ISO 13485:2016 Refresher Training - Stage 1 скачать в хорошем качестве

ISO 13485:2016 Refresher Training - Stage 1

This 2-part webinar has been previously recorded three different times. Our previous webinar on the 2003 version of ISO 13485 was split into two parts: Stage 1 and Stage 2. That first webinar was recorded in 2015. The webinars were updated in 2016 and again in 2018. We followed the same format, 2-part Stage 1 and Stage 2, for all of the subsequent ISO 13485 training webinars. Stage 1 is a preparatory review, whereas Stage 2 is the in-depth validation for actual certification. Stage 1 is usually 1 to 1.5 days and can be conducted remotely. Stage 2 is usually 3 or more days in duration. The Stage 1 certification audit training focuses on the following processes: Introduction (0) Scope (1) Normative References (2) Terms and definitions (3) QMS General Requirements (4.1) Quality System Documentation (4.2) Management Commitment (5.1) Customer Focus (5.2) Quality Policy (5.3) Quality Objectives (5.4.1) Quality Planning (5.4.2) Management Responsibility, Authority, and Communication (5.5) Management Review (5.6) Provision of Resources (6.1) Measurement, Analysis, and Improvement (8.1) Feedback (8.2.1) Internal Auditing (8.2.4) Monitoring & Measurement of Processes (8.2.5) Monitoring & Measurement of Product (8.2.6) Data Analysis (8.4) General Improvement (8.5.1) Corrective Action (8.5.2) Preventive Action (8.5.3)