- Auditing (15)
- Management systems (14)
- Medical devices (9)
- Auditor/Lead Auditor (6)
- Quality assurance (6)
- Risk Management (6)
- Process Improvement (5)
- COVID-19 (4)
- Process management (4)
- Supply chain (4)
- Integrated management systems (3)
- Quality planning (3)
- Soft skills (3)
- Business continuity (2)
- Customer stakeholder requirements (2)
- Foundation Auditing (2)
- Internal Auditing (2)
- Measuring performance (2)
- Opinion (2)
- Brexit (1)
- Change management (1)
- Functional management (1)
- ISO 9001 (1)
- Standards (1)
- Transition (1)
Search our content by date or relevance.
How QMSs can ensure safety in medical devices
Karandeep Singh Badwal, Director of QRA Medical and an internal auditor for ISO 13485, outlines some of the common mistakes found in the quality management systems for medical devices.
Driving clinical improvement in the NHS through audit management
Improvement, Innovation and Effectiveness Lead Tracey Brailsford at Derbyshire Community Health Services NHS Foundation Trust explains how a cloud-based system is helping senior leadership and frontline staff learn from performance and continually improve services for patients.
Achieving accreditation as a small company
Su Chantry, Clinical Director at SKC Occupational Health, outlines her journey to ISO 15189 accreditation.
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
Adapting to the new normal: third-party audits
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.
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.
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.
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.