Becoming Licensed/Registered

Apply for API Monogram Licenses & APIQR Certificates of Registration

An organization applies for an API Monogram License or an APIQR Certificate of registration through the myCerts online portal.  .

Information about program requirements, including prerequisites for applying to the programs, can be found in the API Monogram Licensing Program Requirements and APIQR Registration Program Requirements  .

The hundreds of products eligible for licensing under the Monogram program are listed by API specification or standard at Monogram Licenses & Licensing Information Forms.

Once an application has been submitted, program team members will review it and, if necessary, follow up with questions. Please note that follow-up questions need to be resolved within 1 year of the date of application submission or the program will withdraw the application. After the application is accepted, the program will schedule an initial audit through which the applicant organization will demonstrate to an API auditor that it meets all applicable program requirements.

Monogram Applicant Audits

Organizations applying for API Monogram licenses or currently licensed under the program must undergo audits annually to verify conformance with API Spec Q1, applicable API product specifications, and program requirements. Applicants and program licensees are responsible for all audit expenses. First-time applicants, currently licensed organizations applying for licenses at new locations, and organizations returning to the program must pay their audit expenses before their initial audit is scheduled and have 1 year from the date of their application submission to complete the initial audit.

APIQR Applicants

Organizations applying for certification to or currently registered against API Spec Q1, ISO 9001, API Spec Q2, ISO 14001, and/or API Spec 18LCM are also required to undergo audits annually. After application acceptance, API Spec Q1 applicants undergo an initial audit, and applicants for ISO 9001, API Spec Q2, ISO 14001, and API Spec 18LCM (unless already registered as Q2 organizations) undergo a two-stage audit. Stage 1 audits are performed on-site and require organizations to provide the API auditor access to personnel and documents. These documents may include procedures, control features, internal audit reports, management review records, staff responsibilities, and facility layout. Once a Stage 1 audit has been successfully completed, API and the assigned auditor schedule the Stage 2 audit. Stage 2 audits are performed on-site to verify the organization's conformance with program requirements. Stage 2 audits must be completed within 6 months of the Stage 1 audit. Once registered against API Spec Q1, ISO 9001, API Spec Q2, ISO 14001, and/or API Spec 18LCM, organizations undergo annual full system audits to ensure continued conformance with program requirements.

Applicants and program registrants are responsible for all audit expenses. First-time applicants, currently certified organizations applying for registration at new locations, and organizations returning to the program must pay their audit expenses before their initial or Stage 1 audit is scheduled and have 1 year from the date of their application submission to complete the audit.

API will make the certification decision after evaluating the audit findings, conclusions and responses to findings (if any), and reviewing evidence of effective implementation of corrective actions by the organization (if required). A re-audit may be required based on this evaluation before the registration is granted.

How long will my audit last?

The length of an audit depends on many variables including the type of audit, the number of employees working for the organization, and the scope of the organization’s licenses and registrations.

How long will the audit review process take?

API generally processes audits on a “first-in, first-out” basis. The process time to complete an individual audit is largely based on the number of audits in process at a given time, the complexity of the audit and findings, and the timeliness of client responses to nonconformities with appropriate and acceptable corrective actions.

The process time starts when a facility's audit report is uploaded into myCerts by the auditor. At this point, the audit is available for the facility to respond to nonconformities with their corrective actions.

Refer to: Audit Response Instructions (English) before responding to nonconformities.

• After the auditor uploads the audit report into myCerts, the organization has 60 days to respond to nonconformities. Responses must be entered directly into myCerts.
• API review generally begins once audit fees owed by the facility have been paid in full.
• Since the process time to complete an individual audit is largely a function of the number of audits in process at any given time, complexity of the audit and findings, and the timeliness of client responses to nonconformities with appropriate and acceptable corrective actions, API cannot provide a timeframe for the completion of an audit review. Organizations are asked to monitor their account(s) for any changes and to respond to any inquiries from API staff.
• The organization has 30 days to respond to comments and questions from API personnel

Once the organization has answered all nonconformities, and any applicable API comments or questions and the response(s) have been accepted, the audit is reviewed by API’s Licensing and Registration Committee, which makes the final licensing or registration decision.

Additional Questions? Please submit them through the API Monogram and APIQR Contact Form.