ISO 17025 Laboratory Management System – Philadelphia

ISO 17025 certification  Philadelphia

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ISO 17025 certification:

The ISO 17025 certification, standard in Philadelphia is a quality system standard specific to calibration and testing laboratories, demonstrating the potential, competence, and proficiency of the laboratory. The quality doesn’t prescribe how testing is to be performed, rather it requires implementation of a top quality system to assure technical competence, valid results, which the test methods employed provide results that are accurate, repeatable, timely, verifiable, and meet customer requirements. The quality contains five sections: Scope, Normative References, Terms and Definitions, Management Requirements, and Technical Requirements. Management requirements specialize in the operation and effectiveness of the standard system of the laboratory. The technical requirements section contains accuracy, proficiency, and reliability of the tests and calibrations performed within the laboratory.

In 1978, the primary international document on calibration and testing laboratories was published, ISO/IEC Guide 25. Second and third versions were released in 1982 and 1990. ISO/IEC 17025 certification in Philadelphia was first published in 1999 and expanded the references, terms and definitions. The foremost significant change was the addition of the Management Requirements and Technical Requirements sections which became more prescriptive in their requirements. The present version was published in 2005 and revision activity is currently ongoing with publication slated for 2018, followed by a 3 year transition to full implementation of the revised standard.

Laboratory accreditation is very regarded by domestic and international customers as a testament of technical competence of the laboratory and its personnel. Many industries, like the medical device industry, hunt down accredited laboratories for testing services because it gives a high level of assurance of the accuracy and reliability of the test results. This is often particularly important within the medical device industry because the data from ISO 17025 accredited testing laboratories is to support regulatory submissions worldwide.

The process resulting in accreditation can take up to 18-24 months, counting on whether a top quality management system exists or if one has got to be developed from the bottom up. A competent consultant who regularly works with the notified bodies or is an ISO 17025 certification in Philadelphia  assessor are often a useful resource throughout the method as he/she understands the quality and its proper application. A cross-functional team should be put in place, including personnel from quality assurance, document control, operations/technical/laboratory, and laboratory management, because the resources from these areas and lab management are going to be needed to prioritize work for the operations/technical staff.

A copy of the quality should be obtained, and reviewed carefully to start the method. Attending a training class with a licensed instructor will help to elucidate the finer points of the quality. Once an accrediting body is chosen, attending a training session given by the accrediting body is additionally advisable to become more conversant in the accrediting body’s specific requirements, which regularly above and beyond the 17025 standard requirements.

If a top quality system doesn’t currently exist within the organization, an honest place to start out building a 17025 compliant QMS is that the Management Requirements section of the quality. A competent consultant is going to be extremely helpful when tackling the Technical Requirements of the quality. If a QMS exists, then a radical gap assessment should be performed. Detailed checklists to help in performing this gap assessment are often found on accrediting body websites, alongside other useful guidance documents.

If an accrediting body has not already been selected, it should ideally be done early within the process. Scouring the websites of potential accrediting bodies will enable a comparison of the resources offered and therefore the additional requirements above and beyond the 17025 standard requirements. These requirements should be carefully assessed on what they mean to your organization. The accrediting body can supply cost and time estimates for the assessment process. It is vital to ask tons of questions regarding the preparation phase and initial assessment requirements before selecting an accrediting body. Once a choice is formed and an application is submitted, they will be your partner within the process–you want to create a robust relationship with them. You’ll be required to submit procedures and test methods in support of your application in order that they are often reviewed.

Since there’s uncertainty related to every test performed during a laboratory thanks to errors arising at the varied stages of sampling, sample preparation, measurement, and data evaluation, uncertainty measurement or an “uncertainty budget” because it is additionally called, may be a vital metric of the standard of a result or a test method. Each quantitative test within the scope of accreditation must have an uncertainty budget calculated. Corrective action should be taken as appropriate so as to deal with uncertainty budgets which are outside of the specifications identified by the laboratory.

When your quality system documentation is in place, the accrediting body websites can provide important information and useful tools to assist oneself against the interior assessment (audit). This audit is required to be completed before the initial accreditation assessment. A management review also will be required before the accreditation assessment. Any deficiencies from internal audits or issues discovered during management review should be addressed before the accreditation assessment.

A robust proficiency testing program also will be required and a minimum of one test from one discipline included within the scope of accreditation must have a completed proficiency test at the time of the accrediting body on-site audit. Commercial proficiency testing programs must be used, if available. If a commercially available proficiency testing program doesn’t exist for a test, the accrediting body must be petitioned to permit either internal proficiency testing or concurrent testing in conjunction with another laboratory. Proficiency testing is an ongoing future commitment essential to upholding the quality, and to demonstrating the competence of the power.To Know more about ISO 17025 certification in Philadelphia contact our Expertcertifier.

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