What you'll learn
Understand the structural changes between ISO 15189 2012 and the 2022 version
Identify the detail of the additional changes made in the new standard
Understand the actions that are required to be undertaken to comply with the new standard
Create and action plan for implementation of the changes to your own management systems
Requirements
A good understanding of the requirements of the ISO 15189: 2012 standard is necessary before undertaking this course.
Description
ISO 15189:2022 Medical laboratories - Requirements for quality and competence specifies requirements for quality and competence in medical laboratories. This course details the additional requirements of ISO 15189:2022 over and above those in the the previous 2012 edition. As well as providing a gap assessment of the changes to the standard it gives tools to record the implications of the changes as well as to plan implementation actions. This course is designed for those who already have a good understanding of the requirements of ISO 15189:2012 and who wish to plan out the implementation of changes to their existing systems to meet the requirements of the latest version. The course is structured around the requirements of the previous edition so that changes to existing systems can be analysed and required actions identified and planned. At the each of each section covering the the previous standard requirements, there is a opportunity for participants to record their own actions and changes. At end of the course, there is an opportunity to compile the changes and capture them in a spreadsheet which allows actions to be planned and tracked through to completion. Participants will require access to a copy of the new standard in order to make full benefit from the course. Unfortunately this can not be provided due to copyright reasons, but can be obtained from your country' standards agency or from ISO themselves.
Overview
Section 1: Introduction
Lecture 1 Introduction
Section 2: ISO 15189 Major structural changes
Lecture 2 Module 1: ISO 15189 Major structural changes
Lecture 3 Developing the gap assessment
Section 3: Module 3: Changes to introductory section and definitions
Lecture 4 Introductory section and definitions
Section 4: Module 4 Organisation and management responsibility
Lecture 5 Organisation and management responsibility
Lecture 6 Activity 1 - developing your action plan - Part 1
Section 5: Module 5 Quality Management System
Lecture 7 Quality Management System and document control
Lecture 8 Activity 2 - developing your action plan - Part 2
Section 6: Module 6: Service agreements, purchasing and referral
Lecture 9 Service agreements, purchasing and referral
Lecture 10 Activity 3 - developing your action plan - Part 3
Section 7: Module 7: Advisory services, complaints, nonconformities and corrective action
Lecture 11 Advisory services, complaints, nonconformities and corrective action
Lecture 12 Activity 4 - developing your action plan - Part 4
Section 8: Module 8: Risks, improvement, records, evaluation, audit and review
Lecture 13 Risks, improvement, records, evaluation, audit and review
Lecture 14 Activity 5 - developing your action plan - Part 5
Section 9: Module 9: Personnel, accommodation and environment
Lecture 15 Personnel, accommodation and environment
Lecture 16 Activity 6 - developing your action plan - Part 6
Section 10: Module 10: Equipment, reagents and consumables
Lecture 17 Equipment, reagents and consumables
Lecture 18 Activity 7 - developing your action plan - Part 7
Section 11: Module 11: Pre-examination, sample collection and transport
Lecture 19 Pre-examination, sample collection and transport
Lecture 20 Activity 8 - developing your action plan - Part 8
Section 12: Module 12: Examination processes and quality control
Lecture 21 Examination processes and quality control
Lecture 22 Activity 9 - developing your action plan - Part 9
Section 13: Module 13: Post examination processes and reporting
Lecture 23 Post examination processes and reporting
Lecture 24 Activity 10 - developing your action plan - Part 10
Section 14: Lecture 14: Laboratory information systems
Lecture 25 Laboratory information systems
Lecture 26 Activity 11 - developing your action plan - Part 11
Section 15: Module 15: Annexes and requirements for point of care testing
Lecture 27 Annexes and requirements for point of care testing
Section 16: Module 16 - Gap assessment, actions and summary
Lecture 28 Developing an action plan for implementation
Quality management management and staff who are responsible for conducting a gap assessment between the new and old versions of ISO 15189, identifying changes and implementing actions to comply with the new standard.


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