Contract Assembly: Meeting Your Quality Control Standards

When your company depends on third-party manufacturing and contract assembly, nothing less than the best is acceptable. While price is important, especially considering the ultra-competitive business landscape, quality is non-negotiable. How do you know that your contractor will deliver optimal results?

Before entering into any agreement with a third-party manufacturer or assembly contractor, it is important to inquire about their track record of success – and double-check with documentation. Another critical area to check: do they have ISO9001 and AS9001 certifications? If they do, that also means they have:

• Documented – repeatable – quality management processes. To earn accreditation, companies must demonstrate that they have clearly defined quality control processes. The processes in each area or business function are documented, and potential trouble spots are identified and resolved immediately. Customers/clients can be assured that their assembly needs are in competent, certified, hands.
• Systems for continual improvement. Whenever man and machine operate together, there are going to be occasional errors. To be certified, contractors must ensure that these occasions are few and far between, and more importantly, that they are flagged, investigated, and resolved. Further, steps are taken to mitigate or eliminate the chances of that error recurring.
• Ongoing training and support. Staff members are fully trained and receive ongoing education so they remain on the cutting edge of their field. This includes training required to do their current jobs more effectively and efficiently, as well as learning new skills to tackle increasingly complex customer demands.
• Ongoing internal quality audits. These audits ensure that employees follow all safety and quality control standards as set out in the quality management process. There is a strict procedure contractors must follow.

These four factors help ensure third-party manufacturers and contractors abide by the toughest quality control measures – and that customers will receive the quality they need, when they need it.

Medical Device Contract Assembly: Results You Can Trust

When surgeons pick up a scalpel, when technicians administer scans, when patients visit their health care providers, they all depend on precision and accuracy. They have to trust that their careers, results, and health are in good hands – or, rather, in good instruments. Medical device contract assembly depends on the highest level of quality control, consistent application of best practices, and a zero tolerance policy on defects. 

What sets outstanding medical device assembly contractors apart from the rest? A few factors include:

• Policies. Reliable assembly contractors adhere to the rigorous regulations set out by ISO9001 and AS9100C. Certification indicates that contractors meet the high standards of these organizations and will be able to assemble and kit medical device components with exceptional skill, integrity, and final results.

To earn accreditation, companies must document their processes, define their quality control systems, implement processes for remediating or correcting mistakes, conduct regular quality audits, and provide ongoing training and support for employees.

• Processes. As mentioned, to earn certification, contractors must have reliable processes in place for continual improvement to ensure they deliver optimal quality today – and tomorrow. It is important that these processes are clearly documented and adhered to by employees from the top of an organization to the bottom.
• People. The people truly make the difference. While some contractors offer cheap labor and overseas solutions, they are too often at the expense of quality. When manufacturers hire and actively train and support high-potential prospects, customers benefit in a significant gain in precision.

DNKB, Inc., for instance, is committed to hiring veterans and ensuring they secure well-paying, highly-rewarding employment opportunities. Customers benefit from their wide range of skills sets, as well as the discipline they bring to their work.

There is no room for error when assembling medical devices; companies should balance price with quality and choose contractors that can deliver on both counts.

Save Manufacturing Costs with an Assembly Subcontractor

Hiring an assembly subcontractor can help save your company money, streamline the supply chain, improve operational efficiency, and increase the quality of your final output. Look to the best sub assembly contractor in the Phoenix area. DNKB is a veteran owned small business. We are registered ISO 9001: 2008 and AS 9100C. Contact us today for more information: https://goo.gl/zOXOTM

What Does ISO 9001:2008 Certified Mean?

The International Organization for Standardization (ISO) is an international, non-governmental organization dedicated to developing “voluntary, consensus-based market relevant International Standards that support innovation and provide solutions to global challenges.”

In short, the ISO says, International Standards “make things work.” Certified businesses must meet rigorous standards for quality, safety, and efficiency. With members from 162 countries, and a team of highly-trained technical experts, ISO has developed over 20,500 standards. Among these is the “ISO 9000 family.”

The ISO 9000 set of standards deal with quality management. They provide organizations with the tools and support they need to meet market expectations and continually improve quality.

What is ISO 9001:2008 (Recently updated to 9001:2015)?

This International Standard explains the requirements for quality management systems. To earn certification, businesses must, among other

• Demonstrate their ability to consistently provide products that meet customer requirements – as well as applicable regulatory requirements.
• Enhance customer satisfaction through the effective application of the system. They must have a system for continual improvement of the system, as well as a system for assurance that their products conform to customer and regulatory requirements.

Further, ISO 9001:2008 guides every step of a manufacturer’s process, from employee training and production to documentation and internal audits. The emphasis is on quality and ongoing improvement. To that end, businesses must have a process that enables them to continually document, review, assess, and improve each aspect of each process. The end result: a higher level of quality and assurance to customers.

These standards are designed to apply to all organizations, regardless of what they produce or how large they are. 

Why Does This Matter To OEMs?

As mentioned, it is not only assembly that manufacturers entrust to contract assembly providers. It is their names and reputations. When they opt to partner with an assembly contractor that is ISO 9001:2008 certified, they have assurance that they are hiring a quality-conscious organization.

In addition to the highest quality products/processes, benefits include:

• Superior customer service.
• Timely order fulfillment.
• An emphasis on quality improvement, which ensures the OEM’s reputation remains strong.
• Consistent results.
• Reduced waste – which means greater cost savings.

When organizations need to outsource their assembly needs, they should look for a contractor that treats their reputation as if it is their own. ISO 9001:2008 certification is a major indication that they stand for quality, efficiency, and service.