2018 DEC

Making the Grade: Understanding the ISO 9001 Certification

  • Cameron Parchment, Spraying Systems Co. East Coast Facility
  • Quality Management, ISO 9001, Certifications, FDA compliance
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luid Air holds itself to the highest standards of quality. From manufacturing to management, producing world-class solid dosage processing solutions is a top priority for us, and we have been recognized for our dedication to excellence by meeting every requirement outlined to receive the ISO 9001 Certification. But not everyone knows exactly what these credentials mean or what it takes to earn them; let us take a moment to expand our collective knowledge.

First, it is important to understand what ISO 9001 entails: it is the international standard that specifies requirements for a Quality Management System (QMS), a formalized structure that helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness on a continuous basis. This is done by documenting processes, procedures, and responsibilities for attaining superior objectives and practices.

So, what are some of the things Fluid Air has done to meet the requirements of ISO 9001? For starters, we take every step to ensure that members of our team are properly trained, and all products are produced in a quality manner. Many of our customers operate in the food & pharmaceutical industries, and when orders are placed with us, we supply them with “like-for-like" parts manufactured with FDA or EU compliant materials, meaning they will receive an exact replication of the component they normally use. Additionally, our team takes every step to qualify the vendors & subtractors we do business with by carefully verifying that they are in exceptional standing. Furthermore, all parts go through the correct component process checks, receive the proper material certifications, and any non-conforming materials are segregated and documented. Should quality issues arise they are addressed using our Corrective and Preventative Action (CAPA) process.

At Fluid Air, quality record maintenance is done using Good Documentation Practices (GDP/GDocP). This encompasses and stresses methods such as creating accurate documents that are concurrent with the event(s) they describe, ensuring all originals and subsequent copies are legible and approved, signed, and dated by authorized personnel, & that all records are otherwise reviewed, updated and backed up while maintaining a history of all changes made to each document. Suffice to say, we take GDP very seriously.

But again, why is it imperative that our customers know that Fluid Air is ISO 9001 certified? Simply put, attaining certification to this standard greatly enhances an organization’s credibility by showing customers that its products and services meet expectations. So, if you’re unsure if Fluid Air is the right choice, just look upon the standard of proof we proudly display, and you’ll realize this is the team willing & able to do whatever it takes to make the grade.



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