Hallmark Nameplate Attains ISO 13485 Certification

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Hallmark Nameplate achieved certification to ISO 13485, which allows the company to be involved in the production and service of medical devices and related services. It is another commitment to staying abreast of global requirements in the industry.

It is important to everyone at Hallmark Nameplate that their customers are aware of how seriously they take the standards.

At Hallmark Nameplate, their commitment to quality is what sets them apart. The company is proud to announce that they have achieved certification to ISO 13485. This certification is another way they are making constant strides to provide all customers with the best and most up to date products and services that they need.

The ISO 13485 Certification is a major accomplishment for Hallmark Nameplate and will allow the company to be involved in the production and service of medical devices and related services. Their products will be able to provide great services for extremely vital causes that they care about, as the devices they will be working with are medical instruments, machines or in vitro reagents, that are intended for use in the diagnosis, prevention, and treatment of diseases or other medical conditions.

Adding the 13485 Certification is part of Hallmark Nameplate’s commitment to staying abreast of global requirements in their areas of expertise. The standard includes a wide variety of medical devices and equipment, including dentistry, cardiology, and life support.

ISO 13485 is based on the requirements of ISO 9001 and as the same structure of clauses. The ISO 13485 standard, medical devices- quality management systems- requirements for regulatory purposes, is the basis for regulatory compliance in local and most export markets, and having certification demonstrates Hallmark Nameplate’s commitment to meeting customer requirements.

Hallmark Nameplate applied for ISO 13485 in order to manufacture and supply medical devices and components. Some of the specific requirements for manufacture, installation, and servicing requires a validation of process, compliance with statutory and regulatory requirements, effective product traceability and recall systems, and implementation of a quality management system with several enhancements.

The entire certification process involves three simple steps. The first is applying for the certification, followed by a basis audit to check whether the organization is in a state of readiness. That includes confirming that the quality manual conforms to the requirements of the ISO 13485, confirming the scope of certification including any justifiable exclusions, checking legislative compliance, production of a report that identifies any non-compliance or potential for non-compliance, an action plan, and production of an assessment plan. The final step involves a visit in order to document the entire system.

It is important to everyone at Hallmark Nameplate that their customers are aware of how seriously they take the standards. No matter the product, they want it to be the best and most reliable for all clients. Hallmark Nameplate is extremely proud that they are able to extend their variety of products into the medical field, and are excited to see what great things will come of this certification.

When it comes to making quality products that their customers trust, standards are everything. Hallmark Nameplate is certified to ISO 9001, registered to ITAR and UL/CSA recognized on many substrates and adhesives. Their goal is to continue to become certified in areas that will enhance the company and better serve all customers.

Some of the benefits of achieving ISO 13485 Certification include the emphasis of meeting regulatory as well as customer requirements, risk management, and maintaining effective processes. It is also designed to produce a management system that facilitates compliance to the requirements of customers and global regulators.

This certification will give Hallmark Nameplate the ability to communicate the exact quality of products that will in turn, allow customers to recognize the products and services that are reliable and trustworthy. The standard requirement not only addresses the regulatory requirements applicable for medical device realization but also for device specific and customer specific requirements that have potential adverse impact and risk on the product.

What this certification will do is reduce the production loss rate, reduce operational costs, increase effectiveness across the entire Hallmark Nameplate organization, and reassure the customer’s trust. Some of the additional requirements relate to process controls, special processes, traceability, record retention, and regulatory actions. It also emphasizes the cleanliness in the production area, increasing efficiency and safety in the workplace.

Hallmark Nameplate takes its credibility very seriously, and the certifications they have with these groups is yet another indicator of their focus on value and customer satisfaction. Hallmark Nameplate wants all customers to feel confident entrusting them to handle any and all projects, and the results will certainly speak for themselves.

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John Santiago
@AriasBosinger
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