Quality Management System – QMS

A Quality Management System is a systematic process for managing and documenting product quality and compliance with relevant technical and safety standards, usually based on the ISO 9000 (International Organization for Standardization) family of five QMS standards:

  • ISO 9001 sets organisational requirements
  • ISO 9002 applies to production and installation
  • ISO 9003 to inspection
  • ISO 9004 continued organisational success

QMS systems can be certified by third party certification bodies and effective QMS systems are mandatory in a number of sectors including pharmaceuticals and medical devices, aviation, safety equipment, etc. The underlying data for an auditable QMS trail and system can form an important intangible asset for a business and may be seen as a form of quasi-intellectual property. Thus, for example, a QMS system and the data to support it, especially in the context of an audit, is a valuable asset in a drug or medical device business and thus an acquisition.

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