Public Comment, Draft Standard DZ15189:
Standards New Zealand has released the following draft Standard:
DZ15189 Medical Laboratories – Particular Requirements for Quality and Competence ISO 15189: 2007
now available for public comment!
Under the auspices of Standards New Zealand the International Medical Testing Standard ISO 15189 was adopted as a New Zealand Standard soon after its release in April 2003. The standard has been the primary criteria document for medical laboratory accreditation in New Zealand since that time.
The International Standard was based upon the generic laboratory and quality management system standards, ISO/IEC 17025 and ISO 9001. These standards were under revision in 2003 and it was understood at that time that ISO 15189:2003 may need to be realigned with these base-documents when they were re-issued in 2005. Thus it has been necessary to re-issue the medical laboratory standard, ISO 15189: 2007, with some minor modifications to maintain the intended consistency with the parent documents.
Standards New Zealand Committee P15189 was convened on 25 July 2007 to review the amended International Standard, ISO 15189:2007 and make recommendations on the appropriateness of its adoption as a New Zealand Standard. The minor amendments apparent on detailed review of the standard may be summarised as follows:
• Minor editorial amendments to the Foreword and Normative References sub-clauses to reflect the modified nomenclature of the generic criteria i.e. ISO/IEC 17025:2005 and ISO9000:2005.
• Scope 1.2 – an additional sub-clause stating the intended use of ISO 15189:2007.
• Terms and Definitions 3.1 and 3.14: two additional terms are defined – accreditation and Quality Management System.
• Organisation and Management 4.16: an additional sub-clause equivalent to ISO/IEC 17025: 2005 sub-clause 4.16.
• Preventive Action 4.11.2: minor editorial amendment.
• Annex A: amended cross-referencing to reflect the updated ISO/IEC 17025:2005 and ISO 9000:2005 standards.
The Committee agreed that the changes outlined above were of a very minor nature, of no significance to the general applicability of the standard in New Zealand. It was thought that laboratories operating in compliance with the current version of the standard would continue to comply with the amended version. Consequently, the committee was able to recommend without reservation that ISO 15189:2007 be adopted as a New Zealand Standard.
If you or anyone in your organisation would like to review and provide comment on this draft, you can download it free from the Standards New Zealand website.
If you have problems downloading this draft please call 0800 782 632.
You can either comment online by clicking on the 'Enter comments online' tab, or you can comment by downloading and completing the comment form and sending it to Kiri Cook-Green.
The closing date for comments on these drafts is 18 September 2007
Kiri Cook-Green
Project Administrator
DDI: 04 498 5906
Email: kiri.cook-green@standards.co.nz
Revision of AS/NZS 2243.3:2002:
Safety in laboratories Part 3:
Microbiological
aspects and containment facilities
The above draft was issued for public comment as DR07335 on 15
August 2007 and the closing date for comments will be 26 October 2007.
Committee members will be able to obtain a copy of DR07335 through the
Current publications link on the CH-026 web site.
For others, DR07335, Safety in laboratories Part 3: Microbiological
aspects and containment facilities, will be available from 22 August
2007 by free download through Standards Australia's publisher. It will
be available through SAI Global's web site:
http://www.saiglobal.com/shop/script/Provider.asp?Db=AS
by using the
Search for a Draft link that appears under the drop-down menu obtained
using the Search tab along the top of the web page.
The form to be used for submitting public comment is available via the
following link:
http://www.saiglobal.com/shop/misc/Public%20Comment%20Form.doc
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