Re: Quality Plan Template or Example Needed
As best I can determine, ISO 13485 does not require a quality plan. However, under 7 Product Realization, there is a Note 1 that states, " A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan."
FDA's Quality System Regulation requires a quality plan "which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured." According to the FDA's Quality System Inspection Manual:
"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. 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), 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. Quality plans may be specific to one device or be generic to all devices manufactured at the firm. Quality plans can also be specific to processes or overall systems."