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Term: non-conformances
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Review of the Top Ten Most Frequently Cited Non-Conformances to the Version 7.0 and 7.1 of the IQMH Accreditation Requirements for Medical Laboratories

By Editor on 10/29/2019
The IQMH Centre for Accreditation is in the final stages of approval of Version 8 of the IQMH Accreditation Requirements for Medical Laboratories.  Version 7 was used for assessment of our medical laboratory participants starting in early 2017, with Version 7.1 coming into effect in mid 2017. This article is a review of the most frequently cited non-conformances to these requirements. It is based on data from 287 assessments and included laboratories in Ontario, New Brunswick, Newfoundland and some international clients.
accreditation assessment
Centre for Accreditation
IQMH accreditation requirements

Important Enhancement to the IQMH Accreditation Process

By Editor on 1/31/2019
All laboratories undergoing scheduled surveillance visits as part of the ISO 15189 Plus™ program are advised of the following change to the criteria for escalating minor non-conformance to major non-conformances between assessment events.
Centre for Accreditation
conformity assessment
process improvement

Accreditation Station: Top ten non-conformances

By Editor on 3/24/2016
The IQMH Centre for Accreditation has retired Version 6.0 of the Requirements and Guidance Information. Version 6.0 came into effect on January 1, 2014 and has been used as the basis for 254 accreditation assessment visits. The following is a listing of the top ten non-conformances from those visits along with links to resources to help laboratories achieve conformance.
accreditation requirements
accreditation station
Centre for Accreditation

Eye on Accreditation: New Categorization of Non-Conformances

By Editor on 11/26/2014
We are pleased to announce a significant change to our position statement on the categorization of non-conformances at assessment visits, approved by the Accreditation Advisory Panel on October 29, 2014. The new definitions better reflect our efforts to put less emphasis on documentation and more on patient safety and outcomes. With this change, if a laboratory demonstrates through observation and records that an effective practice is in place, a lack of a documented process or procedure to support that practice will result in the citation of a minor non-conformance as opposed to a major.
position statement

How is risk mitigation built into the accreditation requirements and the assessment process?

By Editor on 11/26/2014
There’s no doubt that risk is a hot topic in laboratory management these days. The purpose of this article is to provide a summary of how the concept of risk assessment and mitigation is addressed in our accreditation requirements. It also explains how IQMH will enhance our assessments by considering the laboratory’s own responsibility for the assessment of risk when potential non-conformances are noted.
ISO 15189 Plus
ISO 15189:2012
risk management
risk mitigation


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