This form takes a design from input review to validation, recording the requirements, the go or no go decision, the project plan and each approval along the way.

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This form template is supplied in fully editable MS Word format and can be easily customised and edited. The document uses pre-defined style formatting throughout, with all text in Calibri font for improved readability.
The following document labelling is included in the footer:

• Form number and title
• Information-classification
• Version
• Page number / total pages

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Further Reading

Further guidance on design and development control:

• ISO 9001 Clause 8.3 - Design and Development
• ISO 9001 Clause 6.3 - Planning of Changes
• The Process Approach
• Management Systems knowledge base

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To get access to this file please click on Add to Cart to purchase for immediate download. If you have an alphaZ Subscription just click on Download Files to view all the files available to download. This form is also included in the ISO 9001 Toolkit and every alphaZ ISO toolkit that covers design and development, so the toolkit route gives you this file plus everything else you need in one download.

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Design Review and Planning Form Template

The Design Review and Planning Form records a design or development project from first review to validation. Part 1 - Design Input Review records the design number, title and objective, the functionality and performance requirements, and an assessment of each design input criterion, ending in a decision on whether to proceed. Part 2 - Project Planning, Design Controls and Output Review plans the project and records problems and design changes, design outputs, verification and validation, each with an approval and date.

It supports ISO 9001 clause 8.3 on design and development of products and services, covering planning, inputs, controls, outputs and changes.

Built for Controlled Design and Development

The form keeps the design record in one place, from the first review to final validation.

• Reviews design inputs, including previous similar designs, statutory and regulatory requirements and standards, and the potential consequences of product failure.
• Plans the resources a design needs - materials, equipment, manpower and competence, external providers, timescale and costs.
• Records a clear decision on whether to proceed before project work starts.
• Tracks phases, activities, deliverables and responsibilities, with research and development time allocated.
• Captures problems and design changes, output acceptance criteria, verification against inputs and validation through testing or prototypes, each with approval.

What's Included in this Design Review and Planning Form

The sections below are taken from the form.

• Design Details - design number, date, design lead, design title and project objective.
• Functionality and Performance Requirements - a brief description of what the design must do.
• Design Input Criteria, Planning and Assessment - previous similar designs, statutory and regulatory requirements and standards, necessary design stages, potential consequences of failure, material, equipment and manpower or competency requirements, externally provided processes, products and services, and timescale and costs, each with comments and approval.
• To Proceed - a yes or no decision on going ahead.
• Project Details - date assigned, project start date, date required, project lead and a brief description of project requirements.
• Drawing, Record and Resource Requirements - what the project needs to produce, keep and use.
• Phases / Activities / Deliverables / Responsibility - the project plan, with research and development time allocation, reviewed by and date completed.
• Problems / Actions / Design Changes - issues and changes raised during the project, with approval.
• Design Outputs - monitoring and measuring requirements and acceptance criteria, with approval.
• Verification - confirmation that the design meets the input requirements, with approval.
• Validation - testing, prototype or proof of concept, with approval.

Who Needs a Design Review and Planning Form?

Any business that designs or develops its own products or services and includes design in its ISO 9001 scope. Design leads, engineers, project managers and technical managers in small and medium businesses use it at the start of each design project and keep it as the project record through to validation.

Included in the ISO 9001 Toolkit

This form is part of the ISO 9001 Toolkit - the forms, registers, procedures and guidance for running a management system in one download - and is included in every alphaZ ISO toolkit that covers quality management.

Pairs with the Design Change Request

Changes that come out of a review are controlled on the F-Q13 Design Change Request, so the two forms cover a design from first plan to controlled change.