Training Course Syllabus:
Path paved by the International Standard for ISO 9001:2015 for ISO 13485, the Medical Device Standard Webinar Time: 10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Instructor: Meena Chettiar
ISO 9001, is the leading international quality standard that has helped millions of organizations to improve their quality and operational performance. The new version ensures ISO 9001 maintains relevance in today´s market place and continues to offer organizations improved performance and business benefits.
Why Should you Attend
The new standard provides a great opportunity for your organization to review your quality management system and ensure that its aligned with the strategic priorities of your organization. Understanding ISO standard requirements is very important in all production environments. Similarities and differences between the two major ISO standards will help career transitioning of quality and management between regulated industries.
Objectives of the Presentation:
- ISO 9001: 2015 requirements and its applications
- History of correlation between ISO 9001 to ISO 13485
- Important differences in audit elements that make ISO 13485 unique to the medical device industry
- Key FDA focus items from ISO 13485 such as CAPA (Corrective and Preventive Actions) , DHR (Device History File) and DMR (device Master Record)
- Items being added to ISO 13485: 2016 from ISO 9001:2015
- How do you transfer knowledge from ISO 9001 to ISO 13485 during career transitions to enhance customer satisfaction and manufacture products that meet customer satisfaction and withstand regulatory scrutiny?