standards such as ISO 9001, ISO 14001, ISO/TS 16949, OHSAS 18001, ISO 13485, AS9100 etc.
Our training division recognises the importance our customers place on the professional standing of our courses and programmes. Batalas offers a range of training courses which lead to professional qualifications.
Our training centre is IRCA (International Register of Certificated Auditors) approved and can therefore offer a comprehensive programme of courses which are internationally recognised.
The standard is based on the ISO 9001 standards but places a more significant focus on regulatory compliance, requiring risk management to be in place for all stages of product realisation, training and supervision of staff, project site specs, and prevention of contamination.
This 1-day practical course provides a basic background to the structure and requirements of ISO 13485 and how it relates to frameworks such as the Medical Device Regulations (MDR). Students benefit from interactive sessions where they can develop the knowledge they gain.
The aim of this course is to provide delegates with the knowledge and skills required to perform an audit of part of a quality management system based on ISO 13485 and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.
This two-day course provides an in-depth understanding of ISO 13485:2016. It’s designed specifically for those who are looking to further their knowledge of the management system.
The ISO 13485:2016 Medical Devices Quality Management Systems Lead Implementer course empowers professionals with the knowledge and skills necessary to lead the implementation of ISO 13485 within their organizations.
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