ISO 15189 2022 Package

$289 Inc VAT

  • Provide a framework for accreditation of medical laboratories.
  • Complete documentation of the requirements for ISO 15189 accreditation and a practical guide for its implementation.
  • ➡️All documents required for accreditation.
  • ➡️ 30-day money-back guarantee.
  • ➡️ Immediate download
  • ➡️ 24/7 Support Service
  • ➡️ Document types included: Docx, PPT, Excel, PDF

The ISO 15189 document package is designed to help laboratories improve the quality of results and meet the requirements for accreditation. It includes a set of documents that define the minimum characteristics that the laboratory must meet to achieve ISO 15189 accreditation.

These documents can be used by laboratory personnel to enhance their understanding of quality systems, to ensure effective and consistent implementation of procedures, and to assist personnel in complying with accredited requirements.

The documents proposed by the ISO 15189 package include guidelines on results management, laboratory procedures and practices, internal and external controls, and quality assurance in medical laboratories.

It also provides a detailed description of laboratory policies and procedures to be implemented to ensure that all tests performed meet the standards required by the accreditation system.

👉 What is the ISO 15189 standard?

ISO 15189 is an international standard that defines the criteria that a medical laboratory must meet for quality control and accuracy of results.

It defines the minimum quality and safety requirements for the accreditation of medical laboratories and for their acceptance by national health systems. It includes requirements for personnel management, analytical procedures, validation of results, and appropriate equipment and controls.

ISO 15189 is globally recognized as a quality standard for medical laboratories and ensures that a certified laboratory provides services that meet the highest levels of quality and accuracy.

Certified laboratories are regularly monitored to ensure that they meet the required quality standard.

ISO 15189 certification is recognized as an international mark of quality and allows national accreditation bodies (NABs) to grant accreditations to medical laboratories meeting this standard.

👉 ISO 15189 requirements:

The requirements of ISO 15189 include specific quality and safety requirements that must be met by accredited medical laboratories. The standard contains elements such as quality assurance principles, internal control, and the accreditation system. It also specifies requirements for personnel management, appropriate use of data and information, and the technical characteristics required to ensure adequate support of analytical activities.

ISO 15189 also contains requirements for documentation and identification of procedures in place to ensure proper operation and effective quality control. Medical laboratories must provide complete documentation of their analytical techniques, the quality controls they perform, and their results validation process. They must also have a comprehensive and up-to-date documentation system that covers all regulations applicable to the laboratory’s work.

In addition, to ensure the highest quality of testing performed by the medical laboratory, it is necessary for the medical laboratory to ensure that it implements appropriate measures to maintain an ongoing focus on continuous improvement of service to patients.

Medical laboratories must therefore demonstrate that they can properly consider all relevant information related to clinical needs or applicable laws in order to ensure public health and protect the well-being of each patient whose analysis the process.

In addition, to ensure good compliance with ISO 15189, a medical laboratory must be able to thoroughly monitor the results obtained against existing international and national standards. For this, a rigorous system must be put in place that can constantly monitor the lab’s performance to ensure ad-hoc support if necessary in case of non-compliance or if you observe a decrease in the overall performance of the lab.

👉 This package will help you to:

  • Assess and improve your lab’s compliance with ISO 15189 standard requirements.
  • Provide comprehensive information on analytical procedures, quality controls and result validation process.
  • Implement comprehensive and up-to-date documentation systems to ensure proper operation and effective quality control.
  • Provide specific guidance regarding personnel management, appropriate use of data and information, and technical specifications required to ensure adequate support of analytical activities.
  • Provide tools to continuously monitor laboratory performance to ensure optimal quality of analyses performed and to properly address relevant information related to clinical needs or applicable laws.
  • Enable your laboratory to benefit from strict compliance with ISO 15189.
  • Provide a detailed guide on how to apply the good practices identified by the standard within the laboratory and how to integrate them into the daily process to achieve greater efficiency.
  • Finally, the package will provide a detailed analysis of how your organization can maintain the constant focus on continuous improvement of the service offered to patients, as well as a complete list of regulations applicable to the work of the laboratory to ensure the public health and protect the well-being of every patient treated by the laboratory.

👉Who this package is for:

This package is intended for medical laboratory professionals who want to ensure compliance with ISO 15189 standard requirements ;

  • It is specifically designed for laboratory managers, as well as staff members involved in the analytical process and quality ;
  • The package provides a comprehensive view of the integrated procedures necessary to continuously improve the quality of medical testing performed by the laboratory;
  • The package provides a complete view of the integrated procedures necessary to continuously improve the quality of the medical tests performed by the laboratory; it can therefore be useful for all those who are looking for a practical and efficient solution to ensure strict quality control and ad-hoc management if necessary or if the overall performance of the lab is diminished;
  • The package will also be very useful for experts in charge of training and informing staff on the application and adaptation of good practices at all stages of analysis in the context of optimal compliance with ISO 15189 standards.

👉What are the expected results?

– A complete and accurate assessment of the laboratory’s compliance with ISO 15189 standard requirements

– Detailed information on analytical procedures, quality controls and results validation process

– Establishment of an organized documentation system to ensure proper and efficient operation

– Specific guidance on personnel management, appropriate use of data and information, and required technical specifications

– Tools to constantly monitor the performance of the laboratory to ensure optimal quality of the analyses performed by the laboratory

– A comprehensive guide on how to apply the good practices identified in the standard in the laboratory

– A detailed analysis of how your organization can maintain a focus on continuous improvement of service to patients

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How many users can access this package?

This package can be used by all people working in the same company, no matter their position or department. It provides a comprehensive suite of solutions to help streamline processes and procedures, while simultaneously increasing productivity and efficiency. With this package, up to 50 users can work together in real-time, allowing them to share important data quickly and efficiently.

Is there a version of the package available in any other languages?

Yes, there are versions of the package available in several other languages. In addition to Italian, German, Portuguese, Swedish, and Japanese, Chinese is also offered. For those looking to use the package in a language other than English, this gives them a great option. If you have any queries, please contact us on the chat or send an email to

Is there a money-back guarantee if I’m unhappy with the service?

If you are not completely satisfied with the product or the service provided, we offer a 30-day money-back guarantee! We provide a secure, risk-free option so that you can feel confident in your decision to use our service. We understand that sometimes things don't work out as planned and therefore we want to give you the opportunity for a refund.

What payment options are available to me?

There are several payment options available to you. You can choose to pay by credit card, debit card, or PayPal. We also offer a convenient layaway plan for those who would like to pay for their purchase over time. If you have any questions about our payment options, please feel free to contact us.

When I order, how long will it take before I receive the entire package of documents ?

Your purchase will take you directly to the download page and a link to get your file is instantly sent to your inbox. The documents are provided in a safe, secure .zip folder that needs extracting. In case of any difficulty with downloading, kindly reach out at - our team would be more than happy to help!


ISO 15189 2022 PackageHello, awesome people!
Marilyn C.
from the QSE Academy team 👋.

Marilyn C. is a leading expert in accreditation and laboratory standards set out by the International Organization for Standardization (ISO). She has extensive knowledge of ISO 17025, 17020, 17024, 17034 and 17043 accreditation, including the process of assessment and certification according to these standards. She also has experience with the implementation of Quality Management Systems (QMS) that adhere to ISO 9000 standards.

Marilyn is a highly experienced consultant who has helped numerous organizations achieve their desired ISO accreditations or certifications. She provides guidance on how to improve processes and procedures in order to meet the requirements set out by international standards bodies such as ISO and IEC. She works closely with clients to ensure that laboratory operations meet these high standards so that they can maintain their certifications for long-term success.

In addition, Marilyn offers training courses on quality management systems (QMS), risk assessments, and internal auditing for those who wish to pursue ISO accreditation. She has also published several papers on the subject and is a regular speaker at various industry conferences.

Marilyn’s expertise in accreditations and standards makes her an invaluable asset to any lab or organization looking to meet international standards of excellence. Her commitment to quality and customer service ensures that clients receive the best possible results when working with Marilyn C., making her an excellent choice for those seeking ISO certification or QMS guidance.

Marilyn is well-versed in developing and implementing quality management systems for laboratories that are compliant with ISO standards. She has the capability to review existing systems and identify areas of non-compliance or improvement. Additionally, she is capable of providing training courses to staff in order to increase their understanding of the ISO requirements and how they should be implemented within a laboratory environment.

Marilyn has worked extensively with many different organizations on accreditation projects, ensuring they could meet all the relevant criteria set out by international bodies. She also possesses experience in conducting audits of laboratory facilities to check compliance with relevant standards.

As an experienced consultant in this field, Marilyn can offer her clients advice on what changes need to be made to ensure full compliance with international standards. She can provide guidance on improving the quality of laboratory services and develop plans for future accreditation.

👉 Who’s behind QSE Academy?

QSE Academy is a small team of independent ISO consultants working from all around the world. Our team is dedicated to providing best-in-class quality and environmental standards consulting services that help businesses reach their full potential. We strive to provide personalized, cost-effective services tailored to each client’s needs. Our consultants hold numerous certifications in the fields of ISO 9001, 14001, and 45001, making them well-equipped to meet any quality or environmental challenge. At QSE Academy, we’re passionate about helping businesses grow and succeed by providing the tools they need to reach their goals. Our team is committed to offering comprehensive consulting services that are tailored to each client’s unique business needs. We strive to make sure our clients get the most out of their investments by providing top-notch service and support. With years of experience in quality, environmental, and safety standards consulting, we’re here to ensure that you reach your desired level of success. We look forward to working with you.

👉 Quick links


👉 Are you available to discuss how I can get in touch with you?

Yes, absolutely. I would love to discuss how you can get in touch with me. The best way to reach me is via email at I check my emails multiple times a day and typically respond within 24 hours so that’s the quickest way to get in touch with me. What’s more, you’ll also have 24/7 chat support around the clock.

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👉 This package provides you with the following features:

  • Full lifetime access
  • Access on a laptop, desktop, and mobile
  • Certificate of completion

👉 This Package Includes


  1. Quality Manual
  2. Document Control Procedure
  3. Record Control Procedure
  4. Internal Audit Procedure
  5. Corrective Action Procedure
  6. Preventive Action Procedure
  7. Control of Nonconforming Output Procedure
  8. Management Review Procedure
  9. Competence, Training, and Awareness Procedure
  10. Equipment Calibration and Maintenance Procedure
  11. Purchasing and Supplier Evaluation Procedure
  12. Sample Reception and Handling Procedure
  13. Pre-analytical Procedure
  14. Analytical Procedure
  15. Post-analytical Procedure
  16. Reporting of Results Procedure
  17. Quality Indicators and Monitoring Procedure
  18. Customer Complaints Procedure
  19. Confidentiality and Information Security Procedure
  20. Laboratory Safety Procedure
  21. Waste Management Procedure

Records and Forms:

  1. Quality Manual Approval Form
  2. Document Change Request Form
  3. Training Record Form
  4. Internal Audit Report Form
  5. Corrective Action Request Form
  6. Preventive Action Request Form
  7. Nonconformance Report Form
  8. Management Review Meeting Minutes
  9. Equipment Calibration and Maintenance Records
  10. Supplier Evaluation and Approval Form
  11. Sample Reception and Handling Log
  12. Test Result Record
  13. Quality Indicator Monitoring Log
  14. Customer Complaint Log


  1. ISO 15189 Quality Manual


  1. Laboratory Quality Policy
  2. Laboratory Scope of Accreditation
  3. Organizational Chart
  4. Job Descriptions


  1. SOP for Document Control
  2. SOP for Record Control
  3. SOP for Internal Audits
  4. SOP for Corrective Actions
  5. SOP for Preventive Actions
  6. SOP for Control of Nonconforming Outputs
  7. SOP for Management Review
  8. SOP for Competence, Training, and Awareness
  9. SOP for Equipment Calibration and Maintenance
  10. SOP for Purchasing and Supplier Evaluation
  11. SOP for Sample Reception and Handling
  12. SOP for Pre-analytical Processes
  13. SOP for Analytical Processes
  14. SOP for Post-analytical Processes
  15. SOP for Reporting of Results
  16. SOP for Quality Indicators and Monitoring
  17. SOP for Customer Complaints
  18. SOP for Confidentiality and Information Security
  19. SOP for Laboratory Safety
  20. SOP for Waste Management
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