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Common mistakes found in the quality management systems for medical devices.

How QMSs can ensure safety in medical devices

Published: 11 Jan 2023

Karandeep Singh Badwal, Director of QRA Medical and an internal auditor for ISO 13485, outlines some of the common mistakes found in the quality management systems for medical devices.

Audit SIG attendees and the future of audit

Published: 3 Oct 2022

The Chartered Quality Institute’s Audit SIG Conference, in partnership with Inmarsat and sponsored by Société Générale de Surveillance (SGS), took place on September 15 at Inmarsat’s headquarters in London. At the end of the event, delegates and Audit SIG members stopped to share their thoughts on the future of the audit industry and their key takeaways from the event.

Avoiding auditing pitfalls

Published: 8 Jun 2021

Stanley O'Donnell IRCA Principal Auditor, has conducted audits globally in a variety of industries including aerospace, medical, oil and gas, to name a few. He has experienced many pitfalls when auditing and shares some of the obstacle’s auditors should avoid.

Adapting to the new normal: third-party audits

Published: 24 Feb 2021

Damien Tiller, CQP MCQI, IRCA Lead PQMS and QMS Auditor, highlights the way the SOC® Service Organizations: Trust Services Criteria Report could overcome the difficulties inherent in remote auditing.

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’.

Maintaining independence for internal audits

Published: 10 Nov 2020

Andy Nichols, CQP MCQI, Program Manager at Michigan Manufacturing Technology Center, US, explains how internal auditors can achieve the independence requirements of ISO 9001.