ISO 13485 quality management system (QMS) templates

At ZP we have an ISO 13485 Quality Management System (QMS) highly tuned to the development and manufacturing of electrochemical biosensors and in-vitro diagnostics. Therefore all the templates on this page are tuned towards these types of products.

 

Note a download link to the document will be provided shortly after payment is received.  Please note ZP can provide a consulting service to clients who wish to discuss the filling out of these documents after purchase.

TPL-2020-0004 Systems Requirement Specification Template 0.3

The System Requirements Specification Template is a document that described the product requirements

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TPL-2020-0006 Risk Analysis 0.2

The Risk Analysis is is a document that describes the risks associated with a product and helps evaluate those risks.

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