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On-Site ISO 13485:2016 Training

ANSWERED ON THIS PAGE:

  • How do we involve our entire team in the ISO 13485:2016 implementation process?
  • What do our employees need to know about ISO 13485:2016 to maintain compliance?
  • Is there an efficient, cost-effective way to train our team on the QMS system?

Implementation and maintenance of your ISO 13485:2016 quality management system requires the participation of your entire team. For your QMS to succeed, it is critical that your employees understand the necessary procedures and daily functions. The new ISO 13485:2016 focuses on the entire supply chain of the medical device industry, with emphasis on risk management.

Emergo's ISO 13485:2016 employee training class provides your employees with an overview of ISO 13485 and their responsibilities. It is conducted on-site by a senior consultant with extensive, real-world auditing and manufacturing experience across various device types and quality systems. Your team will receive an in-depth ISO 13485 training session tailored to the needs of your organization.

Upgrading to ISO 13485:2016? See how we can help.

Customized on-site ISO 13485:2016 training for a fixed price, regardless of how many employees attend.

Our fee for ISO 13485:2016 training is based on a set daily rate plus travel expenses. Our training is a great value for companies training two or more employees at a time. On-site training allows your employees to ask questions--something they cannot do easily with online classes--and ensures every employee receives consistent information.

What your team will learn in this intensive one-day ISO 13485 awareness training class:

  • Overview of the ISO 13485:2016 standard and the implications to your company.
  • Benefits of adopting or upgrading to the ISO 13485:2016 standard, and its relationship to EN ISO 13485:2016.
  • Recognize the key changes between ISO 13485:2003/EN ISO 13485:2012 and ISO 13485:2016.
  • How changes may impact your organization and its current QMS.
  • The responsibility and commitment of senior management, as well as the participation from company employees.
  • Identify key personnel inside your company who will be involved in implementation or transition, and maintenance.
  • Improve your company's understanding of why the process approach works.
  • Setting measurable Quality Objectives and defining responsibilities.
  • How key changes in ISO 13485:2016 impact the roles of design and development, purchasing, production, customer communications, and other teams.
  • Document control and record keeping.
  • Incorporation of risk management activities throughout the device lifecycle.
  • Process validation, monitoring and traceability, control of measurement devices, environmental controls, and data analysis.
  • How to strengthen supplier control processes.
  • Increased focus regarding feedback mechanisms.
  • Monitoring and maintaining the effectiveness of the quality system: how and why.

Optional: Additional days may be added to incorporate how the standard relates to other international regulations, including registration requirements in various markets like Canada, Europe, Australia, and others.

Ask us for detailed information about ISO 13485 training services.

Learn about the process, costs and timelines.

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Common questions:

Who should attend the training?
The training is appropriate for all levels of employees, from upper-level management to assembly line staff.

Do employees receive a certificate after the training is completed?
Yes, Emergo will issue each attendee a signed certificate within one week after the training. The employee must attend the entire session to receive a certificate. Notified Bodies often request this certificate during registration audits, so it is necessary to keep these on file for each employee.

What is the daily training schedule?
Training usually starts at 9 am each day and runs until 5 pm, with breaks in the morning and afternoon, and one hour for lunch. However, this can be changed to suit your specific business needs.

 

Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries.  This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers.  UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.