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Online Training
Objective Evidence of Competency for: ISO 9001, AS9100, 14001, IATF 16949, and more
ISO Training Information
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ISO 13485 Lessons
- S001 - ISO 13485: 2016 Overview
- S002 - ISO 13485: 2016
- S003 - Suggestion…Change Management Tool
- S004 - CLASS METHODOLOGY
- S005 - Two Models of the Fundamentals of ISO 13485
- S006 - First Model: Plan Do Check Act (PDCA)
- S007 - PDCA-Method for EFFECTIVENESS
- S008 - Second Model: PROCESS APPROACH TO MANAGEMENT
- S009 - ISO 13485 + SIPOC + PDCA
- S010 - ISO 13485 SIPOC PDCA
- S011 - In Summary: Basic Process Model
- S012 - Major Changes From ISO 13485: 2003
- S013 - Major Changes From ISO 13485: 2003
- S014 - Major Changes From ISO 13485: 2003
- S015 - Improvement
- S016 - Highlights of Each Section
- S017 - Objective Evidence
- S018 - Quality Management System
- S019 - 4.0 QMS Requirements
- S020 - Quality Management System
- S021 - General Requirements – Sec 4.1.1
- S022 - General Requirements – Sec 4.1.2
- S023 - General Requirements – Sec 4.1.3
- S024 - Apply to Your Situation
- S025 - General Requirements – Sec 4.1.4
- S026 - General Requirements – Sec 4.1.5
- S027 - General Requirements – 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
- S033 - 4.2.3 Medical Device File
- S034 - Control of documents 4.2.4 1/2
- S035 - Medical Device file (OE)
- S036 - Control of documents 4.2.4 2/2
- S037 - Control of documents (OE)
- S038 - 4.2.4 Control of Records 1/2
- S039 - 4.2.4 Control of Records 2/2
- S040 - 4.2.4 Control of Records (OE)
- S041 - Management Responsibility
- S042 - Management Responsibility
- S043 - 5.1 Management Commitment
- S044 - 5.2 Customer Focus & 5.3 Quality Policy
- S045 - 5.4 Planning
- S046 - 5.5 Responsibility & Authority (1-3)
- S047 - 5.6 Management Review
- S048 - 5.6.2 Management Review Inputs
- S049 - 5.6.2 Management Review Inputs
- S050 - 5.6.3 Management Review Output
- S051 - Management Responsibility (OE)
- S052 - Management Responsibility (OE)
- S053 - Management Responsibility (OE)
- S054 - Resource Management
- S055 - Resource Management
- S056 - 6.1 Provision of resources
- S057 - 6.2 Human Resources
- S058 - 6.3 Infrastructure 1/2
- S059 - 6.3 Infrastructure 1/2
- S060 - 6.4 Work environment
- S061 - 6.4.2 Contamination control
- S062 - Resource Management
- S063 - Resource Management (OE)
- S064 - Resource Management (OE)
- S065 - Product Realization
- S066 - Product Realization
- S067 - 7.1 Planning of Product Realization 1/2
- S068 - 7.1 Planning of Product Realization 2/2
- S069 - 7.2.1 Determine Product Requirements
- S070 - 7.2.2 Review Product Requirements 1/2
- S071 - 7.2.2 Review Product Requirements 2/2
- 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
- S077 - 7.3.3 Design & Development Inputs
- S078 - 7.3.4 Design & Development Outputs
- S079 - 7.3.5 Design & Development Review
- S080 - 7.3.6 Design & Development Verification
- S081 - 7.3.7 Design & Development Validation (1/2)
- S082 - 7.3.7 Design & Development Validation (2/2)
- S083 - 7.3.8 Design & Development Transfer
- S084 - 7.3.9 Design & Development Changes
- S085 - 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 1/2
- S091 - 7.4.2 Purchasing Information 2/2
- S092 - 7.4.3 Verification of Purchased Product
- 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
- S097 - 7.5.1 Control of Production & Service Provision 2/2
- S098 - 7.5.2 Cleanliness of Product 1/2
- S099 - 7.5.2 Cleanliness of Product 2/2
- S100 - 7.5.3 Installation activities
- S101- 7.5.4 Servicing 1/2
- S102 - 7.5.4 Servicing 2/2
- S103 - 7.5.5 Particular Requirements for Sterile Medical Devices
- S104 - 7.5.6 Validation of Special Processes 1/3
- S105 - 7.5.6 Validation of Special Processes 2/3
- S106 - 7.5.6 Validation of Special Processes 3/3
- 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
- S115 - 7.6 Control of Monitoring & Measuring Equipment 2/4
- S116 - 7.6 Control of Monitoring & Measuring Equipment 3/4
- S117 - 7.6 Control of Monitoring & Measuring Equipment 4/4
- 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
- S124 - 8.2.2 Complaint Handling 2/2
- S125 - 8.2.3 Reporting to Regulatory Authorities
- S126 - 8.2.4 Internal Audit 1/3
- S127 - 8.2.4 Internal Audit 2/3
- S128 - 8 I.4 Internal Audit 3/3
- S129 - 8.2.5 Monitoring & Measurement of Processes
- S130 - 8.2.6 Monitoring & Measurement of Product 1/2
- s131 - 8.2.6 Monitoring & Measurement of Product 2/2
- s132 - 8.3 Control of Nonconforming Product (8.3.1) 1/2
- S133 - 8.3 Control of Nonconforming Product (8.3.1) 2/2
- S134 - 8.3.2 Actions in response to nonconforming product detected before delivery
- S135 - 8.3.3 Actions in response to nonconforming product detected after delivery
- S136 - 8.3.4 Rework
- S137 - 8.4 Analysis of Data 1/3
- S138 - 8.4 Analysis of Data 2/3
- S139 - 8.4 Analysis of Data 3/3
- S140 - 8.5 Improvement
- S141 - 8.5.1 General
- S142 - 8.5.2 Corrective Action 1/2
- S143 - 8.5.2 Corrective Action 2/2
- S144 - 8.5.3 Preventive Action 1/2
- S145 - 8.5.3 Preventive Action 2/2
- S146 - Corrective Action vs. Preventive Action
- S147 - Measurement, Analysis and Improve. (OE)
- S148 - Questions??
- S999 - ISO 13485 Competency Test & Certificate
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