ISO 7101 Lead Implementer Course

ISO 7101 Healthcare Quality Lead Implementer Course Healthcare is a sector where medical knowledge is necessarily in focus. The management system shall take this into account when determining the approaches applied. Knowledge management of the clinical processes is the general approach for operational application of medical knowledge. Maintaining medical knowledge is a requirement related to personal competence for the staff of the organization. Systematic approaches to develop and maintain medical knowledge are requirements related to resource management. – ISO 7101:2023 In healthcare three main types of processes providing services to the main customers are identified: — clinical processes; — healthcare research processes; and — healthcare educational processes. Systematic management of clinical processes is dependent on a common understanding of the components and context for the clinical work. To support this a clinical process model is beneficial. Such a model is concretizing the definitions and is a suitable common base to determine, analyse, plan, perform and evaluate the clinical processes of the healthcare organization. ISO 13940:2016 is the only standard providing such a model. This 5 day course would expose participant to:

Identify and plan Health Care process
Design and develop Health Care processes and services
Implement Health Care processes
Monitor, measure and evaluate Health Care Service performance
Manage health care incidences and non-conformities
Document and manage health care knowledge
Design clinical processes
Manage health care needs assessment, investigation, treatment and evaluation processes
Take post treatment evaluation and corrective actions

For whom:

Clinical Quality Manager
Healthcare Quality Manager
Healthcare Research Quality Manager
Healthcare Education Quality Manager

Certification Upon successful completion of this programme, you will receive Cognicert ISO 7101 Healthcare Quality Lead Implementer Certificate from Cognicert UK.

Course Content Healthcare Quality Management Planning · Quality Management Principles · Healthcare Quality Management System · Quality Management Tools · Context of Quality Management · Health care stakeholders requirement management · Legal requirements · Healthcare Risk Management · Healthcare Quality Management Plan Healthcare Quality Operations Management · Healthcare Quality documents and record management · Operational considerations: The Critical Process Issues. · Healthcare Quality Services Design and Development · Healthcare Quality Verification and Validation Processes · Healthcare Quality operational controls: processes and procedure development and improvement. · Healthcare Quality Human Resources Management · Health Care Needs Assessment, Impact and Training · Managing Organisational Health Care Knowledge · Developing requirement for Healthcare Service Provision · Health care service design and development · Health care process management · Use of ICT in Healthcare Quality Management · Healthcare Quality Procurement and Supplier Management · Healthcare Service Provision Management · Developing Identification and traceability system · Managing property belonging to customers · Post-delivery Healthcare Customer Services · Change Management and Controls · Release of Healthcare services · Measurement Equipment Maintenance and Calibration · Management health care incidences and noconfomities Healthcare Quality Performance Monitoring and Evaluation · Monitoring and auditing techniques and evidences · Customer feedback survey, Supplier Evaluation and employees · Monitoring and evaluating Healthcare Quality Performance · Auditing Healthcare Quality System · Evaluating and Reviewing Healthcare Quality Activities Improving Healthcare Quality performance · Implementing Corrective actions · Risk Mitigation and Preventive actions Training Methodologies § Case Study § Individual Exercises § Role Play § Group Exercises § Group Presentation § Examination Assessment and Qualification Learning is assessed through: · 3 hours open examination. Passing the exams qualifies the candidate for Cognicert ISO 7101 Healthcare Quality Lead Implementer Course (CPD Certificate) · Practical experience of 25 days with activity log qualifies participants for Cognicert ISO 7101 Healthcare Quality Lead Implementer Course (Implementer Category) I.D Card and Certificate · Practical experience of 50 days with activity log qualifies participants for our Cognicert ISO 7101 Healthcare Quality Lead Implementer Course (Lead Implementer Category) I.D Card and Certificate Course Delivery Options Self-Study Material, Exam and Certification Online Training, Material, Exam and Certification Classroom Training Location Here (Fee to be decided by delivery partners)

TRAINING DATES	EXAM	APPLICATION DEADLINE	LATE APPLICATION	ONLINE FEE	SELF-STUDY FEE	ENROL
20–24 April 2026	24 April 2026	31 March 2026	6 April 2026	£800	£300	Enrol
13–17 July 2026	17 July 2026	15 June 2026	25 June 2026	£800	£300	Enrol
12–16 October 2026	16 October 2026	21 September 2026	2 October 2026	£800	£300	Enrol

ISO 7101 Lead Implementer Course

Training, exam and application dates

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