DOXPUB 09-0010-SOP PDF

Summary:

Describes the procedure for evaluating existing and potential suppliers of goods or services, as well as reviewing supplier capability through product or service evaluation and/or quality systems auditing. Also includes procedures for determining an initial supplier status as qualified, approved, approved with conditions or disapproved. Applicable to suppliers of purchased products and services whose performance could impact the performance, safety or efficacy of a inventory controlled product.

Included Sections:

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

Included Attachments/Appendices:

None

About This Document:

This is not a generic template, it's a 6-page procedure that was actually created and used in the Quality Assurance 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:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel