API Monogram Licensing Support

If your organization intends to obtain an API Monogram License, we can provide consultancy support to prepare your QMS and operational processes for the applicable API requirements.

Our support may include:

Application Preparation → QMS Development → Product Specification Review → Product Realization Controls → API Monogram Requirements → Internal Audit → Management Review → Pre-Assessment → API Audit Preparation → Corrective Action Support

API's transition notification states that organizations seeking API Monogram licensing and Q1 registration are required to meet the applicable Q1 requirements, and the API Monogram program has specific requirements associated with the licensing process.