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everise
New Member
Malaysia
58 Posts |
 Posted - 09/12/2009 : 08:46:39
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[url=http://www.iso9001-standard.us]ISO 9001:2008 Requirements[/url] – Documentation Requirements
Include in the [url=http://www.iso9001store.com]quality management system[/url] documentation:
? Documented statements of a [url=http://www.iso-consults.com]quality policy[/url] and quality objectives
? A quality manual
? Documented procedures and records required by ISO 9001
? Documents and records determined by the organization to be necessary for the effective planning, operation, and control of its processes
NOTE 1: Where “documented procedure” appears within the Standard, this means that the procedure is established, documented, implemented, and maintained. A single document may address the requirements for one or 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:
? Size of the organization and type of activities
? Complexity of processes and their interactions
? Competence of personnel
NOTE 3: The documentation can be in any form or type of medium.
4.2.2 Quality Manual
Establish and maintain a quality manual with:
? Scope of the quality management system
? Details and justification for any exclusions
? Procedures or references to the procedures
? Description of interaction between processes
4.2.3 Control of Documents
Control the documents required by the [url=http://www.e-wia.com]quality management system[/url]. Records are a special type of document and must be controlled as required by clause 4.2.4.
Establish a documented procedure to:
? Approve documents for adequacy prior to issue
? Review, update as necessary, and re-approve documents
? Identify the changes and current document revision status
? Make relevant documents available at points of use
? Ensure the documents remain legible and readily identifiable
? Identify external documents and control their distribution
? Prevent obsolete documents from unintended use
? Apply suitable identification if obsolete documents are retained
4.2.4 Control of Records
Establish and control records as evidence of conformity to requirements and to demonstrate the effective operation of the [url=http://www.iso14000store.com]quality management system[/url].
Establish a documented procedure to define the controls needed for record:
? Identification
? Storage
? Protection
? Retrieval
? Retention
? Disposition
Keep records legible, readily identifiable, and retrievable.
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ISO 9001:2008 Requirements – Documentation Require
