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ISO 9001:2015 Internal Auditor Training (LAB-0384)

ISO 9001:2015 Internal Auditor Training

Course Overview:

This highly participative course provides comprehensive instruction on auditing quality management systems based on the ISO 9001:2015 requirements. The course begins with a high-level overview of the differences between ISO 9001:2015 and ISO 9001:2008. Through practical workshops, case studies, and simulated assessments you will develop an understanding of how the new requirements will affect your organization and your audits. The training will teach process based audit skills, which are useful in internal and external audits. Additionally, by using real-world audit situations, you will practice your auditing skills and techniques to help you fully understand the requirements of auditing to the ISO 9001:2015 standard.  

Student Prerequisites:  Each student shall be required to have studied the current published version of ISO 9001:2015 prior to attending the course.  Please bring a copy of the standard with you to the course.

Key Session Topics:

  • Overview of ISO 9001:2015 requirements
  • Critical linkages between the Quality Policy, Objectives, Management Review, and internal auditing   
  • Understanding risks and opportunities
  • Design and development controls
  • Determination of requirements for products and services
  • Control of externally provided products and services
  • Coordinate a quality management system audit
  • Construct an audit program and the preparation of audit checklists
  • Audit effectively
  • Prepare nonconformity statements
  • Evaluate the significance of audit findings
  • Methods for improving communication skills
  • Report audit findings and conclusions
  • Develop and implement corrective action programs
  • Evaluate corrective action responses
  • Effectively follow-up audit findings to recognize if the nonconforming situation has been effectively resolved
  • Understanding the difference between quality system registration and accreditation

 

Student Prerequisites:  Each student shall be required to have studied the most newly revised version of ISO/IEC 9001:2015 prior to attending the course.  Please bring a copy of the standard with you to the course.

QUESTION & ANSWER TIME - "ASK THE ASSESSOR"

  • Gain insight and best practice advice and tips

WHO SHOULD ATTEND

Those responsible for planning and scheduling an internal audit program for ISO 9001, those who must perform audits to ISO 9001, quality assurance managers, quality assurance professionals, ISO project managers and team members.

Group(s): Training
Speaker: Gretchen McAuliffe
Speaker Gretchen McAuliffe
Gretchen McAuliffe is one of the co-founders of Labtopia.  As a Principal, Gretchen oversees operations for Labtopia Staffing and is Senior Consultant for Labtopia Solutions, Labtopia Training and Labtopia Informatix.  Gretchen specializes in providing quality assurance support to ISO and GxP manufacturers, laboratories, and distributors.  As a QA professional, she ...

Gretchen McAuliffe is one of the co-founders of Labtopia.  As a Principal, Gretchen oversees operations for Labtopia Staffing and is Senior Consultant for Labtopia Solutions, Labtopia Training and Labtopia Informatix.  Gretchen specializes in providing quality assurance support to ISO and GxP manufacturers, laboratories, and distributors.  As a QA professional, she is an expert in developing integrated systems for regulated industries.  She has extensive experience in quality management systems, technical writing, business process mapping, database requirements and implementation, document control, and laboratory compliance.  During her career, she has managed and conducted domestic and international audits of manufacturers, distributors and laboratories.  



Gretchen has a B.S. in Biology from the University of Houston and a M.S. in Biological Sciences from the University of Houston-Clear Lake. She is an American Society for Quality (ASQ) Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA), Certified HACCP Auditor (CHA).  She is also one of the first GMP professionals in the world to be certified to ASQ Certified Pharmaceutical GMP Professionals (CPGP) criteria.  She is also a certified ISO 9001:2000 lead auditor. She has received training in Good Laboratory Practices, Good Manufacturing Practices and International Pharmaceutical Excipient Council Good Manufacturing Practices for Excipients.  In addition, Gretchen is a trained Administrator for ThermoFisher Scientific’s SampleManager LIMS.



Gretchen has provided support to companies who must comply with good manufacturing practices (GMPs), good laboratory practices (GLPs), good clinical practices (GCPs), ISO 9001:2008, ISO 17025:2005, ISO 22000 and Safe Quality Foods (SQF).  



When she finds time to relax, Gretchen enjoys spending time with her husband Shannon McAuliffe and their two daughters, Caitlin & Ciara.  She enjoys traveling, a good book and a dinner with family and friends.


 

Full Description
Organizer Labtopia Training

At Labtopia Training, we are scientific and technical professionals just like you. Therefore, we understand the unique challenges you face in your workplace.  With over 25 years of industry experience, we understand the importance of consistent, effective training programs.

When?

Tue, Oct. 31 - Wed, Nov. 1, 2017
8:30 a.m. - 4:30 p.m.
(GMT-0600) US/Central

Event has ended

Where?

Labtopia Classroom
12929 Gulf Freeway, Suite 108
Houston, TX 77034
United States of America