Thursday, June 04 2020

T 72v16 - E-Learning - ISO 13485 training package - Readiness and internal audit version 2016

E-Learning (online courses) - Implementation, maintenance, improvement and internal audit of your medical devices ISO 13485 quality management system version 2016. You save 75 euros on the second course and 56 euros on provided documents!

PQB is referenced in France on DATADOCK as a training organisation since 19/10/2017
$
252.79
Ex. VAT
T 72v16 - E-Learning - ISO 13485 training package - Readiness and internal audit version 2016
 

Description

T 22v16 ISO 13485 readiness version 2016

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)

T 42v16 ISO 13485 internal audit version 2016

The important and fundamental elements of an internal audit

  • scope
  • normative references
  • principles
  • audit programme (responsibilities, records)
  • audit conducting (objectives, evidence, conclusions)
  • auditor competences (knowledge, training)

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
  • 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)