During the first week of July 2016, a dedicated team of employees from Datapak began a seminar with delegates from the Michigan Manufacturing Technology Center. This seminar, which spanned a total of 80 hours led to Datapak receiving certificates of compliance for ISO 9001:2016 and ISO 13485:2016. These levels of compliance place Datapak within reach of ISO certification.
While some may read the information above and nod their head with approval, others may just see letters and random numbers. For anyone unfamiliar, the acronym ISO stands for the mouthful “International Organization of Standardization,” and according to ISO’s website:
“(ISO) brings together experts to share knowledge and develop voluntary consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.”
So why does ISO matter? ISO matter? Simply put, international standards are what keep almost everything in our world consistent, reliable and above all, safe. Again, ISO states:
“(international standards) give world-class specifications for products, services and systems to ensure quality, safety and efficiency.”
ISO will argue that when things don’t work as they should, it often means that standards are absent.
If you are sitting at a desk with a computer, take a second to look at your keyboard. If you have become comfortable with its layout, design and functionality, then you can thank the ISO standard 9995, which “defines a framework for the layout of all alphanumeric and numeric keyboards.”
If you have enjoyed milk at any point in your life, then you can thank the ISO standard 6785, which “specifies a method for the detection of Salmonella in milk and milk products.”
To shed light on Datapak’s decision to pursue ISO 9001 and ISO 13485 certifications, Client Service representative Dave Buck responded-
“The initial reason Datapak began working towards ISO certification was due to a client, MC10. This client is currently working towards the goal of having their product become a registered medical device. In order for any business to take part of the design, manufacturing or distribution of a registered medical device, they must be ISO 13485 certified. This certification specifies requirements for a quality management system regarding medical devices.”
Regarding ISO 9001 certification, which specifies requirements for a quality management system, Buck stated-
“It was only logical for Datapak to also pursue ISO 9001 certification in addition to ISO 13485. With the 9001 certification, we will bring proof to any current or future client our ability to provide services which meet industry regulatory requirements.”
Datapak’s next steps towards the ultimate goal of ISO 9001 and 13485 certifications are to continue creating internal ISO management systems. Buck stresses the importance of robust documentation regarding all steps leading up to the eventual hiring of a 3rd party ISO auditor. These data trails will provide proof that Datapak has and will continue to uphold all ISO standards.
Datapak has set an internal goal of July 2017 to become ISO 9001 and ISO 13485 certified.