ISO 13485:2016

This course is available for virtual delivery – please contact us for further details (1 face-to-face training day typically translates into 2 to 4 virtual sessions per day, this is determined by the specific course content. Number of sessions and specific session times will be confirmed in advance of course delivery.)   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.

Delivery Mode

  • Public

    23 Sep 2020
  • Customised

    Contact Us


What's covered?

  • 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 participate?

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?

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?

Kevina O’Donoghue

Kevina O’Donoghue is a PhD graduate of the National University of Ireland, Galway with 10+ years experience working as a Microbiologist and 7+ years as a trainer, auditor and consultant, she has the expertise to deal effectively with both Cleanroom and Quality related issues. She is experienced in problem solving, reviewing and critically analysing documentation, investigating non-conformances, writing reports, meeting deadlines and working with various teams. She is skilled in dealing with human related issues and has an admirable way of interacting and engaging at an interpersonal level with people at all levels of the business. With the wealth of experience Kevina has accumulated to date working with many different life science companies both nationally and internationally, she can appreciate and identify many similar situations thus allowing her to link examples and communicate clearly and effectively, to ensure understanding.

Kevina is knowledgeable in many different quality and regulatory standards within the medical device, pharmaceutical, laboratory, & healthcare industries, is a strong and experienced auditor consistently challenging systems for compliance in a fair and consistent manner. Her main focus is on improvements rather than non-conformances, giving businesses a clear, objective insight into their current conformance status and constructive feedback on how to improve and ensure business goals are achieved successfully. Her interpersonal skills, allied with her excellent communication skills make her a very effective trainer. Kevina’s outstanding attribute is her ability to motivate learners and enable their learning through sharing her knowledge and work-based experiences, in a simple and easy to understand way.

Kevina is engaging, enthusiastic and very passionate about her work. Confidentiality and professional impartiality are strong values and principles that she works to at all times.

How do we train and support you?

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.

Kevina O’Donoghue

Duration: 1 dayPublic Price: €450

Kevina O’Donoghue

Duration: 1 dayVirtual Training Price: €350

Contact SQT today