CALIBRATION SUPPLIER AUDIT CHECKLIST Auditor: ____________________ Date: ______________________ 1. Verify existence of the following documents: Qualit...
CALIBRATION SUPPLIER AUDIT CHECKLIST Auditor: ____________________ Date: ______________________ 1. Verify existence of the following documents: Quality Manual Document Tree (in QM) Document Control Procedure List of documents and their current revision
ISO ISO ISO ISO
17025: 17025: 17925: 17025:
Y 4.2.2 ISO 13485: 4.2.2 4.2.5 4.3 4.3.2.1
N
Observations:
2. Verify records of Management Reviews indicating top management review of: ISO 17025: 4.15.1 The suitability of policies and procedures The reports from managerial and supervisory personnel The outcome of recent internal audits Corrective and preventive actions Assessments by external bodies The results of interlaboratory comparisons or proficiency tests Changes in the volume and type of work Customer feedback Complaints Recommendations for improvement Other relevant quality related factors Resources and staff training
Y
N
Y
N
Observations:
3. Verify the availability of following records if applicable Internal audits ISO Customer complaints and resolutions ISO Verbal instructions from clients ISO Critical supplier evaluation ISO
4. Select three pieces of equipment on the floor and verify label match with records ISO 13485: 7.6 ______________________ Equipt. ID
____________________ Equipt. ID
Y
N
___________________ Equipt. ID
Calibration due date Last calibration date Also verify that records show correct owner/location Equipment description Observations:
5. For three records for supplier equipment verify they contain ISO 17025: 5.10.5
_________________________ Equipment ID/Record #
________________________ Equipment ID/Record#
Y
N
________________________ Equipment ID/Record #
Identity of the item of equipment and its software Manufacturer’s name, type id and serial number or other unique ID Checks that equipment complies with the specification ( 17025:5.5.2) The current location where appropriate Manufacturer’s instructions if available or reference to their location Dates, results and copies of reports and certificates of all calibrations, adjustments, acceptance criteria and the due date of next calibration The maintenance plan, where appropriate and maintenance carried out to date Any damage, malfunction, modification or repair to equipment Observations:
6. For three Tech Group equipment records, verify certifications contain the following: ISO 17025: 5.10.2/5.10.4 _________________________ Equipment ID/Record #
________________________ Equipment ID/Record#
________________________ Equipment ID/Record #
Title (i.e. Calibration Certificate, Test Report) Unique identifier for calibration certificate Identification of equipment being calibrated Standard used to calibrate equipment Test or calibration results Identification of the method used When device adjusted or repaired, as found/as left data Uncertainty of measurement or appropriate statement of compliance 4:1 TAR where appropriate Traceability to NIST Environmental conditions Signature and date Company name and address Observations:
7. How is customer equipment identified and traced? ISO 13485: 7.5.4 Observations:
8. How are customer verbal instructions recorded? ISO 13485: 7.2.3 Observations:
14. How is the corrective/preventive action program implemented? ISO 13485: 8.5.2, 8.5.3 Observations:
15. How is it ensured that all personnel understand and implement the quality policy? ISO 13485: 5.3 QSM Rev 11: Quality Policy Observations:
16. What are your measurable quality objectives? ISO 13485: 5.4.1 Observations:
17. General Observations ISO 13485: 6.4 Work place clean and free from clutter Good safety practices adhered to Lighting adequate to the task undertaken Evidence of adequate pest control Other observations of note Observations:
