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: Participants must be familiar with ISO 9001 (there will not be a clause-by-clause review of all sections of the standard)
Learning Objectives
- Demonstrate an understanding of the changes within ISO 9001 and what that means to your organization in the healthcare industry
- Identify the benefits the process approach of ISO 9001 can deliver to any business management system
- Provide Lessons Learned about the Process Approach
- Identify the different levels of processes within an organization and how they link to maximize effectiveness and efficiency in the organization
- Define basic quality system terminology
- Demonstrate effective communication skills and techniques
- Manage Conflict
- Plan, prepare and perform an internal quality audit
- Identify the process approach impact upon auditing technique and methodology
- Simulate an audit using documentation from an actual organization
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
- Any member of an ISO 9001 implementation team
- New internal auditors and experienced auditors that have not attended training in over three years
- 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
