ISO 9001:2015 Documentation Requirements

Management SystemsISO 9001:2015 clause 4.4 Quality management systems and its processes requires an organization to “maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confident that the processes are being carried out as planned.”

Clause 7.5.1 General explains that the quality management system documentation shall include: a) documented information required by this International standard; and b) documented information determined by the organization as being necessary for the effectiveness of the quality management system.  QMS documented information can differ from one organization to another due to the: (1) size of organization and its type of activities, processes, products and services;  (2) complexity of processes and their interactions, and (3) competence of persons.

Documented information maintained by the organization for the purpose of communicating the information necessary for the organization to operate (low level, specific documents). See 4.4.  Although ISO 9001:2015 does not specifically requires any of them, examples of documents that can add value to a QMS may include:

  • Organization charts
  • Process maps, process flow charts and/or process descriptions
  • Procedures
  • Work and/or test instructions
  • Specifications
  • Documents containing internal communications
  • Production schedules
  • Approved supplier lists
  • Test and inspection plans
  • Quality plans
  • Quality manuals
  • Strategic plans
  • Forms

Where it exists, all the documentation that forms part of the QMS, including all that is maintained (records) has to be controlled in accordance with clause 7.5. Documented Information. 

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