Preparation for the audit:
Establish context of the audit
Establish objectives of the audit
Establish scope of the audit
Establish criteria of the audit
Ensure audit monitoring systems are in place
Request documented information from auditee
Assign audit team and lead auditor
Review documented information:
Review auditee's documented information
[Conditional] Resolve the documented information issues
Assign work to audit team
Make arrangements with auditee
Ensure relevant audit information is accessible
Context of the organization (4.0):
Assess the organization and its context
Assess the needs and expectations of interested parties
Assess leadership of the QMS
Assess organizational roles and responsibilities
Assess documentation of risks and opportunities
Assess quality objectives
Assess change management procedures
Assess organization and allocation of QMS resources
Assess HR integration with QMS
Assess QMS infrastructure
Assess QMS work environment
Assess monitoring and measurement of resources
Assess organizational knowledge of QMS
Assess communication of QMS within the organization
Assess documented information
Assess operational planning and control
Assess operational risk management
Assess configuration management
Assess prevention of counterfeit parts
Assess requirements for products and services
Assess customer communication
Assess requirements for products and services
Assess design and development of products and services
Assess control of externally provided services and processes
Assess type and extent of control
Assess information of external providers
Assess production and service provision
Assess control of production and service provision
Assess identification and traceability
Assess property belonging to customers or external providers
Assess preservation procedures
Assess post-delivery activities
Assess control of changes
Assess release of products and services
Assess control of nonconforming outputs
Performance evaluation (9.0):
Assess systems and procedures for QMS monitoring
Assess customer satisfaction
Assess analysis and evaluation procedures
Assess previous internal audits
Assess management review procedures
Assess continuous improvement policy
Assess nonconformity and corrective action