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Course Description:

This course explains the ISO 13485:2016 Auditing Principles.  It helps auditors understand the responsibilities and competence requirements for a successful audit including understanding Internal audit planning process and execution, documentation and reporting of non-conformities Reporting Internal audit.

Intended Audience:This course is intended for a single employee to:
  • management and active teams
  • internal auditors and
  • persons of interests in ISO 13485

Cost:

$895 (for 12 months access)

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Course Agenda:

  • ISO 13485: 2016 Overview
  • ISO 13485: 2016
  • Suggestion…Change Management Tool
  • CLASS METHODOLOGY
  • Two Models of the Fundamentals of ISO 13485
  • First Model: Plan Do Check Act (PDCA)
  • PDCA-Method for EFFECTIVENESS
  • Second Model: PROCESS APPROACH TO MANAGEMENT
  • ISO 13485 + SIPOC + PDCA
  • ISO 13485 SIPOC PDCA
  • In Summary: Basic Process Model
  • Major Changes From ISO 13485: 2003
  • Improvement
  • Highlights of Each Section
  • Objective Evidence
  • Quality Management System
  • 4.0 QMS Requirements
  • Quality Management System
  • General Requirements – Sec 4.1.1
  • General Requirements – Sec 4.1.2
  • General Requirements – Sec 4.1.3
  • Apply to Your Situation
  • General Requirements – Sec 4.1.4
  • General Requirements – Sec 4.1.5
  • General Requirements – Sec 4.1.6
  • 4.1 Implementation (OE)
  • Documentation Req. – 4.2
  • Quality Manual– 4.2.2
  • Documentation Requirements 4.2.1 & 4.2.2 (OE)
  • 4.2.3 Medical Device File
  • 4.2.3 Medical Device File
  • Control of documents 4.2.4 1/2
  • Medical Device file (OE)
  • Control of documents 4.2.4 2/2
  • Control of documents (OE)
  • 4.2.4 Control of Records
  • 4.2.4 Control of Records (OE)
  • Management Responsibility
  • 5.1 Management Commitment
  • 5.2 Customer Focus & 5.3 Quality Policy
  • 5.4 Planning
  • 5.5 Responsibility & Authority (1-3)
  • 5.6 Management Review
  • 5.6.2 Management Review Inputs
  • 5.6.3 Management Review Output
  • Management Responsibility (OE)
  • Resource Management
  • 6.1 Provision of resources
  • 6.2 Human Resources
  • 6.3 Infrastructure
  • 6.4 Work environment
  • 6.4.2 Contamination control
  • Resource Management
  • Resource Management (OE)
  • Product Realization
  • 7.1 Planning of Product Realization
  • 7.2.1 Determine Product Requirements
  • 7.2.2 Review Product Requirements
  • 7.2.3 Customer Communication
  • Planning of Processes (OE)
  • 7.3 Design
  • 7.3 Design & Development
  • 7.3.1 & 2 Design & Development
  • 7.3.3 Design & Development Inputs
  • 7.3.4 Design & Development Outputs
  • 7.3.5 Design & Development Review
  • 7.3.6 Design & Development Verification
  • 7.3.7 Design & Development Validation
  • 7.3.8 Design & Development Transfer
  • 7.3.9 Design & Development Changes
  • 7.3.10 Design & Development Files
  • 7.3 Design & Development (OE)
  • 7.4, 7.4.1 Purchasing Process
  • 7.4.1 Purchasing Process
  • 7.4.2 Purchasing Information
  • 7.4.3 Verification of Purchased Product
  • Purchasing (OE)
  • 7.5 – Production and Service Provision
  • 7.5.1 Control of Production & Service Provision
  • 7.5.2 Cleanliness of Product
  • 7.5.3 Installation activities
  • .5.4 Servicing
  • 7.5.5 Particular Requirements for Sterile Medical Devices
  • 7.5.6 Validation of Special Processes
  • 7.5.7 Particular requirements for validation of process for sterilization & sterile barrier systems
  • 7.5.8 Identification
  • 7.5.9 Traceability
  • 7.5.9.2 Particular requirements for implantable medical devices
  • 7.5.10 Customer Property
  • 7.5.11 Preservation of Product
  • Production (OE)
  • 7.6 Control of Monitoring & Measuring Equipment
  • Calibration (OE)
  • Measurement, Analysis & Improvement
  • 8.1 General
  • 8.2 Monitoring and Measurement
  • 8.2.2 Complaint Handling
  • 8.2.3 Reporting to Regulatory Authorities
  • 8.2.4 Internal Audit
  • 8.2.5 Monitoring & Measurement of Processes
  • 8.2.6 Monitoring & Measurement of Product
  • 8.3 Control of Nonconforming Product (8.3.1)
  • 8.3.2 Actions in response to nonconforming product detected before delivery
  • 8.3.3 Actions in response to nonconforming product detected after delivery
  • 8.3.4 Rework
  • 8.4 Analysis of Data
  • 8.5 Improvement
  • 8.5.1 General
  • 8.5.2 Corrective Action
  • 8.5.3 Preventive Action
  • Corrective Action vs. Preventive Action
  • Measurement, Analysis and Improve. (OE)
  • Questions??
  • ISO 13485 Competency Test & Certificate


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