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D 22 MCT quiz and case studies ISO 13485 medical devices QMS set of documents

This set of three documents covers the requirements of the medical device Quality Management System (QMS). This 42-page document kit is a key resource to help quality managers and their teams understand and assimilate the requirements of the ISO 13485 standard. The documents are ready to use and editable (Word format) to adapt to your specific context and needs. These documents include 56 multiple-choice tests (MCTs) with questions and answers, 98 quiz questions and answers, and 20 ISO 13485 version 2018 case studies. All documents are part of the D 22v16 document set, which are the annexes to the T 22v16 "ISO 13485 readiness" training course.

 
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D 22 MCT quiz and case studies ISO 13485 medical devices QMS set of documents
  • Added the: 15/02/2017
  • Last update: 09/01/2026
  • Number of pages: 42
See other documents

See the set of documents D 42v16 ISO 13485 Internal audit

See the set of documents D 82v16 ISO 13485 package
 

You have an unlimited access for one year to the whole set of documents. This includes access to all the modifications (improvements) which could be made during that period.

Description

Free quiz without registration on the requirements of the ISO 13485 standard that you can exercise by clicking on the "QUIZ" button:

Documents forming part of the set of documents D 22v16 ISO 13485 Readiness part of the online training T 22v16 ISO 13485 readiness version 2016

See also the training package T 82v16 ISO 13485.

ISO 13485 procedures and instructions are in set D 13v16.

Documents related to the quality management system are in set D 15v15.

See also the documents in set D 64v19 Risk management DM ISO 14971.

 

Classroom exam paper form with the answers at the end

 

MCT D 22 ISO 13485 version 2016 readiness
 
  • Presentation
  • MCT (multiple choice test) Beginning, 10 questions (can be seen on the free demo)
  • 1 Quality approach
    • 1.1 Background and references
    • 1.2 Scope
  • 2 Principles and steps
  • MCT Quality approach, 8 questions (can be seen on the free demo)
  • 3 Process approach
    • 3.1 Process
    • 3.2 Process mapping
    • 3.3 Process approach
  • Case Interested parties
  • MCT Process approach, 6 questions (can be seen on the free demo)
  • 4 QMS
    • 4.1 General requirements
    • 4.2 Documentation
  • Case New risk
  • Case Risk treatment
  • Case Risk register
  • MCT QMS, 9 questions (can be seen on the free demo)
  • 5 Management responsibility
    • 5.1 Management commitment
    • 5.2 Customer focus
    • 5.3 Quality policy
    • 5.4 Planning
    • 5.5 responsibility
    • 5.6 Management review
  • Case Management review
  • 6 Resource management
    • 6.1 Provision of resources
    • 6.2 Personnel
    • 6.3 infrastructure
    • 6.4 Work environment
  • Case Customer and need
  • Case Clean room
  • MCT Management responsibility, 8 questions
  • 7a Product realization
    • 7.1 Planning
    • 7.2 Customers
    • 7.3 Design and development
  • Case Priority tasks
  • Case Communication
  • Case Design review
  • MCT Planning, 8 questions
  • 7b Product realization
    • 7.4 Purchasing
    • 7.5 Production
    • 7.6 Monitoring and measuring
  • Case Process stability
  • Case Selecting suppliers
  • Case New ligne
  • 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 Nonconformity
  • Case Audit readiness
  • Case Audit program
  • Case Auditor question
  • Case Audit report
  • Case Kaizen and problem
  • MCT Continual improvement, 9 questions
  • MCT End, 20 questions
D 22v16 MCT, quiz and case studies ISO 13485 version 2016
Codification Description Questions Pages
PQBD22v16A22 MCT ISO 13485 version 2016  56 14
PQBD22v16A19 Quiz requirements ISO 13485 version 2016 questions and answers   98 7
PQBD22v16A23 Case studies ISO 13485 version 2016  20 20
PQBD22Menu Menu ISO 13485 version 2016   1
Total 174 42