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Minimum of 24 hours
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.
Minimum of 24 hours
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.
Minimum of 40 hours
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.
Maintaining quality standards in disruptive times through internal audits
Youmna Abboud, Quality Assurance and Regulatory Affairs Associate at Zimmer Biomet, Middle East, explains why internal audits are required during the coronavirus pandemic.
A lesson on clinical audits at the CQI Greater Peterborough and Cambridge branch
Josefina Gil-Moya explored why clinical audits are crucial in setting priorities and making improvements in patient care.
IRCA Occupational Health and Safety Certification Scheme ISO 45001 , BS 18001
The IRCA Occupational Health and Safety Certification Scheme is for auditors using ISO 45001 or BS18001.
Assuring against Ebola
Natasha Cowan spoke to Colonel Chris Gibson to find out how he used innovative quality techniques to stop the Ebola virus in its tracks.
Quality World magazine
The leading independent magazine dedicated to quality. Find out how to subscribe, read a sample below, or access this month's issue online now if you're a member of the CQI or IRCA.
Update: New health and safety standard delayed
The new international standard for occupational health and safety, ISO 45001, has been delayed after national standard bodies narrowly rejected the latest draft.