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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.
Setting up a new CQI Professional Network
Our Professional Networks are led by a dedicated team of over 200 volunteers who help provide networking and professional development opportunities to the membership.
Meet the Fellow: Paul Sexton
Paul Sexton, Director of QHSE (Quality, Health, Safety and Environment) Help Pty Ltd in Perth, Australia, explains the importance of achieving the Fellowship grade after a long and lucrative career in quality.
Providing good governance for information security
How businesses can improve and strengthen their information security, cybersecurity and privacy protection through the latest update to ISO/IEC 27014.
Quality tool: Cause and effect diagram
Richard Green, CQP FCQI, Director of Kingsford Consultancy Services, UK, takes us through the Cause and Effect Diagram and how to apply the tool correctly.
Six Sigma in the manufacturing industry
Husain Al-Omani, Master Black Belt, Board Member of the AACE (Association for the Advancement of Cost Engineering) International Marketing Board, highlights the importance of the Six Sigma approach and why more businesses should adopt this quality management methodology.
Managing quality and risk in projects
Abdullah Shaiban, Project Inspection Supervisor at Saudi Aramco – a multinational petroleum and natural gas company – highlights the importance of integrating risk into a quality management system.