Document Control in ISO 9001:2008

WHAT DOCUMENTATION IS REQUIRED?

The updated ISO 9001:2008 standard specifically requires a Quality Policy and Quality
Objectives, a Quality Manual, and Documented Procedures.  Documented procedures include
specific documents identified in the ISO 9001:2008 standard and other documents needed to
ensure effective Process Planning, Operation and Control (Element 4.2.1).
The “minimum” procedures specifically required by the updated ISO 9001:2008 standard
include the following:
Document Control Procedure (4.2.3).
• Records Control Procedure (4.2.4).
• Internal Audit Procedure (8.2.2).
• Control of Nonconforming Product Procedure (8.3).
• Corrective Action Procedure (8.5.2)
• Preventive Action Procedure (8.5.3).
To determine what additional documents are needed, the new standard emphasizes a “process
approach” and a “system approach” to documenting and managing the QMS.  A company must
identify and document “needed” individual and system processes (activities with inputs and
outputs) including linked inter-departmental activities and interactions.  The quality management
principles underlying the requirements in the new standard imply that control and synergy can
only be achieved by understanding, monitoring, and improving system-wide processes with their
inherent cross-functional interdependencies and linkages.  The ISO 9004:2008 “Guideline”
standard describes these and other quality management principles that are “integrated in the
contents” of the requirements.
“Needed” QMS documentation should be appropriate for the size and type of the organization,
the complexity and interaction of processes, and the competence of personnel.

EXAMPLES OF NEEDED ISO 9001:2001 DOCUMENTATION
Examples of other specific ISO 9001:2000 requirements that may require appro
documentation include:

• Planning (5.4)
• Communications (5.5.3)
• Management Review (5.6)
• Resource Management (6)
• Training (6.2.2)
• Infrastructure (6.3)
• Customer-related Processes (7.2)
• Design and Development (7.3)
• Purchasing (7.4)
• Production and Service Control (7.5.1)
• Validation of Processes (7.5.2)
• Identification and Traceability (7.5.3)
• Customer Property (7.5.4), Preservation of Product (7.5.5)
• Customer Satisfaction Measurement (8.2.1)
• Internal Audit (8.2.2), Process/Product Monitoring and Measurement (8.2.3/8.2.4),
• Control of Nonconforming Product (8.3)
• Continuous Improvement (8.5.2).
• Other applicable standards and statutory/regulatory requirements

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