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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.

Setting up a new CQI Professional Network

Published: 8 Feb 2021

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

Published: 8 Feb 2021

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. 

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.  

Lack of engagement from top management

Published: 18 Jan 2021

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). 

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.