Once you have accreditation, NATA regularly returns to reassess your laboratory quality system. This will be within 12-18 months of your first assessment – the date can come around quickly! So your NATA homework is not over.
Preparation for the reassessment begins the day you get accreditation
It is vital to continue putting the quality system into practice, get the internal audit program running smoothly, and help all staff understand how they contribute to meeting accreditation standards. We help labs with this ongoing work of continuing to comply with NATA standards by scheduling regular visits to help you meet your goals through the quality management system.
The assessment types and timelines vary depending on whether you have ISO 17025 accreditation. ISO 15189 accreditation, or GLP recognition. Your next visit from NATA could be a surveillance visit, a full technical assessment or a study audit (GLP).
A surveillance visit focuses on checking records and quality system elements, while a reassessment includes a technical assessor and is more focused on evaluating quality control, proficiency, staff competence and how you report results. A study audit is an in-depth review of a particular GLP study.
Whether it’s a surveillance visit, a first reassessment or a study audit, NATA will leave you with a detailed report, including non-conformances. There can be major non-conformances (major conditions, C) and minor non-conformances (minor conditions, M). This time, you only need to provide evidence for the major conditions – NATA will follow up on minors at the following assessment or surveillance visit.
Beware of only dealing with the minor conditions shortly before the following assessment. Although coded as minor, some 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.
If you would like support to meet NATA requirements, improve your systems and meet your goals, get in touch!