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8 hours
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.
Minimum of 14 hours
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.
Minimum of 16 hours
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.
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.
Does the NHS need a QMS overhaul? Or does it just need a QMS?
Christina Champion, director of The Light Blue Consultancy Company, explores if quality professionals need to bring their expertise in quality management systems (QMS) to the NHS
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.
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.