This comprehensive course provides detailed understanding of ISO 9001:2015 requirements and practical auditing techniques for quality management systems. Participants will gain thorough knowledge of each clause and sub-clause of the standard, with emphasis on the context of the organization, risk-based thinking, and process approach. The course focuses on developing skills to effectively audit against ISO 9001:2015 requirements, including interpretation of requirements, evidence collection, and finding formulation. Through practical examples and case studies, attendees will learn how to assess conformity and identify opportunities for improvement in quality management systems.
Understanding and Auditing ISO 9001:2015 Requirements
Operational Auditing and Quality Assurance
October 25, 2025
Introduction
Objectives
Upon completion of this course, participants will be able to:
- Interpret and understand ISO 9001:2015 requirements
- Apply the process approach to quality management system auditing
- Assess organizational context and risk-based thinking implementation
- Plan and conduct audits of specific ISO 9001:2015 clauses
- Evaluate evidence of conformity against standard requirements
- Identify non-conformities and opportunities for improvement
- Document audit findings accurately and completely
- Verify effectiveness of quality management system processes
- Provide value-added recommendations for system improvement
Target Audience
- Internal quality auditors
- Quality assurance professionals
- Process owners and operators
- Quality management representatives
- Operations and production managers
- Compliance and regulatory staff
- Suppliers to certified organizations
- Anyone involved in ISO 9001 implementation or maintenance
Methodology
- Clause-by-clause analysis workshops
- Practical audit scenario exercises
- Case studies on requirement interpretation
- Group discussions on auditing challenges
- Individual exercises on finding development
- Real-world quality system examples
- Peer review of audit approaches
Personal Impact
- Enhanced understanding of quality management principles
- Improved auditing and evaluation skills
- Stronger analytical and interpretation capabilities
- Better attention to detail and systematic thinking
- Increased confidence in quality system assessment
- Enhanced ability to identify improvement opportunities
Organizational Impact
- Improved ISO 9001:2015 implementation quality
- More effective internal audit programs
- Better preparation for external certification audits
- Enhanced quality management system performance
- Reduced non-conformities in external audits
- Continuous improvement in quality processes
Course Outline
Unit 1: ISO 9001:2015 Framework and Concepts
Quality Management Principles- Seven quality management principles
- Process approach and PDCA methodology
- Risk-based thinking concepts and application
- High-level structure and terminology
- Clause 4: Understanding organization and its context
- Needs and expectations of interested parties
- Quality management system scope and boundaries
- Process identification and interaction
Unit 2: Leadership and Planning Requirements
Leadership Commitment- Clause 5: Leadership and commitment
- Customer focus and quality policy
- Organizational roles and responsibilities
- Management review requirements
- Clause 6: Planning for quality management system
- Risk and opportunity assessment and treatment
- Quality objectives and planning to achieve them
- Planning of changes
Unit 3: Support and Operation Requirements
Resource Management- Clause 7: Support requirements
- Resource provision and competence
- Awareness, communication, and documented information
- Infrastructure and work environment
- Clause 8: Operational planning and control
- Design and development of products and services
- Control of externally provided processes and products
- Production and service provision
Unit 4: Performance Evaluation and Improvement
Monitoring and Measurement- Clause 9: Performance evaluation
- Monitoring, measurement, analysis, and evaluation
- Customer satisfaction and internal audit
- Management review inputs and outputs
- Clause 10: Improvement requirements
- Nonconformity and corrective action
- Continual improvement methodologies
- Preventive action concepts
Unit 5: Auditing ISO 9001:2015 Requirements
Audit Planning and Preparation- Developing clause-specific audit questions
- Creating audit checklists for ISO 9001 requirements
- Document review against standard requirements
- Identifying objective evidence sources
- Interviewing for requirement conformity
- Documentation and record review techniques
- Observation of process implementation
- Evaluating effectiveness of quality processes
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