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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.
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.
Maintaining independence for internal audits
Andy Nichols, CQP MCQI, Program Manager at Michigan Manufacturing Technology Center, US, explains how internal auditors can achieve the independence requirements of ISO 9001.
Providing a fair assessment
In the first of our Auditor Dilemmas series, Ben Dewison, Specialist Member of the Institute of Customer Service, UK, outlines his steps for assessors to ensure the accreditation process is managed fairly and objectively.
Maintaining quality standards in disruptive times through internal audits
Youmna Abboud, Quality Assurance and Regulatory Affairs Associate at Zimmer Biomet, Middle East, explains why internal audits are required during the coronavirus pandemic.