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Boosting manufacturing recovery with LPAs

Published: 9 Jul 2021

At EASE Inc, Chief Executive Eric Stoop says that layered process audits hold the key to greater product quality and a faster manufacturing recovery.

Continuing risk-based audits during a pandemic

Published: 8 Jul 2021

Gordon McNeil, IRCA Principal Auditor, has conducted audits globally in a variety of industries, including nuclear, defence, aerospace and civil aviation. He shares his experience and advice on how remote audits can continue to be conducted during the Covid-19 pandemic.

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.

Dealing with time pressures

Published: 9 Feb 2021

In our latest dilemma, find out how to avoid delays with audits and ensure they’re delivered within the audit plan’s designated timeframe.

Course code
PR370
Course code
Duration

Minimum of 24 hours

Category Auditing
Level Professional
Scheme(s)
Medical devices

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.

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
PR369
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.