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Month: December 2017

The Benefits of Being ISO:13485 Certified

Medical devices must be precise in their design and manufacture because they impact lives for the better or worse. To reach high levels of reliability in production, quality standards are essential. The benefits of adhering to ISO 13485, which outlines quality management system standards for medical devices, include efficient cycle times, less waste and a reputation for reliability that can permeate throughout the medical industry.

Overview of ISO 13485

According to the International Organization for Standardization, ISO 13485 applies to companies in one or more stages of medical device production. This includes the sourcing of materials, distribution, design, and sterilization, among other functions in the manufacturing life cycle. Quality management system general requirements, management’s responsibility, documentation standards, and product realization are among the subjects covered in ISO 13485. If an organization can prove conformance to the elements of the quality management system, it can become ISO certified.

Faster Cycle Times

Quality and process excellence initiatives utilize statistical process control, waste reduction and systems thinking to increase customer satisfaction. A common result of quality management system deployment is faster cycle times in the supply chain and on the production facility floor. This is because products, processes, and systems are under constant review and re-design when quality management is part of organizational culture. Whether it’s in administration, accounting or purchasing, quality can lead to faster cycle times and better service.

Less Waste

Waste reduction in all parts of the production process is a direct result of building an organization to conform to ISO standards. Identification and removal of overproduction, waiting, excess inventory, defects, and scrap are among the benefits of quality management system deployment. There are also fewer internal machinery failures and fewer customer returns. All of this leads to lower production costs and higher profit margins. Reduction of labor hours allows for cost-savings and the reallocation of resources to value-added activities.

Systematic Process Improvement

Although it’s the responsibility of employees at all levels of an organization to enhance the efficiency and effectiveness of operations, it’s hard to do so without having a common language to describe inefficiencies and process improvements. A quality management system not only creates effective communication channels to articulate deficiencies, but it also provides systematic methods for improving processes through six sigma and lean techniques. Whether it’s through quality auditing or corrective action requests, systematic improvement is a benefit of ISO 13485 certification.

Higher Customer Satisfaction

Quality management systems reduce the cost of non-conforming products, enhancing customer satisfaction. This is true for suppliers of raw materials and other entities in the supply chain, and it can lead to better customer experiences. Given that medical devices have such an impact on people’s lives, there is little room for error or customer returns. For example, statistical process control can help remove special cause variation from the machining process, to create a product that rarely deviates from design thresholds. This can enhance the quality of people’s lives over the long run because medical devices can withstand environmental strains and deliver on their intended purpose.

Higher Prestige

Meeting ISO requirements enable companies in the medical device industry to better market their products and services. When they become certified, they have met an objective standard of excellence that enhances their competitive advantage in the marketplace. While creating an organization that meets quality management system standards is not a simple process, it is well worth the effort and investment of time and energy. This is because quality is the driving force behind business success and failure.

To remain competitive in the global economy, medical devices must meet exceptional quality and service standards. ISO certification communicates a message to all potential business partners that certified companies are world-class businesses capable of delivering value and long-lasting support, in the fiercely competitive and ever-expanding world of medical device providers.

The prestige and enhanced efficiency associated ISO:13485 are enough to justify being certified. What’s more, the quality of medical devices, along with the profitability of operations and the morale of your employees, will hit new levels of excellence. Process excellence is the key to better business outcomes.

At Hallmark Namplate we are proudly ISO:13485 certified, and ready to help businesses meet the highest standards of quality.

Customer Advantages of Ordering from a Small Business

Effective sourcing of products and materials is critical for maintaining a competitive advantage in the marketplace, and ordering from a small business is often the best strategic choice. Ordering from a small company can lead to faster delivery times, less waste during installation or manufacturing and personalized service. These and other benefits make sourcing nameplates, overlays, membrane switches and electronic assemblies a more reliable process.

Product Customization

When it comes to nameplates, personalized service and support can lead to higher quality, longer lasting plates that are aesthetically pleasing. Ordering these pieces from a small business allows better communication of product requirements, creating customized plates that fit on specific surface areas. Customization also includes serialization, indoor or outdoor design, and the appropriate gloss, matte or velvet finish. While larger companies can customize nameplates, they may not have the time or flexibility that a small business does to focus on one client’s needs.

Higher Functionality

Products that meet functionality requirements have a multitude of benefits including driving operational efficiency and increased employee morale. For example, sourcing graphic overlays that meet texture, embossing, surface, and environmental requirements remain highly functional for longer periods of time. It takes resources and testing to meet customer requirements, with communication between customers and overlay providers proving a critical part of the process. Small businesses have the motivation to maximize communication and functionality to maintain business relationships and supplier agreements.

Long-Lasting Relationships

All businesses value their customers, but small companies must work harder at maintaining their current relationships. Otherwise, small suppliers can find themselves in a precarious position, if they lose even one major client. As a result, small companies tend to work harder at maintaining their relationships through higher quality products and attentive service. This is beneficial to customers because it can lead to longer-lasting relationships, where suppliers learn the nuances of customer requirements. Strong relationships allow for flexibility in the supply chain, along with the reduction of defects and errors.

Exclusive Relationships

Quality management philosophies dictate that customers and suppliers create special, long-term relationships that drive efficiency and reduce waste. When ordering from a small business, exclusive supplier agreements can be reached, which creates the opportunity for better supply chain management. Having a supplier that understands the nuances of product requirements can prove to be invaluable in terms of product quality and flexibility. The more effective a supplier agreement is, the more nimble and competitive customers can be.

Exclusive relationships help customers and small businesses grow, allowing suppliers to support their customers more effectively over the long run. If customers do not help their suppliers scale up, then their own growth initiative may be hampered. Working with a single supplier can create a wealth of benefits for all parties involved.

Greater Customer Leverage

Large suppliers tend to have a lot of leverage when it comes to pricing and delivery times because they can afford to lose one client if that client’s terms are not as attractive compared to others. This is not the case with small suppliers. When customers order from a small business, they have more leverage in almost all aspects of the transaction. This is beneficial on multiple levels, especially when a customer’s financial situation is strained and they need a flexible purchase agreement.

Fast & Competitive Quotes

Clear communication and efficient cycle times are keys for effective supply chain management, and small businesses have a vested interest in providing quick, attentive service. Fast service includes responsiveness when it comes to providing detailed quotes and competitive terms on orders. Customers that need sales and engineering support can find the personalized service they need when they utilize a small company. Fast and competitive quotes for products leads to better decision-making for customers, allowing for optimal order quantities at the most advantageous prices.

Sourcing from a small business has multiple advantages ranging from personalized service and support to exclusive vendor contracts. Having a reliable business partner that provides quality products can enhance competitive advantage over the long-term. This makes working with a small business for nameplates and related products a strategic benefit.

Why Our Inspection Process is Crucial

A stringent inspection process is very important for any company that manufactures any sort of electronic devices. However, a strict inspection routine is even more important for a company that manufactures electronics. This is because the slightest error in the construction of an electronic device can lead it to be completely inoperable. Small companies that do not mass-produce their electronics have to even be even more vigilant about looking for errors. This is why we have instituted a very thorough inspection process. To learn more about our inspection process and why inspecting these items is so critical, read on.

What Our Inspection Process is Like

There are three main parts to the inspection process. Of course, our trained engineers will do a visual inspection when the item is almost ready to be shipped out. However, this is far from the only level of scrutiny that we subject your items to. We also do auto-optical inspections and x-ray inspections. Auto-optical inspections involve a computer with a camera scanning the item as it’s being made and looking for any defects. X-Ray inspection is fairly self-explanatory. The item goes through an x-ray machine, which automatically tests for any defects that may have gone undetected up to that point.

Our Inspection Process Compared To a Lax Inspection Process

Many small manufacturers have relatively lax inspection processes. Nearly all of them will at least do a visual inspection. However, this is not enough if they want to reduce the incidences of defects by as much as possible. A company that does not perform either x-ray or auto-optical inspections will inevitably have many more defects in their products then one that does.

The Dangers of Not Having an Inspection Process at All

There are a few less than reputable manufacturers that do not have an inspection process at all. This is more common in countries such as China and Vietnam that are known for producing very cheap electronics. The practice is rare in the United States, but it has been known to happen. Companies may be tempted to do this because it will save on man-hours, which translates into less cost for the company. However, companies that don’t have a proper inspection process will have much higher rates of defects in their products. Many consumers feel the lower prices are not worth it.

Benefits of Having a Stringent Inspection Process

One obvious benefit of having a strict inspection process is a lower rate of errors. However, this is not the only benefit of having a strict inspection process. One underrated benefit of having such good motivation for producing items properly is the Improvement in company culture. Having a stringent inspection process encourages employees to be careful and painstaking in their work. It lets employees know that quality is more important than speed in the company’s operations. Studies have shown that corporate culture is very important in the quality of the products that the company puts out.

Training Employees to Inspect Items

Of course, employees must be trained to inspect the items properly. They have to be carefully trained in visual inspections, auto-optical inspections, and x-ray inspections. The employees that make it through this training that are assigned to the inspection process are well prepared to ensure the quality of every single item that we put out. We take pride in having highly trained and experienced employees. This results in higher quality products, as well as more knowledgeable customer service to everyone that we work with.

How to Learn More About Our Inspections

If you are interested in having us produce a device for you, you can contact us and we can give you more detail about our inspection process and the rest of our operations. We have a team of highly-trained and experienced engineers that’ll be happy to speak with you and explain how our process works. If you have any questions about the options you want to go with regarding your device, you can give our experts the details of the situation and they will make an informed suggestion for you. Of course, the final decision is up to you. We always respect our client’s decisions and execute their instructions the best of our ability.