ISO 9001 standard and general aspects
  • Introduction
  • A few words about ISO 9001
  • The ISO 9000 family
  • Process approach
  • Risk based thinking
  • Understanding the organization and its context
  • Needs and expectations of interested parties
  • Determining the scope of the management system
  • Quality management system and its processes
Leadership
  • Leadership and commitment
  • Customer focus
  • Establishing and communicating the quality policy
  • Organizational roles, responsibilities and authorities
Planning
  • Actions to address risks and opportunities
  • Quality objectives and planning to achieve them
  • Planning of changes
Support
  • Resources
  • People
  • Infrastructure
  • Environment for the operation of processes
  • Monitoring and measuring resources
  • Organizational knowledge
  • Competence
  • Awareness
  • Communication
  • Documented information
Operation
  • Operational planning and control
  • Customer communication
  • Determining the requirements for products and services
  • Reviewing the requirements for products and services
  • Design and development of products and services
  • Design and development planning
  • Design and development inputs
  • Design and development controls
  • Design and development outputs
  • Design and development changes
  • Control of externally provided processes, products and services
  • Control of production and service provision
  • Identification and traceability
  • Property belonging to customers or external providers
  • Preservation
  • Post-delivery activities
  • Control of changes
  • Release of products and services
  • Control of nonconforming outputs
Performance evaluation
  • Monitoring, measurement, analysis and evaluation
  • Customer satisfaction
  • Analysis and evaluation
  • Internal audit
  • Management review
Improvement
  • Improvement
  • Nonconformity and corrective action
  • Continual improvement
Management system auditing
  • Management system auditing
  • Types of management system audits
  • Audit scope, objectives and criteria
  • Audit team
  • Audit plan and working documents
  • Audit activities
  • Nonconformities
  • Audit report
  • ISO 9001:2015 Quality Management System Auditor