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ISO 13485:2016 Corporate Portal (5 employees)
In 2016, the latest edition of ISO 13485 standard for the Medical Device Industry was published by ISO. The new 13485:2016 has some significant changes and any organization with a certification needs to understand the impact for an easy transition.This course covers the changes on a clause-by-clause basis.
Because it covers Objective Evidence - it is a very useful course for ISO 13485 Internal Auditors.
Below is an abbreviate listing of the lessons covered:
S001 - ISO 13485: 2016 Overview
S003 - Suggestion…Change Management Tool
S005 - Two Models of the Fundamentals of ISO 13485
S006 - First Model: Plan Do Check Act (PDCA)
S007 - PDCA-Method for EFFECTIVENES
S008 - Second Model: PROCESS APPROACH TO MANAGEMENT
S009 - ISO 13485 + SIPOC + PDCA
S010 - ISO 13485 SIPOC PDCA
S012 - 8.3.3.3 Special characteristics - IATF
S017 - Objective Evidence
S018 - Quality Management System
S019 - 4.0 QMS Requirements
S020 - Quality Management System
S021 - General Requirements – Sec 4.1.1 to Sec 4.1.6
S028 - 4.1 Implementation (OE)
S029 - Documentation Req. – 4.2
S030 - Quality Manual– 4.2.2
S031 - Documentation Requirements 4.2.1 & 4.2.2 (OE)
S032 - 4.2.3 Medical Device File
S034 - Medical Device file (OE)
S035 - Control of documents 4.2.4 1/2
S037 - Control of documents (OE)
S038 - 4.2.4 Control of Records 1/2
S041 - Management Responsibility & Management Commitment
S044 - 5.2 Customer Focus & 5.3 Quality Policy
S045 - 5.4 Planning
S046 - 5.5 Responsibility, Authority & Communication
S047 - 5.6 Management Review
S048 - 5.6.2 Management Review Inputs
S050 - 5.6.3 Management Review Output
S051 - Management Responsibility (OE)
S055 - Resource Management
S056 - 6.1 Provision of resources
S057 - 6.2 Human Resources
S058 - 6.3 Infrastructure 1/2
S060 - 6.4 Work environment
S061 - 6.4.2 Contamination control
S062 - Resource Management (OE)
S066 - Product Realization
S067 .- 7.1 Planning of Product Realization 1/2
S069 - 7.2.1 Determine Product Requirements
S070 - 7.2.2 Review Product Requirements 1/2
S072 - 7.2.3 Customer Communication
S073 - Planning of Processes (OE)
S074 - 7.3 Design
S075 - 7.3 Design & Development
S076 - 7.3.1 & 2 Design & Development: Input, Outputs & Review
S080 - 7.3.6 Design & Development Verification
S083 - 7.3.8 Design & Development Transfer
S084 - 7.3.9 Design & Development Changes
S086 - 7.3.10 Design & Development Files
S087 - 7.3 Design & Development (OE)
S088 - 7.4, 7.4.1 Purchasing Process
S089 - 7.4.1 Purchasing Process
S090 - 7.4.2 Purchasing Information
S093 - 7.4.3 Verification of Purchased Product
S094 - Purchasing (OE)
S095 - 7.5 – Production and service Provision
S096 - 7.5.1 Control of Production & Service Provision 1/2
S098 - 7.5.2 Cleanliness of Product 1/2
S100 - 7.5.3 Installation activities
S101 - 7.5.4 Servicing 1/2
S103 - 7.5.5 Particular Requirements for Sterile Medical Devices
S104 - 7.5.6 Validation of Special Processes 1/3
S107 - 7.5.7 Particular requirements for validation of process for sterilization & sterile barrier systems
S108 - 7.5.8 Identification
S109 - 7.5.9 Traceability
S110 - 7.5.9.2 Particular requirements for implantable medical devices
S111 - 7.5.10 Customer Property
S112 - 7.5.11 Preservation of Product
S113 - Production (OE)
S114 - 7.6 Control of Monitoring & Measuring Equipment 1/4
S118 - Calibration (OE)
S119 - Measurement, Analysis & Improvement
S120 - Measurement, Analysis and Improvement
S121 - 8.1 General
S122 - 8.2 Monitoring and Measurement
S123 - 8.2.2 Complaint Handling 1/2
S125 - 8.2.3 Reporting to Regulatory Authorities
S126 - 8.2.4 Internal Audit 1/3
S129 - 8.2.5 Monitoring & Measurement of Processes
S130 - 8.2.6 Monitoring & Measurement of Product 1/2
S132 - 8.3 Control of Nonconforming Product (8.3.1) 1/2
S134 - 8.3.2 Actions in response to nonconforming product detected before delivery
S136 - 8.3.4 Rework
S137 - 8.4 Analysis of Data 1/3
S140 - 8.5 Improvement
S141 - 8.5.1 General
S142 - 8.5.2 Corrective Action 1/2
S144 - 8.5.3 Preventive Action 1/2
S146 - Corrective Action vs. Preventive Action
S147 - Measurement, Analysis and Improve. (OE)
| Duration: | 12 months |
| Price: | $1,295.00 |