QATrax is the ultimate test lab compliance tool
We conclude our ISO 17025 blog sequence by going through sections 6 and 7 resource and process requirements, as well as how QATrax helps you stay in compliance.
QATrax is testing lab management software specifically designed for discrete manufacturers’ testing environments. To meet process requirements, QATrax includes a built-in procedure for raising work requests and work orders. QATrax integrates equipment and technicians in the test schedule, which drives the record-keeping required for ISO 17025. Our QATrax compliance software is your all-in-one test lab compliance solution.
What are some of the ways QATrax supports 17025 Compliance?
Section 6 Resource Requirements
6.4 Equipment
QATrax Test Equipment Item features to address the following clauses related to equipment;
6.4.8 All equipment requiring calibration or which has a defined period of validity shall be labeled, coded, or otherwise identified to allow the equipment user to readily identify the status of calibration or period of validity.
6.4.13 Records shall be retained for equipment that can influence laboratory activities. The records shall include the following, where applicable:
a.) the identity of equipment, including software
b.) the manufacturer's name, type identification, and serial number or other unique identification
c.) evidence of verification that equipment conforms with specified requirements
d.) the current location
e.) calibration dates, results of all calibrations, adjustments, acceptance criteria, and the due date of the next calibration or the calibration interval;
f.) documentation of reference materials, results, acceptance criteria, relevant dates, and the period of validity;
g.) the maintenance plan and maintenance carried out to date, where relevant to the performance of the equipment
h.) details of any damage, malfunction, modification to or repair to of the equipment.
QATrax records equipment information, status log, all Work associated and stores it in one place, making it easier to manage. TEI information Fields include id, type, manufacturer, Serial number #, and more.
Abilities to attach certificates and all other evidence of verification. Location, Calibration Dates, Date of Next calibration, Calibration Cycle, Certification Attachments, non-testing events, Attachments, photos.
ISO 17025 compliance is a must for any laboratory, and QATrax has you covered. We’ve presented ISO requirements in sections 6 and 7 of this blog series, including the need to maintain accurate records about equipment. To help make it easier for your team to find what they need when they need it, we provide features that allow users to attach certificates or other evidence of verification and store all work associated with ISO-related tasks in one place. In addition, our software will enable you to track calibration cycles and manage your lab schedule more efficiently by integrating equipment into the test schedule so technicians can plan accordingly. If ISO 17025 Compliance sounds intimidating, but you want help enacting these principles, let us know! Our team is ready to help you.
Section 7 Process Requirements
7.1 Review of requests, tenders, and contracts
7.1.1 The laboratory shall have a procedure for the review of requests, tenders, and contracts. The process shall ensure that:
a.) the requirements are adequately defined,
Built-in Work request workflow logic requires all tests to be selected from an approved menu of services then submitted and accepted by the lab before scheduling. All Work Request statuses changes are logged and visible in work request and work order status logs.
7.1.2 The laboratory shall inform the customer when the method requested by the customer is inappropriate or out of date.
Automate Emails for Slippage notes. Users can run the “Get Schedule in Autoscheduler to see the first available timeslots. If the desired end date cannot be met, the scheduler changes a WR status from submitted back to draft.
7.1.3 When the customer requests a statement of conformity to a specification or standard for the test or calibration (e.g., pass/fail, in-tolerance/out-of-tolerance), the specification or standard, and the decision rule shall be clearly defined. Unless inherent in the requested specification or standard, the decision rule selected shall be communicated to and agreed with the customer.
7.1.4 Any differences between the requestor tender and the contract shall be resolved before laboratory activities commence. Each contract shall be acceptable both to the laboratory and the customer
System Setting of “limit request edit functionality” restricts any customer changes to request if the status is submitted, processed, or in progress.
7.1.5 The customer shall be informed of any deviation from the contract.
Slippage notes must be added and configured to send email to the requestor or
7.1.6 If a contract is amended after work has commenced, the contract review shall be repeated, and any amendments shall be communicated to all affected personnel
7.1.7 The laboratory shall cooperate with customers in clarifying the customer's request and in monitoring the laboratory’s performance in relation to the work performed.
7.1.8 Records of reviews, including any significant changes, shall be retained. Records shall also be retained of pertinent discussions with a customer relating to the customer's requirements or the results of the laboratory activities
ISO 17025 ISO standards are designed to ensure that laboratories maintain the highest level of quality which is highly important for test labs. QATrax offers ISO compliance by keeping track of all your ISO-related documentation in one place inside our laboratory information management (LIMS) system. With our LIMS software, you can manage records including any significant changes, details of any damage or malfunctioning equipment, as well as review contracts before work begins with customers. Let us show you how we’ve helped other labs stay compliant and save time and money so they can focus more on what matters most: their customers!
Conclusion
In our blog series, we went over many different clauses of ISO 17025 as they pertain to your test lab management compliance. The exciting part is that QATrax, our product, helps you stay compliant with all of this!
ISO 17025 compliance is a complicated process. The ISO 17025 clauses we’ve covered in this blog series are not exhaustive but should provide you with an idea of the types of standards your test lab must meet to remain compliant. Questions?
Book a demo with us today and find out how QATrax can keep your test labs compliant with ISO 17025 and stay risk-averse at Traxstar.com/demo.
