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08 Procedure For Design and Development Preview en

This document outlines an organization's procedure for product design and development. It includes a purpose and scope, references ISO 9001:2015 requirements, and describes a multi-step process involving preliminary design, planning, inputs, project review, execution, controls, outputs, and changes. The procedure aims to define the design control process used during all development projects to help ensure requirements are met.

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Hadj Ali Boumediene
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197 views4 pages

08 Procedure For Design and Development Preview en

This document outlines an organization's procedure for product design and development. It includes a purpose and scope, references ISO 9001:2015 requirements, and describes a multi-step process involving preliminary design, planning, inputs, project review, execution, controls, outputs, and changes. The procedure aims to define the design control process used during all development projects to help ensure requirements are met.

Uploaded by

Hadj Ali Boumediene
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 4

** FREE PREVIEW VERSION **

[Organization logo]

[Organization name]

PROCEDURE FOR DESIGN AND DEVELOPMENT

Code:

Version: 0.1

Created by:

Approved by:

Date of version:

Signature:

Distribution list
Copy Returned
Distributed to Date Signature
No. Date Signature

©2015 This template may be used by clients of EPPS Services Ltd. www.advisera.com in accordance with the License
[organization name]

Change history
Date Version Created by Description of change

0.1 9001Academy Basic document outline

Table of contents
1. PURPOSE, SCOPE AND USERS................................................................................................................. 3

2. REFERENCE DOCUMENTS....................................................................................................................... 3

3. DESIGN AND DEVELOPMENT PROCESS................................................................................................... 4

3.1. PROCESS FLOW..........................................................................................................................................4


3.2. FORMING PRELIMINARY DESIGN...................................................................................................................4
3.3. DESIGN AND DEVELOPMENT PLANNING..........................................................................................................5
3.3.1. Planning design and development stages and activities...............................................................5
3.3.2. Authorities and responsibilities in design and development.........................................................5
3.4. DESIGN AND DEVELOPMENT INPUTS..............................................................................................................5
3.4.1. Functional and performance requirements..................................................................................5
3.4.2. Statuary, regulatory and other requirements...............................................................................6
3.4.3. Information gathered from previous similar projects...................................................................6
3.4.4. Other requirements important for design and development........................................................6
3.5. DEVELOPING THE PROJECT PLAN AND REVIEW................................................................................................6
3.6. DESIGN AND DEVELOPMENT EXECUTION.........................................................................................................7
3.7. DESIGN AND DEVELOPMENT CONTROLS..........................................................................................................7
3.7.1. Verification of design and development process..........................................................................7
3.7.2. Validation of design and development process............................................................................7
3.8. DESIGN AND DEVELOPMENT OUTPUTS............................................................................................................8
3.9. RELEASE IN PRODUCTION/MARKET................................................................................................................8
3.10. DESIGN AND DEVELOPMENT CHANGES...........................................................................................................8
3.11. PROJECT REVIEW.......................................................................................................................................8

4. MANAGING RECORDS KEPT ON THE BASIS OF THIS DOCUMENT.............................................................9

5. APPENDICES.......................................................................................................................................... 9

Procedure for Design and Development ver. [version] from [date] Page 2 of 4

©2015 This template may be used by clients of EPPS Services Ltd. www.advisera.com in accordance with the License
[organization name]

1. Purpose, scope and users


The purpose of this procedure is to define the design control process used by [organization name]
during the design and development of its products.

This procedure applies to all product development, product modifications, line extensions, product
change projects and customer projects.

Users of this document are members of the design and development team of [organization name].

2. Reference documents
 ISO 9001:2015 standard, clause 8.3
 [other legal and contractual requirements]

Procedure for Design and Development ver. [version] from [date] Page 3 of 4

©2015 This template may be used by clients of EPPS Services Ltd. www.advisera.com in accordance with the License
[organization name]

3. Design and development process


3.1. Process flow

** END OF FREE PREVIEW **

To download full version of this document click here:


http://advisera.com/9001academy/documentation/procedure-design-development/

Procedure for Design and Development ver. [version] from [date] Page 4 of 4

©2015 This template may be used by clients of EPPS Services Ltd. www.advisera.com in accordance with the License

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