This course is designed for both new auditors and those looking to sharpen their current auditing skills. Participants will acquire the necessary skills to become a leader in preparing and conducting 1st and 2nd party audits through interactive methods and avoiding lecture based learning. This course includes a simulated audit, based on documentation from an actual organization, so participants can develop and refine their newly acquired knowledge and skills.
Length: 2 days Prerequisites: None
Learning Objectives
- Perform audits based on the ISO 19011 Standard
- Comply to the ISO 9001 Standard by applying the Process Approach to your quality management system
- Form an audit team
- Conduct an audit meeting
- Determine needed documentation and organize according to the ISO 19011:2002 Standard
- Classify, record, and resolve nonconformities
- Implement preventative measures to avoid future nonconformities
Plexus Learning Model
Learning is maximized through participation. That is why Plexus training avoids lecture-based teaching and focuses on group activities, case studies and hands-on applications. Learn by doing.
Who Should Attend
- Anyone involved in the implementation of ISO 9001 for Healthcare
- Individuals and cross functional teams interested in risk reduction and anyone who wants a better understanding of basic FMEA and risk management methodology
- Representatives from key functional groups involved in an organization’s quality management system
Instructors
Plexus Master Trainers. Plexus Master Trainers train and evaluate:
- ISO 9001:2008, ISO/TS 16949:2009, AS9100, ISO 14001:2004 Environmental Management Systems, FSSC 22000:2005 Food Safety, ISO 9001:2008 for Healthcare and ISO 13485:2003 for Medical Devices.
- Plexus trains 3rd party auditors and wrote the materials used to certify all of them
Agenda
Day 1
- A brief review of ISO 9001
- Quality System Terminology
- What is an Audit? Types, objectives and relation to a standard
- Internal Auditors: attributes, roles and responsibilities
- Communication Skills: verbal, nonverbal and conflict situations
Day 2
- Plan For The Audit
- Prepare For The Audit
- Perform the Audit
- After The Audit
