CML PCB Factory-Starteam Obtains Medical Certification ISO13485:2016

Reading time ( words)

CML PCB factory- Starteam, is a German PCB manufacturer located in Sichuan, China. The key strength of our factory lies within our German quality mindset, German and Chinese management system.

The quality, reliability and flexibility of our services are crucial to our customers, especially for the medical sector. With the overall rise in global demand from the medical sector and insufficient supply, the management team realized the imminent implementation of ISO13485:2016. We are proud to announce that on 26th June 2020, SGS issued the ISO 13485:2016 certification to Starteam. This will allow us to serve the growing demands in medical within our customer base and extend our reach to new customer needs. It took about 6 months from project approval to completion. At Starteam, we have adopted continuous improvement into our organizational culture as part of our philosophy. Throughout the ISO process, it provided a good opportunity to put our philosophy into practice, engage our team and further strengthen their awareness and processes towards quality management system.

The scope of certification is for PCB Manufacture of Active Medical Device. From the beginning of the COVID-19 outbreak in China in January 2020, Starteam received the first medical device order from Chengdu Fan Mi Technology and Sichuan Youkede for infrared thermometers. With the strain on communities and healthcare systems across the world, Starteam was entrusted by many global companies to produce PCBs for their hospitals and critical care products such as thermal cameras, Powered Air-Purifying Respirators, blood dialysis machines and ventilators.

Starteam is rapidly growing, developing and adapting to external factors to enhance our competitiveness, efficiency and productivity. We believe in investing into our production facility and our people in order to ensure sustainable long-term results that will benefit our customers. Our team of experts can provide the solutions you need and contribute to the success in different industries and technologies together.



Suggested Items

W. Edwards Deming’s Lost Chapters Recovered

08/12/2020 | Happy Holden, I-Connect007
I was cleaning up my bookcase recently and came across a tired, dog-eared set of papers that was Dr. Deming’s initial draft of his book "On The Management of Statistical Techniques for Quality and Productivity," which I received when he came to HP to lecture about quality and productivity on March 11, 1981.

Focus on the Impact of Data

07/08/2020 | Nolan Johnson, PCB007
Nolan Johnson recently spoke with Dana Korf about his experience with total quality management (TQM) throughout his career. Dana recommends not getting stuck on the process of collecting the data and documenting it, but instead to look at the impact. If you haven’t made an impact, then you haven’t done a good job.

June PCB007 Magazine on TQM: A Preview

06/10/2020 | Nolan Johnson, I-Connect007
The June issue of PCB007 Magazine will be published next week. Can’t wait to download it? Enjoy this preview of how we arrived at the topic of TQM, as well as what you can expect to read inside. One gem: Happy Holden retrieves some of W. Edwards Deming’s lost chapters after uncovering pre-publication drafts of the 1985 Deming book that Happy received as a training handout at Hewlett-Packard from Deming himself.

Copyright © 2020 I-Connect007. All rights reserved.