ISO 17025

Table of Contents What is ISO 17025 ? Overview of ISO 17025 ISO 17025 Success Factors Self-Assessment Survey How can PQA Help? ISO 17025 FAQ

What is ISO 17025 ? ISO 17025 was developed so that testing & calibration laboratories were recognized for their capabilities & areas of competence.  All measurements and decisions should be based on accurate, repeatable, verifiable, cost effective, timely, and believable measurements, opinions, and recommendations.  ISO 17025 helps assures this happens first time, every time, and on-time. Without these assurances, the data, opinion, and recommendations are immediately suspect, questionable, risky, and of greatly reduced value and usability. Customers should ensure that all data and opinions upon which they rely can be traced back through an unbroken chain of data based on ISO 17025. Top of Page Overview of ISO 17025 ISO 17025 is one of the most popular quality standards for all laboratories; whether or not they do business with international customers. Currently, there are over 300 laboratories certified to ISO 17025 in Canada. In 1891, British physicist Lord Kelvin wrote, “When you can measure what you are speaking about, and express it in numbers,  you know something about it.” Mikel Harry, a noted Six Sigma authority, extends this thought as, “We don't know what we don’t know; we can’t act on what we don’t know; we won’t know until we search; we won’t search for what we don’t question; we don’t question what we don’t measure.” Both imply that if you failed to quantify the results of what you were doing, in a way, it means that you might not understand what you were really doing. Hence, organizations that are unable to track their processes, their products, or their raw materials are unable to fully manage their businesses. All other quality initiatives (eg. ISO 9001, ISO/TS-16949, Six Sigma, TQM, DOE, QFD, etc.) depend on reliable measurements, comparisons, and recommendations based on international standards. ISO 17025 controls all aspects of how laboratories conduct their business (ie. who, what, when, where, how, how much, & why) of measurement, testing, certifying, recommending, & reporting. Top of Page ISO 17025 Success Factors Research into what makes a ISO 17025 implementation a success has revealed 11 Critical Success Factors. They are, in order of importance: Leadership & commitment, preferably by Top management but at least by somebody.   A simple, comprehensive implementation plan Training & support for everyone involved or affected by the implementation project Buy-in and voluntary support & commitment from a critical mass of people  (>1 person, building to 25% of employees) Early successes that clearly prove that ISO 17025 will benefit customers, suppliers, management, and especially workers Adequate resources and time to achieve all that needs to be done Rapid and effective communication, feedback, and recognition on efforts made, results achieved, and work to be done Expert, pre-experienced advise, coaching, cheerleading, pre-warnings, and technical expertise on ISO 17025 implementation.   Auditing, training, and remedial assistance to achieve consistent compliance to minimum requirements.   Dress-rehearsal audit, final fixes, then formal Registration Audit by Accredited Registrar   Continuous assessment, improvement, and re-registration of systems. Top of Page Self-Assessment of ISO 17025 Current Status Sometimes, it helps to get a clear view of today so we can better understand where we need to go in the future.  PQA has prepared an ISO 17025 Self-Assessment Survey which you can use to assess your lab's current capabilities.  In 31 questions, we cover most of the requirements of ISO 17025 that typically impact on customers, employees, and accreditation.  Self-scoring is provided.  Discussion of your answers among the Sr. management team will probably be beneficial to deciding when and how to proceed. How can PQA help your ISO 17025 Implementation ? PQA's personnel were involved in their first study of measurement repeatability & reproducibility in 1984, inter-laboratory calibration in 1985, ISO 9001 (Guide 25 ) implementation in 1987.  Since then, we have helped hundreds of organizations with gaining effective compliance to International Quality Standards through: Executive Overview Training for ISO 17025 Gap Assessment to ISO 17025 Project Planning, Scheduling, & Management Worker Training Generic Templates for Policies, Procedures, Process Maps, and Documentation Systems Statistical Data Analysis of 7 Characteristics of a Metrology Systems Repeatability Reproducibility Linearity Bias Hysteresis Accuracy Granularity (Resolution) Calibration Models & DOE on Measurement System Capabilities Inter-Lab Calibrations Reducing measurement system sensitivity to Operator, Environmental, Common cause, and Special Causes Developing Customized tests and measurement criteria. Process Auditing Error Reduction Investigations & Program Implementations Management Reviews for Accountability, Cost Reduction, and Independent (Third Party) Verification Dress rehearsal audit prior to official registration accreditation audit You are the expert in your lab, and in the analysis of your customer's samples.  We are the experts in the implementation of ISO 17025. While it is possible to achieve, what would you say to a customer who was considering testing their own samples instead of using your services?  What about implementing ISO 17025 on your own, without the expert guidance & assistance from PQA?  Is there any difference between these two cases? For more information on how PQA can help you achieve ISO 17025, please e-mail PQA at dwhitred@pqa.net or discuss your specific situation with Don Whitred, one of PQA's Senior Consultants, at 519-667-1720. ISO 17025 FAQ If you have some questions about ISO 17025, send them to PQA, and we'll attempt to answer the question for you.  Frequently Asked Questions for ISO 17025