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.
QSR Quality Manual