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ISO 9001 � Requirements of a Quality Management System

What is ISO 9001 Quality Management System?

  • Unlike Occupational Health and Safety Management and Environmental Management, Quality Management does not have a national Act. Quality Management only complies with an international standard known as ISO 9001. ISO 9001 compasses the requirements intended to be used in those organisations which provide a service, or design, develop, manufacture, and install a product. In order to fulfill customer satisfaction to ultimately meet customer expectations, the services and products need to comply with the requirements set out in ISO 9001.

Transition from ISO 9001:2015 to ISO 9001:2015

Clarifications concerning the existing requirements of ISO 9001:2015 are introduced BY ISO 9001:2015. Some changes were done with the intention of improving consistency with ISO 14001:2004. However, no new requirements were added. When upgrading a quality management system, it needs to be checked against the amended version to see whether or not it is following the clarifications of the newer version.

The main revisions made to ISO 9001:2015 include:

  • Statutory requirements are now given scale as all other legal or customer's requirements;
  • The statutory requirements include suppliers as well;
  • A purchased process is the same as any other product that the organisation purchased. If it's affecting any product it must be included in the quality system;
  • Two quality processes may be included in one document and also split one process into two documents;
  • A management representative must be a member of the company�s management;
  • It is a requirement to ensure that all training are suitable for the product in advance and not evaluate the training effectiveness after it was taken;
  • The information system is now officially considered as a substructure;
  • Factors concerning the employees' health, such as humidity, noise, and temperatures, are considered part of a working environment;
  • Measuring is viewed as one of the activities of product realisation;
  • The purpose must be to identify not only on the shelves but throughout the entire realisation process


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