ISO9001 System Document Package (15) | Design and Development Control Procedure (8.3)

Document Description

This procedure corresponds to clause 8.3 "Design and development of products and services" of ISO 9001:2015, and is one of the core procedures in the "Product realization" process (COP) of the quality management system. It covers the entire lifecycle from design planning, design input, design output, design review, verification, validation, to design changes. Its purpose is to ensure that the company's new product development and existing product improvement activities are under control, making design inputs complete, clear, and conflict-free, design outputs meet input requirements, and design changes are reviewed and approved to avoid uncontrolled phenomena such as "designing while producing" and "drawings flying around, versions mismatching." This procedure applies to all manufacturing enterprises with independent design and development functions, especially those in industries such as equipment manufacturing, electronics, hardware and plastics, and packaging and printing, which involve custom design according to customer requirements, multi-variety small-batch development, and prototype production. Enterprises that process solely according to customer drawings or perform pure incoming inspection can apply this procedure in a simplified manner.

1. Purpose

To standardize the management of the entire design and development process of the company's products, ensuring:

1. Design and development activities are planned, phased, and clearly assigned;
2. Design inputs are fully, completely, and clearly defined, and are reviewed and confirmed to be free of contradictions;
3. Design outputs meet input requirements and provide sufficient basis for procurement, production, and inspection;
4. Design defects are identified and eliminated in a timely manner through design reviews, verifications, and validations, reducing development risks;
5. Design changes are controlled, and change information is accurately communicated to relevant departments to prevent the use of invalid design documents.

2. Scope of Application

This procedure applies to the design and development of all new products and the improvement design of existing products, including but not limited to:

1. Conceptual and detailed design of new products;
2. Custom design of products (structural, performance, and appearance design according to customer requirements);
3. Major improvements to existing products (changes in materials, structure, processes, and performance parameters);
4. Prototype production, trial production verification, and final release of design outputs;
5. Review, verification, validation, and control of design changes during the design and development process.

It does not apply to scenarios where products are manufactured solely based on customer-provided drawings or samples (such scenarios should follow the "Control of processes for products and services provided to customers" procedure and the "Control of production and service provision" procedure).

3. Responsibilities

4. Work Procedures

4.1 Design and Development Planning

1. The Sales Department or the General Manager proposes design and development requirements based on market demand, customer requirements, or company development plans, and fills out the "Design and Development Task Book," specifying the development purpose, product function and performance requirements, target cost, and completion timeline.
2. The Technical Department Manager organizes the preparation of the "Design and Development Planning Book," which includes: a) Division of design and development stages (conceptual design, detailed design, prototype production, small batch trials, final release, etc.); b) Arrangements for input, output, review, verification, and validation activities at each stage; c) Division of responsibilities, progress milestones, and interface relationships at each stage (information transmission methods between the Technical Department and Quality, Production, and Purchasing); d) Required resources (personnel, equipment, funds, external technical support).
3. Design and development stages and progress can be adjusted as development progresses, and any adjustments must be approved by the Technical Department Manager and the planning book updated accordingly.

4.2 Design and Development Input

1. Before conceptual design, the Technical Department should determine the design inputs and form the "Design and Development Input List." The inputs should include: a) Functional and performance requirements (including explicit and implicit customer requirements); b) Applicable legal and regulatory requirements and industry standards (such as mandatory safety, environmental, and energy efficiency requirements); c) Lessons learned from previous similar designs and mature technologies that can be referenced; d) Constraints and target costs for raw materials and purchased parts; e) Analysis of potential failure consequences (using FMEA if necessary).
2. The Technical Department Manager organizes a review of the design inputs to confirm their sufficiency, suitability, and completeness, ensuring that the input requirements are complete, clear, and free of contradictions. The review results are recorded in the "Design Input Review Record."
3. Incomplete, ambiguous, or contradictory requirements should be clarified or resolved during the input review, and necessary communication with the customer should be conducted for confirmation.

4.3 Design and Development Output

1. Design outputs should be documented (drawings, BOM, technical specifications, process documents, inspection standards, etc.) and approved before distribution.
2. Design outputs should meet the following requirements: a) Meet the design input requirements; b) Provide sufficient information for procurement, production, and service (such as material lists, processing procedures, inspection standards); c) Include or reference product acceptance criteria (such as inspection items, tolerances, test methods); d) Specify characteristics critical to the normal use and safety of the product (such as key dimensions, safety parameters).
3. Before the release of design output documents, they must be prepared, proofread, reviewed, and approved (small enterprises can simplify to preparation, review, and approval). These documents should be included in the document control scope and managed according to the "Document Control Procedure."

4.4 Design and Development Review

1. Systematic design reviews should be conducted at appropriate stages of the design process (usually after the completion of conceptual design, detailed design, before prototype production, and before trial production).
2. The review is chaired by the Technical Department Manager, and participants include design personnel and representatives from Quality, Production, Purchasing, Sales, and other relevant departments. Customers or external experts may be invited to participate if necessary.
3. Review content: a) Whether the design meets the input requirements; b) Feasibility, economy, manufacturability, and testability of the design solution; c) Risk identification and response measures (technical risks, schedule risks, cost risks); d) Coordination with related processes (whether procurement, production, and inspection capabilities are aligned).
4. The review results and subsequent actions are recorded in the "Design and Development Review Record." Issues raised during the review should have clear responsible persons, measures, and completion timelines, and should be tracked to closure.

4.5 Design and Development Verification

1. To ensure that the design output meets the design input requirements, design verification should be conducted. Verification methods include but are not limited to: a) Prototype testing and trials (dimensional, performance, durability, environmental tests, etc.); b) Design calculations and simulation analysis comparisons; c) Comparisons with verified similar designs; d) Reviews of trial-produced prototypes.
2. Verification activities are implemented by the Quality Department or the Technical Department according to the prototype inspection and test plan, and the results are recorded in the "Design and Development Verification Report." If the verification is nonconforming, the design personnel should analyze the cause, modify the design, and re-verify until it is qualified.

4.6 Design and Development Validation

1. Design validation should be completed before product delivery or mass production, confirming that the designed product meets the specified usage requirements or intended purpose.
2. Validation methods: a) Inviting customers to trial use, trial installation, or on-site confirmation; b) Finished product inspection and customer usage simulation tests after small batch trials; c) Customer sample approval.
3. The validation results and subsequent actions are recorded in the "Design and Development Validation Report." Issues discovered during validation should be addressed according to section 4.7, and the design should be re-validated.

4.7 Design and Development Changes

1. Design changes include: changes due to customer requirement changes, correction of design defects, process improvements, material substitutions, and standard updates.
2. The department proposing the change fills out the "Design and Development Change Request Form," explaining the reason, content, and scope of the change, which is then reviewed and approved by the Technical Department.
3. The change review should evaluate the impact of the change on product components, delivered products, procurement, production, and inspection activities. If necessary, partial or complete verification and validation of the changed design should be conducted.
4. After the change is implemented, relevant design documents (drawings, BOM, process documents, etc.) should be updated promptly, version control should be maintained, and old versions should be recalled according to the "Document Control Procedure" to ensure that all on-site documents are valid.
5. Design changes involving customer requirements must be confirmed in writing by the customer before implementation.

4.8 Process (Textual Flowchart)

Design Requirement Proposal → Design Task Book Approval → Design Planning (Stages/Progress/Responsibilities) → Design Input Determination and Review
→ Conceptual Design → Design Review (First) → Detailed Design → Design Output (Drawings/BOM/Specifications) Approval
→ Prototype Production → Design Verification (Prototype Inspection/Testing) → Design Review (Second)
→ Small Batch Trial Production → Design Validation (Customer Confirmation/Usage Validation) → Design Finalization and Release → Mass Production
→ Design Change (Request → Review → Approval → Implementation → Document Update → Verification) → Document Archiving

4.9 Form References at Each Stage

5. Related Records

6. Related Documents

1. Quality Manual
2. Document Control Procedure
3. Record Control Procedure
4. Control of Processes for Products and Services Provided to Customers
5. Control of Procurement and External Provision
6. Control of Production and Service Provision
7. Control of Monitoring and Measuring Resources
8. Risk and Opportunity Management Procedure
9. Applicable national and industry standards and customer technical agreements

Usage Instructions

1. How to Modify According to Actual Enterprise Conditions

1. Organizational Structure Adaptation: For enterprises without an independent R&D department, design responsibilities can be assigned to the Technical Department or the Process Department, and the review group members can be adjusted accordingly. In small enterprises with multiple roles, ensure that "design, review, and approval" are performed by different individuals to avoid self-review.
2. Product Type Adaptation: Hardware manufacturing enterprises should focus on drawings, BOM, and prototype verification. Software or service enterprises can replace "prototype production" with "prototype or trial version development and testing" and "customer confirmation" with "trial operation or acceptance confirmation." Enterprises that process solely according to customer drawings can simplify this procedure and specify drawing management responsibilities in the contract.
3. Development Process Simplification: For small and simple products, reviews, verifications, and validations can be combined and completed in one go with a single record. For large and complex projects, strict stage control should be maintained, with clear release criteria for each stage.
4. Form Consolidation and Simplification: Small enterprises can merge the "Design Task Book" and the "Design Planning Book" into a single form. Review, verification, and validation records can be unified into a "Design and Development Review/Verification/Validation Record Form" with separate columns for each activity.
5. Relationship with External Design: When entrusting external organizations for design, the contract should clearly specify the responsibilities for design outputs, intellectual property, and review, verification, and validation activities, and the external design should be included in the scope of this procedure.

2. Audit Focus Points (Key Points for Certification Audits)

1. Consistency Between Planning and Actual Activities: Randomly check development projects to confirm that actual development activities align with the stages and review points specified in the planning book, avoiding "one set of plans, another set of actions."
2. Input Review Evidence: Whether the design input list has review records, and whether the input requirements are complete and free of contradictions (especially when both regulatory and customer requirements are present).
3. Differentiation Between Review, Verification, and Validation: Auditors often focus on verifying whether these three activities are genuinely conducted and documented, rather than just having a review sign-in sheet.
4. Closed-Loop for Changes: Whether design changes have application, review, and approval records, whether changed documents are updated, old versions are recalled, and whether on-site drawings are valid.
5. Sufficiency of Verification and Validation: Whether the prototype inspection items cover the key characteristics of the input requirements, and whether validation is completed before delivery or mass production.
6. Retention of Documented Information: Whether records of the entire design and development process are retained as specified, and whether the storage period meets the requirements.

3. Common Errors

1. Not reviewing design inputs, leading to incomplete or contradictory requirements being discovered midway through development, causing repeated rework.
2. Conducting superficial reviews where participants only sign without providing opinions, leaving issues to be exposed during mass production.
3. Confusing verification and validation—verification is about "whether it is done correctly" (against input requirements), and validation is about "whether it is usable" (against usage requirements). The two cannot be substituted for each other.
4. Only modifying drawings without updating the BOM and process documents, leading to procurement and production still following old information.
5. Not re-verifying and re-validating after changes, introducing new defects.
6. Lack of version control for design output documents, resulting in the use of both new and old versions on-site.

Controlled throughout the design process, reviewed, verified, and validated, with changes tracked and documented.

Knowledge code: 2.3.1

Version: v20260809

Author: Quality Think Tank Quality Think Tank is dedicated to providing systematic professional knowledge, methodologies, and practical tools for quality management practitioners, helping enterprises continuously improve their quality capabilities.