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ISO 13485:2016 Overview & Transition, Internal Auditor Issues
Instructor: Brandon Kerkstra
Released: 05-11-2017
Price: $ 1095
Certificate: Must complete all lessons
Table of Contents
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13486 Overview
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 EFFECTIVENES
   

S008 - Second Model: PROCESS APPROACH TO MANAGEMENT
   

S009 - ISO 13485 + SIPOC + PDCA
   

S010 - ISO 13485 SIPOC PDCA
   

S011 - In Summary: Basic Process Model
   

S012 - 8.3.3.3 Special characteristics - IATF
   

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 - Medical Device file (OE)
   

S035 - Control of documents 4.2.4 1/2
   

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 & Communication
   

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 2/2
   

S060 - 6.4 Work environment
   

S061 - 6.4.2 Contamination control
   

S062 - Resource Management (OE)
   

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 - 7.3.1 & 2 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 - 8.2.4 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??
   

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Description
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.

Be sure to use the 50% discount promotion code from your Registrar.



Price
1 Year: $ 1095
Instructor
Brandon Kerkstra
Brandon Kerkstra has worked with hundreds of companies in a wide range of industries during the past 14 years as president of MSG. In addition to building the successful business, Brandon has facilitated the implementation of ISO 17025, ISO 9001, ISO 14001, ISO 13485, APQP, CMMI, & SPICE (ISO 15504).  Brandon has also trained on Project Management, Time Management and Lean Concepts, and more recently implemented and trained on AS 9100 and AS 9115 as well as DO178B requirements.

Before launching MSG, Brandon Kerkstra was responsible for business development at the North American division of the British Standards Institution Inc., the world's largest registrar of quality management systems, and for technical business development at Entela, Inc., the world’s leading automotive and manufacturing registrar.  Kerkstra also held positions as a lead trainer for both organizations.

With extensive experience in product testing, inspection, and quality, Kerkstra is familiar with a wide range of ISO 9000, ISO/TS 16949 and ISO 14000 management systems assessments for the military, nuclear, aerospace, and automotive industries.

Kerkstra has appeared as a keynote and motivational speaker at professional and international conferences and on national television about the benefits and technical aspects of management system registration to international standards. As a paid speaker, he has addressed Siemens VDO and the Trinidad and Tobago Bureau of Standards on the subject of international standards in registration.

Brandon holds a bachelor's degree in chemical engineering from Michigan Technological University as well as numerous technical certifications.

Courses by this instructor

Name Level Release Date
ISO 9001:2015 Transition Overview 10-14-2015
ISO 14001:2015 Overview & Transition 11-30-2015
Effective Corrective Actions 12-14-2015
ISO 14001:2015 Internal Auditor Training 02-13-2016
ISO 19011 Auditing Management System 03-05-2016
ISO 9001 2015 Internal Auditor Training 03-21-2016
Risk Requirements in ISO 9001 2015 12-14-2015
IATF 16949: Transitioning from ISO/TS 16949:2009 (single student) 10-31-2016
AS9100 D 05-06-2017
ISO 13485:2016 Overview & Transition, Internal Auditor Issues 05-11-2017
Automotive Core Tools (with Internal Auditor Information) 06-25-2017