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