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With over 20 years of experience as a leader in manufacturing stem cell reagents, STEMCELL's focus on quality is unrelenting. To be a market leader we have to make an unconditional commitment to quality -be it in terms of development, manufacture or service.
We don't just want to be good; we want to be the best!
Superior product quality and customer service driven by Continuous Improvement, Customer Satisfaction and Innovative Scientific Research.
Our vision of quality is based on the following principles:
STEMCELL's commitment to quality is integral to our global business foundation and what sets us apart from our competition. Every employee around the globe from senior management through all levels of our organization is committed to providing the highest quality products and services to our customers. Our commitment is to continually strive to improve the overall quality, consistency and reliability of our products and services to support our customer's scientific endeavors.
Our Quality Management System, which outlines the policies, procedures, and processes, supports this commitment.
STEMCELL's Quality Management System is certified to ISO 13485, Medical Devices. This ISO standard considers inputs and outputs throughout the entire product management lifecycle, from design to production to gaining feedback from our customers on how to improve. We participate in an annual certification process to leverage external insights on how to continuously improve our Quality Management System as a whole. Our global certification is important to us as it supports our commitment to our customers around the world.
Our ISO 13485 certified Quality Management System is comprised of critical areas such as:
Quality at STEMCELL is a process-centered approach to ensuring that we provide the best possible products and services. The goal is to ensure excellence is inherent in every product and service we provide to our customers. STEMCELL ensures that our products, whether they are new or improved are produced with the highest quality materials, in the most comprehensive way and with the highest standards. Our goal is to exceed our customer's expectations using a robust and accountable process to deliver products that will help you advance your research and business.
Our Product Management Lifecycle includes the following formal stages:
Our customers define quality each and every day in the way they use and view our products and interact with our services.
Our customers include scientists around the world both academic and industrial alike, all striving to advance stem cell research. STEMCELL will provide you with the highest quality products to ensure your success.
We put our customers first and continuously strive to provide the highest level of excellence and value. We are committed to quality, innovation and continual improvement in the products, services and support that we offer you.
Quality is essential to enabling our customers to capture their innovative advantage. Quality and innovation work hand in hand; they facilitate excellence, improve your business processes and increase your chance of success in the market place. Quality is about driving improvement today, tomorrow and far into the future. ‘Scientist helping Scientists' is our company's mantra and the founding principle that drives our approach to quality.
We embed these quality principles each and every day as we partner with you and all of our other customers to engage the process of innovation.
Your advantages at a glance:
Customer feedback is an essential component in our continuous improvement initiatives, which enable STEMCELL to understand what issues are important to you - and to improve the performance of our global operations on a focused basis.
A critical part of compliance to ISO 13485, Medical Devices includes customer feedback and ensuring your voice is heard by top management in the organization. This is achieved using surveys', customer visits, customer audits, compliments, complaints and inquiries. These inputs are carefully reviewed and continuously measured and corrective actions put in place to ensure our customer's expectations are exceeded.
Quality is built into the foundation of STEMCELL's business and we pride ourselves in a dedicated Quality team which includes:
In today's every changing economic climate STEMCELL strives to mitigate risks to our business and to our customers. It is our priority to analyze our projects, products and processes through a risk analysis lens. Clear inputs include the following:
Since 2005, STEMCELL™ Technologies Inc. has CE marked a number of IVD Products according to European Union Directive 98/79 EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices. This is a mandatory conformity mark for products place on the market in the European Economic Area (EEA).
Having the CE Mark on our products demonstrates STEMCELL's commitment to the highest standards of quality and design control in line with the stringent guidelines of the European regulations for medical devices. By meeting safety, health, and environmental monitoring requirements, STEMCELL can cater to these requirements set forth in the European Union and other countries that recognize the CE Mark for commercial distribution purposes
A list of products that have been registered as CE-IVD can be viewed here.
These products comply with the below requirements:
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