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ISO 15189 for Medical Laboratories

Course summary
Length: 1 day
Location: Nationwide
Next available date: Enquire for Pricing and Available Dates - Nationwide
Provider: Bywater plus

ISO 15189 for Medical Laboratories

Bywater Excel - Auditing Courses and Training

Introduction to ISO 15189:2012 Medical Laboratories - Quality & Competence Requirements Course

This one day interactive and practical foundation course is designed to provide delegates with an understanding of the requirements of ISO 15189:2012 with specific emphasis on those requirements specified in the Clinical Laboratory Accreditation document ‘Standards for the Medical Laboratory’ Nov 2010.

These requirements cover arrangements for requisition, patient preparation, identification, collection of samples, transportation, storage, processing and examination of clinical samples, together with subsequent validation, interpretation, reporting and advice, in addition to considerations relating to safety and ethics in medical laboratory work.

The Introduction to ISO 15189 course will acquaint delegates with the requirements of the standard for Medical Laboratories and highlight the additional requirements to be met over and above the current (2010) CPA requirements.

Course Highlights:

  • Overview of laboratory accreditation 
  • Requirements of ISO 15189:2012 
  • Quality and quality management concepts 
  • Inter-relationship between ISO 9001 and ISO/IEC 17025
  • Additional requirements of ISO 15189 over and above those required by CPA 
  • Combination of interactive workshops and discussion tutorials
  • Course Code: BE108

Suitability - Who should attend?

BywaterExcel's Introduction to ISO 15189 course is suitable for:

  •  Laboratory Quality/Technical managers
  •  Laboratory Technicians/Supervisors
  •  Assessors of Laboratory management systems
  •  Personnel responsible for procurement and evaluation of Laboratory Services
  •  Users of clinical test services


Outcome / Qualification etc.

Key Skills/Learning Objectives:

Through the combination of interactive tutorials and workshops, BywaterExcel's Introduction to ISO 15189 course will enable the delegates to:

  • Interpret the basic requirements of ISO 15189 and the inter-relationship between ISO 9001/CPA and ISO/IEC 17025 Quality Management System standards.
  • Identify the key requirements and actions that would be required to meet ISO 15189 requirements over and above those specified by CPA.

Practical workshops are designed to reinforce the discussions and topics. 

Training Course Content

An overview of key elements covered in BywaterExcel's Introduction to ISO 15189 training course:

  • Quality and Quality Management concepts
  • Commonly used quality management system standards
  • Overview and requirements of ISO 15189:2012
  • Additional requirements of ISO 15189 over CPA (2010)
  • Differences between ISO 15189:2012 and 2007 editions
  • Structure of Quality System Documentation


The price includes course materials, lunch and refreshments.

This course can also be run in-house and tailored to your organisation's requirements.

In-House Training - Making an Informed Decision

Training that is delivered in-house can be a more cost-effective training solution as well as being more specific to
organisational needs.

As specialists in in-house training, Bywater Excel have compiled a document outlining the key features and benefits of in-house training, helping you decide if it's right for you.

Download the paper

Provider: Bywater

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Providing Approved Auditor & Management Systems Training & Consultancy

Bywater is one of the largest independent providers of IRCA and IEMA approved Auditor and Management Systems training in Europe.  Bywater specialise in the improvement of business performance, supported by appropriate management systems, through provision of auditor training, consultancy and business management...

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Reviews by course attendees

Premaitha   |   06/02/2017   |   Bywater
Tutor managed difficult questions well. Provided lots of information, very good presentation 5 out of 5 for course materials.I liked the workshop elements throughout, makes people practically apply the knowledge. Professional presentation of materials.
Private Booking   |   16/01/2017   |   Bywater
5 out of 5 for the Tutor. The most useful elements of the course were the use of each change within a QMS.
Addenbrookes   |   04/07/2016   |   Bywater
Good detail and discussion. Tutor made a dry subject interesting, facilitated good discussion.
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ISO 15189 for Medical Laboratories
Course rating
Based on 6 reviews
Case Study
Guidance Documents for Laboratories

Read our list of guidance documents to help you interpret ISO/IEC 17025, ISO/IEC 17020 & ISO 15189 standards.

Guides include: 

  • Terminology Guidance References, 
  • Calibration and Traceability Guidance, 
  • Measurement Uncertainty, 
  • Method Validation,
  • Internal Audits for ISO/IEC 17025, ISO/IEC 17020 and ISO 15189.
Read more