Dokumen yang wajib ada dalam ISO9001:2008, adalah: (red font)
1. quality policy (kebijakan mutu) and
2. quality
objectives (sasaran mutu)
3. quality
manual (pedoman mutu),
4. documented
procedures (prosedur terkait mutu)
5. and records (rekaman terkait mutu)
Berdasarkan Klausul di bawah ini:
4.2.1
General
4.2 Documentation requirement
The quality
management system documentation shall include
a) documented statements of 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 ensure the effective planning,
operation and control of its processes, and
NOTE 1:
Where the term “documented procedure”
appears within this International Standard, this means that the procedure is established,
documented, implemented and maintained. A single document may
address the requirement for one and more procedures. A requirement for a
documented procedure may be covered by more than one document.
NOTE 2: The
extent of the quality management system documentation can differ from one
organization to another due to
a) the size of organization and type of
activities,
b) the complexity of processes and
their interactions, and
c) the competence of personnel
NOTE 3: The
documentation can be in any form or type of medium.
