The requirements for quality plans is found in ISO 13485:2016, Clause 5.4.2 - "Quality management system planning." However, the content of that clause is very short. It states that top management shall ensure that: a) planning is carried out to meet the quality management system requirements and the quality objectives, and b) the integrity of the quality system is maintained as changes are planned and implemented.
Unfortunately, it doesn't explain how to do this.
The AAMI guidance document for ISO 13485 provides a few more paragraphs and a list of examples for QMS planning inputs and QMS planning outputs.
The best practice for creating a quality plan is found in ISO 10005:2018. That standard is titled, "Quality Management Guidelines for Quality Plans." There is a EVS ISO 10005:2019 that is identical: [ Ссылка ]
In that guidance, you will find 7 pages detailing what content should be included in your quality plan.
The content mirrors the sections of a quality manual, but you are not required to have all of the elements. You need to decide which elements are applicable to the plan you are creating. The essential elements would include:
1. scope
2. inputs
3. objectives
4. responsibilities
5. documented information
6. resources
7. outputs
8. control of nonconformities
9. monitoring and measurement
10. audits
