Published 3/2023MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHzLanguage: English | Size: 865.38 MB | Duration: 1h 48m

An analysis of the additional requirements of ISO 15189:2022 over and above ISO 15189:2012

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, nonconfoies and corrective action

Lecture 11 Advisory services, complaints, nonconfoies 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.

HomePage: