Home └TM 007 Medical Devices Quality Management System ISO 13485 2016 └ISO 13485 : 2016 QMS Training - Section 1 : Introduction

TM 007 Medical Devices Quality Management System ISO 13485 2016

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ISO 13485 : 2016 QMS Training - Section 1 : Introduction

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1. Question 1: What was the previous version of this standard?
2006 2003 2005 2004
2. Question 2: ISO 13845 is applicable under which of the below product category?
Pharmaceutical Food Chemical Medical Device
3. Question 3: Which of the following is the main emphasis in the ISO 13485?
Product safety and performance Product Recall Product traceability Product identification
4. Question 4 : How many clauses are there in this standard?
10 9 8 7
5. Question 5 : Which of the following statements is false about the PDCA cycle?
It is only applicable for QMS It is important when implementing any change It can be use when starting a new improvement project It is an incessant management cycle used to continuously improve quality and control of business processes