Q5.

the documentation shall include (A) statements of quality policy and quality
objectives
(B) Quality Manual-A quality manual shall be established and maintained that
includes (a) the scope of the QMS with details and justification for any exclusions,
(b) the documented procedures or reference to them, and (c) a description of the
interaction among the QMS processes
(C)Required documented records and procedures-Documents required by the
QMS shall be controlled. Records are special type of documents. A documented
procedure shall be in place to define the controls needed to (a) approve documents
prior to use, (b) review, update, and re-approve as necessary, (c) identify the
current revision status, (d) ensure that current versions are available at the point of
use, (e) ensure that documents are legible and readily
(D) Needed documents to ensure effective planning ,operation , control of
processes and records-Records which are established to provide evidence of
conformity to requirements and the effective operation of QMS shall be controlled.
A documented procedure shall be established to define the controls needed for the
identification, storage, protection, retrieval, retention and disposition of records.
Records shall remain legible, readily identifiable and retrievable