ISO 15189 Quality System for Medical Testing Laboratories

ISO 15189 Quality Manual Accreditation Kit | ISO 15189 Standard |

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ISO 15189 Quality Manual  

If you wish to document an ISO 15189 quality system yourself, you may purchase our  "Customize It Yourself" Quality Manual for only $340.  This manual will save you months of documentation time, significantly reducing your costs.

This ISO 15189 Quality Manual also meets ISO 9001:2008 requirements.  It includes 25 associated procedures and 37 forms, which you customize specifically for your needs.  As an added bonus, we will send you our Measurement Uncertainty training course material, free of charge.  This course includes a PowerPoint presentation, hand-outs, and exercises in MS Word.  We will also send you download links for free accreditation guidance documents and measurement uncertainty software.  This software will assist you in calculating and analyzing measurement uncertainty that incorporates the concepts and methods presented in the International Organization for Standardization (ISO) Guide to the Expression of Uncertainty in Measurement (GUM).   

Best of all, due to its unique design, your manual can be uploaded to your company web site and viewed through a web browser or any Smartphone with an internet account.  You can collaborate with your customers, suppliers, and team members anywhere in the world.  


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Since its foundation in 1901 as the Engineering Standards Committee, BSI Group has grown into a leading global independent business services organization providing standard-based solutions in more than 120 countries.

BSI Group:

Purchase ISO 15189 Standard from BSI


ISO 15189:2012 Accreditation Kit

The ISO 15189:2012 Accreditation Kit for only $750.00 includes the following products: 

A pre-written quality manual, including 25 associated procedures, 37 forms/checklists, and a work instruction template for documenting examination/test instructions

Measurement Uncertainty training course material and free software

VQC Advisor computer-based training/advisory program

Suggested implementation plan which can be modified to your needs

Computer-Based ISO Internal Auditor Training (unlimited number of students)

ISO Internal Auditor Training for Small Business Kit (includes a PowerPoint presentation and exercises and forms in MS Word format) 

Free accreditation guidance documents 

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Laboratory Safety Training Courses

Laboratory Safety Training Videos from Compliance and Safety



Healthcare Training Videos from Compliance and Safety



Medical Laboratory Supplies




Measurement Uncertainty Software

Quality Systems Innovations, Inc. is an authorized affiliate of Qualisyst Ltd.  QMSys GUM software is comprehensive software for the evaluation of measurement uncertainty.  Whether you are a scientist, metrologist, design engineer, production engineer, test engineer or anyone else dealing with measurement accuracy, this software will simplify your measurement uncertainty calculations and reporting.  QMSys GUM Software furnishes the statistical analysis, while you furnish the technical knowledge.

GUM Standard offers the classical calculation of the measurement uncertainty for linear models of the measurement process according to GUM Uncertainty Framework.

GUM Standard 

GUM Professional offers fast and reliable analysis of measurement uncertainty for linear and non-linear models of the measurement process according to GUM Uncertainty Framework and validation of the results using the Monte Carlo method.

GUM Professional

GUM Enterprise is the ultimate software tool for precise and accurate analysis of the measurement uncertainty, using the two most powerful methods to calculate the measurement uncertainty - the GUM uncertainty framework and the Monte-Carlo method.

GUM Enterprise


ISO 15189 Consultant        

VQC Advisor is a computer-based training/advisory program that provides you with an overview of key ISO management system requirements and then advises on the best way to customize your documentation to satisfy those requirements.

ISO Consultant


What is ISO 15189?

ISO 15189 Medical laboratories — Requirements for quality and competence was published by ISO in January 2003 and revised in 2007 and 2012.   It was developed by the International Organization for Standardization's Technical Committee 212 (ISO/TC 212).   The standard is based on ISO/IEC 17025 and ISO 9001, but it takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.  The objective of ISO 15189 is to establish a framework for laboratory management so that the laboratory’s focus is on the users/customers of the laboratory services.

ISO 15189 couples a total quality management approach with documentation methodology to establish a management system that focuses on the elimination of errors with continual improvement in all activities. Some elements of the management system include requirements for collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency, and the role of the laboratory in the education and training of its staff.       

What are the benefits of compliance? 
  • Marketing advantage - increased business

  • Improved efficiency and profitability

  • Increased customer satisfaction

  • Consistent quality and timely delivery of services

  • Improved control of processes 

  • Improved performance from suppliers

  • Responsibilities of personnel clearly defined

  • Documented system provides useful reference

  • Lower error rates and operating costs

  • Improved control during periods of change or growth

  • Improved records in case of litigation

  • One quality system to meet multiple customer quality requirements

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Software


Training