Tentang QMS Dokumen Wajib

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.