The quality plan is a document or documents which together specify the quality standards, practices, resources and specifications relevant to the product.

The quality plan should contain the following:

• Quality Objectives
• Process steps
• Responsibilities
• Specific documented standards and procedures
• Reference to a risk procedure
• Specific testing, and inspection at specific stages of product realization
• A documented change procedure
• A method for measuring the achievement of the quality objectives

The quality plan is the framework of procedures that is needed in order to realize product.

The firm must have a written quality plan that defines the quality practices, resources and activities relevant to the devices that are being designed and manufactured at that facility.

The manufacturer needs to have written procedures that describe how they intend to meet their quality requirements.

Device Planning

For firms that manufacture devices as well as other products, there must be a quality plan that is specifically relevant to devices.

Much of what is required to be part of the plan may be found in the firm’s quality system documentation, such as, the Quality Manual, Device Master Record(s) (DMR), production procedures, etc.

Therefore, the plan itself may be a roadmap of the firm’s quality system.
The plan in this case would need to include reference to applicable quality system documents and how those documents apply to the device(s) that is the subject of the plan.

In order to ensure a quality plan is easily identifiable a high-level policy may be established as the organizations global quality plan which establishes the plan for all products but allows for each product to have its’ own plan should it need to be differentiated for some reason.