Calibration System Summary

Documentation provided:

·         Boilerplate documented procedure for establishing the requirements for and fundamental controls of monitoring and measurement equipment, to define calibration requirements for the organization, and to establish the responsibilities and link with the record keeping database provided.  This procedure covers all the fundamental requirements in section 7.6 of the ISO 9001 standard and the other standards based on ISO 9001, such AS9100 and ISO 13485 which include:

ü  The monitoring and measurement to be done and the appropriate equipment are determined,

ü  Where necessary to ensure valid (measurement) results, measurement equipment is calibrated (verified) at specific intervals, or before use….. against a measurement standard traceable to an national or international measurement standards…. And where no standard exists (such as electronic equipment software) the basis of the calibration or verification must be defined and recorded.  Calibrated equipment must:

ü  Be adjusted or re-adjusted as necessary,

ü  Be identified as calibrated and its calibration status visible,

ü  Be protected from adjustments that would invalidate the measurement results, and

ü  Be protected from damage or deterioration during storage, handling, and maintenance.

ü  When a calibrated item is found to be ‘out-of-tolerance’ during a calibration, the organization must take appropriate actions regarding the equipment, and any product that might have been affected.

ü  RECORDS of calibrations are required!  (Should include results and actions as a minimum.)

ü  When computer software provides for specified monitoring and measurement requirements, the ability for the system and software to satisfy the intended application must be verified before initial use and reconfirmed as necessary.

·         Boilerplate/sample instruction for the internal calibration of calipers.  Relates back to the overall Calibration Procedure, and provides detailed instructions for performing internal calibrations, for a specific tool/device/equipment type or family.  The boilerplate/sample template is organized into 4 sections:

ü  Generic In-House Calibration Strategy, Methods, & Guidelines for this Equipment Type

ü  Pre-Calibration Checks

ü  Calibration Process

ü  Recordkeeping

·         Boilerplate/sample instruction for the internal calibration of OD micrometers.  (Same as above, but for Outside Dimension Micrometer tool type/family.)

·         Boilerplate/sample internal calibration instruction template.  (Same 4 section strategy as above.  Open template to create calibration instruction for additional tool types.)

Database Features:

·         Unlimited number of tools can be entered.

·         Define tools by tool types - calipers, micrometers, pin gauges, multimeters, etc. Each tool type can have a calibration work instruction created and linked to each tool type. Identify tool purchase dates, calibration status, calibration cycle, tool parameters, tolerances, calibration strategy - regularly calibrated, calibrated before use, reference only. Link picture of tool.

·         Quickly view and search for tools by tool type, asset number, model no, calibration strategy, facility, work center, and/or departments.

·         Manage internal or external calibration records.

·         Create and define calibration measurement requirements for each tool designated to be calibrated internally. Define all measurements to be taken, the calibration standard used for each and the acceptable tolerance. Each out-of-tolerance measurement creates a incident record. PER ISO 9001 requirements, an assessment must be completed regarding any product that may have used the out-of-tolerance tool. Closure of out-of-tolerance measurements is required before tool is returned to service.

·         Quickly view and search tools calibration history, calibration certificates, calibration results and failure reports.

·         Automatic email notifications for expired tools, tools needing calibration in 30 and 60 days.

·         Visible Alerts for expired tools, tools in calibraiton process.