Quality Audits for the Medical Device Industry


Quality audits are an important element in implementing and maintaining an effective Quality Management System (QMS). Audits are one of the most powerful tools that management has to assure on effective QMS.

Event Type:
Workshops/Training Courses
Dec. 1-2, 2016
San Francisco , CA , USA

In this workshop, participants review the various kinds of audits to understand their role. Internal quality audits (1st party) help a company evaluate itself. Customer/supplier audits (2nd party) play a role in an effective supplier management program; your company could be the subject of the audit. Independent audits (3rd party) can help provide assurance about the health of a QMS.This workshop provides the tools to establish and maintain an effective quality audit program for medical device manufacturing. This includes the two major elements. First, is a plan to schedule, conduct, report, and close audits. Second, is the assignment of qualified people based on skill and considerations of conflict of interest. The workshop explains how to implement these quality audit program elements using examples and exercises that help develop the necessary skills.

Another important part of an audit program is responding to audit nonconformances. This includes correction, investigation, and corrective action. An effective audit program determines and eliminates the causes and contributors to the nonconformity. These methods are important in all three audits types. The workshop provides methods and exercises for these important activities.Management needs to understand the results from each audit type as part of Management Review. The presentation should use statistical methodology to analyze quality audit reports. The workshop discusses the role of management review and helps identify the appropriate statistical methodology.

Learning Objectives

  • Learn the difference among the audit types
  • Learn the difference among audit methods (system, product, process, etc.)
  • Understand audit scheduling and methods to establish and update the schedule
  • Recognize the role of auditor competency and how to determine it
  • Recognize which audits an auditor could conduct and which ones to avoid
  • Understand the role of correction and corrective action related to an audit nonconformance
  • Develop an effective approach for reporting at management review

Who can Benefit

  • Audit Managers
  • Lead Auditors
  • Audit Team Members
  • Management Representative
  • Quality Assurance Managers
  • Quality Engineers
  • Regulatory Affairs Managers
  • Supplier Management and Purchasing
  • Supplier Quality Engineers

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