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D 42 MCT ISO 13485 internal audit medical devices quality management system online course set of documents

MCT (multiple choice test) and case studies of your online training module ISO 13485 internal audit version 2016 with 41 questions, answers and comments

 
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D 42 MCT ISO 13485 internal audit medical devices quality management system online course set of documents
  • Added the: 08/12/2015
  • Last update: 25/01/2022
  • Number of pages: 22
See other documents

See the set of documents D 22v16 ISO 13485 readiness

See the set of documents D 72v16 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

Documents provided as annexes in the training course Internal audit ISO 13485.

See also the training package ISO 13485.

Other documents procedures and instructions ISO 13485 medical devices are in the set D 13v16.

 

Classroom exam paper form with the answers at the end

 

MCT 42 ISO 13485 version 2016 internal audit
 
  • Presentation
  • MCT Beginning, 10 questions (can be seen on the free demo)
  • 1 Scope
  • 2 Normative references
  • 3 Definitions
  • 4 Principles
    • 4.1 Management principles
    • 4.2 Audit principles
    • 4.3 QMS performance
  • MCT Internal audit, 7 questions (can be seen on the free demo)
  • 5 Audit program
    • 5.1 General
    • 5.2 Objectives
    • 5.3 Establishing
    • 5.4 Implementing
    • 5.5 Monitoring
    • 5.6 Reviewing and improving
  • Case New risk
  • Case Audit program
  • MCT Audit program, 11 questions
  • 6a Audit preparation
    • 6.1 General
    • 6.2 Initiating
    • 6.3 Preparing the audit
  • Case Nonconformities
  • Case Audit readiness
  • MCT Audit preparation, 8 questions
  • 6b Conduct an audit
    • 6.4 Audit actvities
    • 6.5 Audit report
    • 6.6 Completing the audit
    • 6.7 Audit follow-up
  • Case Audit finding
  • Case Audit report
  • Case Management review
  • MCT Conduct 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 competence, 7 questions
  • MCT End, 20 questions