[Description of the ISO 9001/2000 certification process in the parenteral nutrition area]

Farm Hosp. Nov-Dec 2007;31(6):370-4. doi: 10.1016/s1130-6343(07)75408-9.
[Article in Spanish]


Objective: In order to guarantee quality and safety and to increase user satisfaction, healthcare organisations have integrated quality management systems into their structures. This study describes the process for introducing the UNE-EN-ISO-9001/2000 standard in the parenteral nutrition area.

Method: A multidisciplinary group established the scope of the standard, focusing on transcription, preparation, dispensation and microbiological control.

Results: A detailed procedure describing the sequences of circuits and associated activities, the responsible staff and the action guidelines to be followed was established. Quality and activity markers were also established.

Conclusions: This process has enabled a standard system to be implemented, with its operation perfectly described and documented, allowing its stages to be traceable and supervised. As there is no record of the data obtained beforehand, no direct comparison can be made; its evolution must therefore be analysed in the future.

Publication types

  • English Abstract

MeSH terms

  • Certification*
  • Humans
  • Parenteral Nutrition / standards*
  • Pharmacy Service, Hospital / standards*
  • Quality Assurance, Health Care / standards*
  • Spain