ISO 13485:2016

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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 publ... Read More

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 has now completed its transition period since April 2019.

This Standard specifies requirements for a Quality Management System (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/Regulation 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 13485:2016 requirements, if they are certified to this standard.

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What's covered?

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  • Course Objectives & Introduction
  • ISO 13485:2016 – all sections of ISO 13485:2016, with focus on the updates. This will be discussed in a discussion-based environment and using tutors experience with the Standard. This allows participants to interact and discuss their current systems / processes in operation, how well these meet the requirements or if there are any challenges they may be experiencing.

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?

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The course is suitable for all personnel from medical device manufacturing or service/support industries who need to know the ISO 13485:2016 requirements or who may need a refresher of these requirements. Personnel who perform both internal audits or external audits on suppliers may also require this knowledge.

What will I learn?

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Participants will achieve the following learning outcomes from this programme;

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

Who are the tutors?

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How do we train and support you?

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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.

NOTE: This course can be coupled with The Medical Device Regulation (CE Making Process & Key Updates) training program to run onsite as a two-day programme.

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

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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...

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ISO 13485:2016

Duration: 1 dayPublic Price: €450
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