Inspection of the quality management system is critical when selecting a laboratory to conduct testing (QMS). The Quality Management System (QMS) ensures that the quality of the job is constant and of an acceptable standard. ISO accreditation is a sign that a lab adheres to established standards. Sample handling techniques and regular hygiene routines are among these norms. Analytical results must be monitored for compliance with ISO/IEC 17043:2010.
Participating in a proficiency testing (PT) system, also known as external quality assessment (EQA), is a good technique to review lab operations (EQA). As a result, any QMS should have PT as an essential component.
As we’ll see, proficiency testing has several benefits when done correctly, and we’ll go through those in this post.
Proficiency testing is a means to evaluate the lab’s procedures and the people who follow them. People like Public Health England and LGC Standards, which offer PT programs. Each PT program in the United Kingdom, Europe, and the United States will have its own set of guidelines and procedures for handling participant data.
Samples for known contamination levels will be prepared in each administration center. Testing is carried out by cooperating labs and results are forwarded back to the administration center for further analysis. The administration center then compiles the data and assigns a score to each participant.
The results of any participant laboratories are kept strictly confidential. Participating labs can compare their testing results with those of other labs while maintaining their privacy.
The accreditation of a laboratory according to ISO/IEC 17043:2010 has numerous advantages:
A specialized standardized system for the world is formed by ISO (the International Organization for Standardization), and IEC (the International Electrotechnical Commission). Technical committees created by ISO or IEC allow national organizations to participate in the formulation of International Standards.
The technical committees of ISO and IEC work together in areas of mutual interest. As well as the ISO and IEC, several international organizations, both governmental and non-governmental, are involved in the project.
The ISO Committee on Conformity Assessment (CASCO) is responsible for developing International Standards and Guides in the field of conformity assessment.
The ISO/IEC Directives, Part 2 provides the guidelines for the development of international standards.
Voting on draft International Standards is done by national organizations. In order to become an International Standard, at least 75% of the national organizations that cast a vote must approve of it.
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The ISO Committee on Conformity Assessment drafted standard ISO/IEC 17043. (CASCO).
ISO and IEC national bodies were asked to vote on it, and both organizations voted in favor of it.
Revisions have been made to ISO/IEC 43-1:1997 and ISO/IEC Guide 43-2:1997, which have been canceled and replaced by the new first edition of ISO/IEC 17043.
For a variety of reasons, interlaboratory comparisons are increasingly popular around the world.
For laboratories and their customers, as well as regulators, laboratory accreditation bodies, and other organizations that set standards for laboratories, the need for continued confidence in laboratory performance is crucial.
A laboratory’s involvement and performance in proficiency testing must be considered by accreditation authorities in accordance with ISO/IEC 17011. Other conformity assessment tasks, such as product certification or inspection, are becoming increasingly dependent on proficiency testing.
This International Standard’s criteria cover a wide range of topics, from management and planning to design and people to quality assurance and secrecy, to name just a few.
The purpose of this International Standard is to provide all interested parties with a uniform basis for evaluating the competency of organizations that provide proficiency testing services.
As a result, ISO/IEC Guide 43:1997 and its two sections are no longer applicable. It was included in ISO/IEC Guide 43 not only instructions on the development and operation of proficiency testing but also descriptions of the most common types of proficiency testing.
With this international standard, ISO/IEC Guide 43’s proficiency testing principles have been preserved and updated, while the information types of competency assessment programs and guidelines for appropriate statistical methods have been retained.
The information on the selection and use of proficiency assessment programs by laboratories and other interested parties has been preserved and updated throughout the official guide.