DOXPUB 11-0033-SOP

Summary:

Defines the requirements necessary to develop and maintain a quality system used for calibration to assure that applicable measuring and test equipment is calibrated and maintained within specified accuracy limits. Intended to assure the suitability for use of test and measurement equipment used to determine the acceptability of a material, product, test or process and the suitability of the environment in which samples are produced, tested or stored. Covers the calibration and tracking of automatic, mechanical and electronic equipment used in development, production, environmental control, and testing of products. Applicable to, but not limited to, R&D, Manufacturing, Facilities, Product Engineering, and QA/QC.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

Examples of Calibration Labels, New Instrument Calibration Request Form, Examples of Discontinued Calibration Labels

About This Document:

This is not a generic template, it's a 19-page procedure that was actually created and used in the Facilities & Equipment operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.

Reasons to Buy:

• Use it as a starting point for your own documentation project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Manufacturing Personnel
• Facilities Managers
• Laboratory Personnel