What are Quality Management Systems?

Quality Management is the application of best practices to manufacturing a product to pre-defined specifications, identifying risks to product quality, observing variation in the manufacturing process and resulting products, and continuously improving the processes that affect product quality.

Quality Management Systems (QMS) are not new to manufacturing, and have been well established by ISO guidelines and Pharmaceutical Good Manufacturing Practices. QMS guidelines are the basis for manufacturing high quality products (i.e. low variation), and protect consumer health and safety through rigorous application of Quality Risk Management.

QMS is applied throughout the entire product lifecycle, and will, over time, improve product development activities, as well as product quality, through a process described as Continuous Improvement.

Applying a Risk Based Approach.

Quality Management Systems can be applied in any manufacturing system, but our application focuses on Good Manufacturing Practices of products meant for human consumption. QMS, therefore, applies to product development, botanically derived Active Pharmaceutical Ingredients (APIs), Dietary and Nutritional Supplements, and Wellness products.

Elements of Quality Management Systems should be applied at the appropriate Product Lifecycle. Research and Development for improving manufacturing processes benefit from applying QMS, although it is not critical as applying QMS to manufacturing products for human consumption. In all scenarios, the application of standards, Good Manufacturing Practices, and Quality Management Systems to manufacturing is best served on a Risk Based Approach.

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