Adopting a Risk-Based Mindset in the Wake of ISO 17025

June 27, 2019 Kym Faylor
Adopting a Risk-Based Mindset in the Wake of ISO 17025 Teaser

As an organization that constantly strives to lead in our GxP compliant testing, it is fundamental that here at Azzur Labs, we stay ahead of stringent federal and international regulations.

The International Organization for Standardization’s (ISO) regulations ensure that the testing we implement for our clients is up-to-date, reliable, precise, and strictly managed through every stage of the life cycle. In 2017, their international reference of “general requirements for the competence of testing and calibration laboratories,” ISO 17025, was revised to focus heavily on risk-assessment. Needless to say, the market and technology have changed drastically since the requirements were last updated in 2005.
The scope of these regulations has been broadened to now cover all of our laboratory activities, and, from testing and calibration to sampling, these processes will be carried out with risk-based thinking in mind. 
So what do we mean when we say risk-based thinking? Now, preventative measures are required in ISO’s newest revision where possibilities for change are factored in. While we’ve always been practicing this in our lab, ISO’s regulations treated it separately. We must identify risks and opportunities that can ultimately affect our products’ or services’ compliance with standards, as well as measure and analyze them so we continue to stay ahead of the curve.
This is in the wake of other pertinent updates to regulations such as quality management, ISO 9001. The process approach aligns with new standards of placing emphasis on results rather than descriptions of the varied projects and steps required previously. ISO 15189, quality of medical laboratories, and the ISO/IEC 17000 series, standards for conformity assessment activities, now align with this aforementioned change. 
Katie Neetz, Azzur Labs’ Quality Director in Schnecksville, Pennsylvania, explains “We’re transitioning our procedures and requirements to be more action-based. By utilizing a comparison checklist between the old version and revised version, we plan to have completely transitioned by summer 2019.” 
As she explained, the new regulations require us to show more of the lab process and the attention is shifted away from the documentation-centric requirements previously mandated. “We are thrilled about this because it assures clients that the strict standards we hold ourselves to in the lab are accredited and backed by a regulatory organization,” says Neetz. 

It’s an exciting time in the life sciences field, and we are eager to get rolling on this new transition. This update to ISO 17025 is a step a new direction toward regulations that place lab activities as paramount over just records.

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Kym Faylor

Kym Faylor is the President of Azzur Labs and has over 20 years of experience in managing a microbiology laboratory and assuring compliance with governing agencies, client specifications, and developing the quality assurance aspect to conform to current advances in pharmaceutical, medical device, biotechnology and cosmetic industries. She has an extensive background in microbiology, specializing in validation of microbiological methods and compendia testing.

Kym's experience includes compliance with USP, FDA, ISO, EU, AAMI & AOAC requirements, general microbiology testing, Environmental Monitoring data analysis and trending, and microbiology quality assurance programs. Recent certifications include: Certificate from UCSD in Regulatory Affairs, certified manager of quality/organizational excellence, and certified quality auditor from ASQ. Kym also serves on the Controlled Environments Testing Association as a board member, American Society for Microbiology as a Science Educators Network Mentor & Reviewer, and Society for General Microbiology as a reviewer.

Kym is a member of Regulatory Affairs Professional Society (RAPS), American Society for Quality (ASQ) -Senior Member, Parenteral Drug Association (PDA), Institute for Validation Technology (IVT) and Bio-pharmaceutical Education and Training Association (BETA). She has several publications and has served as a lecturer & trainer for USP <797> compliance.
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