ISO/DIS 9001:2015, Clause 0.1

The General section (clause 0.1) of the Introduction to the ISO 9001:2015 draft standard can be summarized as:

  • Adoption of a quality management system is a strategic decision
  • A robust quality management system can improve performance
  • Its design and implementation is influenced by the context of the organization
    • Specific objectives and associated risks
    • Needs and expectations of customers
    • Products and services
    • Process complexity and interactions
    • Competence of employees
    • Size and organizational structure
    • Culture and socio-economic conditions

What has Changed?
The draft ISO 9001:2015 standard adds two considerations to the list above: the needs and expectations of the organization’s customers and relevant interested parties, and the competency of the persons within, or working on the behalf of, the organization.

Context of the Organization

ISO 9001:2008 refers to the organizational environment, changes in that environment, and the risks associated with that environment. The draft ISO 9001:2015 standard replaces “organization environment” with “context of the organization.” It also expands upon the business environment to include internal factors, such as culture, and external factors, such as socio-economic conditions

Remainder of Clause 0.1

A summary of the remainder of Clause 0.1 is shown below:

  • All requirements of the standard are generic
  • Can be applied in different ways by different organizations
  • Not intended to imply uniformity of systems or documentation
  • Complements product and service requirements
  • NOTEs in the standard are for guidance and clarification
  • Standard can be used to assess ability to meet requirements (customer, statutory, regulatory, and organization)
  • Standard can be used to assess organization’s aim to enhance customer satisfaction