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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.

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). 

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.

Influencing objectivity and integrity in audits

Published: 15 Dec 2020

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

Published: 13 Oct 2020

Vimala Balusamy, CQP MCQI, Quality and Project Management Consultant, India, shares her five steps to help prevent poor quality costs in businesses.

Creating a quality culture with TQM

Published: 14 Sep 2020

Miguel Cartañá, Senior Quality Consultant at AQC Group, Spain, explains the importance of Total Quality Management (TQM), and the principles quality teams and their businesses should adopt to achieve success.

Setting and meeting KPI targets

Published: 8 Sep 2020

Paul Vaughan, CQP FCQI, Quality Manager at Siemens Rail Automation, UK, explains the importance of setting key performance indicators (KPIs) for business.