ISO 13485 quality management system (QMS) templates for Biosensor and In-vitro Diagnostics Development Companies

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

250,00 €
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TPL-2020-0006 Risk Analysis 0.2

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

250,00 €
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TPL-2020-0002 Basic SOP Template 1.0

The Basic SOP Template is a QMS Template for which can be used to generate standard operating procedures.

250,00 €
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TPL-2020-0005 SW Requirements Specification Template 0.3

The Software requirements specification template is intended for describing the software requirements as part of a biosensing/IVD technology

250,00 €
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TPL-2020-0245 Supplier Quality Agreement Template 1.0

Supplier Quality Agreement Template

250,00 €
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TPL-2020-0008 Document Plan 1.0

The Document Plan a is a document that describes the documents  associated with a product.

250,00 €
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TPL-2020-0009 Design Review Record Template 1.0

Design Review Record Template

250,00 €
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TPL-2020-0010 Design Review Validation Plan#SW Tools#1.9

Software Validation Template

250,00 €
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TPL-2020-0013 Supplier Questionnaire Template 1.0

A questionnaire for evaluating suppliers

250,00 €
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TPL-2020-0014 Supplier Evaluation Template 1.0

A template for evaluating suppliers

250,00 €
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TPL-2020-0015 Internal Audit Program 1.0

Am internal audit template

250,00 €
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TPL-2020-0019 Role Description

A template for describing a role 

250,00 €
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TPL-2020-0022 Document Approval Template 1.0

This document lists the records and templates approved for publishing according to the Documents & Records Control SOP.

250,00 €
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TPL-2020-0030 CAPA Report 1.0

A template for documenting a Corrective Action Preventative Action (CAPA).

250,00 €
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TPL-2020-0031 Purchase Order 1.0

This is a Purchase Order (PO) template

250,00 €
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TPL-2020-0032 Change Request Template 1.0

A change request template

250,00 €
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TPL-2020-0036 - NC

This is a Non-conformance report template

250,00 €
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TPL-2020-0037 - Basic Work Instructions Template

A work instructions template.

250,00 €
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TPL-2020-0071 Training Record 1.0

A training record template

250,00 €
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TPL-2020-0072 - List of participants 1.0

A list of participants template.

250,00 €
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TPL-2020-0085 IQC report 2.0

A template for Incoming Quality Control 

250,00 €
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TPL-2020-0088 - RMA Request Template

A return mechandise authorization request template

250,00 €
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TPL-2020-0090 Management Review 1.0

A template for Management Review

250,00 €
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TPL-2020-0094 - RMA Processs Validation Plan #Process or Item# 1.0

A template for validating a process or item

250,00 €
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TPL-2020-0095 IQ #Process or item# 1.0

A template for Installation Qualification of a process or item

250,00 €
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TPL-2020-0096 OQ #Process or item# 1.0

A template for Operational Qualification of a process or item

250,00 €
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TPL-2020-0097 PQ #Process or item# 1.0

A template for Performance Qualification of a process or item

250,00 €
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TPL-2020-0098 Process Validation Report #Process or item# 1.0

A template for Process Validation

250,00 €
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TPL-2020-0099 Periodic Review Report #Process or item# 1.0

A template for the Periodic Review of a process or item

250,00 €
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TPL-2020-0100 Process Requirements Sepecification #Process or item# 1.0

A template for Requirements Specification

250,00 €
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TPL-2020-0099 Periodic Review Report #Process or item# 1.0

A template for the Periodic Review of a process or item

250,00 €
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TPL-2020-0100 Process Requirements Specification #Process or item# 1.0

A template for Requirements Specification

250,00 €
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TPL-2020-0160 Framework Agreements

A template for Framework agreement.

250,00 €
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TPL-2020-0169 Project Development Plan 1.0

A template for the Project Development Plan

250,00 €
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  • Available

TPL-2020-0245 Supplier Quality Agreement 1.0

A template for the Supplier Quality Agreement 1.0

250,00 €
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  • Available
TPL-2020-0364 Technical Report Template

A template for Technical Reports

250,00 €
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  • Available

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