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.
This two day course explores the requirements of the ISO 13485:2016 Quality Management System standard, clause by clause, and provides a clear understanding of the key principles of the standards as well as the steps needed to implement ISO 13485:2016 within your organisation.
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.
This ISO 13485 training is a one-day course for the introduction to medical device manufacturers. There is no such word as negotiable within the vocabulary of the medical device world and that is the sole purpose of the development of this course.
The ISO 13485 standard is developed to meet the vast requirements for a Quality management system. It provides a foundation for manufacturers to address the requirements pertaining to the EU Directives, regulations, responsibilities as well as the commitment to the safety and quality of related to ...
ISO 13485 quality management systems for medical devices and IVDs provide the framework to consistently produce safe and effective medical devices. The latest version has additions such as regulatory harmonisation and a greater emphasis on risk management. In addition, many countries have committed
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