Introduction to ISO 15189 Medical Laboratories - Particular Requirements for Quality and Competence

Overview

This interactive and practical foundation course is designed to provide delegates with an understanding of the requirements of ISO 15189:2012.

ISO 15189 'Medical Laboratories – Particular requirements for quality and competence' specifies quality system requirements applicable to medical laboratories. 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. This interactive and practical foundation course is designed to provide delegates with an understanding of the requirements of ISO 15189 with specific emphasis to those specified in the Clinical Laboratory Accreditation document ‘Standards for the Medical Laboratory’ Nov 2010

Course Objectives

This short course will acquaint delegates with the requirements of ISO 15189 and highlight the additional requirements to be met over and above the current (2010) CPA requirements.

Key Skills / Learning Objectives

Through the combination of interactive tutorials and workshops, our course will enable the delegates to:

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

ISO 15189 Course Outline

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

Who Should Attend?

• 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

Booking and ISO 15189 Course Fees

Fees include:

• Delegate workbook, including reference information
• Training provided by qualified and experienced tutors with extensive practical management auditing experience across a variety of manufacture and service industries
• Lunch and refreshments during the day
• Certificate verifying attendance and completion of course

Lunch and refreshments during the day

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