Once you have accreditation, NATA regularly returns to reassess your laboratories against ISO 15189 and NPAAC requirements. So it is essential to keep NATA compliance front of mind and not fall behind with your compliance systems. Crucial to this is a quality system and team that is NATA-ready at all times while keeping the compliance burden to a minimum and finding opportunities for your business along the way.
ISO 15189 Reassessment Timeline
The assessment schedule for pathology labs varies depending on the size of the organisation your laboratory is a part of. The guidelines for this are explained in NATA’s Procedures for Accreditation pages 20 & 21.
After NATA grants your lab accreditation, they will schedule a reassessment 12 months after the initial assessment. Reassessment is similar to the first assessment, with technical assessors and pathologists included on the assessment team.
NATA will leave you with a detailed reassessment report, including non-conformances. There can be major non-conformances (major conditions, C) and minor non-conformances (minor conditions, M). You only need to provide evidence for the conditions – NATA follows up on minor conditions at the following assessment.
After that, the following applies:
NATA arranges a technical assessment (similar to the first two assessments) every two years, covering about half of the scope of accreditation.
Multi-site pathology services
NATA develops a 4-year schedule with different assessments, including organisational governance structure reviews, designated person assessments and branch site assessments. You should expect an assessment every year at the primary site, focusing on one discipline. This assessment scheduling approach is pretty new, so it may change as NATA gets more experience with this assessment approach. For more details, contact NATA and read up on the Procedures for Accreditation.
Assessment reports and follow-up
No matter what type of assessment NATA does, they will leave you with an assessment report containing major non-conformances (major conditions, C) and/or minor non-conformances (minor conditions, M). You only need to provide evidence for the major conditions – NATA follows up on minor conditions at the following assessment. Use our guidelines on responding to assessment findings to save time and confusion.
We recommend revisiting all NATA assessment findings about six months before the next assessment, to make sure they have been effectively addressed. Even those that were coded as minor can take quite a bit of time and effort to address effectively. In addition, if NATA finds these same issues coming up again, you will then have a major non-conformance.