Basic Audit Data
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Conducted on?
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Audit No.
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Department Being Audited?
Auditors and Auditees
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Audit Officer?
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Person Being Audited?
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Auditors In Training?
Activity Information
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Order No?
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Customer Ref Number?
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Serial Number?
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Instrument Description?
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Certificate No?
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Customer Name?
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This audit covers some aspects of the following 17025 Clauses: 6.2, 6.3, 6.4, 7.1, 7.2, 7.5, 7.6, 7.8
Audit Information
Personnel - ISO 17025 Clause 6.2 – QM Section 13
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6.2.3 - Does the person performing the test have internal training records to support the procedure?
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Give Detail: Who, Job Position, Level of training, CP number, when completed.
Facilities and Environment Conditions – ISO 17025 Clause 6.3 – QM Section 14
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6.3.1 & 6.3.2 - Check the laboratory temperature measurement results are within the parameters specified in the quality manual.
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6.3.3 - Have there been any reported incidents in the last 3 months or any significant changes within the laboratory?
Equipment – ISO 17025 Clause 6.4 – QM Section 16
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6.4.6, 6.4.13, 6.5.2 - List ALL the equipment used to perform the calibration.
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Give detail: Was it labelled, recall date, Reference numbers, Certificate & laboratory numbers. Follow the traceability route until a UKAS certificate is witnessed.
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6.4.7 & 6.4.13 - Was the equipment logged within the Laboratory Equipment Register with correct recall dates and acceptance criteria?
Review of Requests, tenders and contracts - ISO 17025 Clause 7.1 – QM Section 4
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7.1.1 & 7.1.8 - Is there a procedure in place for the review of tenders and contracts?
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7.1.1a - How have the customers’ requirements been defined?<br>Have records of the review been retained?
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Give Details: Purchase order, quotation, email correspondence
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7.1.1b - Is the equipment / equipment type listed on the ‘Calibration Capability and Standard Price Register’?<br>Has the register been reviewed during the last year?
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7.1.1c - Has the customer (if required) given approval for the laboratory to use an external supplier to carry out the calibration of their equipment?<br>
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7.1.1d - Has the customer been informed of the appropriate method / procedure to be used?
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7.1.5 - Has there been any deviation of contract? If yes has the customer been informed?
Selection, verification and validation of methods– ISO 17025 Clause 7.2 – QM Section 15
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7.2.1.2 & 7.2.1.3 - What specification has the item been calibrated to?
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Give details: Where the spec is from, is it the most recent version, is it controlled. Then was the standards list reviewed?
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7.2.1.2, 7.2.1.3, 7.2.1.4 - What is the procedure and issue number(s), is the procedure appropriate for this calibration?
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Give details, is this the latest issue, did it document the method to the required level. When was it reviewed.?
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6.4.10 & 7.7.2 - Are the QC checks up to date?
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Give details: Last 2 months, any issues
Handling of Calibration Items– ISO 17025 Clause 7.4 – QM Section 18
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7.4.1 - Is there a procedure in place for the transportation, receipt, handling, protection, storage, retention, and disposal or return of calibration items?
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7.4.2 - Has the equipment been uniquely identified within the electronic system?<br>Is there an identity tag attached to the equipment? <br>Does the information on the tag match the equipment?
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7.4.2 - Does the equipment have any accessories?<br>Have the accessories (if any) been logged on the electronic system?
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7.4.3 - Was the equipment received in good condition? <br>If not has this been recorded on the system and reported to the customer?
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7.4.3 - Does the equipment conform to description/information provided by the customer?<br>If not has this been recorded on the system and reported to the customer?
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7.4.4 - Did the equipment need to be stored under specific environmental conditions? <br>If so, have these conditions been maintained, monitored and recorded?
Technical records– ISO 17025 Clause 7.5 – QM Section 20, 10
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7.5.1 - Did the certificate state the conditions that the laboratory performed the calibration?
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Give Details: What are they, did the customer specify any additional requirements?
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7.5.1 - Did the calibration require raw data calculations?
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Give Details: If yes. What form did they take? If no, why was it not needed?
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7.5.1 - Using the information available, Give detail how the the test and readings could be reproduced with acceptable limits?
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6.4.5, 7.6.1, 7.6.2 - Are the measurement uncertainty values reported on the certificate correct to the applied / required values?<br>
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Give details: Budget number(s), issue, reviewed data.
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6.4.5, 7.6.1, 7.6.2 - Are the values equals to or greater than the values on our UKAS schedule?
Reporting the results– ISO 17025 Clause 7.8 – QM Section 20
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7.8.2.1 & 7.8.4 - Does the certificate include all the basic requirement for the calibration certificate as per the standard and QM?
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Give details: Logo correct size, statements included, clear and unambiguous?
Witnessed Calibration
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Has the technician demonstrated the activity in accordance with the procedure?
