ISO 9001 clause 8.3 Design and development of products and services requires the following records:

- Project Plan and Review (outlining the planning process for design and development. This should include stages, required reviews, verification and validation activities, responsibilities, and necessary resources)

- Design Review Minutes (documenting all product or service design inputs. This can include customer requirements, regulatory and legal requirements, internal requirements, standards or guidelines to be followed, and any other relevant data. Recording design and development controls, detailing how changes are managed, how decisions are made, and how design reviews are conducted)

- Product Specification (documenting the outputs of the design and development process. This should include specifications for the product or service, details on how it meets input requirements, and any necessary information for production and service provision)

- Change Review Record (recording changes made after validation, during the lifecycle of the product or service, including the rationale for the changes, who authorized them, and how they were implemented)

ISO 9001 clause 8.3 Design and development of products and services requires writing the following documents, if applicable:
- Project Task

The following documents are not mandatory, and companies can decide whether to write them (note, these may be one document or separate):
- Procedure for Design and Development