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Transitioning To The TNI 2016 Standard

What's New In TNI 2016?

 

  • Volume 1 Changes: Reporting requirements have shifted back to PTRLs. The opening date of the second study is now 7 days after the closing date of the first study and is no longer linked to the analysis dates. There are new requirements for specific reporting requirements for both radiochemistry and WET.

 

  • Volume 2 Changes: The alterations within this section of the 2016 standard primarily revolve around ABs. Not only has the definition of an accreditation body changed with the implementation of the new standard, so have the roles and abilities of both primary and secondary ABs.

 

  • Volume 3 Changes: This volume within the TNI 2016 standard has been edited and revised the most. Volume 3 was rewritten in order to match the ISO/IEC 17043 format. All proficiency testing providers are now required to be ISO/IEC 17043 accredited. There are now a series of requirements for protozoan PT, radiochemistry, and WET. Appendix A for homogeneity verification and stability testing (TNI 2009) has been removed from the standard as a guidance document; This is because many parts of it were deemed arbitrary and redundant.

 

  • Volume 4 Changes: This volume highlights changes based around PTPAs. Now harmonized to the ISO/IEC 17011:2004 standard, redundant requirements within the TNI standard were removed for simplification. Information has been added regarding PTPA data monitoring.

What Do I Need To Know and Do About Transitioning To The TNI 2016 Standard?

 Step 1 - Talk to your accreditation body. Becoming TNI 2016 accredited is paramount as the sooner you are accredited the sooner your lab is active. Talk to your accreditation body as soon as possible to understand their timeline.

Step 2 - Review and familiarize yourself with the new TNI 2016 standard. Becoming well versed in the new standard is the best thing you can do while in the transition period. While many things have certainly changed, some have remained the same.

Step 3 - Develop a Transition Plan. We recommend a Gap Assessment to kick off your transition process. During the Gap Assessment, we evaluate your current system to determine your current level of compliance with the new TNI 2016 standard. The Gap Assessment will provide you with a checklist of necessary changes that need to be implemented to be fully compliant with the TNI 2016 standard.

Step 4 - Provide training and awareness for all parties within the organization that have an impact on the quality management system.

Step 5 - Update your existing quality management system to meet the new requirements.

How Can Labtopia Help With My Organization's Transition To TNI 2016?

Gap Assessments

Our comprehensive assessment focuses on your current documented quality management system and will provide a clear picture of your QMS’ readiness for transition. The gap assessment results in a precise checklist of action items that need to be implemented to meet the new standard’s requirements. 

Labtopia's Gap Assessments Include:

  • A formal review of existing practices against requirements of the standard and your business application Identification of how you already meet specific new requirements

  • Identification of areas where you might be unclear on how requirements apply or whether you meet them

  • Highlights any risks and weaknesses based on the new requirements

  • Deliverables include a Checklist with the GAPS

Customized Consulting

Labtopia offers TNI 2016 consulting services geared to supporting existing quality systems in the laboratory or manufacturing environment. Implementing a quality system can drain a company’s resources and can be frustrating and costly if not done properly. Our experts have aided large multi-national, global companies. At the same time, we recognize that small and medium sized businesses must meet the same quality and regulatory requirements as their larger counterparts and some companies may not need full-time support.

Transitioning: Lead or assist your team with a gap assessment, transition planning, and effective documentation development.

Internal Audits: Conduct an on-site internal audit of your quality management system. Identify process effectiveness and any process deficiencies found.

Corrective Action Review: Assist with corrective action review and closure.

Training: Management System Training, Technical Support Procedure Training, and Data Integrity & Ethics Training.

Pre-Certification Audit Support: Conduct on-site pre-certification audit prior to the certification body audit to boost confidence of system effectiveness and certification success.

Audit Support for Accreditation Audit: A Labtopia Assessor is onsite to assist your Quality Manager during your accreditation audit. Assistance with findings and corrective actions can also be provided, if needed.

Management Review: Labtopia prepares and facilitates Management Review meetings with the laboratory personnel. Additionally, Labtopia will record the meeting notes and issue the minutes

Custom Consulting: Custom consulting services defining your specific needs and requirements.

Contact

Need help with the transitioning process? Click here to contact a Labtopia representative!

Click here to go to the NELAP Institute website and learn everything about the changes that come with the TNI 2016 standard.