Overview

The unconventional term "product realization" completes the evolution of ISO 9001 into a framework of requirements that is more accessible to organizations that provide software and services, to organizations that serve exclusively internal customers (e.g., Management Information Systems and Information Technology departments), and to organizations that provide commodity or off-the-shelf products. Product realization encompasses processes that take a product or service from concept and requirements, to design and development, and to manufacturing, delivery, and postinstallation support.

PARAGRAPH 7 is presented in six paragraphs that define requirements for processes that are common to all product and engineering life cycles. Four of the paragraphs address primary processes, which transform concept into delivered product or service:

• 7.1 Planning of product realization

• 7.2 Customer-related processes

• 7.3 Design and development

• 7.5 Production and service provision.

In spite of the title, parts of PARAGRAPH 7.5 apply to design and development as well as to production (manufacturing) and service provision (installation, support, etc.). As portrayed in Exhibit 1-4, the three parts of PARAGRAPH 7.5 that apply to design and development as well as to production and service provision are:

• 7.5.3 Identification and traceability

• 7.5.4 Customer property

• 7.5.5 Preservation of product.

The remaining two paragraphs in PARAGRAPH 7 address activities that support all phases of the product life cycle:

• 7.4 Purchasing

• 7.6 Control of monitoring and measuring devices

Compliance with ISO 9001 does not require that all of the primary and supporting processes be part of an organization's business model or within the scope of an ISO...