API Spec Q2 Certification Consulting

1. Availability of Quality Manual, describing scope of manufacture and identification and justification of any exclusions taken. Quality Manual shall meet other requirements as specified in API Spec Q2 (clause 4.4.1(b).
2. Completed API Sec Q2 conformity matrix
3. Establishing, maintaining and implementing a documented QMS (Quality Management System) meeting the applicable requirements of Spec Q2 for at least four months.
4. A full system internal audit has been performed within the last 12 months.
5. A Management review has been conducted and documented.
6. Availability of the authorised copy of latest edition of the API Spec Q2.

Applications are accepted and reviewed by API online along with the applicable 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 do in-depth review of your Organization’s procedures for conformance to requirements of API Spec Q2 and will verify the demonstrated implementation of these documented procedures.

Auditor(s) will prepare a detailed audit report, along with the 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 registration by APIQR is based on the verification of conformance with API Spec Q1 requirements.

A successful evaluation of your QMS and applicable requirements by APIQR, shall be the basis for issuance of The Certificate of Registration to your Organization. Your Organization’s name shall be listed into APIQR’s list of Registered Organizations.

Your QMS evaluation is a continued process with on-site surveillance audits performed by APIQR at least once every calendar year. The frequencies can be shorten as the discretion and as determined by API. The surveillance audit shall be conducted in a manner similar to the initial audit and shall cover all elements of the QMS.

Following these audit(s), APIQR notifies the Registered Organization of the results of the audit. Upon receipt of the Registered Organization’s response, APIQR decide any required further action, which could include notification of suspension or cancellation, or a follow-up, or a re-audit may be required.

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