A Singapore firm in the printing business switched to making masks amid COVID-19.
Stendard played a part in making that happen!
While previously engaged in printing services that were affected due to cancellations of major events and trade shows, AVS Technologies was not to be derailed and quickly adapted to making medical masks in the wake of COVID-19. This feat is no small achievement as such manufacturing activities are vastly different from activities that they used to engage in – ranging from the distributing of printing equipment to providing printing services such as 3D printing.
For one, a medical mask is classified as a medical device, and is so subject to regulatory requirements enforced by authorities. These requirements include the need to set up a Quality Management System (QMS) compliant with the ISO 13485 standard, as well as run the appropriate clinical tests to prove the quality of the product. A huge challenge for a company new to the market would be to even begin researching and understanding where to start.
Setting up a QMS from scratch in record time.
Stendard was engaged in April for our consultancy services when AVS Technologies made the decision to move ahead with this new business plan of manufacturing medical masks. As the team at AVS Technologies worked closely with our consultants, we successfully implemented a QMS in line with the ISO 13485:2016 standard in the short span of one month! This included the preparation of a full set of QMS documents and records, setting up of processes such as verification and validation tests besides thorough QC checks, as well as training of all 30 staff at AVS Technologies who were enlisted to participate in mask production. Our consultants were able to provide advice and reviews of the appropriate technical tests to be performed, and helped refine the checking procedures required of the manufacturing processes and products, in order to ensure that product quality is not compromised.
Remote collaboration on our cloud platform.
In part, this achievement was possible due to the use of an Enterprise Quality Management System (EQMS) and Document Management System (DMS) software. Stendard Solution™ allowed AVS Technologies to automate their workflows and notify various teammates of their assignments and due dates. While much documentation and approvals are required as part of a QMS, the team at AVS Technologies was not hampered by the remote working situation as the e-signature feature of the software allowed for document preparation and approvals to be done even while away from the office. Confusion over document versions, commonly experienced by other companies, was also removed as everyone was kept on the same platform with clear document version-control through the system.
Entering the market and expanding abroad with a good QMS foundation set!
Besides the record time taken to implement a proper QMS, Stendard was able to support AVS Technologies through a smooth HSA audit, which allowed for the production and distribution of the masks in Singapore to start in May!
Beyond the Singapore market, AVS Technologies is expanding internationally. We have been able to see through the CE-marking product registration for the EU market in July, and are excited to continue in assisting with the US, Canadian, and Australian markets (FDA, MDEL, and TGA). As AVS Technologies continues maintaining their QMS as set up, the correct documents required for these product registrations can be easily retrieved from Stendard Solution™. The registration process will be smooth as the QMS is in place and automated, without gaps that would be questioned by authorities.
With a long-term perspective and business strategy, AVS Technologies is keeping up with these QMS processes, which would allow them to explore future opportunities with its more advanced capabilities in 3D printing. Maintaining a good QMS is indeed invaluable in setting the stage and removing roadblocks for further growth and development.
