Our Goal
STEMCELL Technologies Inc. is invested in Quality. We pride ourselves in designing products that meet high Quality standards as well as building robust processes to ensure that we meet our
customers’ requirements every time. Our goal is to exceed customer expectations by providing the best products, services, support, quality and innovative solutions.
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!
STEMCELL Quality Policy
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:
- Quality is determined by our customers
- Quality means understanding and exceeding customer expectations
- Quality begins at top management
- Quality is woven into the fabric of our business
- Quality needs to be integrated into the entire product management lifecycle
- Quality is measurable and transparent
- There is always room to improve
Our Quality Management System
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:
- Ensuring all our staff is trained to effectively support all customer needs related both to science and service
- Ensuring all equipment used to design, manufacture and test product are qualified, calibrated, and maintained
- Stringent supplier qualification and management process to ensure suppliers are selected for their ability to provide materials and/or services that ensures consistent quality and dependable supply
- Comprehensive traceability of components and products
- Same global quality standards for all our facilities around the world
- Continuous improvement mandate which has shifted our culture toward teams, employee engagement, open communications and has helped identify new ways of improving our products, processes, quality and
customer satisfaction
- Corrective and Preventative Action Program
- Internal auditing all critical processes
Our Process
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:
- Defining design and test requirements
- Prototype or pilot batch
- Intensive Quality Control Testing
- Scale-up
- Stability Testing
- Post Market Surveillance
Dual Benefit for the Customer: Quality and Experience
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:
- Global Experience
- High Quality Standards
- Confidence
- Cutting edge innovation
- Reliability
- Customer Proximity
- Worldwide presence
- Supply Chain Continuity
- Understanding the global regulatory landscape
The Voice of the Customer
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 Unit
Quality is built into the foundation of STEMCELL’s business and we pride ourselves in a dedicated Quality team which includes:
- Quality Control Team focused on testing critical raw materials and final products to ensure all quality and regulatory specifications are met. Standard quality and
consistency aren’t enough. STEMCELL exceeds common practices with screening raw materials and testing final products.
- Quality Assurance Team focused on building, maintaining and improving STEMCELL’s Quality Management System certified to ISO 13485, Medical Devices, which spans the
entire product lifecycle.
- Regulatory Affairs Team focused on navigating the ever changing global regulatory landscape for both STEMCELL and our customers. Regulations we comply to:
- ISO 13485, Medical Devices
- CE-IVD
- CE-EE
- RoHs
- WEEE
- ETL
- 2004/108/EC, Directive of Electromagnetic Compatibility
- 2006/95/EC, Low Voltage Directive
- 98/79/EC, InVitro Diagnostic Device Directive
- IEC 61010-1:2001, Safety Requirements for Electrical Equipment
- IEC 61326-1:2005, Electrical Equipment for Measurement, Control and Laboratory Use
- Each segment of the Quality Unit reports directly to Senior Management to ensure all quality and regulatory needs are being met throughout our global organization.
Maximize Quality. Minimize Risk.
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:
- Risk analysis of all product types
- Risk plans for critical products
- Supply continuity plans
- Robust Supplier Evaluation Program
CE-IVD
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:
- These products have been correctly classified as General IVDs and are self-declared through our Authorized Representative located in Germany.
- The products meet the Essential Requirements as required in Annex 1 of the Directive.
- The relevant technical documentation has been prepared as is available upon request to competent authorities which details the manufacturing process and fulfills the requirements of the
directive.
- An EC Declaration of Conformity has been drawn up and signed as required by Section 1 (Annex III) of the Directive.
- The CE mark has been affixed to the product labels and product inserts where appropriate.
- Prior to May 2011, products have been notified (equivalent to registered) in European countries as a CE Marked product where STEMCELL meets the language and labeling requirements. As of May 2011,
this notification is not required, but the requirements remain. European countries where STEMCELL CE-IVD products meet all requirements are Austria, Belgium, Bulgaria, Cyprus, France, Germany, Ireland,
Italy, Lichtenstein, Luxembourg, Malta, Romania, Spain and Switzerland.
- As the above products are classified as General IVDs and therefore low risk products, there are no certificates issued by the Competent Authorities which will show compliance with the Directive nor
is there a requirement to obtain such certification.
- These products are also suitable for research applications, and in appropriate circumstances, as raw material components in further manufacturing applications. It is the end user’s
responsibility to qualify these products for their specific application. These products have not been qualified for, nor are they intended for any animal or human therapeutic uses.