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ISO 9001 requires that you maintain Control of Documents (4.2.3)

Control the documents required by the quality management system. Records are a special type of document and must be controlled as required by clause 4.2.4.

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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 quality management system.

Establish a documented procedure to define the controls needed for record:

  • Identification
  • Storage
  • Protection
  • Retrieval
  • Retention
  • Disposition
  • Keep records legible, readily identifiable, and retrievable.