DNV Danmark

ISO 13485:2016 Foundation Course

ISO_13485

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: 

• DNV GL – Introduction 

• Delegate Introduction 

• 5.6 Management Review

• 6.2 Human resources

• 6.4 Work environment and contamination control

Session 2: 

• 7.4 Purchasing

• 7.5.6 Validation of processes for production and service provision

• 7.6 Control of monitoring and measuring equipment

Session 3:

• 8.2.4 Internal audit

• 8.2.5 Monitoring and measurement of processes

• 8.3 Control of Nonconforming products

Session 4:

• Test

• Personal Action Plan 

• Reflection

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Register for the training class here

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Varighed:

Duration: 1 day. The training is held online.

Pris:

Course fee: DKK 6.800,- (ex. VAT). Course material and certificate of participation is included in the price.

Yderligere information:

You can find our cancellation policy, terms & conditions and practical information about the course here: www.dnvgl.dk/betingelser

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: 

• DNV GL – Introduction 

• Delegate Introduction 

• 5.6 Management Review

• 6.2 Human resources

• 6.4 Work environment and contamination control

Session 2: 

• 7.4 Purchasing

• 7.5.6 Validation of processes for production and service provision

• 7.6 Control of monitoring and measuring equipment

Session 3:

• 8.2.4 Internal audit

• 8.2.5 Monitoring and measurement of processes

• 8.3 Control of Nonconforming products

Session 4:

• Test

• Personal Action Plan 

• Reflection

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