Lecture summary:

  • Operational planning is about controlling the design and development process.
  • Identify all the specifications and characteristics of a product including quality requirements.
  • Define the controls that will ensure intended outcomes—validation and verification.


What does this mean? What does it include? It represents master planning. It means that you have to include objectives of planning, realizing, controlling, leading, guiding, and instructing all participants on the different functions and roles that are involved in the realization of a product.

Make sure you can answer the following questions:

  • How to manage design and development?
  • How to prepare it for the realization?
  • How to identify and locate the appropriate resources?
  • Which activities are needed?
  • Which controls are to be applied?
  • Which documented information is necessary?
  • How one verifies or validates the results?
  • Which evidence is expected?

It’s expected from you to have a clear vision of all this asked above in order to make good planning and control.

The ISO 9001 Standard requires practical actions needed for planning and controlling, it requires to be conducted through processes.


Quality plan

A quality plan can be a very helpful tool for planning quality. It will help you because it represents a methodical approach or structure that describes all the requirements needed to be followed, met, maintained, and documented while realizing the product. It integrates all relevant demands for activities, resources, and information concerning the realization of a product. Plus, it makes them available to any interested party.

Here you should plan, implement and control the processes needed to meet requirements for the provision of products and services, and to implement the actions that determine in clause 6 by determining the requirements for the products and services.


Changes in the Quality Plan

The quality plan is an ever-changing document and might be impacted by changes. Where processes, operations, or activities may be changed over time or where conditions are changed, their relevant documentation such as procedures or instructions as well as relevant resources may need to be modified and updated.

Quality plan can be changed in case of:

  • Product’s characteristics that must be changed
  • Changes in processes or resources
  • Processes that are found unstable






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