Legal requirements and standards: ISO 9001:2015

There are five generic cases.

• Sectors in which traceability is regulated or even legal.

  This has been the case, for example, with cattle farms since BSE, road hauliers (the tachograph), nominative computer files (the French Data Protection Act requires the authorization of those concerned), commercial measuring equipment (regular calibration labeling), air transport (aircraft use and maintenance), nuclear power plants, etc.

  The legal requirement can also be indirect.

  Example

  When food manufacturers are asked to indicate the GMO content of their products, they must be able to prove it.

• More generally, compliance with applicable regulations (articles 1 Scope of application and 4.2 Understanding...