ISO 13485:2016 Foundation Course

This 1-day course clarifies ISO 13485:2016 requirements and interpretations. Organizations that need to show evidence that they can provide medical devices which consistently meet customer and regulatory requirements will benefit from understanding ISO 13485. Whether you are an ISO 13485 novice or an old pro looking to refresh your skills, this course is a must.

About ISO 13485:2016 Foundation Course

Course Objectives

This course pack is designed to help you to understand;

• Quality/ medical management system 

• Interpreting the requirements of the ISO 13485

• The benefits of implementation

At the end of this course, participants should be able to describe: 

• Gain detailed knowledge of the Clauses of ISO 13485:2016 

• Understanding of important Terms and Definitions 

• The relationship between ISO 13485:2016 and other quality management standards (e.g. ISO 9001:2015) 

• The importance of understanding regulatory requirements for the market you serve.

Who can attend this course

This course is highly recommended for anyone involved in auditing, designing, implementing, maintaining and/or improving a medical device quality management system, or who simply want to further their knowledge of the ISO 13485 standard. 

Recommended follow-up courses

ISO 9001:2015 QMS Foundation and Internal Auditor, Root Cause Analysis and Problem Solving 

Course agenda

Session 1: 

Delegate Introduction 

Background and introduction ISO 13485:2016+Amd 11

Chapter 4 Quality Management System, 

Chapter 5 Management Responsibility and 

Chapter 6 Resource Management


Session 2 after lunch: 

Chapters 7 Product Realization and 

Chapter 8 Measurement, Analysis and Improvement


Session 3:

Test

About ISO 13485:2016 Foundation Course

Course Objectives

This course pack is designed to help you to understand;

• Quality/ medical management system 

• Interpreting the requirements of the ISO 13485

• The benefits of implementation

At the end of this course, participants should be able to describe: 

• Gain detailed knowledge of the Clauses of ISO 13485:2016 

• Understanding of important Terms and Definitions 

• The relationship between ISO 13485:2016 and other quality management standards (e.g. ISO 9001:2015) 

• The importance of understanding regulatory requirements for the market you serve.

Who can attend this course

This course is highly recommended for anyone involved in auditing, designing, implementing, maintaining and/or improving a medical device quality management system, or who simply want to further their knowledge of the ISO 13485 standard. 

Recommended follow-up courses

ISO 9001:2015 QMS Foundation and Internal Auditor, Root Cause Analysis and Problem Solving 

Course agenda

Session 1: 

Delegate Introduction 

Background and introduction ISO 13485:2016+Amd 11

Chapter 4 Quality Management System, 

Chapter 5 Management Responsibility and 

Chapter 6 Resource Management


Session 2 after lunch: 

Chapters 7 Product Realization and 

Chapter 8 Measurement, Analysis and Improvement


Session 3:

Test

Management Systems Training

 

Træningsmetodik og fordele

DNV's kurser blander auditekspertise, dataanalyse og LMS-tilgængelighed (Learning Management System).

 

APQP4Wind kurser

APQP4Wind is the common frame of reference to be used in the industry to strengthen the cooperation between manufacturers and suppliers

 

Automotive og aerospace kurser

At sikre kvalitet og sikkerhed i alle dele af forsyningskæden er afgørende for bil- og luftfartsindustrien.

 

Kurser i energi- og miljøledelse

Offentlighedens bekymring for miljø- og energiudfordringer, strengere lovgivning og øget medieopmærksomhed stiller større krav til virksomhederne i dag.

 

Kurser inden for fødevareområdet

Føde- og drikkevareindustrien bevæger sig for at tilfredsstille kravene fra internationale forbrugere og for at åbne nye markedsmuligheder.

 

Kurser i arbejdsmiljøledelse

Din virksomhed forventes at tage sig af sine medarbejdere ved at håndtere sikkerhed og sundhed på en professionel måde.

 

Kurser i informationssikkerhed og IT-service management

Cyber- og informationssikkerhed er for alvor kommet på den ledelsesmæssige agenda, da det medfører særlige forpligtelser.

 

Medical Device Training Courses

DNV offers a wide range of medical device training courses supporting you in the challenges of meeting regulatory requirements and maintaining quality management systems.

 

Kurser inden for Kvalitetsledelse

Et effektivt kvalitetsledelsessystem på plads kan forbedre din virksomheds kvalitetsprocesser, samlede præstationer og succes

 

Risikostyring og business continuity kurser

Formålet med risikostyring er ikke at eliminere risiko, men at forstå den, så du kan udnytte fordelene og minimere ulemperne.

 

Kurser i bæredygtighed og socialt ansvar

At sikre din forpligtelse til at beskytte menneskerettighederne og operere på en etisk, ansvarlig måde er afgørende for at indgyde etisk praksis og fremme en kultur med bæredygtighed i virksomheden.

Interne kurser for din virksomhed

Kontakt os