Search | CQI | IRCA Skip to main content

Search

Filter by

Search our content by date or relevance.

Course code
PR371
Course code
Duration

Minimum of 24 hours

Category Auditing
Level Professional
Scheme(s)
Medical devices

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.

Course code
PR371
Course code
Duration

Minimum of 40 hours

Category Auditing
Level Professional
Scheme(s)
Medical devices

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.

Quality tool: Cause and effect diagram

Published: 3 Feb 2021

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

Published: 28 Jan 2021

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

Published: 20 Jan 2021

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.  

Update to ISO standards

Published: 18 Jan 2021

Richard Green, CQP FCQI, Managing Director of Kingsford Consultancy Services, UK, provides the latest update for the ISO 45000 series of standards.

Developing a strategic approach for audits

Published: 18 Jan 2021

Hadi El Cheikh, Quality Health and Safety Executive at Veolia Water Technologies, Middle East, explains how a strategic approach can lead to a more successful audit on the assessment day.

Utilising the '8D Approach' in business

Published: 15 Dec 2020

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

Published: 15 Dec 2020

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'

Published: 15 Dec 2020

Roland Tan, Principal Consultant/Director at EQOSH Management Pty Ltd, Australia, provides some key considerations and guidance for performing audits in the ‘new normal’.