Transition between ISO 15189 2012 and ISO 15189 2022

Name: Transition between ISO 15189 2012 and ISO 15189 2022
Rating: 4.5 (75 reviews)

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

Created byTim Alcock

Last updated 4/2023

English

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

Course content

16 sections • 28 lectures • 1h 48m total length

Module 1: ISO 15189 Major structural changes4:35
To understand differences in structure between the old and new standards
Developing the gap assessment1:38
This section introduces the assignment work in the course in developing your own gap assessment and highlights the resources available to download

Organisation and management responsibility18:07
Identify how ISO 15189:2022 expands organisation and management responsibilities, including impartiality, confidentiality, and risk assessment. Explain leadership commitments, resource provision, and organization structure with delegated duties.
Activity 1 - developing your action plan - Part 10:40
Use the word or excel spreadsheet provided in Module 1 Lecture 3 to record your analysis and actions

Quality Management System and document control4:52
Navigate the ISO 15189 transition's impact on the quality management system and document control, including risks and opportunities, continual improvement, and internal audits.
Activity 2 - developing your action plan - Part 20:13
Record the gaps from this module into a word document or spreadsheet using the same method as the previous module, and save them for the end review.

Service agreements, purchasing and referral4:05
Explore ISO 15189 transitions from 2012 to 2022, covering service agreements, purchasing, referral laboratories, communication requirements, critical results, external providers, and personnel qualifications.
Activity 3 - developing your action plan - Part 30:13
Record the gaps from this module into a word document or spreadsheet, following the previous module, and save your work for the end-of-module review.

Advisory services, complaints, nonconformities and corrective action3:52
Interpret updated ISO 15189 provisions for advisory services, complaints, nonconformities, and corrective action, emphasizing risk management, investigation of nonconformities, patient safety, and enhanced record-keeping.
Activity 4 - developing your action plan - Part 40:13
Record the gaps from this module into a word document or spreadsheet as you did in the previous module, and save it for review at the end.

Risks, improvement, records, evaluation, audit and review9:30
Explore how ISO 15189 2022 replaces preventive action with risk and opportunities, and apply risk assessment, opportunities for improvement, corrective actions, and management reviews to strengthen records management and audits.
Activity 5 - developing your action plan - Part 50:13
Record the gaps from this module into a Word document or spreadsheet using the same method as the previous module, then save for review at the end.

Personnel, accommodation and environment4:35
Explain the ISO 15189:2012 to 2022 transition, focusing on personnel sufficiency, external personnel, authorization, and enhanced facility controls, including storage of patient samples and waste disposal.
Activity 6 - developing your action plan - Part 60:13
Develop your action plan by recording module gaps in a word document or spreadsheet, following the previous module’s method, and save the file for end-of-course review.

Equipment, reagents and consumables7:33
Examine equipment, reagents, and consumables management, including installation acceptance testing, calibration, traceability, labeling, recalls, environmental monitoring, and adherence to manufacturer instructions or validated alternatives to safeguard results.
Activity 7 - developing your action plan - Part 70:13
Record the module gaps in a Word document or spreadsheet using the same method as the previous module, and save it for final review.

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.

Who this course is for:

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.

Transition between ISO 15189 2012 and ISO 15189 2022

What you'll learn

Explore related topics

Course content

ISO 15189 Major structural changes2 lectures • 6min

Introduction1 lecture • 6min

Module 3: Changes to introductory section and definitions1 lecture • 7min

Module 4 Organisation and management responsibility2 lectures • 19min

Module 5 Quality Management System2 lectures • 5min

Module 6: Service agreements, purchasing and referral2 lectures • 4min

Module 7: Advisory services, complaints, nonconformities and corrective action2 lectures • 4min

Module 8: Risks, improvement, records, evaluation, audit and review2 lectures • 10min

Module 9: Personnel, accommodation and environment2 lectures • 5min

Module 10: Equipment, reagents and consumables2 lectures • 8min

Requirements

Description

Who this course is for: