COMPANY LOGO
& COMPANY NAME
Design & Development Procedure
Reference Number COMPANY CODE-Q1-PROC-008
Version 1.0
Version Date
Approval Responsibility Signature
Prepared By
Reviewed By
Approved By
Change Register
Version Issue Date Description of Change Changed By Approved By
01 First Issue
COMPANY LOGO
& COMPANY NAME
1. Purpose
To establish a systematic process for planning, controlling, and validating the design and
development of products and services, ensuring conformity to customer requirements and
applicable standards.
2. Scope
This procedure applies to all new product or service developments and any major modifications to
existing designs performed by COMPANY NAME that impact quality, functionality, safety, or
regulatory compliance.
3. Definitions
Design Input: Requirements and expectations for a product or service.
Design Output: Finalized drawings, specifications, and documents used for production.
Design Review: Formal assessment of the design process and deliverables.
Design Verification: Confirmation that design outputs meet input requirements.
Design Validation: Ensures the resulting product meets user needs in real or simulated
conditions.
4. Responsibilities
Role Responsibility
Design Engineer Lead design planning and development
Quality Manager Ensure process alignment with QMS and standards
Technical Manager Review and approve all technical deliverables
Project Manager Monitor timelines, resources, and coordination
Customer Rep. (if involved) Provide input or validation where applicable
5. Procedure
5.1 Design Planning
Identify design stages, responsibilities, required reviews, and resources.
Page 2 of 4
COMPANY LOGO
& COMPANY NAME
Create a Design Plan if applicable, including risk-based considerations.
5.2 Design Inputs
Collected from contracts, customer specifications, statutory requirements, industry codes,
and previous designs.
Documented using the Design Input/Output Form (COMPANY CODE-Q1-FRM-003).
Inputs must be complete, unambiguous, and not conflicting.
5.3 Design Outputs
Must meet input requirements and be suitable for production or implementation.
Output includes drawings, technical specs, BOM, and acceptance criteria.
Linked to records such as the Product Realization Plan and ITP.
5.4 Design Review
Conducted at key milestones and documented using the Design Review Minutes Template
(COMPANY CODE-Q1-TMP-003).
Reviews must involve relevant functions (design, QA, production, customer if required).
5.5 Design Verification
Performed through calculation checks, simulations, or peer reviews.
Objective evidence retained.
5.6 Design Validation
Conducted under actual or simulated operating conditions.
Must confirm the product fulfills intended use.
5.7 Design Changes
All changes must be documented using the Design Change Control Form (COMPANY CODE-
Q1-FRM-004).
Changes reviewed and approved before implementation, and impacts assessed.
6. Records & Evidence
Design records must be maintained for each development project and include:
Design Input/Output Forms
Page 3 of 4
COMPANY LOGO
& COMPANY NAME
Review Minutes
Verification & Validation Results
Design Change Logs
7. Related Documents
Title Document ID
Design Input/Output Form COMPANY CODE-Q1-FRM-003
Design Review Minutes Template COMPANY CODE-Q1-TMP-003
Design Change Control Form COMPANY CODE-Q1-FRM-004
Risk Management Procedure COMPANY CODE-Q1-PROC-004
Page 4 of 4
