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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.

Resilience at the heart of the nation’s defence

Published: 7 Apr 2021

Lisa Taylor, CQP MCQI, Corporate Quality Manager at Dstl, explains how the organisation's resilience planning meant it was able to pivot quickly to remote working and continue to support government and its existing customers in the UK’s response to Covid-19.

Course code
PT219
Course code
Duration

24 hours

Category Auditing
Level Practitioner
Scheme(s)
Medical devices

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.

Course code
PT264
Course code
Duration

Minimum of 14 hours

Category Auditing
Level Practitioner
Scheme(s)
Medical devices

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.

Course code
PT221
Course code
Duration

Minimum of 16 hours

Category Auditing
Level Practitioner
Scheme(s)
Medical devices

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.

Course code
PR370
Course code
Duration

Minimum of 24 hours

Category Auditing
Level Professional
Scheme(s)
Medical devices

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.

Course code
PR371
Course code
Duration

Minimum of 24 hours

Category Auditing
Level Professional
Scheme(s)
Medical devices

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.

Course code
PR371
Course code
Duration

Minimum of 40 hours

Category Auditing
Level Professional
Scheme(s)
Medical devices

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.