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Documented procedures: ISO 9001 specifically requires the organization to have "documented procedures" for the following six

activities: 1] 2] 3] 4] 5] 6] Clause 4.2.3 Control of documents Clause 4.2.4 Control of quality records Clause 8.2.2 Internal audit Clause 8.3 Control of nonconforming product Clause 8.5.2 Corrective action Clause 8.5.3 Preventive action

Document says Do Record says Done

Records - cannot be amended ( if amended it becomes manipulation) Documents - can be amended. (format is a document. Filled format becomes a record)

a process is an integrated set of activities that uses resources to transform inputs into outputs. Processes are interconnected because the output from one process becomes the input for another process.

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