To secure NATA accreditation for your laboratory, NATA assesses you against defined criteria, which are a mix of both international standards and local criteria, developed by NATA.
There can be as many as 20 to 30 documents that you need to go through to identify which requirements may be applied to your laboratory. If you have contacted NATA and been told to download all of these documents and make sure you understand them, you may be feeling overwhelmed. We don’t blame you!
Navigating NATA Paperwork
NATA’s accreditation requirements vary according to what kind of testing you are doing. Check out how NATA groups different types of labs by industries here.
Here are the documents that NATA accreditation requires:
- ISO/IEC 17015 General requirements for the competence of testing and calibration laboratories. Or, ISO 15189 Medical laboratories – Requirements for Quality and Competence.
- General Accreditation Criteria
- General Accreditation Guidance
- Standard Application Documents (otherwise known as the SAD!) There are a few versions of this – one for each international standard: ISO/IEC 17025, ISO/IEC 15189 and OECD GLP.
- Specific Accreditation Criteria ISO/IEC 17025 or ISO/IEC 15189 Application Documents for your industry sector. This may be in the form of an appendix covering the sector in general with more specific annexes, or just an annex. We’re calling these SACs collectively.
- Equipment assurance, in-house calibration and equipment verification criteria and General Equipment Tables (guidance documents)
- NATA Rules
- NATA Procedures for Accreditation
- All in all, 20 – 30 documents that may contain something you need to know.
The main criteria documents, so you know where to look for the information you need, are:
- ISO/IEC 17025 General Requirements for the competence of testing and calibration laboratories.
- ISO 15189 Medical Laboratories – Requirements for quality and competence.
These international standards outline requirements for laboratories that wish to demonstrate they operate competently, and are generating valid test results. These are general requirements, with no prescriptive schedules or test requirements. The emphasis is on monitoring risk and opportunities. The management system requirements in both of these standards are closely aligned with the requirements of ISO 9001.
Standard Application Documents
The ‘SADs’ contain additional criteria for ISO 17025 and 15189 laboratories that NATA has specifically developed based on their rules and their interpretation of those standards. (There’s a ‘RAD’ for OECD GLP).
Specific Accreditation Criteria
ISO 17025 Application Document for your field of testing (or ISO 15189 Supplementary Requirements for Medical Testing) is probably going to seem a lot more relevant to you. There is a separate document for each field, and you will find that the “interpretive criteria” relate to things you may already know something about. There will also be a list of equipment and recommended calibration frequencies – something that is not mandatory to follow, but can be a useful guide.
General Equipment Table
This gives you a suggested equipment calibration frequency for a number of ‘common’ pieces of equipment.
These contain the information you need to know about “NATA-endorsed” test reports – when you can issue them and when you can’t. There is also information about how to use your NATA accreditation in advertising material. The rest of the rules are about how NATA operates, it’s board, what happens if NATA thinks that your laboratory should not be accredited any more (‘suspension’) and so on. It’s worth reading through them when you are away from the day-to-day business of the lab, and thinking about how the rules apply in your situation.
Policy Circulars, Technical Circulars, Annexes and Information Papers
These contain specific information on particular examples. As they can contain additional accreditation criteria, you can’t ignore them. Many have self-explanatory titles, so you can quickly decide if they are relevant to you. Others you really have to read through thoroughly to find out what they are about.