Most manufacturers have ISO certifications, but what is it? Why do we do this? And what’s the ISO Certification process like?
What does an ISO certificate tell you?
ISO is the International Organization for Standardization. An ISO certificate says that our company maintains a Quality System to a certain standard – a standard set by international experts in the manufacturing space. Our ISO certification tells our customers that we’re serious about doing things correctly, that we track our goods and services, that we respond to customer complaints, and that we are continuously improving. It gives you an idea of what to expect. Every company that has an ISO certification goes through the ISO certification process on a regular basis.
Why is it good for us?
Internally, working to ISO standards helps us to speak a common tongue with other manufacturers, whether vendors or customers. Having the ISO standard gives us a benchmark by which to measure ourselves. Our continual process of internal audits and checks keeps things from falling through the cracks, whether that’s employee training needs or infrastructure within or without the company.
What does the process look like?
Over the course of the year, we continually perform internal audits of the various departments within our company. Someone from outside the department comes through and checks the process. This internal audit is recorded for our annual meeting if everything goes well, but if it doesn’t, it’s addressed right then and there. Custom Converting is known for its employees working together as a team, and we don’t wait to fix problems! The ISO certification process serves as a guideline, but we go above and beyond.
At the end of the year, we sit down as a company and review all our materials with senior management. We make goals for the next year, address risks and opportunities, and see where we could continue to improve.
After our internal meetings are complete, we compile all the data and make an appointment with an external auditor (independent from our own operations) come to our facility and audit how we operate and maintain consistent quality throughout our organization. Our Quality Manager and his assistant spend the day with the auditor, bringing in other employees and management for interviews as requested. We go over all of the documented information, records, materials, etc. The auditor is escorted through our facility while manufacturing and managerial operations are taking place live, and verifies that our quality systems and procedures actually are being adhered to.
At the end of the day, the auditor makes his recommendations, which the Quality Manager takes back to senior management for review. If problems are found, we are issued a “Corrective Action Report” by the audit team where we must prove that we have taken the appropriate steps to insure we have corrected any issues and are compliant with our Quality System. Once all is compliant, we are issued a continuance of our certification.
Assuming all goes well, we update our website with any new certifications and move forward with the year ahead. Ant that’s the story of the ISO Certification Process.
Conclusion
Custom Converting is ever-evolving, working to offer you the best converting services possible. Having an ISO certification offers you the security of knowing what to expect, and it offers us a benchmark to not only meet, but exceed our Quality management System.
3M Medical Adhesives play a crucial role in the construction of medical devices, ensuring reliability, comfort, and safety for patients. 3M has over 55 years of experience in developing medical-grade adhesives and films. These materials serve as adhesives within various medical devices, from wearable health monitors to diagnostic patches.
Custom Converting is a 3M Select Converter and we are proud to offer the full line of 3M adhesives and tape products. Not only have we been working in the converting field for 40 years, we’ve been working specifically with the biotech industry, life-sciences industry and medical device industry for decades. We have experience that you can trust.
Do you just need a 3M Medical Adhesive supplier, or someone to convert tapes and/or adhesives for you? We can do that. Would you like custom manufacturing of your component or product? Look no further. Custom Converting makes your parts to your specifications every time.
What products might require a 3M medical adhesive?
Transdermal Drug Delivery Systems: Adhesive patches deliver medications through the skin. Examples include pain relief patches, and hormone replacement therapy patches.
Electrodes for ECG and EEG Monitoring: Medical adhesives attach electrodes to the skin for electrocardiogram (ECG) and electroencephalogram (EEG) monitoring. These electrodes ensure accurate signal transmission.
Ostomy Appliances: Adhesives are used in ostomy bags and pouches to securely attach them to the skin around a stoma (an opening created during surgery, e.g., colostomy or ileostomy).
Surgical Drapes and Incise Films: Adhesives help secure surgical drapes and incise films during procedures. They create a sterile barrier, prevent contamination, and maintain a clear field of view for surgeons.
Medical Tapes and Dressing Adhesives: Medical tapes are essential for securing catheters, tubing, and wound dressings. They provide reliable adhesion while being gentle on the skin.
Diagnostic Wearables and Sensors: Adhesives hold wearable sensors (e.g., glucose monitors, ECG patches) in place on the skin. They ensure continuous monitoring without discomfort. Adhesives that adhere to skin, stay in place, and provide comfort are essential for wearable medical devices. Patients rely on these devices for critical health monitoring.
Orthopedic Braces and Supports: Adhesives secure orthopedic braces, splints, and supports. They enhance patient comfort and stability.
IV Catheter Securement: Transparent film dressings with adhesives are used to secure intravenous (IV) catheters and prevent dislodgment.
3M Medical Adhesives are Designed to Adhere to the Skin while Minimizing Irritation
We are often asked about adhesive allergies. A small percentage of the population (2-3%) are allergic to adhesives of any type. However, so many medical applications require the use of adhesive technology that 3M has developed medical adhesives that minimize irritation and still deliver solid adhesion.
They achieve this balance with:
Skin-Friendly Formulation: 3M formulates adhesives with materials that are gentle on the skin, consequently these materials minimize allergic reactions and irritation.
Low Trauma Removal: 3M adhesives are engineered for painless removal, so they adhere securely during use but release easily without damaging the skin. If you need an even more delicate removal process, silicone-based adhesives are known for their low trauma properties.
Testing and Validation: 3M rigorously tests adhesives for skin compatibility. These tests assess irritation potential, sensitization, and biocompatibility.
Customization for Specific Applications
Different applications require varying levels of adhesion. 3M tailors adhesives to meet specific needs (e.g., strong adhesion for surgical drapes, gentle adhesion for wearable sensors). Choosing the right adhesive for your project is an important part of product development.
Custom Converting has access to the full catalog of 3M adhesives. We have over 40 years of experience in the converting industry, and if you’re not sure which 3M medical adhesive is right for you, we’d be happy to assist.
If you are looking for medical adhesive from someone other than 3M, we work with many other suppliers. We also offer custom adhesive development.
We’d love to discuss your project with you and get you the right adhesive. Complete the form on our website or the detailed request for quotation and email it to sales@customconverting.com. You can also call us at (760) 724-0664.
Custom manufacturing and converting services benefit companies at all levels. From start-ups to established businesses, outsourcing your production saves you time, money, and headaches. How can Custom Converting make your life easier?
Reducing Costs:
Time is money. Doing your own manufacturing is expensive.
First, to manufacture for yourself, you have to find the right equipment, which takes research and engineering hours. Then you’re going to have to find a place in your facility to run the equipment, and you’re going to have to train employees to use it properly.
Employees are expensive, and experience costs money. You not only have to keep employees to run the equipment, you have to keep employees who know how to maintain the equipment. Labor costs are going up.
Rent and overhead are expensive. Adding manufacturing equipment to your floor costs you money every day of the year, not just the days you die cut, slit, or coat adhesive. Most converting equipment has a large footprint, and it doesn’t fold up and store in the corner.
Negotiating relationships with materials suppliers is time-consuming. We negotiate the best prices from established vendors. Why not let us supply your materials? As a 3M Select converter, we can obtain materials unavailable to the public.
Who needs a custom manufacturer? Businesses who want to save money.
Increased Quality and Scalability:
Working with a custom manufacturer allows you to try new ideas. Because you’re not worrying about the details of manufacturing, you can spend that time pursuing creativity and doing market research. Smaller runs allow you to pivot quickly, responding to your customers’ desires. When time is ripe, we can scale up and get millions of parts to you in a timely fashion.
Leave the learning curve to us. We can produce high-quality products because we’ve been doing it for 40 years. Quality is in our DNA, and our customers love us.
We worked with Dan before the pandemic and built a relationship with him. When the pandemic hit, we shipped him millions of parts, even adding a second shift to fulfill his requirements. After the pandemic was over, his need for die cut parts dropped back down; and we still die-cut those parts for him. Does Dan have to worry about employees or equipment investments as demand fluctuates? No! We take care of it for him, and we’ll continue to do so.
Who needs a custom manufacturer? Businesses who want to respond quickly to shifts in demand, and who want to bring a high-quality product to their customers quickly.
Options:
What does it mean to do business with a custom converter? It means that you can utilize any of the capabilities that we have in order to manufacture your product or products. If you’re wondering if we’re the custom manufacturer that you’re looking for, please contact us.
We can provide components for you because we have access to the full 3M catalog of adhesives. Some of our clients only use us to get these materials.
We can provide converting services for a part or parts of your manufacturing process. Some of our clients deliver specialized materials to our dock that we then die cut and return, with or without packaging.
We can provide end-to-end manufacturing services, from purchasing through final packaging, shipping you a product ready to put on the shelf.
Who needs a custom manufacturer? Businesses who want options.
Knowledge is Power:
We will give you a detailed and accurate quotation up front, before beginning the manufacturing process or your issue of a purchase order. This is vital to any business, but it is especially useful for start-ups, or anyone making pricing decisions. Don’t guess how much your product is going to cost – know.
With 40 years of experience, we can help you find solutions to your challenges. Why not make an appointment with our team? Because of the years we’ve been in the business, we’ve had a chance to try making a wide variety of products. We’re happy to share that experience with you. Face-to-face relationships built on trust can last for years, and it does, with Custom Converting.
Who needs a custom manufacturer? Businesses who want to know more.
Made in the U.S.A.
If you work with American-made raw materials and/or components, keep your production onshore and get that “Made in the U.S.A.” seal. This standard is becoming increasingly important to your customers – we’ve heard that large retailers are actively sorting vendors by where they’re manufacturing their product.
Working with a custom manufacturer located in the United States also avoids some of the problems we came across during the years of the pandemic. Supply lines were cut, overseas deliveries were in huge queues, and what was supposed to make everyone’s life easier and faster became a huge hassle.
The global economy is fraught with hazards as of this writing. Not only are shipping boats being hijacked in some parts of the world, there is a chance that we might be at war (or in a proxy war) with countries that are home to many international manufacturers. Do you want your business to collapse if China fires on Taiwan? Bringing your converting and manufacturing home just makes sense.
Who needs a custom manufacturer located in the United States? Businesses who want to mark their goods, “Made in the U.S.A.” and businesses who want to avoid the dangers inherent in depending on offshore manufacturing partners.
Conclusion:
Custom manufacturing and converting services benefit can benefit nearly every business. If you’re looking to save money, bring great products to your customers, and reduce your stress, then this option is for you.
You can contact us via phone (760) 724-0664, via the form on our site, or by emailing the attached form to sales@customconverting.com.
Biotech converters local to the North San Diego County area are few and far between. Biotechnology is one of the major industries in San Diego County, and it’s expanding rapidly. Companies such as Genentech, Therapeutic Solutions International, and Kinovate Life Sciences have made Oceanside their home. Carlsbad hosts even more biotechnological innovation, with Predictive Biology, Open Biopharma, and SeqOnce Biosciences being only a few of the operators in this industry.
As demand increases, will these companies be able to find the infrastructure and partnerships locally that they need in order to produce their products? The biotech industry often requires highly specialized components, produced with very specific materials. Not everyone can handle these jobs, but we can. We’ve manufactured everything from splint material to DNA membrane combs. We die cut special materials like membranes, tapes and a wide variety of adhesives and work to a high degree of accuracy.
Custom Converting has been in business in Oceanside for 40 years, and we’ve been working with the biotech industry since our inception. As a 3M converter, we can source any adhesive material (tapes, etc.) as requested and we are also able to customize adhesives, face stock, and liner. We are ISO 9001:2015 certified and manufacture to cGMP specifications. Our facility is registered to manufacture medical devices in the state of California and with the FDA. We are able to comply with reduced DNA contaminate requirements upon request, and we have a humidity-controlled dry room.
Biotech is a worldwide business, but there are times that having a local converting partner to custom manufacture your parts or products is essential. At Custom Converting, we offer you the opportunity to sit down with one of our experienced team members in person. Biotech is one of the jewels in Oceanside’s crown, and as the industry continues to expand, custom converters will be in progressively greater demand. See all the benefits that working with a local biotech converter offers, and contact us today!
Wearable fitness technology manufacturing can enable your company to take advantage of one of the biggest trends in medical device manufacturing. If you’re looking for a custom manufacturer to make all or part of your product, contact us today.
• We offer custom adhesive solutions, to keep your wearable adhered to the skin. • We offer custom die cutting, which allows us to cut parts to your specifications. • We offer lamination services, if you’d like multiple layers of your product fused together. • And if you want to have your product ready for final sale, we offer packaging services on site.
Wearables manufacturers are often looking for partners to help them solve problems on their way to product creation. Our decades of experience with manufacturing for the medical device field gives us the edge over our competition – we’ve seen a lot, and overcome many challenges along the way. We’ve also worked with the fashion industry and produced millions of topical patches over the years. Why not put that expertise to work for you?
Wearable fitness technology manufacturing has incredible potential for growth. To fuel that growth, you need reliable partnerships, and vendors who are as excited about your new wearable as you are. Do you want to sit down and discuss feasibility? Custom Converting has a seat at the table waiting for you.
Are you looking for a US based manufacturer? We’re able to give your project the personal touch, while we keep it on-shore and shorten your supply chain.
Contact us today to discuss the potential of having all or part of your wearable fitness technology manufactured right here in California. We’re looking forward to hearing from you!
