Access the general requirements for the competence, impartiality and consistent operation of laboratories which is applicable to all organizations performing laboratory activities. In addition to the core requirements for the competence of testing and calibration laboratories, the ISO/IEC 17025:2017 / ISO/IEC 17025:2005 - Competence of Laboratories Transition Set provides updates on the process approach, information technology, risk-based thinking, and terminology. ISO/IEC 17025:2005 is provided to compare changes in ISO/IEC 17025:2017. Competence of Laboratories Transition Set includes:
ISO/IEC 17025:2017 ISO/IEC 17025:2005 ISO/IEC 17025:2017 / ISO/IEC 17025:2005 - Competence of Laboratories Transition Set
ISO/IEC 17025:2017 / ISO/IEC 17025:2005 - Competence of Laboratories Transition Set includes:
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International Organization for Standardization [ISO]
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The International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) issued their latest edition outlining the general requirements for the competence of testing and calibration laboratories, known as ISO/IEC 17025:2017. For food laboratories, ISO 17025 outlines how a competent laboratory should operate from framework and resource requirements to management and process systems. In essence, for a laboratory to generate accurate measurement results, it must build and engage an able structure for that testing. Proficiency testing is a necessary component of this formation.
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ISO 17025 defines proficiency testing as the “evaluation of participant performance against pre-established criteria by means of inter-laboratory comparisons.” Inter-laboratory comparisons take place when two or more laboratories perform and evaluate the same or similar items, within predetermined conditions.
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Explore this issueOctober/November 2018
Food laboratories should be aware of how ISO 17025:2017 differs from its predecessor version of 2005. Somewhat similar to the risk-based approach adopted through the implementation of the Food Safety Modernization Act (FSMA), ISO 17025 applies what it calls risk-based “thinking” that integrates more flexibility and performance-based requirements in its 2017 edition. The updated version of the standard now aligns more closely with other relevant standards for the quality of medical laboratories (ISO 15189) and quality management (ISO 9001).
In order to monitor performance, laboratories under ISO 17025 must compare test results with results from other laboratories. There are two noted avenues for conducting this planned monitoring review: proficiency testing and other inter-laboratory comparisons. The purpose of proficiency testing, and other comparison practices, is to drive improvement in the quality and accuracy of measurements made within the laboratory.
Iso 17025 Risk Analysis
ISO 17025 requires that data from these comparison exercises be analyzed and used to improve a laboratory’s functions. If the data show that test results register outside of predetermined criteria, a laboratory must address the variation and take action to prevent the performance and reporting of test results that are not fit for their intended purpose.
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To address the risks associated with lab testing, laboratories, through their management systems, must seek opportunities for improvement. Laboratories must identify and demonstrate that those actions are pursued. ISO 17025 includes proficiency testing as an external measure to assess the validity of the laboratory’s test in order to drive improvements.
Already in Play
ISO 17025 is already referenced in federal regulation and guidance documents. In its final rule on accreditation of third-party certification bodies that conduct food safety audits, FDA noted a requirement to use a laboratory accredited under ISO/IEC 17025:2005 or another laboratory accreditation standard that provides at least a similar level of assurance for validity and reliability of analytical results. The agency’s draft guidance on the control of Listeria monocytogenes in ready-to-eat foods recommends taking action to ensure that a testing laboratory is knowledgeable, and suggests determining whether the laboratory is accredited to a standard such as ISO 17025.
The Food Safety and Inspection Service (FSIS), an agency with the USDA, accredits nonfederal analytical chemistry laboratories to analyze meat and poultry food products. This FSIS Accredited Laboratory Program recommends that participating laboratories follow standardizing procedures such as ISO 17025.
FSMA contains a provision for laboratory accreditation for the analyses of foods. Section 202 of the law calls for the development of model standards that laboratories must meet to be accredited. As FDA reviews existing standards for guidance, ISO 17025 may well become the basis for these model standards.
Laboratories that are accredited to the previous 2005 version of ISO 17025, while still valid, have three years to transition to the new version.
Proficiency Testing Providers
When it comes to externally provided proficiency testing services, ISO 17025 explains that these services must be suitable in support of the activities of the laboratory. One way to assess the competency of a proficiency testing provider for food laboratories is by its accreditation to ISO/IEC 17043:2010. ISO 17043 accreditation validates a proficiency testing provider’s technical competence and its operation of a quality management system.
Date: July 30, 2019
Time: 11:30 am to 3:30 pm
Member: $255.00
Non-member: $300.00
One of the key changes in ISO/IEC 17025:2017 is to use risk-based thinking in the laboratory's management system. This course will look at what risk-based thinking is, and how to apply it to your management system.
Who should attend
For all laboratory staff who participate in the operation of the laboratory quality system:
Course overview
This half-day course delves into the concept of risk-based thinking and how it can be applied to your laboratory management system. It will look at what is meant by risk-based thinking, ways to implement risk-based thinking, and examples of how to demonstrate where your lab is using risk-based thinking.
This courses uses lectures, discussions, and exercises, including case studies.
Objectives
After completing this course participants will be able to:
With updates to the ISO 17025 standard released in 2017, now is a great time to review some of the changes that we have seen come through, and what updates may be required to maintain compliance to the standard. While there were a number of alterations, there are three key areas to note.
Iso 17025 Risk Assessment Procedure
Newly Designed Process Approach
The general focus of recent standards has been on emphasizing performance-based results, rather than standard directives. While this has the benefit of leaving more room for interpretation and adaptability, it does place the burden on management to identify and closely track key metrics. Failure to do so adequately will likely be viewed as a non-conformance to the revised standard.
Stronger Attention to Information Technology
In recent years, there has been increased scrutiny regarding software validation, and this trend continues in ISO 17025:2017. While most off the shelf software can be considered validated under the revised standard, any altered or custom software will likely require a thorough validation. While software validation can time consuming, this increased focus will help to ensure testing results are reliable and reduce the risk of faulty tests.
Increased emphasis on Risk-Based Thinking
As with the revisions to ISO 9001:2015, the updates to 17025 include a heavy emphasis on implementing a risk-based approach throughout the QMS. This requirement is again somewhat open to interpretation for individual companies but should be present and traceable throughout the entirety of the quality system Risk-based Thinking For Iso 17025 Form
While there is still time to adopt the new standard, the November 29, 2020 due date will approach quickly. Medpoint can help you get started with expert consultants ready to perform gap analysis, pre-assessments, mock audits and assist with any necessary QMS updates or remediation activities. Responding to an updated standard is never simple, but Medpoint has the expertise to help you make a smooth transition. To learn more, contact us: [email protected] or +1 800-200-9292.
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