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The Challenge
As a new entrant in the semiconductor industry, SemiLink faced the challenge of establishing credibility and meeting the stringent quality requirements of major semiconductor device manufacturers. ISO 9001 certification was not just a desirable achievement but a minimum requirement for suppliers in this sector.
Why ISO 9001?
Fred Woods, the Director of Quality at SemiLink, explained their motivation: "SemiLink was established to serve the US domestic Semiconductor manufacturing market with high purity gases and materials. Supplier quality standards and requirements are high in this industry due to the criticality to reduce variation during the manufacturing process. A minimum requirement for suppliers to major semiconductor device manufactures is ISO 9001."
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
Choosing 9001Simplified
Following two strategic planning calls, SemiLink Materials selected 9001Simplified's full-service ISO 9001 Certification Service. This choice was driven by SemiLink's recognition of the critical importance of expert guidance, particularly in light of their previous unsuccessful attempt at implementing a quality management system using another provider's DIY kit. The project, led by seasoned consultant Andy O'Reilly, was designed to provide comprehensive support, aligning with SemiLink's unique needs during the company's startup phase.
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. This flexible approach ensured comprehensive certification guidance while facilitating efficient business establishment. By integrating ISO 9001 requirements with emerging operational frameworks, 9001Simplified delivered a tailored solution that addressed SemiLink's unique needs as a startup.
Andrew O'Reilly – Consultant, Instructor and Auditor
Andrew is one of our experienced management consultants, an IRCA Certified Lead Auditor, and an engaging instructor for our custom on-site and remote training.
Andrew has an extensive background in financial and service industries as well as traditional manufacturing.
Over the last 25 plus years, Andrew has gained much experience in ISO 9001, process management, and continuous improvement.
He is a skilled instructor, auditor, and consultant with a passion for improving operational processes and sustaining performance gains.
Andrew is also an ASQ-certified Six Sigma Black Belt and a Prosci-certified Change Management Practitioner.
Implementation Phase
Following SemiLink's initial contact with 9001Simplified in August 2023, the actual implementation process faced an initial delay due to personnel changes within SemiLink and officially commenced in November 2023, with the company working closely with their consultant Andy.
The implementation process was characterized by a collaborative approach. As Fred Woods noted, "Andy provided the "what" and "why" that needed to be done, and SemiLink provided the "how" that made sense to our organization and business strategy." This synergy between the consultant's expertise and SemiLink's deep industry knowledge proved crucial in tailoring the ISO 9001 system to the company's specific needs and the broader requirements of the semiconductor industry.
The implementation phase was marked by a company-wide effort, with all employees actively participating in the process. Regular all-hands meetings were conducted to prepare staff for each audit stage, ensuring everyone was aligned with the ISO 9001 objectives.
By mid-May 2024, the implementation was essentially complete while SemiLink's operational processes had been built from the ground up. This swift progress can be attributed to the full support of management, the tight cooperation and the effective guidance provided by 9001Simplified.
We consider ISO 9001 as our business management system – not just a quality program. Our business foundation is based on ISO 9001 and gives us the focus to actively manage the aspects of the business needed to provide the products our customers.
Fred Woods
Director of Quality
SemiLink Materials
Challenges and Solutions
While SemiLink's journey to ISO 9001 certification was largely successful, it was not without its challenges:
Starting from scratch: As a new company, SemiLink had no pre-existing quality management system. This was viewed as an advantage, allowing them to build their processes around ISO 9001 from the ground up. However, building all processes from scratch required substantial effort. As Fred mentioned, "There was a lot of work to do since we were starting from ground zero."
Learning curve: While the business startup phase allowed for a clean slate implementation, it also meant facing a steep learning curve. As Fred Woods remarked, "There is naturally a learning curve when it comes to quality and QMS."
External Delays: Despite SemiLink's readiness, the certification audit by Bureau Veritas was delayed due to the registrar's scheduling difficulties and unavailability of auditors. This challenge was mitigated through 9001Simplified's good relationships with its partner registrars, which helped move the process forward.
Despite these challenges, SemiLink Materials successfully navigated the implementation process. The company's positive attitude, combined with the expertise and approach of their consultant, Andy, turned potential obstacles into learning opportunities. As 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."
Certification Audit
SemiLink Materials' certification audit, conducted by Bureau Veritas, exemplified the effectiveness of their ISO 9001:2015 implementation. Despite initial scheduling challenges, the process proceeded smoothly, underscoring the value of 9001Simplified's industry connections. The audit comprised a one-day Stage 1 remote assessment and a 1.5-day Stage 2 on-site evaluation in October 2024. SemiLink's thorough preparation, including company-wide briefings before each stage, contributed significantly to their success.
The audit results were exceptional: no observations or nonconformities were identified, a testament to SemiLink's commitment and 9001Simplified's guidance. The Bureau Veritas auditor commended SemiLink, stating, "SemiLink Materials has implemented a quality management system that meets and exceeds the requirements of the standard." This flawless certification not only validates SemiLink's quality management system but also positions them strongly in the demanding semiconductor industry, demonstrating the tangible benefits of expert-guided ISO 9001:2015 implementation.
Without ISO 9001 we would not have sales.
Fred Woods
Director of Quality
SemiLink Materials
Benefits and Outcomes
Although SemiLink Materials is in the early stages post-certification, they have already observed several significant benefits:
Market Access and Customer Satisfaction
ISO 9001 certification was crucial for SemiLink's entry into the semiconductor manufacturing market. As Fred Woods stated, "Without ISO 9001 we would not have sales." This certification meets a minimum requirement for suppliers to major semiconductor device manufacturers, opening doors to high-value contracts.
Solid Business Foundation
SemiLink views ISO 9001 not just as a quality program, but as their core business management system. Fred Woods emphasized, "Our business foundation is based on ISO 9001 and gives us the focus to actively manage the aspects of the business needed to provide the products our customers [demand]."
Increased Operational Efficiency
The implementation of ISO 9001 processes and procedures has enhanced SemiLink's effectiveness and efficiency in product delivery. This improvement is particularly crucial given their demanding customer base in the semiconductor industry.
Comprehensive Quality Approach
Starting from "ground zero," SemiLink used ISO 9001 to build a quality management system that adds value to their business processes. This approach ensures quality is integrated into every aspect of their operations.
Employee Engagement
The ISO 9001 implementation was a "companywide group effort," fostering a culture of quality awareness and continuous improvement among all staff members.
Positive Audit Outcomes
SemiLink passed their certification audit with flying colors, receiving no observations or nonconformities. The Bureau Veritas auditor commented that SemiLink's quality management system "meets and exceeds the requirements of the standard."
Customer Confidence
While long-term benefits are yet to be fully realized, SemiLink has already leveraged their ISO 9001 certification to instill confidence in their customers. As Fred Woods noted, "We did have the pleasure of telling one of our customers during their audit that we passed ISO 9001 audits."
Take care in selecting your consultant. It is the difference maker.
Fred Woods
Director of Quality
SemiLink Materials
Lessons Learned
SemiLink's ISO 9001 certification journey offers valuable insights for other organizations:
Choose the Right Consultant
Fred Woods emphasized, "Take care in selecting your consultant. It is the difference maker." SemiLink's successful and rapid certification was largely attributed to the guidance provided by 9001Simplified and their consultant, Andy.
Plan for Auditor Availability
Given the current shortage of auditors, companies should factor potential delays into their certification timeline. As Fred advised, "Make sure you take that into your scheduling considerations."
Embrace the Learning Process
Implementing ISO 9001 involves a learning curve, especially for organizations starting from scratch. SemiLink found value in exploring different approaches until they fully understood what was needed and why.
Align ISO 9001 with Business Strategy
SemiLink's approach of using ISO 9001 as their business management system, rather than just a quality program, demonstrates the importance of aligning the standard with overall business strategy.
Engage the Entire Organization
SemiLink's success was partly due to company-wide involvement in the certification process. This inclusive approach helped in creating a quality-focused culture throughout the organization.
Prepare for Audits
SemiLink's thorough preparation, including all-hands meetings before each audit stage, contributed to their successful certification with no nonconformities.
By following these lessons and leveraging the expertise of their chosen consultant, SemiLink was able to achieve ISO 9001 certification efficiently, setting a strong foundation for future growth in the demanding semiconductor industry.
Conclusion
SemiLink Materials' journey to ISO 9001:2015 certification exemplifies the transformative power of a strategically implemented quality management system. Their success underscores the importance of selecting the right consultant, aligning quality processes with business strategy, and fostering a company-wide commitment to quality. The benefits SemiLink has experienced – from gaining market access to building a solid business foundation – demonstrate the far-reaching impact of ISO 9001 certification. Their achievement of zero nonconformities during the certification audit is a testament to the effectiveness of their implementation process and the expertise provided by 9001Simplified.
For organizations looking to embark on their own ISO 9001 journey, SemiLink's experience offers valuable lessons. It emphasizes the importance of choosing the right implementation partner, engaging the entire organization, and viewing ISO 9001 as an integral part of business strategy rather than just a compliance exercise. To learn more about implementing ISO 9001 in your organization or to explore how 9001Simplified can guide you through the certification process, contact our team of experts. Your path to operational excellence and customer satisfaction begins with a robust quality management system – let SemiLink's success inspire your own ISO 9001 journey.
SemiLink Materials
2920 S Garfield St, Missoula, MT 59801, USA
https://www.semilinkmat.com
