What is a Quality Management System (QMS)?

A quality management system (QMS) is a formalised system that records processes, procedures, and roles for carrying out quality policies and objectives. A QMS aids in organising and directing an organization's operations to satisfy customer and regulatory requirements and continuously enhance effectiveness and efficiency.

Every area of an organization's performance is impacted by the implementation of a quality management system.

 

Quality management systems as we know them today were first developed in the US and introduced in Japan in the 1950s. The intention was to inform managers of ways to improve quality within the organisation by focusing on systematic errors, employee issues, poor design, poor manufacturing environments, and supply chain concerns.

What benefits does a QMS provide?

As mentioned above, the early QMS systems were designed to improve the efficiency of how a manufacturing facility was run. But today, with globalisation and with end user safety at the forefront, QMS systems have evolved. An effective QMS should meet the organization's needs while ensuring compliance with regulations and harmonised standard. Ultimately, this results in a streamlined, cost-effective, and resource-efficient process.

Many customer organisations require some evidence of an effective QMS being in place; this in turn fosters confidence in the company, which encourages more repeat business and attracts new customers.

What's out there?

ISO 9001:2015 is the foremost recognised and executed quality management framework standard in the world. It contains all the necessities for a QMS that organisations can utilise to create a basic system.

Other standards exist, such as the ISO 14000 arrangement (environmental management systems), IATF 16949 (quality management systems for automotive-related products), and ISO 13485 (quality management systems for medical devices), which are more industry-specific and thus required for organisations that actively play a role in those respective areas.

For further support on ISO 13485 compliance click here to go to our guidance documents section.