Documents required for the Company Quality Management System are controlled according to established and maintained procedures. This control includes the approval, release, and distribution of documents necessary for the successful operation of the quality system. A document control function is designated for each company location for the control of documents according to established procedures. Controlled documents have a unique identification as described per established procedures. Documents may be in the form of hard copy and/or electronic media.
Document Structure and Hierarchy
Company utilizes a documentation hierarchy which cascades from the highest level down, driving quality system requirements and facilitating navigation. This structure is employed by all company locations. Note that this structure is a tiered approach to be followed where a lower level document can add to, but not take away from, a higher tiered document.
Documents supporting the Company Quality Management System, including procedures used at all locations are controlled in compliance with Company Policies and Procedures.
1. Quality Manual – includes the company Quality Policy and establishes the elements of the company Quality Management System.
2. Policies – establish quality related requirements by Management with Executive Responsibility.
3. Quality System Procedures – describe how requirements are fulfilled (including standards, statutes,
and regulations) and may be global or regional.
4. Product Requirements – are any requirement with which a product must conform. This includes, for example, engineering drawings, labeling artwork, specifications, operating procedures, and work instructions that are unique to each product or class of products intended for commercialization.
5. Records – are used to record monitoring and measuring results and to document the results of other topics where a record is required to be maintained. Records provide objective evidence of activities performed or results achieved. This includes, for example, completed forms, printouts of testing,
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