Conducting Process Audits within both ISO 9001 and ISO 13485

Many companies understand the concept of auditing but not the concept of "Process Auditing" as expected to be compliant within both ISO 9001 and ISO 13485. Even companies that are currently registered to the standards may not have a thorough means for evaluating its processes through their internal audit program. This webinar is intended to review the requirements for determining if a company has its processes under control, with reviews of the requirements and description of the methods to determine which processes are expected to be audited. Emphasis is placed on conducting effective process auditing through an internal audit program within a company’s quality management system.

Areas Covered in the seminar:

• Effective Process Auditing.
• Understanding the process approach to auditing.
• What about process audit scheduling .
• What procedures are required and where to get them.
• Differences of system audits, product audits, and process audits.
• Continual Improvement and Process Control Strategies.
• Report, Follow-Up, and Closure of Non-Conformances.

Who will benefit:

This webinar provides valuable assistance to all companies expected to conduct effective process audits, which includes general manufacturing and service companies ranging from government contractors, specialty process applications (i.e., NADCAP), medical and pharmaceutical fields.

• Top Management
• QA managers and personnel
• Internal Auditors
• Engineering
• Production

Instructor Profile:

Diane Bove, is the founder and CEO of Extreme Quality International, LLC (EQI), a consulting, auditing, and training firm specialized in quality management systems, consumer product quality, environmental, health, safety, and social responsibility related topics. Diane holds a M.S. in Engineering Management and has been published on the subject of Continual Improvement Methods within Quality Management System.

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