Documentation Requirements

Requirements

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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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