ISO 9001:2015 Requirements

ISO 9001:2015 Quality Management System Requirement

Mandatory Documents:

  • Quality Policy
  • Quality Objectives
  • Quality Management System Scope
  • Explanation of the Processes of the Organization
  • Characteristics of product to be produced and service to be provided
  • Internal Audit
  • Management Review Meeting

Mandatory Records:

  • Training, skills, experience and qualifications record
  • Calibration records for monitoring and measuring devices
  • Product/service requirements review records
  • Design and development inputs records
  • Design and development outputs review records
  • Design and development controls records
  • Design and development outputs records
  • Design and development changes records
  • Customer property records
  • Production/service provision change control records
  • Record of conformity of product/service with acceptance criteria
  • Record of nonconforming outputs
  • Monitoring and measurement record
  • Corrective actions record

Those mandatory records are not applicable for all types of organization. If your organization do not have design process than design related records are not applicable for you. In the same way if you get anything from your clients that should be recorded and handle carefully. If your activities is not connected with customer property related any record then that is not applicable for you.

ISO 9001 2015 Quality management system standard requirements have been described in above. However any company can maintain some non mandatory procedures but that is not mandatory like internal audit procedure, MRM procedure, sales procedure etc.