Dáil Éireann debate -
Tuesday, 8 Feb 2000

Vol. 513 No. 6

Written Answers. - ISO 9000 Standard.

Bernard Allen

Question:

175 Mr. Allen asked the Tánaiste and Minister for Enterprise, Trade and Employment if she will make a statement on the situation where Irish research into the worldwide use of the ISO 9000 series of quality systems for healthcare applications suggests that the internationally recognised standard is in itself lacking in standardisation. [3113/00]

Minister of State at the Department of Enterprise, Trade and Employment (Mr Treacy)

The Deputy may be referring to an article published in Medicine Weekly recently detailing studies carried out by John Sweeney of the Irish Society for Quality in Healthcare, which identified variations in the application of ISO 9000 standards in a hospital environment among different certifying bodies in different countries.

The ISO 9000 is a general quality management system standard which can be used in all industrial and service sectors. Specific guidelines have been produced by national bodies or sectoral interests to clarify its application to specific sectors, but it is by no means compulsory to use these guidelines. Guideline documents are intended to provide assistance to companies in the interpretation of ISO 9000 in their particular sector. The guideline documents may vary but must remain within the generic requirements of the ISO standard.

A network of the world's first class certification bodies – the International Certification Network or IQ Net – has been set up, one of whose aims is to ensure the equivalence of certification procedures and interpretations through an ongoing system of peer evaluation. The National Standards Authority of Ireland – NSAI – is an active member of this network.

In addition, Ireland is one of seven countries identified by Mr. Sweeney who have produced guidelines for the application of ISO 9000 standards to health service providers.

In 1997, following consultation with representatives from all areas of the health care sector the National Standards Authority of Ireland – NSAI – published a guideline document for the application of ISO 9000 in a hospital environment. This document is available free of charge to all health service providers and has assisted health care agencies in interpreting ISO 9000 registration in a range of services including acute hospital, mental handicap, care for the elderly and environmental health food control.

The Irish health care industry is very aware that the ISO 9000:1994 series is undergoing revision and that the new ISO 9000:2000 is expected to be published later this year.