Online ISO 13485 version 2016 Quality Management System readiness course
Course
Online
*Indicative price
Original amount in EUR:
200 €
-
INTERNATIONAL INSTITUTE OF MANAGEMENT & ENGINEERING
Post Graduate Diploma OnlinePrice on request -
JRD Global EDU
Certificate Online₹ 25,700 -
The Global Open University
Master Distance learningPrice on request -
INTERNATIONAL INSTITUTE OF MANAGEMENT & ENGINEERING
Post Graduate Diploma OnlinePrice on request -
National Institute of Management
Master Distance learningPrice on request -
The Global Open University
Master Distance learningPrice on request -
Indian Management School & Research Centre
Master Distance learning₹ 22,500 VAT incl.
Description
-
Type
Course
-
Methodology
Online
-
Class hours
20h
-
Duration
60 Days
-
Start date
Different dates available
-
Personal tutor
Yes
Emagister adds to its catalog the Online ISO 13485 v 2016 Quality Management System readiness Course.
The course focuses on readiness for implementation, certification and maintenance of your medical devices quality management system (ISO 13485 version 2016).
The goal is to be able to meet applicable regulatory requirements and improve public heath through safe medical devices.
If you want to enjoy all the benefits of the course, contact us through our website Emagister.co.uk so we can provide you with the most relevant information.
Facilities
Location
Start date
Start date
About this course
This course will help you learn how to implement and maintain your ISO 13485 medical devices quality management system version 2016!
Any person involved in the preparation, implementation, certification and maintenance of your ISO 13485 version 2016 medical devices quality management system
none
Certificate of mastery and attendance
Low price, online course - you can train when you want, where you want, at your own rhythm of progress. There are games, jokes, cases, true stories, good practices, bad practices
You receive an email with links to the course, to the free demo, to the help how to order and details of the contact person
Reviews
Subjects
- Approach
- IT Management
- Management
- Quality Management
- ISO
- Medical Training
- Medical
- Process Control
- Process mapping
- Quality
- Quality Policy
- Quality Training
- Quality manual
Course programme
The important and fundamental elements of a medical device quality management system
- quality approach (quality management principles, PDCA cycle)
- standards and specifications
- process approach (definitions, process types, mapping)
- applicable regulatory requirements
- management review
- risks and opportunities
- resources, communication, documents
- production and service provision
- performance evaluation
- improvement
The menu of the course
- Presentation
- MCT (multiple-choice test) Beginning (10 questions)
- 1 Quality approach
- 1.1 Background and references
- 1.2 Scope
- 2 Principles and steps
- MCT Quality approach (8 questions)
- 3 Process approach
- 3.1 Definitions
- 3.2 Processes
- 3.2.1 Management process
- 3.2.2 Realization process
- 3.2.3 Support process
- 3.3 Process mapping
- 3.4 Process approach
- MCT Process approach (6 questions)
- 4 QMS
- 4.1 General
- 4.2 Documentation
- Case Interested parties
- MCT QMS (9 questions)
- 5 Management responsibility
- 5.1 Management commitment
- 5.2 Customer focus
- 5.3 Quality policy
- 5.4Planning
- 5.5 Responsibility
- 5.6 Management review
- 6 Resource management
- 6.1 Provision of resources
- 6.2 Personnel
- 6.3 Infrastructure
- 6.4 Work environment
- Case Customer & need
- Case Clean room
- Case Management review
- MCT Management responsibility (8 questions)
- 7 a Product realization
- 7.1 Planning
- 7.2 Customers
- 7.3 Design and development
- MCT Planning (8 questions)
- 7 b Product realization
- 7.4 Purchasing
- 7.5 roduction
- 7.6 Monitoring and measuring equipment
- Case Process stability
- Case Selecting suppliers
- Case New line
- MCT Purchasing and production (8 questions)
- 8 Improvement
- 8.1 General
- 8.2 Monitoring and measurement
- 8.3 Nonconforming product
- 8.4 Analysis of data
- 8.5 Improvement
- Case Nonconformities
- Case Audit programme
- Case Kaizen & problem
- MCT Improvement (9 questions)
- MCT End (20 questions)
Additional information
Students per class: 1
Contact person: André Milev
Online ISO 13485 version 2016 Quality Management System readiness course
*Indicative price
Original amount in EUR:
200 €
-
INTERNATIONAL INSTITUTE OF MANAGEMENT & ENGINEERING
Post Graduate Diploma OnlinePrice on request -
JRD Global EDU
Certificate Online₹ 25,700 -
The Global Open University
Master Distance learningPrice on request -
INTERNATIONAL INSTITUTE OF MANAGEMENT & ENGINEERING
Post Graduate Diploma OnlinePrice on request -
National Institute of Management
Master Distance learningPrice on request -
The Global Open University
Master Distance learningPrice on request -
Indian Management School & Research Centre
Master Distance learning₹ 22,500 VAT incl.