What is a Quality Management System (QMS)?

Quality Management System Definition

A quality management system (QMS) is a formal system used to document, track, approve, and adhere to policies, procedures, regulations, and processes. The international standard, ISO 9001:2015, specifies requirements for a quality management system. “QMS” is often used to describe the ISO 9001 standard, but it actually refers to the entirety of the system. Having comprehensive QMS systems in place enables companies to design, produce, and deliver safe and effective products and medical devices by complying with a variety of regulations (e.g., FDA, ISO, EU MDR). This ultimately helps manufacturing companies prevent quality mistakes, cost overruns, and nonconformances by using a single, secure system for all internal teams and their supply chain partners.

What is a Quality Management System


What are the types of quality control?

Four commonly used quality control methods include:

  1. Control Chart – Illustrates whether sampled products or processes are meeting their intended specifications and the degree by which they vary from those specifications.
  2. Taguchi Method – Emphasizes the roles of product design and product development in reducing the occurrence of defects and failures in products. It considers design to be more important than the manufacturing process and tries to eliminate variances in production before they occur.
  3. 100% Inspection Method – Assesses all parts of a product to rule out any flaws.
  4. Six Sigma – Focuses on cycle-time improvement to reduce defects in the manufacturing process to no more than 3.4 occurrences per million units.

*Source: https://www.investopedia.com/terms/q/quality-control.asp

What are the top three benefits to companies using QMS?

The top three benefits for QMS includes the ability to help companies:

  1. Drive continuous improvement and establish compliance with U.S. Food and Drug Administration (FDA), European Medical Device Regulation (EU MDR), International Organization for Standardization (ISO), and other regulations and standards
  2. Improve product performance and reduce costs
  3. Improve customer satisfaction
How does QMS enhance the final product launch?

QMS enables companies to bring safe and effective products to market faster, while enabling quality controls and regulatory compliance.

The Cost

Delivering new products to market is challenging. And It is difficult to see the cost impact of one or more mistakes.

Try our calculator to estimate the impact on your business. Input your business details, select a challenge, and see the real-world cost impact as validated by our customers.