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Training Dates: November 29- 30, Dec 1-3 from 8 a.m. – 12:30 p.m.

Overview:
To successfully implement and maintain a quality management system a company must have an Internal Audit process and use trained auditors to perform the audits. Internal auditors are also a key element in quality system improvement. This new course teaches auditing to the ISO 13485:2016 standard and places a strong emphasis on promoting employee participation in the improvement process.

By the end of the course, participants will understand how to:

  • Describe the goals of an internal audit
  • State the benefits of internal auditing
  • Determine the requirements of an internal audit
  • Explain how ISO 13485:2016 differs from ISO 9001 and the areas of focus for Medical Devices.
  • Plan an internal audit, and develop a guide list
  • Perform an internal audit
  • Identify nonconformity to requirements during an audit
  • Report on an audit and follow up on corrective actions taken in response to audit findings
  • Describe the actions necessary for maintaining a successful audit program

Who Should Attend:
People tasked with conducting Internal Audits of their organization’s ISO 13485:2016 Quality Management System.

Prerequisites:
There are no prerequisites to attend this training course but a basic understanding of the ISO 13485:2016 Quality Management System standard would be beneficial.

Cost: 2-day class (delivered in 5 half-day modules)

Location: Location and driving directions will be emailed separately upon registration.

Tickets

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ISO 13485:2016 - Member
Employees of Oregon Bioscience Association member companies receive discounts on BioPro classes. Visit the Membership Directory for a list of current member companies.
$ 625.00
15 available
ISO 13485:2016 - Non Member
$ 775.00
19 available

Details

Start:
November 29 @ 8:00 am
End:
December 1 @ 12:30 pm
Cost:
$625.00 – $775.00
Event Categories:
, , ,

Organizer

Oregon Bioscience Association
Phone:
(503) 548-4432
Website:
https://www.oregonbio.org/

Venue

Oregon Bio Virtual Classroom
OR United States + Google Map
Phone:
503-953-3145