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

This set of three documents covers the ISO 19011 recommendations for auditing a medical device Quality Management System (QMS), version 2016. This 30-page document kit is a resource to assist quality managers and auditors in conducting the audit when your company is ISO 13485 certified. The documents are ready to use and editable (Word) to adapt to your specific context. These documents include 41 multiple-choice questions and answers, 98 quiz questions and answers, and 10 ISO 13485:2016 case studies. All documents are part of the D 42v16 document set, which are the annexes to the T 42v16 training course, "ISO 13485 Internal Audit."

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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: 21/08/2025
Number of pages: 30

See the set of documents D 22v16 ISO 13485 readiness

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

Contents of the package

3 documents (30 pages) designed to help prepare and conduct internal audits according to the recommendations of ISO 19011 for auditing a medical device quality management system (QMS) ISO 13485 version 2016
detailed content:
- 41 multiple-choice tests
- 98 questions and answers (requirements quiz)
- 10 case studies based on ISO 13485:2016
the documents are ready to use and editable (Word format) to adapt to specific needs

Use and integration

these documents prepare auditors to conduct internal audits in accordance with ISO 13485 requirements
classroom exams are possible in paper format, with answers provided at the end

Target audience

quality managers, trainers, auditors, and teams wishing to assess, reinforce, or test their knowledge of ISO 13485:2016

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

Quiz requirements ISO 13485 version 2016

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

See also the training package ISO 13485.

See also the document sets:

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 External audit nonconformity 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 Case Auditor independence *MCT Auditor competence, 7 questions* *MCT End, 20 questions*

D 42v16 MCT, quiz and case studies internal audit ISO 13485 version 2016
Codification	Description	Questions	Pages
PQBD42v16A14	MCT internal audit ISO 13485 version 2016	41	12
PQBD22v16A18	Quiz requirements ISO 13485 version 2016 questions and answers	98	6
PQBD42v16A15	Case studies internal audit ISO 13485 version 2016	10	10
PQBD42v16Menu	Menu of the course internal audit ISO 13485 version 2016		2
Total		149	30