You must implement a quality manual and quality management system that are compliant with API Spec Q1, and you must have the capability – processes, equipment, and personnel – to manufacture products that meet the technical requirements of the applicable API product specification(s).
You must also perform and document an internal audit and management review in accordance with API Spec Q1. After your quality management system has been operational for at least four months, you may then complete the application documents and send them to API along with a copy of your quality manual and the application fee. Please do not send design documents, procedures or work instructions.