What is the ISO 9001:2015 Certification?

As a precision machine shop, one of our highest priorities is to maintain excellence. We have a responsibility to our customers to manufacture and deliver parts that match their exact specifications.

Quality assurance checks are one of the most important steps in the manufacturing process. Before any parts are shipped to customers, our QA team runs through a series of quality checks. The quality assurance continues throughout the manufacturing process.

Spex is an ISO 9001:2015 certified organization. ISO 9001:2015 is the international standard for quality management systems. It’s the most prominent approach to quality management systems.

What is a quality management system?

A QMS is a collection of processes that focus on meeting customer’s expectations and improving the level of customer satisfaction.

Systems that promote a standard of quality are highly important in the manufacturing industry, especially when parts and components are being produced in high quantities. Customers should expect that the parts they’re ordering are going to meet the necessary standard.

The quality standards we have today weren’t always present. In the early 1900s when Ford began using an assembly line to build cars, quality management systems became more important. Parts were being produced faster and faster, and manufacturers needed a way to maintain quality and consistency.

When machines were being handcrafted, it was easy to do quality checks. Before Ford’s assembly line, a car would take 12 hours to put together. After the assembly line, it took 33 minutes. The reduced speed was certainly a benefit, but the quality checks needed to keep up.

Quality management focuses the quality of products and services, and also on the means to achieve it. Quality management uses quality assurance (QA) and control of manufacturing processes as well as systems to achieve consistent quality.

There are 9 standard elements of a QMS

Quality objectives: These are measurable quality control methods established by a company. For example: Achieve a minimum of 98% on-time deliveries.
Quality manual: This is a document that describes the organization’s QMS. The documents can be used internally for employees and for customers and auditors.
Organizational structure: This provides a foundation for standard operating procedures and routines. It determines which individuals participate in certain decision-making processes.
Data management: This is how data and statistics are organized and used to improve performance.
Processes: The processes outline the standard steps taken in production, quality checks, ordering, purchasing, and more.
Product quality: This is an established level of quality that leads to customer satisfaction without needing subcontracted quality checks.
Continuous improvement: This is an ongoing effort to improve products, services, and customer satisfaction. It includes both corrective and preventive actions.
Quality instrument: These are the tools used to check the quality of products and services.
Document control: This improves knowledge retention and transfer, employee performance, and customer satisfaction by providing documented information.

What are the benefits of a quality management system?

A QMS improves business health from start to finish.

The first of seven quality management principles is customer focus. A primary focus of quality management is to meet customer requirements and to aim to exceed customer expectations.

Understanding the current and future customer needs is what leads to the sustained success of every business. Implementing a QMS increases the value customers receive and improves customer satisfaction. Sustained success is more likely when relationships with suppliers and customers are properly managed.

Within the business, a quality management system helps leaders and employees. Quality systems help maintain consistency and set checks and balances. A QMS will also help leaders make evidence-based decisions, and help guide the business in the right direction.

A Harvard Business Review study found that businesses that adopted ISO standards have higher rates of corporate survival, sales, employment growth, and wage increases than non-adopters. The study also finds that annual earnings per employee grew substantially more rapidly, post-ISO certification.

At Spex, we focus on how the ISO 9001 standards improve our manufacturing operations and benefit our suppliers and customers. We will continue to improve and pass the benefits to you.

At Spex, we can provide a rapid prototype of any custom part using our 3D printer. We also have a variety of CNC machines and mills for fast production of high quantities of precision machined parts.