API Monogram Certification Consulting

1. Availability of Quality Manual, describing scope of manufacture and identification and justification of exclusions taken. Quality Manual shall meet other requirements as specified in API Spec Q1 (clause 4.4.1(b).
2. Completed API Sec Q1 conformity matrix
3. Establishing, maintaining and implementing a documented QMS (Quality Management System) meeting the applicable requirements of Spec Q1 and product specification for at least four months.
4. A full system audit has been performed.
5. A Management review has been conducted.
6. Availability of the authorised copy of latest edition of the API Product Specification(s) for which you are applying licensing.
7. Availability of applicable validated design package(s).

Applications are accepted by API online along with the applicable monogram fees, by using the “myCerts Login” found at https://my.api.org.

On receipt of your completed application, API will review your submitted documents (including application form, quality manual and conformity matrix). If the application documentation does not meet the stated requirements, API notify the deficiencies to you for providing further clarifications and/or re-submission of document(s).

On acceptance of your application, API will assign an API auditor to schedule an on-site audit at a time mutually convenient to your Organization and the designated API auditor. API will provide relevant information regarding preparation of your on-site audit.

API audit team will perform the on-site audit as per agreed scheduled. During the audit, API auditor(s) will verify the capability of your organisation to meet monogram program requirement.

Audit team leader will prepare a detailed report, with list of non-conformances reviewed with your representative(s) during an exit interview. The report along with the reported non-conformances will be available at your ‘myCert Login’ for review and necessary action.

You will provide the correction, root cause analysis and corrective actions for the reported nonconformities. API will review the objective evidences obtained during the audit along with the responses submitted against the NCRs. Decision to issue the license by API is based on the verification of conformance with API quality standards and API Monogram Program requirements.

Your license evaluation is a continued process with on-site renewal audit required every three years and surveillance audits at least once every calendar year. The frequencies can be shorten as the discretion and as determined by API.

In the interim there may be unscheduled periodic or for-cause re-audits, at the sole discretion of API.

Following these audit(s), API shall decide any required further action, which could include notification of suspension or cancellation, or a follow-up, or a re-audit may be required.