Beruflich Dokumente
Kultur Dokumente
➨ Document Hierarchy
➨ Process Landscape
➨ ZF India Document Numbering System
➨ Numbering and Process Flow of Control of documents and
record
➨ Document Template
TS Requirement for Control of
Documents and Records
4.2.3 Control of documents
Documents required by the quality management system shall be controlled. Records are a special
type of document and shall be controlled according to the requirements given in 4.2.4.
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 changes and the current revision status of documents are identified,
d) to ensure that relevant versions of applicable documents are available at points of use,
e) to ensure that documents remain legible and readily identifiable,
f) to ensure that documents of external origin are identified and their distribution controlled, and
g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them
if they are retained for any purpose .
4.2.4 Control of records
Records shall be established and maintained to provide evidence of conformity to requirements and of the
effective operation of the quality management system. Records shall remain legible, readily identifiable and
retrievable. A documented procedure shall be established to define the controls needed for the identification,
storage, protection, retrieval, retention time and disposition of records.
NOTE 1 “Disposition” above includes disposal.
NOTE 2 “Records” also include customer-specified records.
4.2.4.1 Records retention
The control of records shall satisfy regulatory and customer requirements
What is a Document and Record ?
➨ Document
Information and its support medium
➨ Record
Document stating results achieved or providing evidence of
activities carried out.
➨ Procedure
Specified way to carry out an activity or a process
Document requirements
Not OK OK
Document requirements
Purpose: …… Purpose: ……
Process Flow: ….
Scope: ……..
Purpose: ……
Process Flow: ….
➨ legible,
➨ readily identifiable and
➨ retrievable
X
01.12 02.12 03.12 04.12 05.12 06.12 07.12 08.12 09.12
+
2 0 0 1
GM
0 0 1 0
AL
Storage
Can be recovered when required
QA/R/006 Dated: 07.06
Record requirements
➨ identification,
➨ storage,
➨ protection,
➨ retrieval,
➨ retention time and
➨ disposition
Record requirements
➨ Storage
Record requirements
➨ Protection
against unintentional damage or destruction
Record requirements
➨ Retention time
It represents the period of time a document should be kept or
"retained".
At the termination of the retention period, the document is
usually destroyed.
legal, customer-specific
and company evidence
Date of creation of record End of period of use requirements
Retention Period
Document Hierarchy
Quality
Management
Manual
Increasing Level of Detail
(QMM)
Business process
Procedures
Work Instructions
Storage/archiving of original
QMS
Document or info in mandatory
mailing list (w/ instruction:
"destroy invalidated version")
QMS
A
Control of Document and Record