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ISO 7101 Lead Implementer Course

ISO 7101 Healthcare Quality Lead Implementer Course focuses on systematic management of clinical processes in healthcare.

Course fees

Self-study
£300
Online training
£800
Enrol & Pay Online
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  • Globally recognised certificate
  • Flexible online & self-study options
  • Group training discounts available

Course Overview

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)

Who Is This Course For?

  • Quality managers and management system professionals seeking Lead Auditor or Lead Implementer status
  • Consultants advising organisations on standards implementation and compliance
  • Internal auditors looking to formalise and internationally recognise their skills
  • Professionals in regulated industries requiring evidence of independent competence
  • Individuals building a career in certification, auditing, or standards consultancy

No prior certification experience is required. Basic knowledge of management systems is beneficial.

Course Contents

01
Introduction & Standards Background

History, purpose, and structure of the standard. Key requirements and terminology.

02
Planning & Implementation

How to plan and execute a management system implementation aligned to the standard.

03
Audit Principles & Process

Audit types, planning, conducting, and reporting. Evidence-based auditing techniques.

04
Non-Conformities & Corrective Action

Identifying non-conformities, root cause analysis, and verifying corrective actions.

05
Assessment & Certification

Examination format, competency assessment, and the path to professional certification.

Pricing & Enrolment

Online Training

Live instructor-led sessions delivered online. Includes course materials, assessment, and certificate on successful completion.

£800 per person
  • Live virtual classroom sessions
  • Expert-facilitated instruction
  • Course materials included
  • Online assessment
  • Digital certificate on completion
Enrol & Pay Online

Group & Corporate Training

Training your team? We offer in-house and group sessions with custom scheduling and volume pricing for organisations of any size.

Custom contact us for a quote
  • Volume discounts for 5+ delegates
  • In-house delivery at your premises
  • Customised scheduling
  • Dedicated training coordinator
  • Post-training support included