Practical sheet | REF: FIC0389 V1

Identify and implement documentation requirements

Author: Cécile MALATERRE

Publication date: June 10, 2016, Review date: November 27, 2016 | Lire en français

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3. What documented information does ISO9001 require?

ISO9001 specifies a certain amount of information that must be documented. First of all, the organization must maintain documented information structuring the quality management system. This information can be transcribed in documents such as manuals, procedures, instructions, notes, websites, etc. These documents provide structure and organizational information. They correspond to the PLAN phase of the Deming wheel.

3.1 Documented information to be kept up to date

  • Explanation of the QMS scope of application (§ 4.3).

  • Information required for process operation (§ 4.4.2 a).

  • Quality policy (§ 5.2.2 a).

  • Quality objectives (§ 6.2.1)....

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What documented information does ISO9001 require?