Quality at STEMCELL

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 high quality, innovative products, with the best service and support. Our mandate of continuous improvement drives our culture toward teams, employee engagement and open communications, and has helped identify new ways of improving our products, processes, quality and customer satisfaction.

STEMCELL has over 20 years’ experience as a leader in manufacturing quality stem cell reagents. To be a market leader we make an unconditional commitment to quality – be it in terms of development, manufacturing or service.

We don’t just want to be good; we want to be the best!

STEMCELL Quality Policy

A commitment to:

Superior Product Quality and Customer Service Driven by Continuous Improvement, Customer Satisfaction and Innovative Scientific Research.

Compliance with Applicable Regulatory Requirements and Maintaining an Effective Quality Management System.

Our Vision of Quality Is Based on the Following Principles:

  • Quality means understanding and exceeding customer expectations
  • Quality begins at top management
  • Quality is integrated into the entire product management lifecycle
  • Quality is measurable and transparent
  • There is always room to improve

Our Quality Management System

STEMCELL’s Quality Management System is certified to ISO 13485:2016 Medical Devices and ISO 9001:2015. This ISO standards considers inputs and outputs throughout the entire product lifecycle, from design to production to gaining feedback from our customers on how to improve. Our global certification is important to us as it supports our commitment to our customers around the world.

Our certificates can be downloaded below:

ISO 13485:2016
ISO 9001:2015

Our ISO 13485 and ISO 9001 Certified Quality Management System Is Comprised of Critical Areas, Such as:

  • Ensuring our staff are trained to effectively support all customer needs related both to science and service
  • Ensuring equipment used to design, manufacture and test products is 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
  • Corrective and Preventative Action Program
  • Internal auditing of all critical processes

Our Product Lifecycle Management

Quality at STEMCELL is a process-centered approach to ensure that we provide the best possible products and services. Our goal is to exceed our customers' 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
  • Production
  • Stability testing
  • Post Market Surveillance

Dual Benefit for the Customer: Quality and Experience

Our customers include scientists around the world, both academic and industrial alike, all striving to advance stem cell research. 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.

‘Scientists helping Scientists’ is our company’s mantra and the founding principle that drives our approach to quality.

Your Advantages at a Glance:

  • Global Experience
  • High Quality Standards
  • Cutting edge innovation
  • Reliability / Supply Chain Continuity
  • Customer Proximity / Worldwide presence
  • Understanding and supporting the global regulatory landscape

Maximize Quality. Minimize Risk

In today’s ever changing economic and regulatory 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 and mitigation plans during product development
  • Risk Management Files for critical products following ISO 14971:2012
  • Supply continuity plans
  • Robust Supplier Evaluation Program