July 7, 2019 and May 8, 2020. Those are the dates that REDCOM EMS received AS9100D and ISO 13485:2016 certifications, respectively. If you are familiar with QMS (Quality Management System) certifications, you’ll know that each of these certifications requires a tremendous amount of effort to implement successfully. Here’s the story of how REDCOM EMS was able to achieve both certifications within two years.
REDCOM EMS initially achieved certification to ISO 9001:2015 in early 2017. This certification set an industry-standard baseline for quality within the organization and allowed REDCOM EMS to expand its customer base. Shortly after, there were several opportunities that REDCOM EMS could not bid on as they required an AS9100D or ISO 13485:2016 certification. That was when the gears started turning towards those certifications.
For relatively small manufacturers like REDCOM EMS, hiring an external consultant to assist with certifications can be very helpful. This is the path REDCOM EMS took for QMS implementation for the ISO 9001:2015 certification.
During discussions on how to best tackle AS9100D, our consultant informed us AS9100D is based on ISO 9001:2015 and recommended we start there. With ISO 9001:2015 achieved in 2017, we kicked off the process for AS9100D in September 2018.
The first step to AS9100D was performing a gap analysis to identify the additional needs in our documentation and processes. Once the gaps were identified, it was a massive undertaking and team effort within REDCOM EMS to implement and train on the new processes.
In addition to employee training, our internal auditors also needed to be trained and brought up to speed. Despite being a relatively small group, REDCOM EMS has a unique advantage where colleagues from REDCOM Laboratories were willing and able to step up as “internal” auditors. As a result, we had a great pool of objective and impartial auditors. They thought about our processes from different perspectives and in ways that we hadn’t considered before. Much credit is due to that auditing team for pushing the QMS to where it had to be.
The Stage 1 audit for AS9100D was held in May 2019, and the Stage 2 audit was held in June 2019. REDCOM EMS came away with three minor nonconformities and one major nonconformity, all of which were easily and effectively addressed. REDCOM EMS received its official AS9100D certificate on July 7, 2019.
ISO 13485:2016 Implementation
Rather than sit back and relax after the AS9100D certification, the ISO 13485:2016 certification project was kicked off a month later, in August 2019. This standard is based on ISO 9001:2008, which is the previous revision of the standard. Some adjustments were needed to incorporate different terminology into the QMS, but in general, many of the ISO 13485:2016 requirements were at least partially implemented during the AS9100D certification project.
Again, it was a massive team effort to implement any changes needed, and the “internal” auditors again raised the bar for the QMS. The Stage 1 audit for this certification was held in January 2020, and the Stage 2 audit was conducted in February 2020. REDCOM EMS came away with four minor nonconformities, all of which were again easily and effectively addressed. REDCOM EMS received its ISO 13485:2016 certificate on May 8, 2020.
The undertaking of implementing two new QMS certifications within two years was no small feat, and it highlights REDCOM EMS’ underlying dedication to quality and REDCOM management’s investment in the future success of REDCOM EMS. For now, REDCOM EMS plans to nurture and continuously improve upon the existing QMS systems, but it will only be a matter of time before the next project surfaces. Have a specific certification requirement for your products? We’ll get right on that!