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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.
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.
Lack of engagement from top management
In our latest dilemma, Chris Achillea, UK Head of Compliance at Integral, UK, explains how quality managers can encourage senior teams to take ownership and more responsibility for their management system(s).
Interview with Professor Noriaki Kano
CQI Head of Profession Mike Turner, spoke to world-renowned TQM and quality management guru Professor Noriaki Kano.
Utilising the '8D Approach' in business
Stephanie Herring, Quality Manager at Wales Fertility Institute, UK, explains why the 8D approach should be applied when investigating non-conformances.
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.