Lithos Energy Achieves ISO 9001 Certification in 6 Months with PICO

Lithos Energy, based in Hayward, CA, is a leading manufacturer of high-performance battery systems designed for customers operating in some of the most difficult environments, such as mining, defense, and transportation. For these customers, durability and performance are critical, so they turn to Lithos’ robust and reliable energy solutions to accelerate the electrification of off-road equipment.

Lithos introduced PICO into its facilities in 2021, and has since digitized more than 260 processes, connected more than 50 stations, and integrated more than 115 assembly tools to automate data capture and error-proof their assembly operations across multiple battery system production lines. 

The Challenge: Create a Robust QMS to Expedite Certifications & Audits

2024 saw tremendous growth and brought with it new projects of increased complexity. Lithos recognized the need to establish a foundation for their quality management system (QMS) to help them meet their customers’ needs while ramping up production in the new year. As such, Lithos made the strategic decision to pursue an ISO 9001 certification. This certification establishes a globally recognized quality standard and requires organizations to maintain a robust and dynamic QMS.

Lithos Energy is located in Hayward, CA and runs multiple lithium-ion battery production lines using PICO digital work instructions.

"In the battery industry, keeping track of non-conformances is critical, but it’s surprising how many companies still rely on paper to do it,” said Angelo Menotti, Head of Quality at Lithos. In his role, Menotti is solely responsible for ensuring that products consistently meet or exceed customer expectations. To achieve this, he relies on PICO’s digital ecosystem to provide systematic controls for work instructions, change management, and data collection.

PICO at the Center of the QMS

Lithos leveraged traceability and change management to create a structured, digitized approach to establishing their quality management system. Instead of relying on fragmented paper documents and spreadsheets, PICO allows for automated data collection from every build and enables quick access to critical process and product quality information necessary to prove adherence to ISO 9001 standards. 

Primarily, Lithos measured first-pass yield, incident rates, and non-conformance for the ISO 9001 certification. Centralizing this data in one place mitigates the risk of mismatched data that often stems from using multiple factory systems.

“PICO integrates all key ISO 9001 manufacturing requirements and is our tool of choice in proving product genealogy, process control, and build instructions,” said Menotti. “This not only simplified compliance but also established a sustainable framework for continuous improvement.”

Traceability in PICO starts with a simple search of a part number, serial number, or work order to generate all related builds and their complete assembly data.

Certification Secured: Achieving ISO 9001 Certification in Only Six Months! 🎉

Here’s how Lithos established their QMS and secured their ISO 9001 certification in record time using PICO:

• Eliminate paper-based processes: Digital work instructions help standardize work across different production lines and allow for tighter revision control when process updates are required.
• Reduce operator burden and human error: Integrated devices and tools automatically capture data as operators build, ensuring accurate data reporting and error-proofed assemblies.
• Spend less time searching for data: Full backwards traceability provides instant access to every part’s complete genealogy, allowing for the creation of “digital product passports” to demonstrate process efficiency and product quality.

Traceability Is Core to Simplifying Customer Audits

“If you are still living in the manual world, you are probably operating 10-20X slower than digital factories,” Menotti said, adding that PICO’s traceability and change control capabilities have proven to be key in streamlining not only certification processes, but customer audits as well. 

Menotti continues, “Since all manufacturing data is centralized, we can quickly compile comprehensive reports that include a product’s complete build history, from build and test values, to work instructions revisions, and more. Our customers trust the data we share because we can clearly show where defects started, how they spread, and how to prevent them in the future.”

Assembling a Build Book starts with tracing a product’s data in PICO by searching a part or serial number, pulling the resulting report, and entering the information into a template. From start to finish, this process takes one hour per product - but through future integrations with PICO, Menotti hopes to make this process instantaneous at the click of a button.

PICO integrates with testing equipment such as the Cincinnati Test Systems Leak Tester and Vitrek Hi-Pot Tester for in-process quality testing.

The Results

“Overall, the transparency and consistency PICO offers have significantly improved our audit outcomes and customer confidence.” – Angelo Menotti, Head of Quality, Lithos Energy

Lithos has greatly reduced the labor and time requirements of gathering and documenting assembly data by eliminating the burden of maintaining paper records. Through digital traceability, they have instant access to all of the process documentation, build data, and analytics they need to provide a high level of confidence to their customers.

⏯️ Watch the full customer story video:

Looking Forward

With a solid foundation for their QMS in place, Lithos is looking to achieve additional quality certifications - such as the IATF 16949 for the automotive industry - and continue to integrate systems with their PICO environment to optimize their existing processes. As they head into a season of increased production, their focus will be to solidify their digital ecosystem and capitalize on the influx of data for continuous improvement across process efficiency and product quality.

What Other Manufacturers Can Learn from Lithos

Many manufacturers are still relying on pen and paper to document their processes and collect data solely because of the fear of the unknown that surrounds factory digitization. However, digitizing processes and automating data collection is becoming a necessity if manufacturers wish to stay competitive and agile. Fortunately, as Lithos has demonstrated, digitizing processes has significant compounding effects when coupled with features such as traceability. It serves as the first step towards unlocking data insights that not only drive efficiency gains on the shop floor but stimulate growth across the entire business. 

🔹 Don’t put off digitization any longer. Get started for free with PICO digital work instructions.

🔸 Download the free Traceability Implementation Checklist.

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