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Api Monogram Licensing Program Requirements Revision 11

The fee schedule applies to a single quality program at the same facility. For more information on where to send your application fee, see Part 5 – Fee Schedule. For more information, please call (+1) 202-682-8041 or visit our website at www.api.org. The filing of the application documents, including fees, does not give the applicant the right to use the monogram sign of the API. The license agreement takes effect only on the day it is executed by the API. Monogram API Licensing RequirementsIntroductionThe Monogram API Licensing ProgramThank you for requesting information about the Monogram API Licensing Program. By applying for a Monogram API license application, you have already shown that you are ready to take an important first step towards improving processes and customer satisfaction. This document is used to review the requirements of the Monogram API licensing program. If you would like to submit an application, please complete a Monogram license application online with “myCerts Portal Login”, mycerts.api.org.If you have any questions, please contact one of our representatives by calling API at 202-682-8041.

Please send requests by email [email protected] The request will be processed once we have received your payment. And thank you again for your interest in the Monogram API licensing program.REVISION 8 FM-002.pdfPAGE 1 OF 1 This document allows you to review the requirements of the Monogram API licensing program. If you would like to submit an application, please complete a monogram license application online with “myCerts Portal Login”, which you can find under my.api.org. Part 1 – General Requirements Learn how the API executes API monogram licenses and what is expected of the API and the subject. You will also learn how to obtain a complete list of Product Specifications specific to the Monogram API program product available for licensing. 1. The information contained in this document describes the requirements applicable to organisations applying for authorisation to use the API monogram mark. The API assessment and licensing system has superiority over other quality system assessments – such as ISO 9000 – because the API issues monogram licenses only after an on-site audit has verified both: that the licensee`s quality management system as a whole meets the requirements described in the API Q1 specification and that the products manufactured with the API monogram meet the requirements of each API product specification. In contrast, other systems do not require auditors to verify product compliance with individual specifications Monogram API Licensing Program RequirementsPart 3 – Licensing Process1.

Applications are accepted online via the “MyCerts Portal Login” under mycerts.api.org. The myCerts portal guides the candidate through the process and requests relevant information such as company name, location, number of employees, scope of the desired grammatical license, quality manual, Q1 compliance matrix, etc. The request is reviewed by the API once all legal agreements have been signed electronically and payment has been confirmed. Before submitting your application, make sure your company answers YES to all of the following questions:(a) Have you implemented and maintained a management system that meets the applicable requirements of the API Q1 specification for at least four months? (b) Has a full internal audit of the system been conducted? (c) Has a management review been conducted? d) Have you identified and justified the exclusions from the QMS? (e) Do you have an authorized copy of the most recent edition of the API product specification(s) for which you are applying for the license? f) Do you have a validated design set, if any, for each product as part of your license application?2. Application ReviewAfter receiving your complete application, API Certification Program staff will review your quality manual and compliance matrix against the API Q1 specification and api product specification requirements under which you are applying for a license. If the information provided with the application does not meet the specified requirements, you will be informed of any deficiencies and will need to clarify and/or resubmit documents.3. Auditor AssignmentWhen accepting your application, an on-site audit is scheduled at a time favorable to your organization and the designated API auditor and at the expense of your organization. Organizations will be provided with the name of the audit team leader and any other relevant information to prepare for your on-site audit.4. On-site auditAfter the audit is conducted, the head of the audit team prepares a detailed report and any non-compliance is discussed with representatives of the organization during an exit interview. The original report is forwarded to API certification program staff to verify that the program described in the audited organization`s quality manual is present and functioning.

Site audits are required to verify the organization`s proven ability to meet program requirements. The associated examination fee is paid by the institution.5. Audit reviewYour organization must provide a correction, root cause analysis, and corrective actions for any non-compliances identified during the audit. The API staff`s decision to license is based on objective evidence obtained during the audit that verifies compliance with API quality standards and API monogram program requirements. All audit records and actions taken due to nonconformities are kept in myCerts.6. Initial LicenseThe issuance of the license(s) depends on a successful assessment of the organization`s quality manual, the API Spec Q1 compliance matrix, and the satisfactory success of an on-site audit of the organization`s facilities and processes by the API by the auditors it appoints.7. Renewal VerificationLicensor assessment is an ongoing process that requires renewal audits every three years. In the meantime, there may be periodic unscheduled identification or for-ca(b) license information of the API specification and the products for which you are requesting a license. To access the list of licensed vendors who want to apply the API monogram to their devices and materials, they must apply to API for a license.

If the API determines, through an on-site audit, that a manufacturer is able to produce products that meet the API specifications, the API allows that manufacturer to use the API monogram and its license number for specific products manufactured at specific locations. While any manufacturer can claim that their products meet the API specifications without monogram them, only manufacturers with an API license can apply the API monogram to their products. Monogram API Licensing RequirementsPart 1 – General Requirements5. Exclusions from the API Spec Q1 quality management system restricts the sections of the standard applicable to the exclusion (see section 1.Scope). For these conclusions to be valid, the applicant or licensed organization must provide a written justification for the exclusion or exclusions by specifying the exclusions in your quality manual. Even if the activities of the proposed excluded sections are carried out through outsourcing, the applicant or approved organisation must ensure that adequate controls are maintained both in the management system of the outsourced organisation and in its own management system in order to periodically review the outsourced controls. Thus, these activities are not eligible for exclusion. NOTE: The applicant or licensed organization must demonstrate (during audits) that controls are adequately performed and maintained for all activities that may be outsourced.

Examples If no properties provided by the customer (finished product, raw material or intellectual documentation) are permitted as part of the manufacturing or service process of the applicant or the approved body, api Q1 specification, section 5.7.5, may be declared an applicable exclusion. However, if this organization provides its customers with threading, heat treatment or inspection services for finished products, section 5.7.5 cannot be excluded. Similarly, section 5.7.5 is not excluded if this organization receives exclusive designs of products from the manufacture. If the processes that require validation according to the respective product specifications are not applicable (e.B. Welding, EMI and heat treatment), API Q1 specification, section 5.7.1.5, can be declared as an applicable exclusion. However, if an organization needs to carry out such processes and decides to outsource them, section 5.7.1.5 is not appropriate for the exclusion. If no product design is carried out due to the nature of the activities defined within the management system (para. B e.g., threading, maintenance, machining), API specification Q1, section 5.4 can be declared as an applicable exclusion. . . .

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