ISO 13485 Refresher including 2016 Updates

Home / Life Sciences / ISO 13485 Refresher including 2016 Updates
ISO EN 13485:2012 & ISO EN 13485:2016 is the global harmonized Quality Management Systems Standard used by medical device manufacturers to meet certain requirements to support the safety and effectiveness of the products they sell into Europe. IS... Read More

ISO EN 13485:2012 & ISO EN 13485:2016 is the global harmonized Quality Management Systems Standard used by medical device manufacturers to meet certain requirements to support the safety and effectiveness of the products they sell into Europe. ISO EN 13485:2016 was published on 26th February 2016 and companies have a three year transition period in which to comply. This means companies may currently remain certified to ISO EN 13485:2012.

This Standard specifies requirements for a QMS that can be used by an organisation involved in one or more stages of the life cycle of a medical device including the design & development, production, storage & distribution, installation, servicing & final decommissioning & disposal of medical devices.

It can be used by external parties to assess the organisations ability to meet customer & regulatory requirements or Notified Bodies can use this standard when assessing whether companies have a QMS, which supports the European Directive requirements. Such an assessment is required where a manufacturer seeks to apply the CE mark. This means that personnel within this industry must be conversant in the ISO EN 13485:2012 requirements, if they remain certified to this standard, as well as the updates to ISO EN 13485:2016.

Collapse

What's covered?

Expand/Collapse Expand/Collapse
  • Course Objectives & Introduction
  • ISO 13485:2012 – all sections of ISO 13485:2012, including additional requirements of the 2016 revision, will be discussed using group discussions. This allows participants to interact and discuss the current systems / processes in operation, how well these meet the requirements or if there are any challenges they may be experiencing.
  • Summary of Key ISO 13485:2016 Updates
  • ISO 13485:2016 Transition Timelines

The tutor is experienced in auditing against this standard and so will share experiences on expectations and outcomes from this standard in practice.

Who should attend?

Expand/Collapse Expand/Collapse

The course is suitable for personnel from medical device manufacturing or service industries who need to know the ISO 13485:2012 requirements or who may need a refresher of these requirements as well as personnel who are responsible for putting a plan in place for compliance to ISO EN 13485:2016 or who need to have a working knowledge of the ISO EN 13485:2016 updates. Personnel who perform both internal audits or external audits on suppliers may also require this knowledge.

What will I learn?

Expand/Collapse Expand/Collapse

Participants will achieve the following learning outcomes from this programme;

  • Understanding the specific requirements of ISO EN 13485:2012
  • Awareness of what auditors may look for
  • Understand the updated requirements of ISO EN 13485:2016 (What new requirements have been included, What requirements have been removed, What remains the same)

Who are the tutors?

Expand/Collapse Expand/Collapse

How do we train and support you?

Expand/Collapse Expand/Collapse

In-House Courses
Course tutor will contact your organisation in advance to discuss the programme in detail.

In-house courses can be customised to meet your organisation’s specific requirements.

A half day course covering an overview of just the updated sections of ISO EN 13485:2016 is also an option on request.

 

Course Manual
Delegates will receive a hardcopy course manual with relevant course materials.

Share this Programme

SnapshotSnapshot

Duration
1 training day
Course Times

9am to 1pm

Price
€450
Delivery Mode
This programme is available In-House and on certain Public dates

News & UpdatesNews & Updates

ISO 13485:2016 – Guidance for your organisation to transition

We have just launched a new ‘ISO 13485:2016 – Update’ training course. ISO EN 13485:2016 was published on 26th February 2016 and companies have a three ye...

Read More

ISO 13485 Refresher including 2016 Updates

Duration: 1 dayPublic Price: €450
Hide