Online ISO 13485 version 2016 Medical Devices Quality Management System Internal Audit course
Course
Online
*Indicative price
Original amount in EUR:
100 €
Description
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Type
Course
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Methodology
Online
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Class hours
10h
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Duration
60 Days
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Start date
Different dates available
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Delivery of study materials
Yes
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Personal tutor
Yes
To conduct an audit according to ISO 19011 in order to: identify improvement opportunities, increase the satisfaction of interested parties, evaluate the performance of the ISO 13485 v 2016 quality management system medical devices
Facilities
Location
Start date
Start date
About this course
This course will help you learn how to conduct an audit of your ISO 13485 medical devices quality management system v 2016
Any person involved in internal audits of your ISO 13485: 2016 medical devices quality management system and processes
Basic knowledge of ISO 13485: 2016, rudiments of ISO 19011
Certificate of mastery and attendance
Low price, online course - you can train when you want, where you want, at your own rhythm of progress, games, jokes, case studies, trues stories, good practices, bad practices
You receive an email with links to the course, to the free demo, to the help how th order, details of the contact person
Reviews
Subjects
- IT Management
- IT Audit
- Management
- Evaluation
- Quality Management
- Audit
- Auditing
- ISO
- Medical Training
- Audit management
- ISO Quality
- Medical
- Quality
- Quality auditing
- Quality Systems
- Quality Training
Course programme
The menu of the course
- Presentation
- MCT (multiple-choice test) Beginning (10 questions)
- 1 Scope
- 2 Normative references
- 3 Definitions
- 4 Principles
- 4.1 Management principles
- 4.2 Audit principles
- 4.3 QMS performance
- MCT Internal audit (6 questions)
- 5 Audit programme
- 5.1 General
- 5.2 Objectives
- 5.3 Establishing
- 5.4 Implementing
- 5.5 Monitoring
- 5.6 Reviewing and improving
- Case Audit programme
- MCT Audit programme (11 questions)
- 6a Audit preparation
- 6.1 General
- 6.2 Initiating
- 6.2.1 First contact
- 6.2.2 Situations and feasibility
- 6.3 Preparing the audit
- 6.3.1 Document review
- 6.3.2 Audit plan
- Case Audit readiness
- MCT Audit preparation (9 questions)
- 6b Performing an audit
- 6.4 Audit activities
- 6.4.1 Opening meeting
- 6.4.2 Audit evidence
- 6.4.3 Audit conclusions
- 6.5 Audit report
- 6.6 Completing the audit
- 6.7 Audit follow-up
- 6.4 Audit activities
- Case Audit report
- Case Management review
- MCT Performing an audit (8 questions)
- 7 Competence and evaluation of auditors
- 7.1 General
- 7.2 Auditor competence
- 7.3 Evaluation criteria
- 7.4 Evaluation methods
- 7.5 Auditor evaluation
- 7.6 Improving the competence
- Case Auditor question
- MCT Auditor competences (8 questions)
- MCT End (20 questions)
Additional information
Students per class: 1
Contact person: André Milev
Online ISO 13485 version 2016 Medical Devices Quality Management System Internal Audit course
*Indicative price
Original amount in EUR:
100 €