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Medical Laboratories (ISO 15189)

Consulting

MEDICAL LABORATORY CONSULTING

YOUR RELIABLE AND TRUSTED PARTNER IN MEDICAL LABORATORY CONSULTING

ISO 15189 requirements are paramount in the medical laboratory landscape, signifying a commitment to the highest standards of quality and patient care. We guide you seamlessly through the requirements and process, from initial assessment to implementation, guaranteeing that your medical laboratory not only meets but surpasses regulatory requirements.
Medical Laboratories ISO 15189 Start Up and Running Cost Analysis

Start-Up and Running Cost Analysis

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Medical Laboratories ISO 15189 LQMS Development and Implementation

LQMS Development and Implementation

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Medical Laboratories ISO 15189 Quality Assurance Retainer

Quality Assurance (Retainer)

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Medical Laboratories ISO 15189 Staff to Workload Analysis

Staff-to-Workload Analysis

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Medical Laboratories ISO 15189 LQMS Document Toolkits

ISO 15189 Document Template Pack

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Medical Laboratories ISO 15189 Management System Review and Updates

Management System Review and Updates

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Medical Laboratories ISO 15189 Method Development Validation and Verification 1

Method Development, Validation and Verification

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Medical Laboratories ISO 15189 Operations Efficiency and Optimisation

Operations Efficiency and Optimisation

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LABORATORY CONSULTING TO ACHIEVE YOUR QUALITY OBJECTIVES

COMPREHENSIVE ISO 15189 CONSULTING SERVICE

MiChem Dynamics is your gateway to comprehensive ISO 15189 consulting services. As experts in laboratory compliance and quality assurance, we specialize in guiding medical laboratories towards ISO 15189 accreditation, ensuring excellence in patient care and precision in diagnostic processes.

ISO 15189 accreditation is the cornerstone of credibility in medical laboratories, signifying adherence to rigorous quality standards. At MiChem Dynamics, we offer tailored consulting services designed to streamline your laboratory’s processes, elevate its quality standards, and ensure alignment with ISO 15189 requirements.

Our team comprises seasoned professionals with in-depth knowledge of ISO 15189 requirements. We work closely with your laboratory, conducting thorough assessments, providing actionable recommendations, and offering strategic guidance to optimize processes and meet the stringent demands of ISO 15189.

Why choose us? We’re committed to your success. Our dedication to integrity, precision, and client-centric solutions empowers us to deliver exceptional consulting services. Partner with us to embark on a collaborative journey aimed at achieving and maintaining ISO 15189 compliance, ensuring the highest levels of accuracy and patient-centric care.

Explore our comprehensive suite of ISO 15189 consulting services and take the first step towards enhancing your laboratory’s standards by trusting us to be your steadfast partner in achieving excellence in medical laboratory practices.

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ANNA MOYO
~ Marketing and Business Development Manager
+27 74 779 5239 | anna@michemdynamics.com

ANGELINE NEL
~ Business & Training Manager
+27 78 335 0528 | angeline@michemdynamics.com

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Start-Up and Running Cost Analysis

Starting-up or expanding a laboratory is a major, challenging and often times complicated task.

Whether you are building a new laboratory, or expanding your current one, we can assist with determining the financial resources required to achieve your objectives.

Furthermore, we are able to determine the continuous running costs of the laboratory which considers the direct and indirect expenses related to day-to-day operations.

Contact us today for a quote

LQMS Development and Implementation

Do you need to document a Quality Management System (QMS) that is compliant to ISO 15189:2022, relevant regulatory and/or accreditation requirements?

Our extensive services include taking this task off your hands whereby we develop a fully documented QMS which is tailored to your specific laboratory, environment, and processes.

Furthermore, we provide training on the new QMS and manage the implementation process in a structured manner to ensure that you successfully achieve your objectives.

Contact us today for a quote

Quality Assurance (Retainer)

Are you struggling as a Quality Manager to keep up with the activities related to implementing and maintaining your Quality Management System? Or do you rather need someone to take ownership of the quality management role in your laboratory?

We offer an extensive quality assurance retainer service which is tailored to your requirements and managed by our experienced team to ensure you achieve your ongoing quality objectives.

Contact us today for a quote

Staff-to-Workload Analysis

Do you know the actual number of employees that are required to successfully run your laboratory?

We can assist with determining the minimum number of personnel required for each department’s day-to-day functions by taking into consideration all task-based activities, the time required to effectively complete them, as well as consider the non-operational activities which also use personnel time.

By determining the minimum personnel resources that are required to effectively run your laboratory, you can improve the facility’s operations management as well as be in a better position to motivate for changes with top management.

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ISO 15189 Document Template Pack

Are you struggling to effectively document a Quality Management System (QMS) that is compliant to ISO 15189:2022 and accreditation requirements? Or are you rather looking for some fresh ideas as a means of improvement in your QMS?

We have developed an extensive database of document templates to assist laboratories with successfully implementing their quality-related requirements.

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Management System Review and Updates

A Quality Management System (QMS) consists of an extensive list of documents which are required to be reviewed at set intervals to ensure that ISO 15189:2022, regulatory and/or accreditation requirements have been fulfilled, and that the current practices and processes in your laboratory are reflected in the QMS.

Whether you require a single document or the full QMS to be reviewed, we can assist with this process to ensure you remain compliant to the relevant requirements.

Contact us today for a quote

Method Development, Validation and Verification

Do you have a new method which needs to be validated or verified in your laboratory? Or does your current method need to be reverified and you are struggling to find the time and resources required to successfully complete this on time?

Whether you need a method to be developed, validated, or verified, we can assist by fully managing the practical aspect ourselves in your laboratory, as well as ensure the proper documenting of the results and compiling the final reports.

Contact us today for a quote

Operations Efficiency and Optimisation

Do you find that a particular process or workflow is not efficient in your laboratory? Is there a particular aspect of your day-to-day operations that you want to optimise?

Using our extensive hands-on and practical experience in the laboratory industry, we can assist by identifying the bottlenecks and improving your processes and/or workflows to ultimately achieve an efficient and optimised working environment.

Contact us today for a quote
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