Beyond ISO9001 – Good Manufacturing Practises (GMP)

ISO9001 sets a solid base for a manufacturing quality system, but typically does not prescribe specific requirements  However, many industries now have to meet more stringent standards which go into further specific details to ensure that industry safety standards are met.

These standards may be defined by an ISO standard, or in other cases may be prescribed by regulatory bodies such as the FDA or European Union.

Examples of ISO standards are:

ISO13485   Quality Systems for Medical Devices

ISO16949 Quality Systems for Automotive Industy

ISO 22716   Good Manufacturing Practises Guide – Cosmetics

For other industries, guidelines have been established by regulatory agencies such as:

Good Manufacturing Practises for Pharmaceutical Industry (Europe)


These standards typically prescribe minimum requirements to ensure product traceability, and to ensure that processes are guaranteed to be capable of meeting specifications.

As with the iso9001 system, all of these systems require rigor in the documentation of procedures, registation of actions such as controls and corrective actions, and a clear and effective audit process.

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