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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.
Understanding design and development of products and services
Published: 26 Feb 2021
Ravindiran Gurusamy, IRCA Certificated Associate Auditor, offers an overview of ISO9001:2015; Clause 8.3.
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.
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.
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.
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.