The Fred S. Burroughs, North Jersey Chapter of Trout Unlimited (NJTU) is having their annual Fund Raising Banquet at Perona Farms on March 23, 2013. This chapter is made up of 500 volunteer members who actively organize and implement education and conservation programs throughout northwest New Jersey. All proceeds of their banquet directly support conservation in northwest New Jersey. They are not paid employees but are volunteer stewards of their environment.
Donations in cash, products or services will be recognized at their annual banquet, business cards or promotional materials will be prominently displayed next to your donation, and your donation will be acknowledged in their Banquet Program. NJTU relies on donations to help them continue to offer education and conservation programs in northwest New Jersey. Donations will be used to fund these and many other programs:
• Trout in the Classroom • Casting For Recovery
• Coldwater Conservation School • Musconetcong Home Waters Initiative
• Fly Tying Classes • Stream Restoration on the Flatbrook
• Riparian Tree Plantings • Public Awareness Programs
Trout Unlimited was created in 1959 and is today’s leading cold water fisheries advocate. With over 140,000 members and 400 chapters nationwide, Trout Unlimited is making America’s rivers cleaner, healthier and more fishable for children and all future generations and they are doing it right here in New Jersey. But they cannot do it alone, they need your help.
Timothy Good, member of NJTU and this chapter would like to thank everyone for their donations and for your help making conservation a reality in New Jersey. Please contact Tim by phone or email if you have any questions. Donations can be mailed to the bolded address below, or you may call Tim or Tom Mount for a convenient pick up time.
Timothy J. Good, Life Member
35 Island Trail
Sparta, NJ 07860
Phone (973) 580-5885
Please mail your contribution to:
NJTU Banquet Donations
c/o Tom Mount
150 Flocktown Road
Long Valley, NJ 07853
Phone: (908) 979-1631
Trout Unlimited: America’s Leading Coldwater Fisheries Conservation Organization
FRED S. BURROUGHS / NORTH JERSEY CHAPTER
P.O. Box 671, Sparta, NJ 07871
ISO Certification and the Medical Device Industry Part 3 – North American Standardization and Packaging
In this blog we’ll continue our look at ISO certification, and discuss the certifications possessed by NASP.
The current ISO 13485:2003 Standard relates to quality management systems in the field of Medical Devices, including IVD (In Vitro Diagnostic). The standard can be used by an organization for the design, development, production, installation and servicing of medical devices as well as for the design, development and provision of related services.
Every company that has secured certification to any of the ISO standards has persevered through the efforts necessary. For most companies it is a matter of tweaks while for others it may result in a complete overhaul of systems and processes. No matter the road necessary to reach the goal the efforts are well worth the result.
NASP was certified to ISO 9002/ EN 46002 in 2001 and has continuously maintained certifications to present day that include ISO 13485: 2003 for the contract manufacturing of medical devices and ISO 11135-1:2007 for the ethylene oxide sterilization of medical devices. The most recent recertification audit included the addition of design aspect to expand further the qualified services NASP is able to provide to our customers. NASP was able to realize the immediate benefits of securing certification through a broadened customer base by being considered for and securing contracts for products that are distributed in non-US markets. Additionally it reduced the number of and/or depth to which customers (existing and potential) conduct quality system audits. NASP also relies on ISO certifications in identifying, selecting and approving qualified suppliers for the services, materials and components integral to the NASP client base.
This concludes our look at the world of ISO certification, its relation to the medical device industry and its importance to what we do here at NASP.
Picking up where we left off in our last blog, here is an explanation of some of the terminology encountered is the ISO “world:”
Certification – the provision by an independent body of written assurance (a certificate) that the product, service or system in question meets specific requirements.
Registration – certification is very often referred to as registration in North America.
Accreditation – the formal recognition by an independent body, generally known as an accreditation body, that a certification body is capable of carrying out certification. Accreditation is not obligatory but it adds another level of confidence, as ‘accredited’ means the certification body has been independently checked to make sure it operates according to international standard.
Accredited Registrar – (Certification Body) – an organization accredited by a recognized accrediting body for its competence to audit and issue certification confirming that an organization meets the requirements of a standard (e.g. ISO 9001 or ISO 13485). Accreditation means that certification and inspection bodies have been assessed against recognized standards to demonstrate their competence, impartiality and capability.
Notified Body – an organization that has been accredited by a Member State to assess whether a product meets certain preordained standards. Assessment can include inspection and examination of a product, its design and manufacture. For example, a Notified Body may designate that a medical device conforms to the EU Medical Devices Directive, which defines the standards for medical devices. With this Declaration of Conformity, the manufacturer can label the product with the CE Mark, which is required for distribution and sale in the EU.
In our next blog we’ll look specifically at the ISO certifications possessed by NASP.
ISO Certification and the Medical Device Industry Part 1 – An Introduction to ISO and the Benefits of Certification
International Organization for Standardization (ISO) provides International Standards that ensure products and services are consistently safe, reliable and of good quality. From a business perspective using ISO can be a strategic tool to improve the efficiency and effectiveness of company operations. They can help companies to access new international markets, level the playing field in competitive markets and facilitate free and fair global trade. ISO has over 19,000 standards touching almost all aspects of daily life.
When products and services conform to International Standards consumers can have confidence that they are safe, reliable and of good quality. For example, ISO’s standards on road safety, toy safety and secure medical packaging are just a selection of those that help make the world a safer place.
ISO develops and publishes International Standards, including management system standards such as ISO 13485 and ISO 11135. However, it is not involved in the certification to any of the standards it develops. Certification is performed by an external certification body and a certificate is issued by an Accredited Registrar.
A company may decide to seek certification for the multitude of benefits certification may provide:
- Implementing a Quality Management System, in general, helps to motivate staff and provide a better definition of roles and key responsibilities.
- Implementing a Quality Management System specifically tailored for the medical devices industry helps the organization to demonstrate its ability to systematically provide medical devices and services that consistently meet customer requirements, applicable regulatory requirements (compliance) and safety standards.
- Cost savings can be made through improved efficiency and productivity, as product or service deficiencies will be highlighted and corrected.
- Improvements can be developed on a systematic and monitored base, resulting in less waste, less inappropriate or rejected work, and fewer complaints.
- Provides a systematic approach to risk management.
- Systematic, smoother, transparent and documented handling of activities required by regulation such as post-marketing follow-up and surveillance, complaint handling, CAPA implementation, field actions or product recall handling, vigilance and competent authorities reporting, and clinical experience enrichment.
- Systematic incorporation, at an early stage and within the design and development process, of the regulatory requirements impacting on the product itself and its technical features.
- Help creating a systematic vision embracing the medical device lifecycle, medical device packaging, its labeling, its installation, its servicing, and its usability. This includes the information provided together with the medical devices, the commercial claims, the unspoken user expectations, the feedback from users or patients, the risks associated with use, the benefits brought to the single patient and to the Community, the costs and the disposal of the medical device.
In our next blog we’ll go over some of the terminology that comes into play when discussing ISO certification.
Here at NASP we have the flexibility to customize products, processes and services to suit a wide variety of clients and projects. Regardless of the customization that takes place, you can be confident that our quality systems adhere to stringent FDA and ISO requirements.
With more than 200 years of cumulative experience between everyone from the executive level to direct labor staff, we have a wealth of knowledge for our clients to draw upon. We are well versed in growing a base idea into a custom solution for even the most unique applications. And if you have a product that you’d like to upgrade or modify, be it offering the “next generation” version of your star product, or looking to work out some kinks from other suppliers, we’re here to take you through that process.
The customization doesn’t stop once your product is complete. We can also customize the packaging of your device, utilizing everything from a simple pouch to a custom thermoform tray with a tie back barrier for sterilization purposes. And our sterilization processes can be tailored to meet your distinctive design requirements. Though
And to round it all out we have a continuous cost improvement activity to assure we deliver the best at an optimum price.
From product, to packaging, to sterilization and quality testing, we’re here to match our expertise with your needs, and produce a product that surpasses your expectations. We’re excited to get to work.
Here at NASP, we are a vertically integrated facility, meaning our engineering, manufacturing, packaging and sterilization services all take place under one roof. For us, this provides an efficient way of conducting our business. For our customers, this has a profound effect, lowering costs and reducing turnaround times.
Think of us as an extension of your technical staff. We can help you regardless of where you are in your design process. Do you have a fully designed product that you need manufactured? We’ve got you covered. We may even offer some recommendations, be they functional improvements, cost saving measures, or both. How about if you simply have an idea, a concept that you’d like to turn into a finished product? That works too. We’re happy to help bring your idea to fruition.
And once your design is complete, your manufacturing is in good hands. We have the means of providing a great many services in our facility. These include, but are not limited to, solvent bonding, soldering, sonic welding, die cutting and various adhesives applications. Cyanoacrylate, UV, silicone and water adhesives are just some of the adhesives we work with. Because of our extensive array of services, we have the resources to tailor our production process to suit your needs—our capabilities depend on your job.
We pride ourselves on flexibility, action and thought—and above all else customer service. So for your next project, work with us and we’ll take your idea from concept to market.