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API audit AUDIT SERVICES

Simulated API audit refers to comprehensive audit of quality management system and products of applicant enterprise by OcerT in accordance with the method and audit checklist totally the same with external audit authorities before the enterprise receives form audit of API authority, thus to find out difference, correct and minimize nonconformities, thus to lower the risk of failure to pass audit for the first time.

Necessity of simulated audit

Simulated audit for API application may help enterprises to complete the contents in the following aspects:

Ø  Management priority is under internal audit with the assistance of related parties to identify enterprise management responsibilities, resource management, process management, measurement, analysis, and improvement management. Four major management processes in management system enhance enterprise management functions;

Ø  Demands of other related parties, establishment and implementation of a sound management system. Not only statement of enterprise itself is required, external inspection and audit are also needed to promote issuance of relevant audit evidence, thus to facilitate approval of the enterprise by the supplier.

Ø  Lowering organization risk. Enterprise entrusts external related party to perform comprehensive audit of quality management system and product specification in strict accordance with requirements of API Q1 and relevant monogram by the method exactly the same with external API audit authority, thus to find out difference, correct and minimize nonconformities, thus to lower the risk of failure to pass audit for the first time;

Ø  Meeting requirements for management system standard authentication. Two-stage audit or pre-audit is required regardless of ISO 9001 authentication or relevant overseas authentication. Related party's assistance with enterprise audit supplements stage-I audit to better meet requirements for management system authentication;

Ø  Verification on conformance with contract requirements. Enterprise audit by related party helps enterprise to verify conformance of relevant customer requirements to management system, thus to keep Simulated API audit refers to comprehensive audit of quality management system and products of applicant enterprise by OcerT in accordance with the method and audit checklist totally the same with external audit authorities before the enterprise receives form audit of API authority, thus to find out difference, correct and minimize nonconformities, thus to lower the risk of failure to pass audit for the first time.

Necessity of simulated audit

Simulated audit for API application may help enterprises to complete the contents in the following aspects:

Ø  Management priority is under internal audit with the assistance of related parties to identify enterprise management responsibilities, resource management, process management, measurement, analysis, and improvement management. Four major management processes in management system enhance enterprise management functions;

Ø  Demands of other related parties, establishment and implementation of a sound management system. Not only statement of enterprise itself is required, external inspection and audit are also needed to promote issuance of relevant audit evidence, thus to facilitate approval of the enterprise by the supplier.

Ø  Lowering organization risk. Enterprise entrusts external related party to perform comprehensive audit of quality management system and product specification in strict accordance with requirements of API Q1 and relevant monogram by the method exactly the same with external API audit authority, thus to find out difference, correct and minimize nonconformities, thus to lower the risk of failure to pass audit for the first time;

Ø  Meeting requirements for management system standard authentication. Two-stage audit or pre-audit is required regardless of ISO 9001 authentication or relevant overseas authentication. Related party's assistance with enterprise audit supplements stage-I audit to better meet requirements for management system authentication;

Ø  Verification on conformance with contract requirements. Enterprise audit by related party helps enterprise to verify conformance of relevant customer requirements to management system, thus to keep customer as center;

Ø  The audit facilitates improvement of management system. Audit is performed to f customer as center;

Ø  The audit facilitates improvement of management system. Audit is performed to find out problems, analyze problems and find out root causes, and correction and corrective actions are taken to settle problems fundamentally, and nonconformity trend is analyzed to serve for improvement of enterprise management system in future system implementation and operation.

Audit implementation

Ø  OcerT will, in combination with actual conditions of enterprise, get familiar with and understand company system operation documents, understand enterprise scale, organization, and control repeated nonconformities in previous external audit in combination with enterprise products, application specifications; for problems in key area, OcerT will prepare corresponding audit plan according to years of experience of OcerT in external audit, and will centralized process perform and audit in combination with factors;

Ø  Audit days may be planned according to enterprise requirements, with audit mode exactly the same with external audit;

Ø  The audit checklist which totally complies with API Q1 and product specifications is prepared on the basis of enterprise organization, product specifications and personnel structure, thus to realize standardized procedure, identify sampling quantity and samples, keep audit progress as planned, and prevent missing and lacked audit items; and audit records will be kept to provide basis of audit;




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