Course Description
ISO 9001 is the international standard for a quality management system (QMS). To be certified to the ISO 9001 standard, a company must follow the requirements set forth in the ISO 9001 Standard. The standard is used by organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements and to demonstrate continuous improvement.
This course is designed to help participants understand the requirements of ISO 9001:2015 in order to conduct a successful audit. Training includes hands-on workshops to prepare for real-life auditing situations, and participants will learn to manage the audit process and complete reporting.
Who Should Attend
This course is appropriate for individuals responsible for planning and scheduling an internal audit program for ISO 9001:2015 and for those who must perform audits to ISO 9001:2015, manufacturing personnel, suppliers, managers, or anyone interested in conducting first-party, second-party, or third-party audits.
Learning Objectives
Through training, participants will learn to:
- Describe the ISO 9001 Quality Management System (QMS)-Requirements standard and development process
- Identify ISO 9000:2015 QMS terms
- Describe the intent and requirements of ISO 9001:2015
- Determine the evidence needed to demonstrate conformity to ISO 9001:2015
- Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
- Evaluate documented information required by ISO 9001:2015 and the interrelationships between the quality processes, quality planning, policy, and objectives
- Apply the principles, processes, and methods of auditing
- Demonstrate the activities involved in preparing for an audit
- Determine an effective audit in the context of the auditee’s organizational situation
- Apply effective audit skills and practice personal behaviors necessary for an effective and efficient conduct of a management system audit
- Establish and plan the activities of an audit team
- Manage the audit process
- Prepare the audit report and perform an audit follow-up
Course Outline
Day One
- Introduction to quality management systems (QMS)
- ISO 9001 family of documents
- Analyze ISO 9001 standard
Day Two
- Apply ISO 90015 standard
- Product realization process
- ISO 9001:2015 auditing specifics
Day Three
- Types of audits
- Audit approaches
- Audit objectives, scope, and criteria
- Auditor competence
- Auditor principles and methods
- Audit program
- Audit roles and responsibilities
- Audit techniques
- Gather information
- Audit cycle
Day Four
- Team leader roles and responsibilities
- Conflict management
- Select audit team
- Prepare for an audit
- Plan the audit
- Conduct an audit
- Opening meetings
- Gather information
- Closing meetings
- Prepare audit report
- Audit follow-up
Prerequisites
All attendees are required to have their own copy of the ISO 9001:2015 Quality Management Systems – Requirements.
Course Format
40 hours
Combination lecture and classroom exercises
Available virtually in conjunction with a partner organization
9:30am–7:30pm(EST) each day
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