Why Your Parts Supplier Should be ISO 9001 Certified
Protolabs' quality system starts when a customer uploads a part file and runs through the entire manufacturing process and into shipping.
Choosing a contract manufacturing supplier for your company is a critical decision. Certainly from a production standpoint, making sure the supplier is reliable and efficient and can deliver on time and on budget are key elements to consider.
But beyond production factors, your firm’s credibility and reputation is also on the line, because “you’re handing over your company’s processes and production to another business,” said Ken Chess, COO of Fusion OEM. “With your company’s reputation on the line, you need to be highly selective when choosing a contract manufacturer—and you need outside, objective validation that [the contractor’s] business is run effectively.”
That’s why partnering with suppliers that have ISO certification makes sense, because the certification provides independent validation and assures companies that suppliers are meeting verifiable standards. Indeed, in many industries, companies will only do business with certified suppliers because it gives companies confidence that suppliers are working to accepted standards and procedures.
“In the eyes of our customers, it is all about confidence,” said Gian Vallonchini Quality Manager, Protolabs, referring to those companies seeking out contract manufacturers. “In our case, our customers want to have confidence in Protolabs as a supplier that we can deliver good parts.”
What the Standards Cover
ISO standards are set by the International Organization for Standardization, a Geneva, Switzerland-based independent body, recognized worldwide, which develops voluntary quality standards that companies follow. These certifications show businesses that suppliers have met these stringent standards and can be assured that suppliers’ management systems are constantly assessed and improved.
At Protolabs, the Quality Management System (QMS) is designed to meet the requirements of ISO 9001: 2015 for the manufacturing of prototypes and low-volume production of injection-moulded and machined parts. The scope of Protolabs’ QMS is wide ranging, Gian said. Generally, it covers:
- Context of the Organization
- Company Leadership
- Operation, including requirements management, supplier controls, production, and nonconformance control
- Performance Evaluation
Protolabs holds ISO 9001: 2015 certification, which is the most up-to-date set of standards. Accordingly, “our customers know that we have policies, procedures, processes, and systems in place that we adhere to and closely follow,” said Gian. “And that system is focused on the customers and their requirements. That’s really the definition of quality: conformance to requirements.”
The wide scope of the QMS is designed to cover all aspects of Protolabs’ digital thread, said Gian. “So, the quality system starts from the customer uploading a file onto our system, it includes the front-end customer service and order entry activity, all the way through manufacturing and into shipping.”
Continuous improvement is built into the system and the certifications, too. For example, ISO standards are usually upgraded every seven to 10 years (the last certification was ISO 9001: 2008), and then companies are audited typically on a three-year cycle, Gian said.
Beyond ISO 9001:2015, Protolabs also holds ISO 13485: 2012 certification for the production of medical instruments using additive (3D printing) technologies and machining for prototyping and low-volume production.
Plus, smaller, annual surveillance audits are also done. All of these audits are conducted by independent, third-party validation registrars. Protolabs contracts with NQA, which is accredited by UKAS, the United Kingdom Accreditation Service, a management systems certification body.
Globally, Protolabs holds various certifications in countries that are specific to those regions, including in the United States and Japan.