DQS Academy has just provided a public course on ISO 13485:2016 Internal Auditor Training. Emphasis was made on surgical mask manufacturing due to the outbreak of CoViD-19. The course includes ISO 13485:2016 standard understanding, internal audit skills, regulations, and quality control for surgical mask manufacturing, supported with a large number of case studies.

Some trainees attended the on-site training, and some more chose to participate the course with remote access. Thanks to the latest ICT technology, the effectiveness via remote access was proved to be almost as effective as that of onsite approach. The course was smoothly delivered with active and great interactions between the trainer, trainees at site and through remote access.

With small-class approach, the participants had the opportunities for in-depth exchanges, discussions and role plays. Each participant’s questions can be well addressed. From the surveys, the participants gave high ranking on the learning effectiveness, which are verified by exam at DQS Academy website.

About DQS

DQS issued the 1st ISO 9001 certificate in Germany, and is the 1st Certification Body recognized by IATF for ISO/TS 16949 (now replaced by IATF 16949) certifications in the world.
DQS is a certification body for ISO 13485:2016, a Notification Body for medical devices and CE marking, and an Audit Organization (AO)  providing MDSAP audits.

DQS Academy provides Internal Auditor Training and Lead Auditor Training courses. More courses are available at DQS Academy.

 

醫療器械管理體系內審員培訓 (側重口罩製造)

DQS 學堂在近日爲客戶提供了一個公開的ISO 13485 內審員培訓課程。因應近期的疫情,課程側重口罩製造相關內容。該課程包括 ISO 13485:2016標準的理解、內審技巧、口罩製造的品質控制、醫療器械的監管法規和模式等內容,並配備大量的案例。

此次培訓,部分學員選擇現場參加課程,但更多的學員選擇線上遙距參加。有賴於最新的網路通訊技術,線上培訓被證明能以與線下相近的效果進行。培訓過程順利進行,講師、現場學員和線上的學員之間積極互動和討論。

透過小班教學的模式,學員可以有機會進行深入的交流、討論、和角色扮演,並讓每個學員的問題都得到了詳細解答。根據課程調查結果,參加者對他們的培訓學習效果都給了很高的評價。這些效果在DQS 學堂網站上的考試得到驗證。

關於DQS

DQS發行了德國的第一張ISO 9001證書,同時是世界上第一家被 IATF 認可提供 ISO/TS 16949(現更新為IATF 16949) 認證服務的認證機構。
DQS是ISO 13485:2016認證機構、歐盟醫療器械CE標誌審批的公告機構、以及提供多國 醫療器械單一審核方案 (MDSAP) 的審核組織。

DQS學堂 提供內審員培訓主任審核員培訓課程,按此瞭解更多DQS 學堂提供的課程。