Scribd
Upload
324 views3 pages

Implementation Checklist ISO 15189

The ISO 15189:2022 Implementation Checklist outlines significant changes to requirements compared to the 2012 version, focusing on new and major updates. Facilities must provide evidence of compliance with these changes before their accreditation is updated, especially for multi-site facilities. Detailed changes can be found in the Gap Analysis on the NATA website.

Uploaded by

ibuseman99
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
324 views3 pages

Implementation Checklist ISO 15189

The ISO 15189:2022 Implementation Checklist outlines significant changes to requirements compared to the 2012 version, focusing on new and major updates. Facilities must provide evidence of compliance with these changes before their accreditation is updated, especially for multi-site facilities. Detailed changes can be found in the Gap Analysis on the NATA website.

Uploaded by

ibuseman99
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

ISO 15189:2022 Implementation Checklist

Instructions
This checklist identifies the clauses of ISO 15189:2022 where there are new or major changes to requirements compared to the previous 2012
version of the Standard. The checklist does not include the clauses where new or major changes are already covered by existing NPAAC
Requirements.
Minor changes also have not been included in this checklist.
Details of all changes (minor, major and new) to requirements in the new version of the Standard, compared to the previous version, are
documented in the Gap Analysis available from the NATA website at www.nata.com.au.
Prior to an accredited facility’s scope of accreditation being updated to the new version of the Standard, a response together with supporting
evidence to the clauses identified in this checklist must be provided. Confirmation of compliance with all relevant changes will occur during the
on-site NATA assessment.
For a multi-site facility (i.e. a network under the one accreditation number), the response and supporting evidence must cover all of the sites
(physical locations) covered by the accreditation. For such facilities, confirmation of compliance will occur during the assessment of the primary
site (i.e. NPAAC category GX or S laboratory).

Authorised Representative declaration


I declare to the best of my knowledge that the requirements of ISO 15189:2022 have been considered and implemented:
a) at each site detailed in the table on page 2; and
b) the information provided in this checklist together with the supporting evidence is applicable to each site detailed in the table
on page 2.

Signature:

Name:

Date:

April 2023 Page 1 of 3


Facility and site details

Facility accreditation number:

Facility name:

Indicate all applicable site numbers and names for multi-site facilities
(If insufficient space, copy table and complete as necessary)

Site number(s): Site name (s):

April 2023 Page 2 of 3


ISO Emphasis Action taken with reference to supporting evidence (as necessary)
15189:2022 of Change (Attach supporting evidence separately and include reference to the clause number)
Clause No.

4.2.2 New

4.3 New

5.4.1 Major

6.2.3 Major

6.7.2 New

7.2.6.2 New

7.2.7.3 New

7.3.7.2 Major

7.3.7.3 Major

7.8 New

8.1.2 New

8.5.2 New

Annex A - Only applicable if offering Point-of-Care Testing (PoCT)

A.2 New

A.3 New

A.4 New

April 2023 Page 3 of 3

You might also like