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Documentation Requirements

What documentation is needed to comply with management system standards. The answer to this is well explained in ISO helps:

  • High level documents:
    • The scope of the quality management system (4.3)
    • Documented information necessary to support the operation of processes (4.4)
    • The quality policy (clause 5)
    • The quality objectives (clause 6.2)
    • This documented information is subject to the requirements of clause 7.5.
  • Lower level documents. Although ISO 9001:2015 does not specifically require any of these, examples that can add value to a QMS may include:
    • Organization charts
    • Process maps, flow charts, process descriptions
    • Procedures
    • Work instructions
    • Specifications
    • Documents containing internal communications
    • Production schedules
    • Approved supplier lists
    • Test and inspection plans
    • Quality manuals
    • Strategic plans
    • Forms
  • Documented information needed to be retained by the organization for providing evidence of compliance. Note: Many people assume the standards require records for everything as proof of compliance. The truth is that the standards are not only about evidence; they are about good business practice however. In only a few places, the standards specify when a record as needed (see below). the type and amount of records required will differ from one organisation to another:
    • Calibration records
    • Competence of persons
    • Design and development records
    • Evaluation and re-evaluation of external providers
    • Production records
    • Records of traceability
    • Non-conformities
    • Management reviews
    • Internal audits
    • Results of corrective actions.

Source: adapted from http://www.iso.org/iso/documented_information.pdf 

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