Search
Search our content by date or relevance.
Minimum of 14 hours
MD-QMS ISO 13485:2016 Internal Auditor (Medical Device – Quality Management System)
This course provides learners with the knowledge and skills to perform an internal audit of part of a quality management system based on ISO 13485. and applicable international regulatory standards report on the effective implementation and maintenance of the management system.
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.
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.
The evolving role of quality risk management
Jayet Moon, CQP MCQI, Quality Engineering Lead at Terumo Medical Corporation, US, and Veronica Cavendish-Stephens, Principal at Auchincloss-Stephens, explains how quality risk management is developing in line with business responses to Covid-19.
Keeping up with supplier demand
As the coronavirus pandemic continues, Jennifer Feasby, Quality Manager at Hart Biologicals, UK, speaks to Daniel Moore about how the company has continued to supply In Vitro Devices to customers, while tackling the challenges and threats posed by Covid-19.
CQI Coronavirus Statement 4/3/2020
As the spread of the coronavirus becomes a more significant global threat, it is likely to have implications for organisations of all sizes. The CQI has provided some considerations on key areas of focus for quality professionals.
An everyday quality assurance service
Ernesto Quider, CQP FCQI, Health Group Quality Systems Manager/Pathology Quality Manager at Hull University Teaching Hospitals NHS Trust, winners of the Quality Team of the Year Award at the 2018 International Quality Awards, talks to Alicia Dimas, from the CQI, about the team’s achievements and challenges