Course Description
Both our dynamic ISO 9001 online courses and in-person training courses are designed to prepare participants to be effective Quality Management Systems (QMS) auditors for their company. Participants will get an overview of the standard from the lead auditor’s perspective. Valuable additions to the course include realistic case study highlights that require participants to apply the appropriate requirements to actual workplace situations. The course relays the knowledge and processes required to perform an audit of an organization. This is one of the courses that can also lead to ISO certification.
Course Outcomes
- Overview of ISO 9001:2015
- Discuss a brief history of ISO and how it came to be
- What is and what is not ISO
- The PDCA and it’s cycle
- The Process Approach
- How to Conduct an Internal Audit
- Preparing for the Audit
- Risk based thinking
- Basic steps in process approach audit
- Internal audit basics
- Non-conformance or opportunity for improvement
- Section 4 – Context of the Organization
- Understanding the organization and its context
- Understanding the needs and expectations of interested parties
- Determining the scope of the quality management system
- Quality management system and its processes
- Section 5 – Leadership
- Leadership and commitment
- Corporate responsibility
- Process effectiveness and efficiency
- Process owners
- Customer focus
- Quality Policy
- Organizational roles, responsibilities and authorities
- Responsibility and authority for product requirements and corrective actions
- Section 6 – Planning
- Risk Analysis
- Preventive action
- Contingency plans
- Quality objectives and planning to achieve them
- Planning of changes
- Section 7 – Support
- Resources
- People
- Infrastructure
- Environment
- Monitoring and measuring resources
- Laboratory requirements
- Organizational knowledge
- Competence
- Awareness
- Employee motivation and empowerment
- Communication
- Documented information
- Record retention
- Engineering specifications
- Section 8 – Operation
- Operational planning and control
- Requirements for products and services
- Design and development of products and services
- Control of externally provided processes, products, and services
- Production and service provision
- Identification and traceability
- Preservation
- Post-delivery activities
- Control of changes
- Release of products and services
- Control of nonconforming outputs
- Section 9 – Performance Evaluation
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- Monitoring, measurement, analysis and evaluation
- Customer satisfaction
- Analysis and evaluation
- Internal audit
- Management review
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- Section 10 – Improvements
- Nonconformity and corrective action
- Problem solving
- Error proofing
- Warranty management
- Continual improvement
- Closing out the audit
- Non-conformance process
- How to close past audit NCs
- Closing Meeting
Why this ISO 9001:2015 Training Course is different
E&M Design Solutions provides a live instructor—either online or in person. For the online class, this means you get feedback similar to that given in an in-person class without all the travel and expense. This class is divided into several parts so you can still work your regular job and take reasonably spaced classes in between. The class will give you enough information about the ISO requirements that you fully understand them, and where needed, apply your new knowledge to implement the ISO standard in the workplace.
Course Information
Course Instructor
Summer has 10+ years of training experience in various subjects related to Leadership, ISO, IATF, Internal Auditing, HACCP, and other Business Process systems. She has performed Internal Audits for both ISO 9001 and IATF 16949 at several manufacturing companies. She is very familiar with the standards and the requirements needed to assure compliance and allow any company to pass a registration audit.