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  QSR Quality Manual

The objective of the FDA QSR QUALITY MANUAL is to provide you with a template that assists you in either writing or revising your quality management system manual. The manual was written to satisfy the intent and requirements of FDA' Quality System Regulation codified under Title 21 CFR 820. If your company does not currently have a well-defined quality manual, this manual can be used as the framework on which to add material to accurately describe your quality management system and the unique requirements of your organization

In general, your quality manual needs to reflect that you are aware of the requirements of the QSR, have interpreted them correctly for your organization, and have implemented them through your quality management system. Again, every company is unique and as a result, the depth of your quality manual will be largely dependent upon the organization itself, the products and services you offer, and the systems implemented to adequately address organizational and industry requirements. In some instances, requirements may adequately be addressed in the quality manual itself and no lower level procedures may be needed. Often, reference to a lower level form may suffice. Since both the QSR and the manual are generic in nature, the sample manual and any accompanying suggestions and comments should be considered when modifying or creating your own company manual.

Our FDA QSR QUALITY MANUAL addresses all of the requirements of the FDA's Quality System Regulation (QSR). The manual contains suggestions and comments on how to modify or supplement the manual. The manual is organized by subpart and section, corresponding to the 15 subparts of the Quality System Regulation. This manual was also set up to reflect an overall revision, however, you may choose to have each section of the manual individually revision controlled.


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