The Challenge
For SemiLink, ISO 9001 wasn't just a compliance task; it was the key that would unlock the door to their entire market. Without it, they could not generate revenue.
A Barrier to Entry: Certification was a non-negotiable requirement from every major customer in the semiconductor industry.
Building from Absolute Zero: The company launched with no existing processes, requiring a complete QMS to be built from scratch alongside their core operations.
Achieving Compliance Without Operational History: A core difficulty was validating a QMS for processes that were not yet active, demonstrating effectiveness to auditors without the benefit of long-term data.
Without ISO 9001 we would not have sales.
Fred Woods
Director of Quality
SemiLink Materials
The Solution
Faced with the non-negotiable requirement for ISO 9001 certification and the unique challenge of building a system for processes that were still in development, SemiLink needed more than a checklist. They needed an expert partner who could translate their leadership's vision into an audit-ready Quality Management System.
Having previously encountered the limitations of a generic DIY toolkit from another provider, they knew that for their high-stakes, fast-paced startup environment, dedicated expert guidance was essential. They chose 9001Simplified's full-service consultancy to ensure a seamless and guaranteed path to certification.
Following two strategic planning calls, SemiLink selected the 9001Simplified ISO 9001 Certification Service for three key reasons:
Guaranteed Certification: The service provided the certainty of a fast and successful outcome, which was critical to unlocking their revenue pipeline and commencing business operations without delay.
Expertise and Experience: Our senior consultants specialized in designing a QMS tailored to a company's strategic vision. This allowed SemiLink's leadership to build their operational processes in parallel, with the quality system evolving as a integrated core component, not an afterthought.
Collaborative Registrar Approach: Our established relationships with accredited registrars facilitated a constructive dialogue. This partnership was crucial for formulating a realistic certification scope and demonstrating QMS effectiveness to the auditor, even ahead of full-scale production.
This solution provided the framework, but its success relied on expert execution.
The project was led by Andrew O'Reilly, a senior Consultant, Instructor, and IRCA Certified Lead Auditor with over 25 years of experience. His background as a Six Sigma Black Belt and Prosci-certified Change Management Practitioner made him ideally suited to guide a dynamic startup like SemiLink.
The combination of roles was critical: as their Consultant, he designed a QMS tailored to their vision; as their Instructor, he trained and upskilled the team; and as an Auditor, his deep understanding of the registrar's perspective ensured the system was not only well-designed but also demonstrably compliant, perfectly preparing them for a successful audit.
The Implementation
Andrew O'Reilly began the engagement facing a unique challenge: building a certified Quality Management System for a company whose core operational processes were still in the early phases of development. His first step was to immerse himself in SemiLink's strategic vision, working closely with leadership to design a QMS that would serve as a scalable framework for their future growth.
The implementation was characterized by a deep, collaborative partnership. Fred Woods captured the dynamic perfectly: Andy provided the essential 'what' and 'why' of an experienced management and efficiency consultant, while the SemiLink team, leveraging their deep semiconductor industry expertise, defined the practical 'how'. This approach ensured the system was both fully compliant and a natural, value-adding extension of their business strategy.
The process became a company-wide effort, with all employees actively participating. Regular all-hands meetings were conducted, ensuring everyone was aligned and engaged.
Despite the heavy lift of building from scratch, the team maintained a positive spirit. Fred Woods reflected, "Although there was a lot of work to do since we were starting from ground zero, we all had a pretty good time throughout the project."
Our experience with Andy and 9001Simplified exceeded our expectations. As a small startup company serving the semiconductor industry, Andy provided the quality management system foundation not only for ISO 9001 certification, but also as the core for our business management approach.
Fred Woods
Director of Quality
SemiLink Materials
Initially requested as a remote service, the implementation approach evolved to include on-site support for key milestones, adapting to SemiLink's concurrent business process development. Our adaptable, flexible approach accelerated the establishment of SemiLink's business processes in parallel to the build-up of their quality management system. By integrating ISO 9001 requirements with emerging operational frameworks, 9001Simplified delivered a tailored, audit-ready solution within just six months – a testament to full management support and an effective, client-led partnership.
The Certification Audit
SemiLink's QMS was ready for audit in just six months but the final certification was delayed by the registrar due to scheduling difficulties and lack of auditors, a challenge mitigated through our extensive registrar relationships.
SemiLink's two-part certification audit with global leader Bureau Veritas finally took place in October 2024, beginning with a one-day Stage 1 remote assessment, followed by a 1.5-day Stage 2 on-site evaluation. True to the collaborative culture built during implementation, SemiLink conducted all-hands briefings before each stage, ensuring every team member was confident and prepared.
The outcome was exceptional. Bureau Veritas concluded the audit with zero nonconformities and zero observations – a rare and resounding endorsement of the system's robustness – stating "SemiLink Materials has implemented a quality management system that meets and exceeds the requirements of the standard."
Keys to Success
Asked to reflect on his experience, Fred Woods shared the following tips for other business starting their ISO 9001 certification project:
"Choose carefully"
Fred's top recommendation is to choose your implementation partner carefully. "Take care in selecting your consultant. It is the difference maker," he advised. The right consultant becomes a strategic partner, not only guiding you to certification but improving efficiencies throughout your business.
"View ISO 9001 as your business management system"
Fred Woods is adamant that success is rooted in mind set: "Don't view ISO 9001 as a separate quality program, but as the core of your business operations." For SemiLink, this mindset ensured their ISO system added real value and was embraced by the entire company.
"Engage the entire organization from the start"
"Make ISO 9001 a companywide group effort," recommended Fred. "Involve all employees through all-hands meetings and inclusive planning." For SemiLink, this approach lead to a culture of ownership and quality awareness from day one, which was crucial for long term buy-in.
"Plan your audit early"
A lesson learned from their experience is to factor in potential registrar delays. "Seems there is a shortage of auditors," Fred noted, "so make sure you take that into your scheduling considerations." Selecting your registrar early and setting an audit date, aided by a consultant with strong registrar relationships, helps mitigate this common industry challenge.
The Results
For SemiLink, achieving ISO 9001 was not about incremental improvement; it was about creating the fundamental conditions to exist as a company. The results were absolute and foundational.
The certification was the key that opened the door to their entire market and unlocked revenue. As Fred Woods stated plainly, "Without ISO 9001 we would not have sales." This was the primary and most critical return on investment.
Beyond the certificate, they gained a business DNA. The QMS became the core of their management approach. Fred Woods emphasized, "We consider ISO 9001 as our business management system – not just a quality program. Our business foundation is based on ISO 9001..."
ISO 9001 also established operational efficiency form day one. As a startup building everything from scratch, the QMS provided a ready-made framework for clarity, consistency, and effectiveness, embedding quality into their culture from the very first day of operations.
Ready to Replicate This Success?
Let 9001Simplified be the difference maker for your business. Our guaranteed, full-service consultancy will build your audit-ready QMS efficiently, giving you the foundation to compete and grow.
SemiLink Materials
2920 S Garfield St, Missoula, MT 59801, USA
https://www.semilinkmat.com
