The Purpose of a Quality Management System

Quality is a difficulty term to define, but most people know it when they see it. A quality product is made well, with integrity and attention to detail. A quality management system (QMS) is a formal, written set of protocols that a company creates and follows to define specific steps, that add quality at each step of the production process.

Tip

The purpose of a quality management system is to make better products and to ensure customer satisfaction.

The Case for Quality

By standardizing the steps necessary to make a consistent, high-quality product, a quality management system benefits both the company in implementing the protocols and also the customers who buy and use the product. A successful QMS cuts costs, even though it may take significant resources to design and use it. If you follow procedures to create a consistent, effective product, you’ll save money by eliminating waste, and cutting out the need for refunds and damage control. Focusing on practical steps that yield a high-quality result is also an opportunity to articulate your company’s mission and direction, and engage staff in the process of working cohesively toward shared goals. Your customers will see the difference in the products your company offers and in the customer service it provides, and their satisfaction will reward you with long term business and sincere referrals.

Quality Management Processes

Quality management systems incorporate much more than lists of instructions and processes. To work effectively, a QMS should also have a built-in system for tracking variables and tracing particular products that come off the production line. The process of collecting data puts your business in an advantageous position to improve quality and understand variability. If you keep detailed records noting where you source your materials and the yield of each batch, you’ll be able to identify patterns and adjust your processes to leverage trends that increase profitability, consistency and durability. If you institute a policy of marking each batch with a number you can trace, you can proactively address problems by recalling and examining products that were made under similar conditions.

ISO 9001:2015

The International Organization for Standardization periodically updates and releases guidelines for quality management systems. The organization’s ISO 9001:2015 set of standards is the most widely used, respected set of quality management criteria. Its protocols are expressed in generic terms so that they can be applied to virtually any industry. This version of the plan is especially focused on risk, and the steps you can take to eliminate the possibility that your products will harm your customers and your company. This approach is especially important in the field of medical devices, where QMS protocols are often required by FDA regulations.