Quality Edge Management Consulting will provide a complete documentation package that meets the requirements of ISO 9001:2000, ISO 13485:2003, QSR 21 CFR820 or AS9100B in an electronic format. We will customize the documentation to suit your company and industry specifications.
There are a number of different document formats available that are useful for different types of documentation applications. These include text, flowcharts, drawings, process maps and photos, and combinations of several types.
The appropriate document types are determined by working with your organization - establishing the nature of your business, its culture and employees, the level of detail required in your procedures and work instructions, the manner of distribution, the frequency of document usage, etc. These factors have an important role in developing documentation that will be understood and utilized by everyone in the organization and that reflects your organization's unique needs.
Our documentation is designed to reflect the natural flow of your processes such that all personnel can readily understand their roles and responsibilities within the whole organizational system. Auditing by process is simple and efficient as the documentation includes reference to associated documents and records.
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We will maximize the value and ease of use of your documentation at the most reasonable price you will find.
We can also help you develop the processes you need for your everyday Business Operations and Improvement endeavors.
Quality Manual - Tier 1
Quality System Procedures - Tier 2
Work Instructions - Tier 3
Forms and Records- Tier 4
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