Standards Spotlight: ISO/IEC 27001, ISO 9001 in Additive Manufacturing

With digitally powered AM now a feasible fabrication option for a wider range of parts, 3D printing is playing a bigger role in manufacturing than ever. Advances to additive manufacturing have pushed industrial 3D printing forward in two distinct directions:

1.)

With new materials, new fabrication technologies, and continuous improvements to existing processes/materials every year, manufacturers now rely on 3D printing not only for more parts, but also higher value applications and more production parts. Today, 3D printing is used to fabricate parts such as satellite bodies holding valuable payloads in outer space, and end-use steering wheels for jet racing cars hitting speeds of over 270 mph.

Many high-value applications, such as in the aerospace industry, are subject to stringent regulatory requirements. To get value, manufacturers need assurance of deliveries that consistently and reliably meet their needs, so meaningful assurance of consistent and reliable product quality should be top of mind for customers and partners when evaluating additive manufacturing vendors. For these tightly regulated industries, inability to find a vendor meeting these standards can lead to compounding hindrances or terminal failures when qualifying applications.

2.)

Manufacturing processes today have also shifted deep into the digital ecosystem. Cloud connectivity lets companies store thousands of proprietary parts as digital inventory, and connects large networks of 3D printers distributed across the globe for efficient supply chains. Cloud-based 3D printing software features also allow AM users to level up their workflows to save time, effort, and money with smart manufacturing tools: such as AI-powered part inspection, pre-fabrication performance simulation, and slicer integrations for core factory systems.

Data breaches, when they happen, carry deleterious consequences. So far in 2022, individual data breaches cost their organizations $4.35 million on average. Consequences cascade beyond financial damage, as intellectual property can be stolen and sensitive customer data can be leaked. Reputational damage often follows.

ISO/IEC 27001 is an international standard for how organizations manage information security. The objective of this standard is to ensure that information 1.) is confidential and only accessible by authorized users, 2.) has uncompromised integrity, with only authorized users able to make changes, and 3.) is readily available to authorized users when it is needed.

A certification in ISO/IEC 27001 means that the certified organization has the necessary in-house knowledge, procedures, and infrastructure to reliably secure sensitive information stored on the platform.

To achieve ISO/IEC 27001 certification, an organization must develop an information security management system (ISMS). An ISMS is a set of rules that a company must establish through demonstrated policies, procedures, and relevant documents. The ISMS must define stakeholders, identify risks, define controls, set information security objectives, implement controls, measure control performance, and show continuous improvements that will be made to the system moving forward.

Markforged is the first additive manufacturing platform provider to achieve ISO/IEC 27001 certification.

ISO 9001 is the world’s most widely-cited standard for quality management. The purpose of this standard is to build organizational frameworks known as quality management systems (QMS). These systems ensure that the certified organization is consistently meeting customer needs

in their product and service deliveries, and can uphold high standards for quality when faced with the most stringent requirements.