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API认证咨询审核,企业在提交API认证申请前,需确保以下六大问题状态为YES

来源:本站 作者:深圳市肯达信企业管理顾问有限公司 陈小姐 18575592846 发布时间:2020-09-03

API Monogram Licensing Program Requirements

Part 3 – Licensing Process

1. Application Submission

Applications are accepted online using the “myCerts Login” found at https://my.api.org. The myCerts Portal guides the applicant through the process requesting relevant information such as company name, location, number of employees, desired

monogram licensing scope, quality manual, Q1 conformity matrix, etc. The application is reviewed by API once all legal agreements are electronically signed and payment is confirmed.

Before you submit your application, make sure your organization answers YES to all of the following questions:

(a) Have you implemented and maintained a management system that meets the applicable requirements of API Spec Q1 for

least four months?

(b) Has a full system internal audit been performed?

(c) Has a management review been conducted?

(d) Have you identified and provided justification for any QMS exclusions?

(e) Do you own an authorized copy of the most current edition of the API Product Specification(s) for which you are applying licensing?

(f) Do you have a validated design package, if applicable, for each product under the scope of your application for licensing?

2. Application Review

Upon receipt of your completed application, the API Certification Programs staff will review your quality manual against API Spec Q1and the requirements of the API Product Specifications under which you are seeking licensing. If the information provided with the application does not meet the stated requirements, you will be notified of any deficiencies and you will be required to provide clarifications and/or resubmit documents.

3. Auditor Assignment

Upon acceptance of your application, an on-site audit will be scheduled at a time mutually convenient to your Organization and the designated API auditor and at your Organization’s expense. Organizations will be given the audit team leader’s name and all other pertinent information regarding preparation for your on-site audit.

4. On-Site Audit

After the audit is conducted, the audit team leader will prepare a detailed report, and any nonconformances will be reviewed with the Organization representatives during an exit interview. The original report will be forwarded to the API Certification

Programs staff for verification that the program described in the audited Organization’s quality manual is in place and functioning.

Site audits are required to verify demonstrated capability of the Organization to meet program requirements. Associated audit expenses will be paid by the facility.

5. Audit Review

Your organization shall provide a correction, root cause analysis and corrective actions for any nonconformity identified during the audit. The API staff decision to issue a license is based upon objective evidence obtained during the audit that verifies conformance with API quality standards and API Monogram Program requirements. All the audit records and the actions taken as

a result of nonconformities are maintained in myCerts.

6. Initial Licensing

Issuance of the license(s) is dependent upon a successful evaluation of the Organization’s quality manual and satisfactorily passing an on-site audit of the Organization’s facility and processes by API through its designated auditors.

7. Renewal Audit

Evaluation of Licensees is a continuing process with renewal audits required every three years or at a shorter frequency as determined by API. In the interim there may be unscheduled periodic or for-cause re-audits, at the sole discretion of API.

8. Annual Surveillance

API will perform on-site surveillance audits of the management system of Licensed Organizations. The frequency of surveillance  audits shall be at the discretion of API but shall be at least once every calendar year. The scope of the surveillance audits shall be  at the discretion of API but will not necessarily cover all elements of the Organization’s MS. Following the surveillance audit(s), API  shall determine if any further action, which could include notification of suspension or cancellation, or if a follow-up audit may be

required.

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