ISO 9001:2015 - Support Requirements

Clause 7 of ISO 9001:2015 focuses on the support needed to establish, implement, maintain, and continually improve the quality management system. This includes resources, competence, awareness, communication, and documented information.

7.1 Resources

Resource Type Requirements Management Method
People Sufficient qualified personnel Workforce planning, training
Infrastructure Buildings, equipment, systems Maintenance programs
Environment Suitable work conditions Workplace monitoring
Monitoring Measurement resources Calibration system
Knowledge Organizational knowledge Knowledge management

7.1.6 Organizational Knowledge

Knowledge Type Sources Management Methods
Internal Experience, lessons learned Documentation, databases
External Standards, conferences Subscriptions, networks
Process Procedures, work instructions Document control
Technical Product/service knowledge Training programs

7.2 Competence

Requirement Implementation Method Evidence
Determine needed competence Job analysis, role definitions Competency matrices
Ensure competence exists Training, recruitment Qualification records
Take necessary actions Training programs, mentoring Training records
Evaluate effectiveness Performance assessment Evaluation reports
Retain documentation Records management Personnel files

7.3 Awareness

Topic Required Awareness Communication Method
Quality Policy Understanding and relevance Training sessions, displays
Quality Objectives Contribution to achievement Team meetings, updates
Performance Impact Individual contribution Performance reviews
Nonconformity Implications of non-compliance Training, notices

7.4 Communication

Aspect Requirements Implementation
What to communicate QMS information Communication plan
When to communicate Timing and frequency Schedule, triggers
With whom to communicate Target audiences Stakeholder matrix
How to communicate Methods and channels Media selection
Who communicates Responsibilities Role assignments

7.5 Documented Information

Control Requirements

Control Element Requirements
Availability Access and use point
Protection Confidentiality, integrity
Distribution Access control, versioning
Storage Preservation, retrieval
Changes Version control, approval
Retention Time periods, disposal

Documentation Best Practices

  • Clear identification system
  • Appropriate format selection
  • Review and approval process
  • Change control procedures
  • Version management
  • Access control methods
  • Backup and recovery
  • Retention schedules
  • Disposal procedures
  • Electronic system security

Implementation Tips

  • Conduct regular resource reviews
  • Maintain competency matrices
  • Document training effectiveness
  • Establish clear communication channels
  • Implement robust document control
  • Monitor resource adequacy
  • Review communication effectiveness
  • Maintain knowledge databases
  • Regular awareness programs
  • Periodic system audits