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Quality Management System

AS9100 / IA9100, IATF 16949, ISO 9001, ISO 13485, and / or cGMP Services.

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Contact

Contact Name *

Title

Email *

Phone

Company *

Street Address 1

Street Address 2

City

State

Zip Code

Scope of work

Services Requested

Is there a time constraint? What is the target for completion of the scope of work?

Sites

Number of Sites

Site 1 Address

Site 1 Activities

Site 1 Approximate Square Footage

Site 1 Estimated Employees

Site 2 Address

Site 2 Activities

Site 2 Approximate Square Footage

Site 2 Estimated Employees

For Additional Sites, please provide: Site Locations / Site Activities / Approximate Square Footage / Number of Employees at Each Site

Current management system

What standard(s) is the company currently certified to and how long has it been certified? Who is the Registrar?

What are the company's main products and / or services? Are there different product lines at different sites? Please provide additional information so that we can understand the overall operations of your organization.

Are there MRP / ERP or other systems / software being used to support the ISO system? What are they and how many employees have ready access to the computer?

Is there a Document Control system in place, hard copy or electronic? How long has the system been in place? If document control software is being used, which one? Are documents, including forms, adequately controlled; review, approval, distribution, and revision? How are Engineering Drawings controlled?

Is there a Quality Manual and, if yes, approximately how many pages is it?

Are there Level 2 documents (also called Procedures / SOPs, etc.) and, if yes, how many, format (text vs. flowchart) and average size (pages)? Are Level 2 documents clearly identified? How many Level 2 documents are there?

Are quality system records clearly identified and controlled? Is a record master list used to identify record location and retention?

Are there trained Internal Auditors; how many, who trained them? Is there an internal audit process in place? Will Internal Audit be outsourced?

Are there any additional complications or concerns that we should know about?