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Steps To Achieve Iso 17043 Accreditation For Your Proficiency Testing Laboratory
ISO 17043 accreditation establishes the fundamental criterion for laboratories participating in proficiency testing. This accreditation signifies that your laboratory working in proficiency testing is valid and reliable. The certification means that your results are trustworthy and have international standing. Here is a simplified guide with information to help you through the accreditation process.
Step 1. Desktop study of ISO 17043 Standard - Accreditation application starts with really understanding ISO 17043; a standard that sets forth guidelines for laboratories that carry out proficiency testing. It provides guidance on such issues as: staff qualification, equipment qualification, test methods, and record keeping. Personnel implementation of the standard will enable one to bring their processes in line with the requirements.
Step 2. Carrying Out a Gap Analysis - An ISO 17043 gap analysis assists in pinpointing where your current processes fail to meet the requirements of this ISO standard. This entails looking into your laboratory's current setup and procedures to determine what requires improvement. The ...
... gap analysis clarifies the corrective changes that are necessary to be made before ISO 17043 accreditation can be applied.
Step 3. Create a Quality Management System (QMS) - A well-implemented QMS is a prerequisite to ISO 17043 accreditation. The QMS will guarantee that work is carried out effectively. Policies, procedures, and practices in your QMS should encompass all management-related issues concerning proficiency testing activities: qualification of personnel, calibration of equipment, testing methods, and data management.
Step 4. Staff Training - Establishing that your laboratory staff has the qualifications to apply proficiency testing according to ISO 17043 must be trained to understand testing procedures, use of equipment, data analysis, and resolution of nonconformities. This guarantees that the training offered is sufficient to ensure that your staff is competent to fulfill the requirements for accreditation.
Step 5. Establish a Proficiency Testing Program - A proficiency testing program should be set up in your laboratory to control its performance. Selecting appropriate test items, validating testing methods, and comparing results with other laboratories will apply. A well-designed proficiency testing program will provide a means to assess and improve the laboratory's performance.
Step 6. Conduct Internal Audits - Carry out internal audits before applying for accreditation, to assess whether your laboratory conforms to the requirements of ISO 17043. These audits will highlight any issue for correction during the time remaining. Periodic internal audits will keep your laboratory on track.
Step 7. Apply for Accreditation - If your laboratory is ready, apply to an accredited certification body. The application will incorporate your QMS, the proficiency testing program, and the internal audits. The accrediting body will review your application and may request further information.
Step 8. An On-site Assessment - An on-site assessment will be done by the accreditation body in order to demonstrate the laboratory’s compliance with ISO 17043. This will comprise a review of procedures, interviews with staff, and evaluation of testing activities.
Step 9. Address Nonconformities - A corrective action must be taken where any issues are found following the assessment. Once the issues are resolved, you must present proof of evidence to the accrediting body.
Step 10. Maintain Compliance - The frequency of audits is a regular occurrence once accredited, where compliance with ISO 17043 is evaluated. Continuing education, process improvements, and internal audits will ensure that accreditation is maintained.
Good work on gaining ISO 17043 accreditation; it reflects your laboratory's commitment to quality and reliability.
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