API MONOGRAM & APIQR: Audits
For those applying for an API Monogram license, once the application has been accepted, API will schedule an on-site audit. Audits include verifying the organization’s conformance with API Spec Q1 and any applicable API product specification. The audit costs are at the organization's expense.
Organizations licensed under the API Monogram Program will have audits scheduled every three years to ensure continued conformance with the applicable program requirements.
Those applying for certification to ISO 9001, API Spec Q1, API Spec Q2, ISO 14001 and/or OHSAS 18001 may undergo a Stage 1 audit, once the application is accepted. Stage 1 audits are normally performed on-site and require organizations to provide the auditor with documents for review. These documents may include procedures, control features, internal audit reports, management review records, staff responsibilities and facility layout. Once the Stage 1 audit has been successfully completed, API and the assigned auditor will schedule a Stage 2 audit. These audit costs are at the organization's expense.
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. Stage 2 audits must be completed within 6 months of the Stage 1 audit.
Facilities have a one year deadline from the date of application to undergo their Monogram or Stage 1 audit.
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). A re-audit may be required based on this evaluation before granting licensing or quality registration.
Organizations registered under API Spec Q1, API Spec Q2, ISO 9001, ISO 14001 and OHSAS 18001 will have a full system audit every year to ensure continued conformance with the applicable program requirements.
How much will my audit cost?
How long will my audit be?
When will I receive an invoice for the audit?
API bills the facility for an audit after the audit has concluded. The auditor submits their invoice with all incurred expenses associated with conducting the audit to API for review, and once it has been accepted, API will bill the facility. This process can take up to 90 days after the audit has ended.
What is the audit review process?
API generally processes audits on a “first-in, first-out” basis. The cycle 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 the findings, and the timeliness of client responses to nonconformities with appropriate and acceptable corrective actions.
The cycle 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 this helpful guide when responding to nonconformities: Audit Response Instructions (English) | Russian
- After the auditor uploads the audit report into myCerts, the facility client has 60 days to respond to nonconformities. Responses must be made directly into myCerts.
- The API reviewing associate then has 30 days to review your responses and if necessary, send a query regarding your initial responses.
- The facility client has 30 days to respond to the query.
Generally, once the client facility has answered all nonconformities with appropriate corrective actions and any applicable API queries, the audit is reviewed by compliance, management system, and technical experts before a final licensing or registration decision is made.