ISO 9001:2015, 1

Clause 1.1, General, in the Scope section of ISO 9001:2008 has been slightly reworded in clause 1, Scope, of the draft ISO 9001:2015 standard. The term “product” has been expanded to include “service”.

Otherwise, the Scope section continues to state that the ISO 9001 standard specifies requirements for a quality management system where an organization:

  • Needs to demonstrate its ability to consistently provide product or service that meets customer and applicable statutory and regulatory requirements
  • Aims to enhance customer satisfaction through the effective application of the system, including
    • Processes for continual improvement of the system
    • Assurance of conformity to requirements

A clarifying Note states that the terms “product” or “service” only apply to those intended for, or required by, a customer. A second Note states that “statutory and regulatory” requirements can be expressed as “legal” requirements.

Sub-clause 1.2, Application, from ISO 9001:208 is no longer needed since all references to “exclusions” have been removed from the draft ISO 9001:2015 standard.  The only statement retained from that section is that requirements are generic and intended to be applicable to all organizations, regardless of type, size, and product provided.