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Minimum of 16 hours
MD-SAP Auditing Approach (Medical Device – Single Audit Program)
This course aims to provide learners with the knowledge and skills required to understand and complete an audit against the IMDRF Medical Device Single Audit Program (MDSAP AU P0002.005) for medical device quality management.
Minimum of 24 hours
MD-QMS ISO 13485:2016 Auditor Conversion (Medical Device – Quality Management System)
The course is aimed at learners wishing to expand their existing management system knowledge and audit skills to include ISO 13485 and applicable international regulatory standards audits in accordance with ISO 19011, ISO/IEC 17021 requirements as applicable.
Minimum of 24 hours
MD-QMS EU MDR 2017/745 Auditor (Medical Device – Quality Management System)
This course aims to provide learners with the knowledge and skills required to perform audits of medical device quality management systems (MD-QMS) against the European Union’s Medical Device Regulation (EU 2017/745) in accordance with ISO 19011 and ISO 17021 as applicable.
Minimum of 40 hours
MD-QMS ISO 13485:2016 Lead Auditor (Medical Device – Quality Management System)
This course aims to provide learners with the knowledge and skills required to perform first, second and third-party audits of medical device quality management systems against ISO 13485 and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021.
Developing a strategic approach for audits
Hadi El Cheikh, Quality Health and Safety Executive at Veolia Water Technologies, Middle East, explains how a strategic approach can lead to a more successful audit on the assessment day.
Dealing with product discrepancies in audits
Greg Hutchins, Managing Director and Principal Engineer at qualityplusengineering.com, recalls how his dealings with a serious product discrepancy on a project led to improvements across the board.
Auditing Santa's Workshop
With Christmas soon approaching, Hussain Ali, CQP MCQI, Quality Manager at Jacobs Engineering, explains how an audit at Santa’s Workshop taught him how to deliver more efficient audits during and after the festive season.
Auditing in the 'new normal'
Roland Tan, Principal Consultant/Director at EQOSH Management Pty Ltd, Australia, provides some key considerations and guidance for performing audits in the ‘new normal’.
Influencing objectivity and integrity in audits
William Rankin, CQP FCQI, Management System and Audit Manager at Inmarsat, UK, takes a look at how quality managers and internal auditors can work together to ensure objectivity and integrity is achieved during audits.
Process automation and the quality professional
Richard Seddon, Managing Partner at Process Management International (PMI), UK, explains why quality professionals need to embrace process automation tools in this digitally advanced era.