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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