It All Started with an Idea

It is not a secret that the Covid pandemic severely disrupted supply chains. One industry that was severely disrupted was the plastics industry, particularly the medical plastics industry. After having discussions about the supply shortages and seeing that items for diagnostic testing such as pipette tips and deep well plates were in short supply, Graycon CEO Derek Dykstra approached Lucy Eiler about initiating a new division to fill the market’s need.

Most companies seeking to break into an industry would first look at the possibility of acquiring other companies and/or infrastructure to help fast track the process. After evaluating that option Gracon decided to build their new division from scratch. This also included seeking ISO 9001 and ISO 13485 certification before any manufacturing equipment had been purchased or installed. To conquer this challenge, Gracon sought the services of Cavendish Scott to help them design and implement their ISO programs.

Building It All from Scratch

Gracon started their Cleanroom Injection Molding division from scratch, no equipment, no manufacturing lines, and only a couple of employees, and began seeking their ISO 9001 and ISO 13485 certification as they were building the company. Seeking certification while building their facility was challenging especially since a majority of the ISO 9001 implementation process requires manufacturing procedures and records. Considering Gracon had no infrastructure in the beginning, the team from Cavendish helped walk them through what they could accomplish, such as Sales and Purchasing processes, to help give them a head start on certification while they were waiting for their manufacturing equipment to arrive.

“Starting from the very beginning helped us build our program before we developed any bad habits” – Lucy Eiler, Gracon Manufacturing

Setting up a new division is difficult enough but setting one up during Covid and all the associated supply chain disruptions is a whole other level of difficult. Eiler and her team from Gracon approached the setup with meticulous planning and a risk assessment mindset. They looked at equipment vendors and their material supply chain with their start-up and certification dates in mind.

Once the manufacturing equipment started arriving and production lines were being set up, Gracon and Cavendish worked together on setting their process documentation up to be ISO compliant from inception. 

According to Eiler, Kathleen Higgins, the consultant from Cavendish, really helped Gracon dig deep and understand where they may need to pay more attention to meet the ISO standards. Higgins helped coach and train Gracon personnel at the same time to ensure Gracon built their ISO programs on a solid foundation.

Freedom to Build

According to Eiler, Cavendish was extremely helpful in giving them ideas and guidance in how to build their ISO programs. 

“From Management Review to how we organized our documents, there was a lot of freedom to build a system that worked for us.”

Even in instances where Gracon personnel pushed back or disagreed with ISO requirements, Higgins helped them find ways to make the system work for them while ensuring that the system would satisfy ISO requirements.

“Because we built it, it’s a much stronger system.”

While there are ‘pre-fab’ programs that organizations can purchase on their way to ISO certification, there is often an abundance of useless or irrelevant information in them that is not applicable to most companies.

Cavendish takes the opposite approach. Eiler said that the team from Cavendish continually asked questions leading Gracon to think about how they wanted to do things.

Since Gracon was a new company, they built their system with the intent of it being a living document. ISO 13485, the Medical Device standard, can be difficult to implement particularly for a new company. For Gracon, ISO compliance with the Design and Development requirements was exceptionally difficult because they were both a new company without much experience in this area and the difficulty in building a system that can cater to all the products that a company might encounter in the Medical Device industry.

Eiler initially built the framework for Gracon’s ISO 13485 program on her own and said that Higgins helped them separate the wheat from the chaff in determining what was essential and what ancillary documents they needed for support and how they could apply the requirements to different customers.

Products that Lives Depend on

With a background in both manufacturing and medical devices, Eiler understands how important quality, accuracy, and precision are to the products they make. When working with lab equipment, even the slightest error, dip in quality of the plastic, or an out of tolerance draw or aspiration can mean the difference between a correct medical diagnosis and not. Getting her team to understand this helped build consensus among her team and sharpen their focus on how important their mission is.

Certifying to ISO 13485 has also been helpful not only opening doors to opportunities Gracon would have missed, but also in refining their vendor qualification criteria through the standard’s strict Design and Development requirements.

Preparing for Certification

Nobody at Gracon had been through or led an Internal Audit, so they engaged Cavendish to perform the Internal Audit. Emily Myers, Cavendish’s Internal Auditor, helped the team from Gracon be mentally prepared for an audit and coached them on what questions to expect auditors to ask. Being prepped by Cavendish helped Gracon personnel face both their Stage 1 and Stage 2 audits with a much more relaxed mindset. 

I really like our Auditor; she gets really excited about the process. She (Myers) quotes ISO like a Baptist quotes scripture – Lucy Eiler, Gracon LLC

For three people who were new to implementing a Quality Management System and tackling the comprehensive ISO 13485 certification, having only two minor non-conformances in their certification audit is impressive. This is a testament to both how the team at Gracon built their ISO system and how the team from Cavendish coached and trained the Gracon staff in implementation.

Building a Culture of Quality

Gracon is currently a small operation with 4 employees, all of which were intimately involved in building the ISO programs. As they seek to expand moving forward, Eiler does have concerns about how new employees will integrate to the culture of quality set by Gracon’s QMS and how to ensure Gracon employees are sharing institutional knowledge going forward. To help mitigate these concerns, Gracon contracted Cavendish to help create training videos explaining their QMS.

Based on the experience, how well the teams worked together, and how Cavendish prepared them for their audits, Eiler said that going forward, Gracon plans to use Cavendish to perform their Internal Audits for the foreseeable future.

Are you confronted with an ISO certification project, but you do not know how to go about it? Cavendish Scott can help. Our consultants have a high level of expertise in implementing ISO standards in different industry sectors. Cavendish Scott collaborates closely with clients, providing hands-on training and familiarization to help them implement quality standards and improve business efficiency. 

Reach out to Cavendish Scott at info@cavendishscott.com and get professional help with your ISO project.

About Gracon Manufacturing:

Gracon Manufacturing specializes in cleanroom injection molding. Our flexible operation was designed with the goal of manufacturing plastic parts and components to meet our customers’ needs and all regulatory requirements they may have.

As your manufacturing partner, Gracon Manufacturing is an extension of your team. We are committed to providing value, being a reliable partner, and achieving the highest standard of quality.

For more information, email the team at Gracon at sales@graconmfg.com

About the Author:

Christian Salafia is a freelance business journalist currently residing in South Africa. Prior to moving from the US to South Africa in 2021, he worked for over 20 years in the Defense and Energy industries as a Process Engineer, an Engineering Manager, and a Quality Manager where he implemented and managed ISO 9001 programs. When not working, he enjoys spending time with his wife enjoying all the beauty the Western Cape has to offer. For questions, comments, or business enquiries, he can be contacted at christian@sbriskexperts.com 

Upgrading to ISO 13485 from ISO 9001