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ISO 13485

The third-party analysis by IQC The ISO Pros of Tennessee in Byrdstown (TN) provides external and internal verification of the examination, assessment, and compliance of customer procedures, including increasing the trust needed to satisfy the applicable regulatory requirements. The purpose of this specification is to ensure continuous growth, stability, time, and cost savings after the implementation of this norm.

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Organizations engaging in one and more steps of the product production cycle, including design and packaging that relate to the manufacturing, storage/distribution, delivery, or service of medical products, profit from the expertise of our professional staff in quality management.

Although IQC The ISO Pros of Tennessee in Byrdstown (TN) is committed to creating a cleaner environment, ISO 13485 promotes the elimination of unforeseen hazards and enhances the monitoring of these hazards in order to meet the company’s maximum objectives. This enhancement not only improves the credibility of the company and its clients but also provides a realistic and efficient way of demonstrating compliance with regulatory requirements.


AS9101, Audit Standards for Aircraft, Aerospace and Defense Organizations, Quality Control Programs, is a method used by the inspection agency to define the review report to be submitted after every audit, certification or recertification has been completed. This protocol includes a checklist of all the AS9100 clauses that are checked as part of the audit and a scoring system to better assess the effectiveness of the QMS systems and processes during the audit. AS9101 Rev F (against AS9100 Rev D) is the newest revision, however, AS9101 Rev E is still used for QMS audits that have not yet been revised (until September 15, 2018).

This level is significant as the International Aerospace Quality Community (IAQC) Online Aerospace Supplier Information System (OASIS) database lists every company that is accredited as AS9100. The score, calculated by the assessment of the AS9101 checklist, is included in this index and allows customers to assess the differences in the effectiveness of the AS9100 execution of their supplier.


AS9102 First Article Inspection (FAI) is a tool used to produce a component that meets the requirements as intended to validate the production process. Several companies carry out first object checks using AS9102 in the U.S. aerospace and defense sector. Some companies often use controls to validate their processing processes, but they vary in style from company to business to when they are done in the development process.

AS9102 is a prerequisite for the SAE to govern the first articles in the Americas (written by the International Aerospace Standard Community, IAQG). ‘First Article inspection shall be specified by the AS9102 norm as ‘a planned, complete, autonomous and documented inspection and verification method to ensure that the prescribed construction processes have produced an item that complies with the engineering drawings, the DPD, the planning, the purchase order, the engineering specifications and/or other applicable design documents (Ref 9102 Rev B, Sec 3.10.) The journal’s first inspection study, ‘Forms and packages of part quantity, sub-assembly or assembly documents, including related FAI data, as defined in this norm’ (Ref 9102 Rev B, Sec 3.11.)

IQC The ISO Pros of Tennessee can help you implement, train on, consult, and have your company and/or organization certified on the following ISO Certifications:

If you want to enjoy the above-listed benefits, contact IQC the ISO Pros of Tennessee, now. Our services are accessible in all of the below-mentioned cities: