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The High Level Structure is dead. Long life to the Harmonised Approach?
Published: 9 Apr 2021
Horacio Martirena, a CQI technical assessor, IRCA Lead Auditor and Independent Consultant in management systems, outlines the development of the Harmonised Approach and the issues it addresses, and what it needs to resolve.
The future value of auditing from an industry perspective
Published: 7 Apr 2021
Cheekeong Loh, CQP MCQI, MIEAust CPEng, outlines how auditing can develop in the future.
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 Comprehensive EU Medical Device Regulation 2017/745 (EU MDR) Practitioner (Medical Device – Quality Management System)
This course aims to provide learners who have an existing, basic knowledge of, or experience in, quality management in the Medical Device Industry with an in-depth understanding of the application under the European Union’s Medical Device Regulation (EU-MDR 2017/745) Regulation.
MD-QMS ISO 13485:2016 Foundation (Medical Device – Quality Management System)
This course provides learners who have an existing, basic knowledge of, or experience in, quality management in the Medical Device Industry and in the context of the requirements of ISO 13485.
MD-SAP Auditing Approach (Medical Device – Single Audit Program)
This course aims to provide learners with the knowledge and skills required to understand and complete an audit against the IMDRF Medical Device Single Audit Program (MDSAP AU P0002.005) for medical device quality management.
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.