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Process Improvement Essentials by James R. Persse PhD

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Section 7. Product Realization

Section 7 of ISO 9001 can be considered the technical heart of the Standard. You can think of the three previous sections—4, 5, and 6—as preparatory.

Section 4 describes the requirements of the Quality Management System and the need for a documented Quality Manual. That's the foundation of your quality program.

Section 5 describes the responsibility of management in providing for the proper oversight, reviews, resources, and communication channels required for the program's successful deployment.

And Section 6 describes the requirements for providing the right human resources to manage the program, the right tools for the team, and the right environment for the team to work in.

With those elements in place, the organization has an infrastructure that can support the rollout and ongoing evolution of the Quality Management System.

Section 7, Product Realization, defines the core requirements regarding what the QMS (as reflected in the Quality Manual) should contain. It is your process program.

Product Realization is all about steps for creating a quality product, steps that move from planning to requirements, all the way through to production and delivery. To describe it in adequate detail, Section 7 is divided into six subsections. These subsections are:

  • Product planning

  • Customer-related focus

  • Design and development

  • Purchasing

  • Product and service provisioning

  • Control of monitoring and measuring devices

Let's take a brief look at each.

7.1. Planning of Product Realization ...

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