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ISO 9001 survey reveals users split on change
Published: 9 Jul 2021
ISO has published a public report on the results of the ISO 9001 User Survey 2020.
Essentials for a safe on-site audit
Published: 8 Jun 2021
Sharjeel Farooq, IRCA Principal Auditor, and Director of Advanced Certifications Pvt Limited in Pakistan, shares his experience and advice on how to hold a safe on-site audit during the Covid-19 pandemic.
Preventing the recurrence of a nonconformance
Published: 8 Jun 2021
Ravindiran Gurusamy, IRCA Certificated Associate Auditor, offers an overview of nonconformance and the corrective action process for management system standards.
Engagement of people
Published: 19 May 2021
Raffat Khatoon Mohammed, CQP MCQI, ISO 9001, 14001 and 45001 Lead Auditor at Qatar Primary Materials Company (QPMC), explains how ‘engagement of people’ helped QPMC to overcome staff and skill shortages during the Covid-19 pandemic.
MD-QMS ISO 14971:2019 Foundation (Medical Device – Application of risk management to medical devices)
This course provides a basis for learners who wish to go on to complete CQI and IRCA Certified MD-QMS Auditor Training courses
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-QMS ISO 13485:2016 Internal Auditor (Medical Device – Quality Management System)
This course provides learners with the knowledge and skills to perform an internal audit of part of a quality management system based on ISO 13485. and applicable international regulatory standards report on the effective implementation and maintenance of the management system.
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.