T 82v16 - E-Learning - ISO 13485 training package - Readiness and internal audit of your medical devices quality management system QMS version 2016

T 22v16 ONLINE TRAINING ISO 13485 readiness version 2016

Discover the ISO 13485 standard and

• its contents
• its principles
• its requirements
• its stakes

Get used to

• process approach
• medical device terminology
• medical device documents
• ISO 13485 readiness documentation
• ISO 13485 internal audit documentation
• risk-based thinking
• improvement
• feedback

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 ONLINE TRAINING 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)