Organizations applying for licensing under the API Monogram Program must develop and maintain a quality manual that describes their quality management system and how it conforms to the requirements of API Spec Q1.
Organizations participating in the API Monogram Program must also demonstrate continued ability to meet the technical requirements identified in the applicable API product specification(s).
Companies applying for API Spec Q1 / API Q2 Registration must have quality manuals and quality management systems in conformance with API Spec Q1.
Before submitting an application to API, organizations must have had a quality management system in place for at least four months. This includes performing and documenting an internal audit and management review by the applicable standard.
Submit the completed application forms, application fee, and the quality manual (if applicable), and the API Spec Q1, 9th Edition Conformity Matrix and the API Spec Q2 Conformity Matrix. The quality manual must be written in English.
API will review the application forms and the quality manual (if applicable). Should application forms be incomplete, and/or should the quality manual be out of conformance with requirements, API will provide comments?
For those applying for an API Monogram License, once the application package, the quality manual and the API Spec Q1, Q2 Conformity Matrix are accepted, API will schedule an on-site audit. Audits include verifying the organization’s conformance.
Those applying for certification to ISO 9001, API Spec Q1, API Spec Q2, ISO 14001 and OHSAS 18001 may undergo a Stage 1 audit, Stage 1 audits are normally performed on-site and require organizations to provide the auditor with documents for review.
Stage 2 audits are performed on-site and include verifying the organization’s conformance with API Spec Q1, API Spec Q2, ISO 9001, ISO 14001 and OHSAS 18001.
API will make the certification decision on the basis of an evaluation of the audit findings and conclusions, and evidence of effective implementation of corrective actions by the organization (if required).