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ISO/IEC 17025:2005 – General Requirements for the Competence of Testing and Calibration Laboratories, is used to develop and implement laboratory management systems.
By having your laboratory management system accredited to ISO/IEC 17025, your company stands to gain a gold mine of benefits. One of the main advantages is that your laboratory will gain international recognition for its commitment to quality, competency and reliable results. In addition, ISO/IEC 17025 accreditation will signify that you comply with an internationally recognized standard, thus easing the global exchange of valuable information.
ISO/IEC 17025 Accreditation
Let’s begin our path toward accreditation by talking about the first step, filing an application for accreditation services.
Filing an Application
It’s usually a good idea to establish a relationship with an accreditation body in the early stages of implementing your laboratory management system. In that way, you can familiarize yourself with its practices and establish a schedule for accreditation in advance, thereby avoiding possible delays.
Receiving the Quote
It is important that you compare all quotes thoroughly to ensure you are getting the most for your money. Using your information from the application, PJLA will prepare a price quote and an estimate of time required for completing the accreditation assessment. All aspects of the accreditation process are offered up front during our quotation process.
Entering the Contract
After you’ve decided to enter into a contract with PJLA, the relationship is formalized. The contract will spell out the responsibilities of all parties involved including financial obligations and acceptance terms of adherence to the standard and PJLA policies.
Preparing for Accreditation
Your company is ready for accreditation after you’ve implemented an ISO/IEC 17025 management system and allowed ample time for laboratory employees to 1) become familiar with the system and 2) develop a sufficient evidentiary trail of documents that can be assessed.
Laboratory Management System Documentation Review
Once you’re ready to begin the accreditation process, PJLA will request an uncontrolled copy of your laboratory management system documentation. It is recommended that you submit your documentation at least four to six weeks before your scheduled assessment so that if any deficiencies or nonconformances are uncovered, you’ll have ample time to make corrections without delaying the process.
Preliminary Assessment Preparation
The PJLA lead assessor will contact the laboratory at least 4 weeks prior to the assessment. This will include a discussion in regards to the set-up of the laboratory, tests or calibration witness activities to be available during the assessment and the necessary documents required to perform an off-site review prior to the assessment. The lead assessor will conduct a preliminary documentation review and provide the laboratory with feedback prior to the assessment. It is imperative to provide the assessor with your documentation within the requested timeline. Lack of meeting specific timelines could cause the assessment to be postponed. Once the documentation review is completed the lead assessor will provide the laboratory with an assessment plan including start and finish times and an outline of the requirements of the standard to be assessed
The Accreditation Assessment
the assessment team will walk through your laboratory to observe and witness activities. Team members may conduct one-on-one interviews with employees, ask to inspect documents and records, witness selected calibrations or tests, and examine calibration or testing equipment. Throughout the assessment, they will be seeking evidence of technical competency, such as statements, documented procedures, records and written policies, to support their observations. If any deficiencies or nonconformances are found during the course of the assessment, the assessor will bring them to your attention, and record them on a nonconformance report. In the report, the assessor will specifically describe what the nonconformance or deficiency is and the related section of the standard the nonconformity or deficiency pertains to.
Nonconformance Review Process
Clients are expected to appropriately respond within 90 days of the assessment, unless other timelines are provided by the team (i.e. 30-60 days). Failure to submit a corrective action response could cause for an assessment follow-up visit to be conducted. It is encouraged for laboratories to submit corrective action responses on-time to allow the team to conduct an adequate review and provide feedback as necessary. If additional corrective action response time is needed, laboratories should contact PJLA headquarters for an extension.
Once the assessment team accepts the corrective action responses the assessment material is submitted to PJLA headquarters for review. The assessment material is reviewed by PJLA technical program management and then submitted to our accreditation review committee for a final review. As a goal, PJLA makes every effort to process assessment material as soon as possible.
Granting of the Final Certificate
Once PJLA headquarters is notified that a favorable result has been granted by the accreditation review committee a certificate will be developed. Laboratories will receive a draft certificate for review. Once an approval is provided to PJLA headquarters and all outstanding balances are paid the final certificate will be released. Final certificate will be placed on the PJLA website under the listing of accredited laboratories. Laboratories will receive a marketing package including a plaque, banner and flag to promote their accreditation. Additionally, artwork will be provided including the PJLA accreditation symbol and information on how to utilize the ILAC MRA Mark. These graphics can be used on laboratory’s marketing material to show their adherence to the standard and demonstration to their commitment to providing quality and reliable results. PJLA encourage all laboratories to place the PJLA accreditation symbol on all test and calibration reports.
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