20 critical requirements to ensure ISO 9001 compliance for a non-product development unit

ISO 9001 standard specifies the requirements for a Quality Management System, irrespective of the industry. For a product development organization/unit, we need to have proper planning, requirement analysis, design and implementation, followed by verification and validation activities. It means that for a product development organization/unit, majority of the ISO 9001 clauses would be applicable. Now what happens in case of a non-product development organization/unit? This article summarises the critical requirements/points to be ensured in such a case.

  1. Quality policy and Manual
  2. Organizational Structure
  3. Roles, responsibilities and authorities of the personnel defined and communicated
  4. Training and Competency
    • Competency (based on education, training, skills and experience) required for the various roles defined
    • Employees trained on the activities to be done by them
  5. Quantified objectives and plan for continuous improvement
  6. Communication channels through the organization
    • Established methods for customer communication including product/service clarifications and feedback
    • Established methods for communication between employees and management of the organization
  7. Periodic  Management Review Meetings (MRM)
    • Identified MR (Management Representative)
    • Documented  management review activity
  8. Documented plan of activities.
  9. Configuration Management
  10. Back Up of activities
  11. Traceability of activities
  12. Escalation mechanism
  13. Documents Control
    • Documents reviewed and approved prior to issue/usage
    • Mechanism of controlling changes to documents
    • Mechanism of identifying documents even when multiple versions are available
  14. Outsourcing
    • If so,  a defined processes for outsourcing
  15. Review and testing
    • Defined methods of review  and testing
    • Records of reviews and tests maintained
  16. Supplier evaluation
    • Defined mechanism for selection, evaluation and re-evaluation of  suppliers
    • A list of Critical and Approved Suppliers
    • Established requirements and maintained that must be met by suppliers, contractors, and consultants
  17. Defined mechanism to evaluate customer satisfaction
  18. Defined methods for taking corrective for issues reported inside the projects as well as inside the organization
  19. Defined methods for taking  preventive actions for identified potential issues
  20. Internal audit process.