NATA would firstly like to thank the staff of facilities impacted by the recent changes to NATA’s Research & Development (R&D) accreditation program for their valued input.
The feedback provided has made the implementation of the changes more focused and effective in demonstrating the competency of facilities accredited for the provision of testing and related activities in support of research.
The changes include:
- The program will no longer be offered as a stand-alone program but instead fall under NATA’s ISO/IEC 17025 program as that program’s standard best covers the requirements for a facility involved in developmental testing.
- Accreditation will no longer be offered against ISO 15189 as this standard is specifically for medical laboratories offering diagnostic testing.
- The scopes of accreditation have been revised to cover four broad “Services”:
- Analysis in support of research
- Analysis in support of pre-clinical studies and clinical trials
- Analysis in support of the development and/or optimisation of new assays, devices or techniques
- Activities in support of research.
As accreditation will fall under our ISO/IEC 17025 program, the “Activity” described will reflect the relevant industry grouping (as per all other NATA programs), e.g., Agribusiness, Food & Beverage, Healthcare, Pharmaceuticals and Media products, etc.
- Good Laboratory Practice (GLP) will no longer be offered as an overlay, as it confused the market with facilities recognised under NATA’s OECD GLP Program under the Mutual Acceptance of DATA (MAD) arrangement.
- The recognition of Good Clinical Laboratory Practice (GCLP) will only be described as a “capability” in the scope of accreditation if requested.
The Specific Accreditation Criteria (SAC) has also been revised and will now serve as an appendix to the General Accreditation Criteria, ISO/IEC 17025 Application Document. It is now also included into each of the ISO/IEC 17025 NATA Accreditation Criteria (NAC) packages available from the NATA website.