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Documentation Requirements of QMS
Transcript of Documentation Requirements of QMS
Monday 24th March 2014
HSA Corporate Office - Dubai
ISO 9001 : 2008
4.2 Documentation Requirements
ISO/TC 176/SC 2/N 525R2
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures and records required by this International Standard, and
d) documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records
The quality management system documentation shall include
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system,
b) the documented procedures established, or reference to them, and
c) a description of the interaction between the processe.
A documented procedure shall be established to define the controls needed
a) to approve documents for adequacy prior to issue,
b) to review and update as necessary and re-approve documents,
c) to ensure that relevant versions of applicable documents are available at points of use,
d) to ensure that documents remain legible and readily identifiable,
e) to ensure that documents of external origin determined by the organization to be necessary for the planning
and operation of the quality management system are identified and their distribution controlled.
Records established to provide evidence of conformity to requirements and of the effective operation of the
quality management system shall be controlled.
The organization shall establish a documented procedure to define the controls needed for the identification,
storage, protection, retrieval, retention and disposition of records.
Records shall remain legible, readily identifiable and retrievable.