Understanding Quality Management Systems and Certifications

Posted by Casey Cephas | 4/18/20 10:32 PM

Legendary basketball coach, John Wooden, once said, "It isn't what you do, but how you do it." This idea not only applies to sports but also manufacturing. In today's competitive, regulated business environment it's not enough to simply make something. Whether it’s a single component or complete product, it matters how you make it, in order to ensure quality, consistency, and compliance.

How can you be confident that your manufacturing partner is adhering to the latest industry quality and safety standards? A good place to start is by evaluating the company’s quality management system and certifications.

What is a quality management system?

A quality management system (QMS) isn’t a singular thing – it's actually an integrated combination of internal policies, processes, and procedures that work together to ensure comprehensive quality, safety, and compliance. It's also an evolving approach, meaning that the manufacturer is never complacent and constantly looking for ways to improve its system and performance.

A few critical components of a quality management system should include:

  • Establishing internal requirements, as well as ways to make sure those requirements are met
  • Documentation of process, procedures, and work instructions
  • Training on QMS for employees
  • Measurement, monitoring, and reporting
  • Plans for addressing risk and opportunities
  • Internal and external audits

QMS are accredited by organizations such as ISO, ANSI, and other third-party organizations. These certifications should be one of the top factors to consider when selecting a manufacturing partner. If a vendor you're considering doesn't list certifications – ask about them. A reputable manufacturer should be happy and willing to discuss their QMS.

ISO 9001

Many consider ISO 9001 to be the gold standard for quality management certifications. It is a non-industry-specific designation that sets QMS criteria for any type or size of an organization. The most recent version of 9001 was published in 2015, meaning companies who have a 9001:2015 certificate adhere to the latest and strictest requirements.

ISO 13485

Depending on your industry or product, you may also want to look for advanced or specialized certifications for quality assurance and compliance. In the field of medical devices, one of the most sought after certifications is ISO 13485:2016. This certification covers consumer and regulatory requirements, including sterilized environments, advanced risk-based methods, validation planning, and more. ISO 13485 pertains to organizations involved in any stage of the medical device product life cycle, including design, production, distribution, suppliers, and service.

Tapecon’s QMS.

At Tapecon, we take tremendous pride in our quality management system that covers everything we do, including printing, custom converting, fabrication, assembly, and much more. We also hold numerous credentials such as ISO 9001:2015, ISO 13485:2016, and FDA registered, among others.

Get started with contract manufacturing.

At Tapecon, we have over 100 years of experience helping customers solve their complex product challenges. Learn more about our quality management system capabilities.

Topics: Manufacturing, Quality

Written by Casey Cephas

Casey is the Marketing Coordinator at Tapecon Inc.

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