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8 hours
MD-QMS ISO 13485:2016 Foundation (Medical Device – Quality Management System)
This course provides learners who have an existing, basic knowledge of, or experience in, quality management in the Medical Device Industry and in the context of the requirements of ISO 13485.
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.
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.
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.
Eliminating the costs of poor quality
Vimala Balusamy, CQP MCQI, Quality and Project Management Consultant, India, shares her five steps to help prevent poor quality costs in businesses.
Setting and meeting KPI targets
Paul Vaughan, CQP FCQI, Quality Manager at Siemens Rail Automation, UK, explains the importance of setting key performance indicators (KPIs) for business.
Supporting women in quality
Lionel Abbey, CQP FCQI, explains how he has helped support Akorfa Wuttor, Assistant Lecturer at University of Professional Studies, Accra (UPSA), Ghana, in her career, and how UPSA’s quality management course is attracting more women into quality roles across Africa.