For organizations that manufacture any type of product, overall quality and customer satisfaction are extremely critical. This is particularly important for companies that manufacture complex products, such as vehicles or medical devices. Note that vehicle manufacturers, particularly in the United States but also in other countries, have established their own quality standards for third party suppliers.  Additionally, medical device manufacturers are typically required to satisfy specific standards such as ISO 13485.     

And when components and assemblies for the end product are manufactured at different factories worldwide, it’s even more complicated to ensure that quality assurance systems are working properly. 

The International Organization for Standardization (ISO) standards enable manufacturers to continually measure, evaluate, and improve the systems that ensure product quality and reliability. Consequently, manufacturers have to verify that their products always fit together properly, function accurately, and meet customer expectations.

The International Organization for Standardization is an organization that publishes standards for goods, services, and processes. The international standards act as benchmarks for quality and efficiency in a number of industries, the majority related to the supply chain and, as such, manufacturing.

What is ISO 9000?

The ISO 9000 family of standards help companies satisfy the needs of their customers, meet regulatory requirements, and achieve continual improvement. 

ISO 9001, which sets out the criteria for a quality management system (QMS), is the only standard in the family that provides certification. To be certified to the ISO 9001 standard, an organization must follow the requirements set forth in the ISO 9001 standard. 

To become certified, a company hires a third-party firm to audit its processes, services, and products. The auditors measure the proper specifications and determine whether or not the organization meets the ISO 9001 criteria.

Companies use the ISO 9001 standard to demonstrate that they can consistently provide products and services that meet customer and regulatory requirements as well as demonstrate continuous improvement. 

ISO 9001 requires calibration of measuring and testing equipment, i.e. measurement traceability, along with continual improvement of the effectiveness of the QMS. Continual improvement is fueled by the objectives set by an organization’s leaders. At a minimum, the quality objectives should address the improvement of internal efficiency, the individual customer requirements, and the level of performance that the company’s industry experts.

ISO 9001 helps organizations find more effective ways to ensure quality while encouraging businesses to find creative ways to exceed customer requirements. The benefits of ISO 9001 in manufacturing include enabling companies to identify, document, and improve the systems that address customer requirements, such as dimensional and functional specifications and expected production efficiencies. 

Since ISO standards mandate the process of continuous improvement, ISO 9001-certified companies are more apt to reduce overall errors, which saves money, improves customer satisfaction, and makes them more competitive.